Patent Publication Number: US-2020276088-A1

Title: Devices, system and method to control the delivery of oral medications to ensure they are efficacious, taken as prescribed, and to avoid unwanted side effects

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 15/751,371 filed on Feb. 8, 2018, which is a national stage entry of International Application No. PCT/US2016/046491, filed on Aug. 11, 2016, which claims benefit of U.S. Provisional Patent Application No. 62/203,638 filed on Aug. 11, 2015 and U.S. Provisional Patent Application No. 62/252,966 filed on Nov. 9, 2015; which are incorporated herein by reference in their entirety to the full extent permitted by law. 
    
    
     FIELD OF THE INVENTION 
     The present disclosure relates to a novel system to improve medication safety and effectiveness via the utilization of drug specific algorithms to control drug dispensing, avoid drug mediated adverse events, ensure prescription compliance and promote prescription persistence on a cost-effective real-time basis. 
     BACKGROUND OF THE INVENTION 
     Avoiding unnecessary medical complications or death by ensuring a drug is efficacious for the patient and that the patient is compliant and persistent with their prescription(s) represents a major unmet need and a trillion-dollar global market opportunity—this is larger than the global pharmaceutical industry. As an example, according to Express Scripts, the largest pharmacy benefit manager in the United States, only 25 to 30 percent of medications are taken per the prescriber&#39;s instructions (adherence) . . . and of those taken, only 15 to 20 percent are refilled per the prescriber&#39;s instructions (persistence). This lack of adherence and persistence is estimated to result in excess of $300 billion being wasted annually for the treatment of unnecessary medical complications in the United States. 
     Drug-related hospitalizations account for 2.4 to 6.5 percent of all medical admissions in the general population. A meta-analysis found a fourfold increase in the rate of hospitalization related to adverse drug events (ADE) in older adults compared with younger adults (16.6 versus 4.1 percent). A number of factors in older individuals contribute to their increased risk for developing a drug-related problem. These include frailty, coexisting medical problems, memory issues, polypharmacy, and the use of non-prescribed medications. Estimates indicate that 88 percent of the ADE hospitalizations among older adults were preventable, compared with 24 percent among young persons 
     Optimizing drug therapy is an essential part of medical care. The process of prescribing a medication is complex and includes (i) deciding that a drug is indicated, (ii) choosing the best drug, (iii) determining a dose and schedule appropriate for the patient&#39;s physiologic status, (iv) monitoring for effectiveness and toxicity, (v) educating the patient about expected side effects, and (vi) indications for seeking consultation. 
     Avoidable adverse drug events are the serious consequence of (i) inappropriate drug prescribing, (ii) changes in the patient&#39;s reaction to the drug over time due to lifestyle, other medications, other medical conditions, worsening medical condition, or changes in the patients overall well-being, etc., or (iii) addition of new prescription or OTC medications, vitamins, dietary supplements, herbal medicines (e.g., ginseng, ginkgo biloba extract, glucosamine, St. John&#39;s wort, echinacea, garlic, saw palmetto, kava, and valerian root), and/or recreational drugs, etc. Often, clinicians do not question patients about use of herbal medicines and patients do not routinely volunteer this information. Furthermore, most patients do not inform their clinician that they were using unconventional and/or recreational medications. A study of the use of 22 supplements in a survey of 369 patients aged 60 to 99 years found potential interactions between supplements and medications for ten of the 22 supplements surveyed. As a result, any new symptom should first be considered to be drug-related until proven otherwise. 
     Prescribing for older patients, who consume the most medications per capita, presents unique challenges. Premarketing drug trials often exclude geriatric patients and approved doses may not be appropriate for older adults. Many medications need to be used with special caution because of age-related changes in pharmacokinetics (i.e., absorption, distribution, metabolism, and excretion) and pharmacodynamics (the physiologic effects of the drug). 
     Larger drug storage reservoirs and decreased clearance prolong drug half-lives and lead to increased plasma drug concentrations in older people. Particular care must be taken in determining drug dosages. The proportional increase in body fat relative to skeletal muscle that generally accompanies aging may result in the increased volume of drug distribution. Decreased drug clearance may also result from the natural decline in renal function with age, even in the absence of renal disease. 
     The same dose could lead to higher plasma concentrations in an older, compared to younger, patient. For example, the volume of distribution for diazepam is increased, and the clearance rate for lithium is reduced, in older adults. From the pharmacodynamic perspective, increasing age may result in an increased sensitivity to the effects of certain drugs, e.g., benzodiazepines and opioids. 
     The use of greater numbers of drug therapies has been independently associated with an increased risk for an adverse drug event, irrespective of age, and increased risk of hospital admission. Polypharmacy is of particular concern in older people who, compared to younger individuals, tend to have more disease conditions for which therapies are prescribed. Approximately half of the patients taking drugs take two medications and 20 percent five or more. As an example, one study found that among ambulatory older adults with cancer, 84 percent were receiving five or more and 43 percent were receiving 10 or more medications. 
     The risk of an adverse event due to drug-drug interactions is substantially increased when multiple drugs are taken. For example, the risk of bleeding with warfarin therapy is increased with coadministration of selective and non-selective NSAIDs, SSRIs, omeprazole, lipid-lowering agents, amiodarone, and fluorouracil. A study found hospitalizations for hypoglycemia was six times more likely in patients who had received co-trimoxazole. Digoxin toxicity was 12 times more likely for patients who had been started on clarithromycin. Hyperkalemia was 20 times more likely for patients who were treated with a potassium sparing diuretic. 
     Periodic evaluation of a patient&#39;s drug regimen is an essential component of medical care. However, a survey of Medicare beneficiaries found that more than 30 percent of patients reported they had not talked with their doctor about their different medications in the previous 12 months. Furthermore, when these reviews are done, they often overlook OTC, supplements, herbal medicines and recreational drugs that are being taken by the patient. 
     Multiple factors contribute to the appropriateness and overall quality of drug prescribing. These include avoidance of inappropriate medications, appropriate use of indicated medications, monitoring for side effects and drug levels, avoidance of drug-drug interactions, and involvement of the patient and integration of patient values. Current measures of the quality of prescribing generally focus on one or some of these factors, but rarely on all. 
     BRIEF SUMMARY OF THE INVENTION 
     The present invention describes novel methods and drug dispensing devices, drug specific Apps, drug specific dispensing algorithms, and an integrated support center to ensure any oral medication taken by a patient is efficacious; is only dispensed as prescribed by the healthcare professional (e.g., physician, physician&#39;s assistant, nurse practitioner, pharmacist, etc.); is not dispensed if (i) the patient is trying to take the medication sooner than the prescribed interval, (ii) the algorithm deduces that taking the drug may result in an adverse event, even if it could be dispensed within the prescription&#39;s guidelines (iii) the drug is past its expiration date, (iv) the drug was not stored properly, e.g., within the right temperature and/or humidity guidelines, and/or (v) the drug batch has been recalled, etc.; and encourages the patient to continue taking the medication as prescribed. In this way, by increasing the drug&#39;s efficacy/safety profile, the dispensing system saves the healthcare system money by decreasing the number of interventions, physician&#39;s office visits, and hospitalizations—reducing the total cost of care. 
     The drug specific dispensing algorithm uses encrypted communications to control the drug dispensing device and to communicate with the patient and the support center. The algorithm uses the prescription information, dispensing device information, drug cassette information, patient self-assessment and/or digitally captured physiological, psychological, lifestyle, medications currently being taken, and/or environmental data in a novel drug specific diagnostic algorithm to decide if the drug dispenser should dispense the drug or keep the tamper resistant dispensing unit locked. 
     The novel drug specific App, which can be operated from a standalone drug dispensing device, interface device (smart phone, tablet and/or computer, or standalone drug dispensing device, etc. with Internet communication capabilities), reads and aggregates; (i) the drug information from the drug cassette, (ii) the devices serial number, operating, environmental and dispensing information from the dispensing device, (iii) patient self-assessment data from input screens on the standalone dispenser, smart phone, tablet, and/or computer, etc., and (iv) digital data generated by wearable devices, consumed, implanted, or injected diagnostic devices, monitoring devices, machines, instruments, gadgets, contraptions, apparatuses, utensils, implements, tools, mechanisms, and informalgizmos, etc. 
     The drug dispensing device is designed to automatically recognize the drug based upon the drug specific disposable drug cassette docked into the device. The cassette is marked to allow the drug dispenser to ascertain the name of the drug (brand and/or generic), the drug&#39;s NDC number, the drug batch number, and drug&#39;s expiration date, etc. 
     The drug dispensing device is designed to be water proof, tamper resistant, withstand being dropped and/or banged, operate and withstand hot and cold temperatures within defined temperature ranges, to be reusable and rechargeable, to have the drug cassette only docked or removed by a healthcare professional, to remain locked from dispensing unless the dispensing device receives an encrypted signal from the authorized smart App, and to dispense the drug with one click. The device, when interfaced with the drug specific App, transmits its serial number via a secure handshake with the App, reads and transmits the drug information on the drug cassette, transmits the current and historic temperatures since the last dispense, and the date and time the drug is dispensed. The drug dispensing device can be configured to dispense one or more drugs and to be controlled by one or more dispensing Apps, one App for each drug. 
     The multi-drug dispensing units utilize multiple drug cassettes (one each per drug) which are controlled by a consolidation App that combines the individual drug Apps into a single user interface to eliminate duplication of inputs and to facilitate one click drug dispensing for one or more medications. The handshake between Apps is controlled by the biometric security system. 
     The single drug App, as well as the multi-drug App, require biometric sign on by the patient and utilize a drug specific decision tree algorithm to make dispensing decisions. An encrypted sign on alternative may also be provided. No messages or further communication with the patient are required if drug dispensing is within prescribing guidelines and no potential adverse events are detected by the algorithm. However, if the algorithm decides to keep the dispensing unit locked and not to dispense, even if within prescribing guidelines, then a number of alternative messages are shown on the interface device (standalone dispensing unit, smart phone, tablet, and/or computer, etc. with Internet communications capabilities). These range from telling the patient that the next dose is not authorized by the prescription for a specified period of time to a message indicating that a dose, even within the prescription dosing schedule parameters, should not be taken without first talking with the integrated support center (which serves as a disease management center for patients) or the prescribing healthcare professional. The App facilitates calling the support center using a single click on the alert window. 
     The App uses the biometric sign on and encrypted communications with the support center to let them know if, for example, (i) the patient may be heading for an undesired event, (ii) that the prescription should be changed, (iii) the drug may have to be changed based upon efficacy concerns, (iv) the patient tries early dispensing too many times (depends on the drug type, e.g., opioids), (iv) appears to be following an abuse pattern, etc., (v) is not following prescribing guidelines, and (vi) is failing to take the medication, etc. 
     The App allows the patient to ask certain questions regarding when they took their last medication (or medications for multidrug dispensers), how much medication is left, when their next dose is due, the medications expiration date, and the drugs package insert information, etc. It further provides access to personalized analytical charts, some which may be downloaded from the integrated support center&#39;s servers or created by the App from the limited information stored by the App, to show how the patient&#39;s symptoms are affected when the patient takes a drug dose. This is designed to aid in patient prescription persistence and assist in reinforcing the importance of prescription compliance. 
     The integrated support center IT system stores authorized log on information, all App history data and enables the continual update of the App history on all the patient&#39;s devices where the App has been downloaded. The centralized servers are also designed to: (i) update individual App software as required, (ii) exchange information with authorized electronic medical records, (iii) to, on a real time basis, update the call center&#39;s disease management patient specific counselor screens, (iv) conduct metadata analysis on both the patient&#39;s individual data as well as analysis that may include information from the patient&#39;s electronic medical record, (v) carry out comparative patient analysis against metadata across a patient population with similar characteristics, etc. The analytical output is designed to assist the call center&#39;s disease management group in its counseling of the individual patient as well as any reporting and contacts with the patient&#39;s prescribing medical professional. 
     The call center IT systems are designed to allow the call center, via the patient&#39;s drug specific App, (i) to change a patient&#39;s prescription based on an authorized prescriber&#39;s instructions, (ii) to lock and unlock the dispensing ability on the individual drug dispensing unit based upon a discussion with the patient and/or his care giver, and (iii) to lock all appropriate dispensing devices that contain a recalled drug and to instruct the patient via email and/or voice messages to go to their pharmacy to get the drug replaced or to follow the recalling manufacturer&#39;s instructions. 
     The call center&#39;s disease management team uses metadata analysis as well as drug registry information, as requested by the prescribing medical profession, to assist them in developing the best course of therapy based on specific queries of the integrated support center&#39;s databases and any authorized related electronic medical records. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Advantages of embodiments of the present invention will be apparent from the following detailed description of the exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which: 
         FIG. 1  is an exemplary embodiment of a closed loop system controlled by a Drug Specific Dispensing Algorithm. 
         FIG. 2  is an exemplary embodiment showing a Drug Specific App which controls the Drug Dispensing Unit. 
         FIG. 3  is an exemplary embodiment of a Biometric Authentication screen. 
         FIG. 4  is an exemplary embodiment of Patient Self-Assessment Screens. 
         FIG. 5  is an exemplary embodiment of digitally available patient related diagnostic and physiological information. 
         FIG. 6  is an exemplary embodiment of a flow chart/decision tree used by the Drug Dispensing Algorithm. 
         FIGS. 7A and 7B  are an exemplary embodiment of a flow chart of a standard prescription log in, Patient Self-Assessment and drug dispensing control. 
         FIGS. 8A-8D  are an exemplary embodiment of the flow chart of the respective screens utilized to capture clinical trial data and to control the drug dispensing. 
         FIG. 9  is an exemplary embodiment of a Drug Dispenser. 
         FIG. 10  is an exemplary embodiment of a Drug Cassette. 
         FIG. 11  is an exemplary embodiment of Patient Self-Assessment Reporting Screens. 
         FIG. 12  is an exemplary embodiment of the Consolidated Therapy App and various Multi-Drug Dispensing devices. 
         FIG. 13  is an exemplary embodiment of the Centralized IT System. 
         FIG. 14  is an exemplary embodiment of an Integrated Support Center. 
         FIG. 15  is an exemplary embodiment of the design for a single drug Drug Dispenser. 
         FIG. 16  is an exemplary embodiment of how the Drug Dispenser&#39;s clam shell design is assembled for secure closing and opening. 
         FIG. 17  is an exemplary embodiment of the electronic schematic for the Drug Dispenser. 
         FIG. 18  is an exemplary embodiment of the placement of electronics and mechanical components on the outside and within the Drug Dispenser. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     I. Terms and Acronyms 
     Terms used in this document, AKA denotes terms used interchangeably: 
     Adverse Event (AKA: AE, Adverse Event, Adverse Experience, Adverse Drug Reaction, ADR, or Unexpected Adverse Drug Reaction) refers to (i) a medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related, (ii) any response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function, (iii) an unexpected reaction not consistent with applicable product information or characteristics of the drug, and (iv) the unintended effect occurring at normal dose related to the pharmacological properties of a medication, etc. 
     Biometric Authentication (AKA biometric identification and biometric authentication.) The definition encompasses but is not limited to biometric technologies that digitally capture fingerprint, palm and full-hand scanners, voice, facial recognition systems, iris scanning technology, document readers, biometric software, and related services capable of wireless, mobile or stationary use to limit access to the Patient. In this document the term also incorporates any system, while not biometric, that allows access via the use of a Login Name in combination with a Password and/or any additional security information. 
     Consolidation App (AKA multiunit dispenser App) is an App designed to recognize other Drug Specific Apps resident on an Interface Device and then to consolidate the requisite Patient Self-Assessment screens into a single interface for the control and dispensing of multiple drugs. 
     Digitally Captured refers to Patient data captured by diagnostic or monitoring devices and stored in a machine readable format. 
     Dispensing Device refers to the Drug Dispensing Unit with a Docked Drug Cassette whose dispensing is controlled by a Drug Specific App. 
     Dispensing System is comprised of the Dispensing Device and the Integrated Support Center. 
     Docked refers to the Drug Cassette residing in the Drug Dispensing Unit. 
     Drug (AKA pharmaceutical, medication, medicament, OTC drug, supplement, or herbal remedy, etc.) 
     Drug Cassette is the disposable unit that contains a Drug to be dispensed over a defined period of time and/or days per the prescription instructions. 
     Drug Dispensing Unit is the device where the Drug Cassette is Docked and whose dispensing mechanism (lock, unlock, and dispensing) are controlled by a Drug Specific App. 
     Drug Specific App refers to an app that requires Biometric Authentication prior to a Patient being able to respond to Patient Self-Assessment screens which are used by the App&#39;s Drug Specific Dispensing Algorithm to decide whether or not to signal the Dispensing Device to dispense the medication or to indicate to the patient and/or Integrated Support Center why the drug will not be dispensed. 
     Drug Specific Dispensing Algorithm refers to the decision tree based algorithm specifically develop for each drug to ascertain if the drug should or should not be dispensed. 
     Electronic Medical Record (AKA EMR, Patient Medical Record, PMR, etc.) 
     Encryption (AKA Encrypted, Encrypted communications) is the most effective way to achieve data security. Access requires a secret key or password that enables decryption. Unencrypted data is called plain text; encrypted data is referred to as cipher text. 
     Expiration Date refers to the date after which a medication should not be taken. 
     Handshake (AKA Digital Handshake) refers to an exchange of signals between devices ensuring synchronization whenever a connection, as with another device, is initially established. 
     Integrated Support Center refers to a call center designed to provide patient support, disease management services and/or Dispensing Device support for patients, Prescribers, and/or payers. 
     Interface Device refers to the device (standalone drug delivery device, smart phone, tablet, computer, etc. with Internet communications capabilities) where the Drug Specific App resides. 
     Locked indicates the drug cannot be dispensed by the Dispensing Device until the Drug Specific App unlocks the Dispensing Device. 
     Metadata Analysis (AKA structural metadata and descriptive metadata) as used herein refers to the use of the organization of patient data to enable analysis of both individual and patient population data to ascertain how to best manage medication therapy on a drug by drug and patient by patient basis. 
     Patient refers to the individual that is prescribed and is taking a medication or medications. Examples include physicians, physician assistants, nurse practitioners, nurses, pharmacists, etc. 
     Patient Self-Assessment (AKA patient-reported outcome or PRO) covers a whole range of potential types of measurement self-reported by the patient. Each self-assessment scale or question measures a single underlying characteristic(s). 
     Prescriber is defined as any healthcare professional authorized by an individual country to write a prescription for a drug. 
     Recall refers to a drug recall issued by the manufacturer or a regulatory agency indicating that a particular drug batch or drug should not be taken. 
     Tamper Resistant refers to a design that makes it difficult to change, open, remove the cassette, or cause damage to the unit by anyone but authorized persons. 
     II. List of Drugs, Drug Mechanisms of Action, and Diseases that Invention in its Various Embodiments is Applicable to 
     The invention and its various embodiments can enable the personalization of drug therapy, improve each drugs safety profile, ensure the continued efficacy of a drug for each patient, improve the quality of care, improve the patients quality of life by ensuring proper prescribing and prescription compliance, by promoting prescription persistence, and thereby decreasing the number of drug related medical interventions, and disease related physician visits and hospitalizations thereby decreasing the total cost of patient care. This Invention in its various embodiments is applicable to and by reference incorporates the drugs, drug mechanisms of action, and diseases listed in Table 1-Table 8. 
     Table 1 lists oral drugs with REMS programs. The listed approved drugs are encompassed in the embodiment of the invention by reference can benefit from an improved drug safety profile. The Invention mitigates prescription risk for the drug manufacturer and prescriber as it shifts the responsibility to the patient. The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc.). In addition to Table 1, the embodiment incorporates by reference the Food and Drug Administration&#39;s (FDA) Approved Risk Evaluation and Mitigation Strategies (REMS) drugs listing. 
     
       
         
           
               
             
               
                 TABLE 1 
               
               
                   
               
               
                 Oral Drugs with Required REMS Programs 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
            
               
                   
                 Antipsychotic 
               
               
                   
                 Seroquel (Quetiapine) 
               
               
                   
                 Pain Relievers 
               
               
                   
                 Opioids 
               
               
                   
                 Codeine 
               
               
                   
                 Fentanyl and Analogs 
               
               
                   
                 (Causing Overdoses) 
               
               
                   
                 Hydrocodone 
               
               
                   
                 Hydromorphone 
               
               
                   
                 Methadone 
               
               
                   
                 Oxycodone 
               
               
                   
                 Oxymorphone 
               
               
                   
                 Sedatives (Barbiturates) 
               
               
                   
                 Amytal (amobarbital) 
               
               
                   
                 Nembutal (pentobarbital) 
               
               
                   
                 Seconal (secobarbital) 
               
               
                   
                 Stimulants (ADHD) 
               
               
                   
                 Adderall (Amphetamine) 
               
               
                   
                 Methylphenidate 
               
               
                   
                 Daytrana 
               
               
                   
                 Concerta 
               
               
                   
                 Ritalin 
               
               
                   
                 Tranquilizers 
               
               
                   
                 A. Benzodiazepines, Like 
               
               
                   
                 Klonopin (clonazepam) 
               
               
                   
                 Valium (diazepam) 
               
               
                   
                 Xanax (alprazolam) 
               
               
                   
                 B. Non-Benzodiazepines, Like 
               
               
                   
                 Ambien (zolpidem) 
               
               
                   
                 Lunesta (eszopiclone) 
               
               
                   
                 Sonata (zaleplon) 
               
               
                   
                 Others 
               
               
                   
                 Chantix 
               
               
                   
                 Revlimid 
               
               
                   
                 Tracler 
               
               
                   
                 Xeljans (Jak Compounds) 
               
               
                   
               
            
           
         
       
     
     Table 2 lists the Paragraph IV Challenged Drugs that can benefit from the increased patent protection afforded by the drug/device (Invention) combination. The following approved drugs and the FDA&#39;s Paragraph IV Drug Product Applications: Generic Drug Patent Challenge Notifications list are encompassed in the embodiment of the invention by reference. The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     
       
         
           
               
             
               
                 TABLE 2 
               
             
            
               
                   
               
               
                 Paragraph IV Challenged Drugs 
               
            
           
           
               
               
               
            
               
                   
                 BRAND 
                 GENERIC NAME 
               
               
                   
               
               
                   
                 Ampyra 
                 Dalfampridine 
               
               
                   
                 Daliresp 
                 Roflumilast 
               
               
                   
                 Angeliq 
                 Drospirenone and Estradiol 
               
               
                   
                 Nexavar 
                 Sorafenib Tosylate 
               
               
                   
                 Kuvan 
                 Sapropterin Dihydrochloride 
               
               
                   
                 Pradaxa 
                 Dabigatran Etexilate Mesylate 
               
               
                   
                 Tradjenta 
                 Linagliptin 
               
               
                   
                 Thalomid 
                 Thalidomide 
               
               
                   
                 Gabitril 
                 Tiagabine Hydrochloride 
               
               
                   
                 Zohydro ER 
                 Hydrocodone Bitartrate 
               
               
                   
                 Viibryd 
                 Vilazodone Hydrochloride 
               
               
                   
                 Abstral 
                 Fentanyl Citrate 
               
               
                   
                 Letairis 
                 Ambrisentan 
               
               
                   
                 Lamictal XR 
                 Lamotrigine 
               
               
                   
                 Zorvolex 
                 Diclofenac 
               
               
                   
                 Zytiga 
                 Abiraterone Acetate 
               
               
                   
                 Ella 
                 Ulipristal Acetate 
               
               
                   
                 Xartemis XR 
                 Oxycodone Hydrochloride and 
               
               
                   
                   
                 Acetaminophen 
               
               
                   
                 Doryx 
                 Doxycycline Hyclate 
               
               
                   
                 Noxafil 
                 Posaconazole 
               
               
                   
                 Tekturna HCT 
                 Aliskiren Hemifumarate and 
               
               
                   
                   
                 Hydrochlorothiazide 
               
               
                   
                 Promacta 
                 Eltrombopag Olamine 
               
               
                   
                 Gilenya 
                 Fingolimod 
               
               
                   
                 Afinitor 
                 Everolimus 
               
               
                   
                 Gleevec 
                 Imatinib Mesylate 
               
               
                   
                 Brisdelle 
                 Paroxetine 
               
               
                   
                 Tikosyn 
                 Dofetilide 
               
               
                   
                 Hysingla ER 
                 Hydrocodone Bitartrate 
               
               
                   
                 Suboxone 
                 Buprenorphine Hydrochloride and 
               
               
                   
                   
                 Naloxone Hydrochloride 
               
               
                   
                 Latuda 
                 Lurasidone Hydrochloride 
               
               
                   
                 Trokendi XR 
                 Topiramate 
               
               
                   
                 Contrave 
                 Naltrexone Hydrochloride and 
               
               
                   
                   
                 Bupropion Hydrochloride 
               
               
                   
                 Equetro 
                 Carbamazepine 
               
               
                   
                 Minastrin 24 Fe 
                 Norethindrone Acetate and Ethinyl 
               
               
                   
                   
                 Estradiol and Ferrous Fumarate 
               
               
                   
               
            
           
         
       
     
     Table 3: Marketed Drugs lists approved drugs which are encompassed in the embodiment of the invention by reference. Drug compounds of interest are also listed in: Goodman &amp; Gilman&#39;s, The Pharmacological Basis of Therapeutics (12th Ed) (Goodman et al. eds) (McGraw-Hill) (2011); and 2015 Physician&#39;s Desk Reference which are also encompassed in the embodiment of the invention by reference. The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     
       
         
           
               
             
               
                 TABLE 3 
               
               
                   
               
               
                 Marketed Drug 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
            
               
                 Abilify (aripiprazole) 
               
               
                 Abraxane (paclitaxel protein-bound particles for injectable suspension) 
               
               
                 ABREVA (docosanol) 
               
               
                 Abstral (fentanyl sublingual tablets) 
               
               
                 Abthrax (raxibacumab) 
               
               
                 Accolate 
               
               
                 Accretropin (somatropin rDNA Original) 
               
               
                 Aciphex (rabeprazole sodium) 
               
               
                 Actemra (ocilizumab) 
               
               
                 Actemra (tocilizumab) 
               
               
                 Actiq 
               
               
                 Activella (Estradiol/Norethindrone Acetate) Tablets 
               
               
                 Actonel 
               
               
                 ACTOplus met (pioglitazone hydrochloride and metformin hydrochloride) 
               
               
                 ACTOS 
               
               
                 Acular (ketorolac tromethamine ophthalmic solution) 0.5% 
               
               
                 Acuvail (ketorolac tromethamine) 
               
               
                 Acyclovir Capsules 
               
               
                 Adcetris (brentuximab vedotin) 
               
               
                 Adcirca (tadalafil) 
               
               
                 Adderall (mixed salts of a single-entity amphetamine) 
               
               
                 Adderall XR 
               
               
                 Addyi (flibanserin) 
               
               
                 Adempas (riociguat) 
               
               
                 Advicor (extended-release niacin/lovastatin) 
               
               
                 Afinitor (everolimus) 
               
               
                 Afrezza (insulin human) Inhalation Powder 
               
               
                 Agenerase (amprenavir) 
               
               
                 Aggrenox 
               
               
                 Agrylin (anagrelide HCL) 
               
               
                 AK-Con-A (naphazoline ophthalmic) 
               
               
                 Akten (lidocaine hydrochloride) 
               
               
                 Akynzeo (netupitant and palonosetron) 
               
               
                 Alamast 
               
               
                 Albenza (albendazole) 
               
               
                 Aldara (imiquimod) 
               
               
                 Aldurazyme (laronidase) 
               
               
                 Alesse (100 mcg levonorgestrel/20 mcg ethinyl estradiol tablets) 
               
               
                 Alimta (pemetrexed for injection) 
               
               
                 Alinia (nitazoxanide) 
               
               
                 Allegra (fexofenadine hydrochloride) 
               
               
                 Allegra-D 
               
               
                 Alora 
               
               
                 Aloxi (palonosetron) 
               
               
                 Alphagan (brimonidine) 
               
               
                 AlphaNine SD Coagulation Factor IX (Human) 
               
               
                 Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] 
               
               
                 Alrex 
               
               
                 Altabax (retapamulin) 
               
               
                 Altocor (lovastatin) Extended-Release Tablets 
               
               
                 Alvesco (ciclesonide) 
               
               
                 Amaryl (Glimepiride) 
               
               
                 Amerge 
               
               
                 Amevive (alefacept) 
               
               
                 Amitiza (lubiprostone) 
               
               
                 Amoxil (amoxicillin) 
               
               
                 Ampyra (dalfampridine) 
               
               
                 Amrix (cyclobenzaprine hydrochloride extended release) 
               
               
                 Amturnide (aliskiren + amlodipine + hydrochlorothiazide) 
               
               
                 Androderm (Testosterone Transdermal System) 
               
               
                 AndroGel testosterone gel 
               
               
                 AneuVysion Assay 
               
               
                 Anexsia 
               
               
                 Angiomax (bivalirudin) 
               
               
                 Anoro Ellipta (umeclidinium and vilanterol inhalation powder) 
               
               
                 Antizol Injection 
               
               
                 Anturol (oxybutynin) Gel 
               
               
                 Anzemet 
               
               
                 Aphthasol 
               
               
                 Aplenzin (bupropion hydrobromide) 
               
               
                 Apokyn (apomorphine hydrochloride) 
               
               
                 Apthasol (Amlexanox) 
               
               
                 Aptiom (eslicarbazepine acetate) 
               
               
                 Aptivus (tipranavir) 
               
               
                 Arava 
               
               
                 Arcapta (indacaterol maleate inhalation powder) 
               
               
                 Aredia (pamidronate disodium for injection) 
               
               
                 Arestin (minocycline hydrochloride) 
               
               
                 Argatroban Injection 
               
               
                 ARICEPT (donepezil hydrochloride) 
               
               
                 Arimidex (anastrozole) 
               
               
                 Arixtra 
               
               
                 Amuity Ellipta (fluticasone furoate inhalation powder) 
               
               
                 Aromasin Tablets 
               
               
                 Arranon (nelarabine) 
               
               
                 Arthrotec 
               
               
                 Arzerra (ofatumumab) 
               
               
                 Asacol (mesalamine) 
               
               
                 Astelin nasal spray 
               
               
                 Astepro (azelastine hydrochloride nasal spray) 
               
               
                 Atacand (candesartan cilexetil) 
               
               
                 Atracurium Besylate Injection 
               
               
                 Atridox 
               
               
                 Atrovent (ipratropium bromide) 
               
               
                 Atryn (antithrombin recombinant lyophilized powder for reconstitution) 
               
               
                 Aubagio (teriflunomide) 
               
               
                 Augmentin (amoxicillin/clavulanate) 
               
               
                 Auryxia (Ferric citrate) 
               
               
                 Avandamet (rosiglitazone maleate and metformin HCl) 
               
               
                 Avandia (rosiglitazone maleate) 
               
               
                 Avastin (bevacizumab) 
               
               
                 Aveed (testosterone undecanoate) injection 
               
               
                 Avelox I.V. (moxifloxacin hydrochloride) 
               
               
                 Avinza (morphine sulfate) 
               
               
                 Avita Gel 
               
               
                 Avonex (Interferon Beta 1-A) 
               
               
                 Avycaz (ceftazidime-avibactam) 
               
               
                 Axert (almotriptan malate) tablets 
               
               
                 Axid AR (nizatidine 
               
               
                 Axona (caprylidene) 
               
               
                 AzaSite (azithromycin) 
               
               
                 Azmacort (triamcinolone acetonide) Inhalation Aerosol 
               
               
                 Azor (amlodipine besylate; olmesartan medoxomil) 
               
               
                 Azulfidine EN-tabs Tablets (sulfasalazine delayed release tablets, USP) 
               
               
                 Bactroban Cream 
               
               
                 Bactroban Nasal 2% (mupirocin calcium ointment) 
               
               
                 Banzel (rufinamide) 
               
               
                 Baraclude (entecavir) 
               
               
                 Baycol (cerivastatin sodium) 
               
               
                 Bayer Extra Strength Asprin 
               
               
                 Beleodaq (belinostat) 
               
               
                 Belsomra (suvorexant) 
               
               
                 Belviq (lorcaserin hydrochloride) 
               
               
                 BeneFIX (coagulation Factor IX (recombinant)) 
               
               
                 Benicar 
               
               
                 Benlysta (belimumab) 
               
               
                 Benzamycin (erythromycin 3%-benzoyl peroxide 5% topical gel) 
               
               
                 Bepreve (bepotastine besilate ophthalmic solution) 
               
               
                 Berinert (C1 Esterase Inhibitor (Human)) 
               
               
                 Besivance (besifloxacin ophthalmic suspension) 
               
               
                 Betapace AF Tablet 
               
               
                 Betaxon 
               
               
                 Bexsero (Meningococcal Group B Vaccine) 
               
               
                 Bextra 
               
               
                 Bexxar 
               
               
                 Biaxin XL (clarithromycin extended-release tablets) 
               
               
                 BiDil (isosorbide dinitrate/hydralazine hydrochloride) 
               
               
                 Bio-T-Gel (testosterone gel) 
               
               
                 Blincyto (blinatumomab) 
               
               
                 Boniva (ibandronate) 
               
               
                 Bosulif (bosutinib) 
               
               
                 Botox (onabotulinumtoxinA) 
               
               
                 Botox Cosmetic (botulinum toxin type A) 
               
               
                 Bravelle (urofollitropin for injection, purified) 
               
               
                 Breathe Right 
               
               
                 Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) 
               
               
                 Brilinta (ticagrelor) 
               
               
                 Brintellix (vortioxetine) 
               
               
                 Brisdelle (low-dose paroxetine mesylate) 
               
               
                 Bromfenac 
               
               
                 Brovana (arformoterol tartrate) 
               
               
                 BSS Sterile Irrigating Solution 
               
               
                 Bunavail (buprenorphine and naloxone) 
               
               
                 Busulflex 
               
               
                 Butrans (buprenorphine) Transdermal System 
               
               
                 Bydureon (exenatide extended-release for injectable suspension) 
               
               
                 Byetta (exenatide) 
               
               
                 Caduet (amlodipine/atorvastatin) 
               
               
                 Cafcit Injection 
               
               
                 Cambia (diclofenac potassium for oral solution) 
               
               
                 Campath 
               
               
                 Campostar 
               
               
                 Campral (acamprosate calcium) 
               
               
                 Camptosar 
               
               
                 Canasa (mesalamine) 
               
               
                 Cancidas 
               
               
                 Captopril and hydrochlorotiazide 
               
               
                 Carbaglu (carglumic acid) 
               
               
                 Carbatrol 
               
               
                 Cardizem (R) (Diltiazem HCl for injection) Monvial (R) 
               
               
                 Carrington patch 
               
               
                 Caverject (alprostadil) 
               
               
                 Cayston (aztreonam for inhalation solution) 
               
               
                 CEA-Scan 
               
               
                 Cedax (ceftibuten) 
               
               
                 Cefazolin and Dextrose USP 
               
               
                 Ceftin (cefuroxime axetil) 
               
               
                 Celexa 
               
               
                 CellCept 
               
               
                 Cenestin 
               
               
                 Cerdelga (eliglustat) 
               
               
                 Cemevit 
               
               
                 Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant 
               
               
                 Cetrotide 
               
               
                 Chantix (varenicline) 
               
               
                 Children&#39;s Advil (pediatric ibuprofen) 
               
               
                 Children&#39;s Motrin Cold 
               
               
                 Chloraprep (chlorhexidine gluconate) 
               
               
                 Cholbam (cholic acid) 
               
               
                 Cialis (tadalafil) 
               
               
                 Cimetadine Hydrochloride Oral Solution 300 mg/5 ml 
               
               
                 Cimetidine Hydrochloride Oral Solution 
               
               
                 Cimzia (certolizumab pegol) 
               
               
                 Cinryze (C1 Inhibitor (Human)) 
               
               
                 Cipro (ciprofloxacin HCl) 
               
               
                 Cipro (ciprofloxacin) I.V. and Cipro (ciprofloxacin HCI) tablets 
               
               
                 Clarinex 
               
               
                 Clarithromycin (Biaxin) 
               
               
                 Claritin RediTabs (10 mg loratadine rapidly-disintegrating tablet) 
               
               
                 Claritin Syrup (loratadine) 
               
               
                 Claritin-D 24 Hour Extended Release Tablets (10 mg loratadine, 240 mg 
               
               
                 pseudoephedrine sulfate) 
               
               
                 Clemastine fumarate syrup 
               
               
                 Cleocin (clindamycin phosphate) 
               
               
                 Cleviprex (clevidipine) 
               
               
                 Climara 
               
               
                 Clindamycin phosphate topical gel 
               
               
                 Clindamycin Phosphate Topical Solution USP 1% 
               
               
                 Clolar (clofarabine) 
               
               
                 Clomipramine hydrochloride 
               
               
                 Clonazepam 
               
               
                 Coartem (artemether/lumefantrine) 
               
               
                 Colazal (balsalazide disodium) 
               
               
                 Colcrys (colchicine) 
               
               
                 Combivir 
               
               
                 Cometriq (cabozantinib) 
               
               
                 Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) 
               
               
                 Comtan 
               
               
                 Concerta 
               
               
                 Condylox Gel 0.5% (pokofilox) 
               
               
                 Confide 
               
               
                 Contrave (naltrexone HCl and bupropion HCl) 
               
               
                 Copaxone 
               
               
                 Corlanor (ivabradine) 
               
               
                 Corlopam 
               
               
                 Corvert Injection (ibutilide fumarate injection) 
               
               
                 Cosentyx (secukinumab) 
               
               
                 Cosopt 
               
               
                 Covera-HS (verapamil) 
               
               
                 Cresemba (isavuconazonium sulfate) 
               
               
                 Crestor (rosuvastatin calcium) 
               
               
                 Crinone 8% (progesterone gel) 
               
               
                 Crixivan (Indinavir sulfate) 
               
               
                 Curosurf 
               
               
                 Cuvposa (glycopyrrolate) 
               
               
                 Cycloset, bromocriptine mesylate 
               
               
                 Cylert 
               
               
                 Cymbalta (duloxetine) 
               
               
                 Cyramza (ramucirumab) 
               
               
                 Cystaran (cysteamine hydrochloride) 
               
               
                 Dacogen (decitabine) 
               
               
                 Daklinza (daclatasvir) 
               
               
                 Daliresp (roflumilast) 
               
               
                 Dalvance (dalbavancin) 
               
               
                 Daptacel 
               
               
                 Degarelix (degarelix for injection) 
               
               
                 DentiPatch (lidocaine transoral delivery system) 
               
               
                 Depakote (divalproex sodium) 
               
               
                 Depakote ER (divalproex sodium) 
               
               
                 Dermagraft-TC 
               
               
                 Desmopressin Acetate (DDAVP) 
               
               
                 Desonate (desonide) 
               
               
                 Detrol (tolterodine tartrate) 
               
               
                 Detrol LA (tolterodine tartrate) 
               
               
                 Diclegis (doxylamine succinate + pyridoxine hydrochloride DR tablets) 
               
               
                 Differin (adapalene gel) Gel, 0.1% 
               
               
                 Dificid (fidaxomicin) 
               
               
                 Diltiazem HCL, Extended-Release Capsules 
               
               
                 Diovan (valsartan) 
               
               
                 Diovan HCT (valsartan) 
               
               
                 Ditropan XL (oxybutynin chloride) 
               
               
                 Doribax (doripenem) 
               
               
                 Dostinex Tablets (cabergoline tablets) 
               
               
                 Doxil (doxorubicin HCl liposome injection) 
               
               
                 Droxia 
               
               
                 Duavee (conjugated estrogens/bazedoxifene) 
               
               
                 Duexis (ibuprofen and famotidine) 
               
               
                 Dulera (mometasone furoate + formoterol fumarate dihydrate) 
               
               
                 DuoNeb (albuterol sulfate and ipratropium bromide) 
               
               
                 Duopa (carbidopa and levodopa) enteral suspension 
               
               
                 Durezol (difluprednate) 
               
               
                 Dutasteride 
               
               
                 Dyloject (diclofenac sodium) Injection 
               
               
                 Dymista (azelastine hydrochloride and fluticasone propionate) 
               
               
                 Dynabac 
               
               
                 DynaCirc CR 
               
               
                 Edarbi (azilsartan medoxomil) 
               
               
                 Edarbyclor (azilsartan medoxomil and chlorthalidone) 
               
               
                 EDEX 
               
               
                 Edluar (zolpidem tartrate) 
               
               
                 Edurant (rilpivirine) 
               
               
                 Effexor (venlafaxin HCL) 
               
               
                 Effexor XR (venlafaxin HCI) 
               
               
                 Efient (prasugrel) 
               
               
                 Egrifta (tesamorelin for injection) 
               
               
                 Elaprase (idursulfase) 
               
               
                 Elelyso (taliglucerase alfa) 
               
               
                 Elestrin (estradiol gel) 
               
               
                 Elidel 
               
               
                 Eligard (leuprolide acetate) 
               
               
                 Eliquis (apixaban) 
               
               
                 Elitek (rasburicase) 
               
               
                 Ellence 
               
               
                 Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) 
               
               
                 Elmiron (pentosan polysulfate sodium) 
               
               
                 Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] 
               
               
                 Eloxatin (oxaliplatin/5-fluorouracil/leucovorin) 
               
               
                 Embeda (morphine sulfate and naltrexone hydrochloride) 
               
               
                 Emend (aprepitant) 
               
               
                 Enbrel (etanercept) 
               
               
                 Entereg (alvimopan) 
               
               
                 Entocort EC (budesonide) 
               
               
                 Entresto (sacubitril and valsartan) 
               
               
                 Entyvio (vedolizumab) 
               
               
                 Envarsus XR (tacrolimus extended-release) 
               
               
                 Epanova (omega-3-carboxylic acids) 
               
               
                 Epivir (lamivudine) 
               
               
                 Eraxis (anidulafungin) 
               
               
                 Erbitux (cetuximab) 
               
               
                 Erivedge (vismodegib) 
               
               
                 Erwinaze (asparaginase Erwinia chrysanthemi) 
               
               
                 Esbriet (pirfenidone) 
               
               
                 Esclim 
               
               
                 Estradiol tablets 
               
               
                 Estradiol Transdermal System 
               
               
                 Estratab (.3 mg) 
               
               
                 EstroGel (estradiol gel 0.06%) 
               
               
                 Estrostep (norethindrone acetate and ethinyl estradiol) 
               
               
                 Ethyol (amifostine) 
               
               
                 Etodolac 
               
               
                 Eulexin (flutamide) 
               
               
                 Evamist (estradiol) 
               
               
                 Evista (raloxifene hydrochloride) 
               
               
                 Evotaz (atazanavir and cobicistat) 
               
               
                 Evoxac 
               
               
                 Exalgo (hydromorphone hydrochloride) extended release 
               
               
                 Excedrin Migraine 
               
               
                 Exelon (rivastigmine tartrate) 
               
               
                 Exparel (bupivacaine liposome injectable suspension) 
               
               
                 Extavia (Interferon beta-l b) 
               
               
                 Extina (ketoconazole) 
               
               
                 Eylea (aflibercept) 
               
               
                 Fabrazyme (agalsidase beta) 
               
               
                 Famvir (famciclovir) 
               
               
                 Fanapt (iloperidone) 
               
               
                 Farxiga (dapagliflozin) 
               
               
                 Farydak (panobinostat) 
               
               
                 Faslodex (fulvestrant) 
               
               
                 Femara (letrozole) 
               
               
                 Femhrt Tablets 
               
               
                 FemPatch 
               
               
                 Femstat 3 (butoconazole nitrate 2%) 
               
               
                 FEMSTAT One 
               
               
                 Fenofibrate 
               
               
                 Feraheme (ferumoxytol) 
               
               
                 Feridex I.V. 
               
               
                 Ferriprox (deferiprone) 
               
               
                 Ferrlecit 
               
               
                 Fertinex (urofollitropin for injection, purified) 
               
               
                 Fetzima (levomilnacipran) 
               
               
                 Finacea (azelaic acid) Gel, 15% 
               
               
                 Finevin 
               
               
                 Firazyr (icatibant) 
               
               
                 Flagyl ER 
               
               
                 FLOMAX 
               
               
                 Flonase Nasal Spray 
               
               
                 Flovent Rotadisk 
               
               
                 Floxin otic 
               
               
                 Floxin Tablets (ofloxacin tablets) 
               
               
                 Flublok (seasonal influenza vaccine) 
               
               
                 Flucelvax, Influenza Virus Vaccine 
               
               
                 FluMist (Influenza Virus Vaccine) 
               
               
                 Fluzone Preservative-free 
               
               
                 Focalin (dexmethylphenidate HCl) 
               
               
                 Follistim (TM) (follitropin beta for injection) 
               
               
                 Folotyn (pralatrexate injection) 
               
               
                 Foradil Aerolizer (formoterol fumarate inhalation powder) 
               
               
                 Forteo (teriparatide) 
               
               
                 Fortesta (testosterone gel) 
               
               
                 Fortovase 
               
               
                 Fosamax (alendronate sodium) 
               
               
                 Fosrenol, lanthanum carbonate 
               
               
                 Fragmin 
               
               
                 Frova (frovatriptan succinate) 
               
               
                 Fulyzaq (crofelemer) 
               
               
                 Fusilev (levoleucovorin) 
               
               
                 Fuzeon (enfuvirtide) 
               
               
                 Fycompa (perampanel) 
               
               
                 Galzin (zinc acetate) 
               
               
                 Gardasil (quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine) 
               
               
                 Gastrocrom Oral Concentrate (cromolyn sodium) 
               
               
                 GastroMARK 
               
               
                 Gattex (teduglutide) 
               
               
                 Gazyva (obinutuzumab) 
               
               
                 Gelnique (oxybutynin chloride) 
               
               
                 Gemzar (gemcitabine HCL) 
               
               
                 Generic Transdermal Nicotine Patch 
               
               
                 Genotropin (somatropin) injection 
               
               
                 Genotropin (somatropin) lyophilized powder 
               
               
                 Geodon (ziprasidone mesylate) 
               
               
                 Geref (sermorelin acetate for injection) 
               
               
                 Gilenya (fingolimod) 
               
               
                 Gilotrif (afatinib) 
               
               
                 Gleevec (imatinib mesylate) 
               
               
                 Gliadel Wafer (polifeprosan 20 with carmustine implant) 
               
               
                 Glipizide Tablets 
               
               
                 Glucagon 
               
               
                 Glyburide Tablets 
               
               
                 Glyset (miglitol) 
               
               
                 Gonal-F (follitropin alfa for injection) 
               
               
                 Gralise (gabapentin) 
               
               
                 Grastek (Timothy Grass Pollen Allergen Extract) 
               
               
                 Halaven (eribulin mesylate) 
               
               
                 Harvoni (ledipasvir and sofosbuvir) 
               
               
                 Havrix 
               
               
                 Hectorol (Doxercalciferol) Injection 
               
               
                 Hepsera (adefovir dipivoxil) 
               
               
                 Herceptin 
               
               
                 Herceptin (trastuzumab) 
               
               
                 Hetlioz (tasimelteon) 
               
               
                 Hiberix (Haemophilus b Conjugate Vaccine; Tetanus Toxoid Conjugate) 
               
               
                 Horizant (gabapentin enacarbil) 
               
               
                 Humalog (insulin lispro) 
               
               
                 Humatrope (somatropin [rDNA origin] for injection) 
               
               
                 Humira (adalimumab) 
               
               
                 Hycamtin (topotecan hydrochloride) 
               
               
                 HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human 
               
               
                 Hyaluronidase] 
               
               
                 Iamin 
               
               
                 Ibrance (palbociclib) 
               
               
                 Iclusig (ponatinib) 
               
               
                 Ilaris (canakinumab) 
               
               
                 Imagent (perflexane lipid microspheres) 
               
               
                 Imbruvica (ibrutinib) 
               
               
                 Imitrex (sumatriptan) injection and tablets 
               
               
                 Imitrex (sumatriptan) nasal spray 
               
               
                 Impavido (miltefosine) 
               
               
                 Incivek (telaprevir) 
               
               
                 Increlex (mecasermin) 
               
               
                 Incruse Ellipta (umeclidinium inhalation powder) 
               
               
                 Infasurf 
               
               
                 INFERGEN (interferon alfacon-1) 
               
               
                 Inform HER-2/neu breast cancer test 
               
               
                 Injectafer (ferric carboxymaltose injection) 
               
               
                 Inlyta (axitinib) 
               
               
                 Innohep (tinzaparin sodium) injectable 
               
               
                 Inspra (eplerenone tablets) 
               
               
                 Integrilin 
               
               
                 Intelence (etravirine) 
               
               
                 Intermezzo (zolpidem tartrate sublingual tablet) 
               
               
                 Interstim Continence Control Therapy 
               
               
                 Intron A (Interferon alfa-2b, recombinant) 
               
               
                 Intuniv (guanfacine extended-release) 
               
               
                 Invanz 
               
               
                 Invega (paliperidone) 
               
               
                 Invirase (saquinavir) 
               
               
                 Invokana (canagliflozin) 
               
               
                 Iontocaine 
               
               
                 Iressa (gefitinib) 
               
               
                 Isentress (raltegravir) 
               
               
                 Istodax (romidepsin) 
               
               
                 IvyBlock 
               
               
                 Ixempra (ixabepilone) 
               
               
                 Ixiaro (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) 
               
               
                 Jakafi (ruxolitinib) 
               
               
                 Jalyn (dutasteride + tamsulosin) 
               
               
                 Januvia (sitagliptin phosphate) 
               
               
                 Jardiance (empagliflozin) 
               
               
                 Jentadueto (linagliptin plus metformin hydrochloride) 
               
               
                 Jetrea (ocriplasmin) 
               
               
                 Jevtana (cabazitaxel) 
               
               
                 Jublia (efinaconazole) 10% topical gel 
               
               
                 Juvisync (sitagliptin and simvastatin) 
               
               
                 Juxtapid (lomitapide) 
               
               
                 Kadcyla (ado-trastuzumab emtansine) 
               
               
                 Kadian 
               
               
                 Kalbitor (ecallantide) 
               
               
                 Kaletra Capsules and Oral Solution 
               
               
                 Kalydeco (ivacaftor) 
               
               
                 Kapvay (clonidine hydrochloride) 
               
               
                 Kcentra (Prothrombin Complex Concentrate) 
               
               
                 Kengreal (cangrelor) 
               
               
                 Keppra 
               
               
                 Kerydin (tavaborole) 
               
               
                 Ketek (telithromycin) 
               
               
                 Ketoprofen 
               
               
                 Keytruda (pembrolizumab) 
               
               
                 Kineret 
               
               
                 Kineret, anakinra 
               
               
                 Klaron (sodium sulfacet amide lotion) Lotion, 10% 
               
               
                 Kogenate FS (Antihemophilic Factor Recombinant) 
               
               
                 Korlym (mifepristone) 
               
               
                 Krystexxa (pegloticase) 
               
               
                 Kuvan (sapropterin dihydrochloride) 
               
               
                 Kybella (deoxycholic acid) 
               
               
                 Kynamro (mipomersen sodium) 
               
               
                 Kyprolis (carfilzomib) 
               
               
                 Kytril (granisetron) solution 
               
               
                 Kytril (granisetron) tablets 
               
               
                 Lamictal (lamotrigine) Chewable Dispersible Tablets 
               
               
                 Lamictal Chewable Dispersible Tablets 
               
               
                 Lamisil (terbinafine hydrochloride) Dermagel, 1% 
               
               
                 Lamisil (terbinafine hydrochloride) Solution, 1% 
               
               
                 Lamisil (terbinafine hydrochloride) Tablets 
               
               
                 Lamisil Solution, 1% 
               
               
                 Lantus (insulin glargine [rDNA origin] injection) 
               
               
                 Latuda (lurasidone) 
               
               
                 Lazanda (fentanyl citrate) nasal spray 
               
               
                 Lemtrada (alemtuzumab) 
               
               
                 Lenvima (lenvatinib) 
               
               
                 Lescol (fluvastatin sodium) 
               
               
                 Lescol (fluvastatin sodium) capsules, Rx 
               
               
                 Lescol XL (fluvastatin sodium) tablet, extended release 
               
               
                 Letairis (ambrisentan) 
               
               
                 Leukine (sargramostim) 
               
               
                 Levaquin 
               
               
                 Levitra (vardenafil) 
               
               
                 Levo-T (levothyroxine sodium) 
               
               
                 Levoxyl 
               
               
                 Lexapro (escitalopram oxalate) 
               
               
                 Lexiva (fosamprenavir calcium) 
               
               
                 Lexxel (enalapril maleate-felodipine ER) 
               
               
                 Lidoderm Patch (lidocaine patch 5%) 
               
               
                 Linzess (linaclotide) 
               
               
                 Lipitor (atorvastatin calcium) 
               
               
                 Liptruzet (ezetimibe and atorvastatin) 
               
               
                 Lithobid (Lithium Carbonate) 
               
               
                 Livalo (pitavastatin) 
               
               
                 Lo Minastrin, (norethindrone acetate, ethinyl estradiol, ferrous fumarate) 
               
               
                 Lodine (etodolac) 
               
               
                 Lodine XL (etodolac) 
               
               
                 Lotemax 
               
               
                 Lotrisone (clotrimazole/betamethasone diproprionate) lotion 
               
               
                 Lotronex (alosetron HCL) Tablets 
               
               
                 Lovenox (enoxaparin sodium) Injection 
               
               
                 Lucentis (ranibizumab injection) 
               
               
                 Lucentis (ranibizumab) 
               
               
                 Lumigan (bimatoprost ophthalmic solution) 
               
               
                 Lunesta (eszopiclone) 
               
               
                 Lupron Depot (leuprolide acetate for depot suspension) 
               
               
                 Lusedra (fospropofol disodium) 
               
               
                 Lustra 
               
               
                 LUVOX (fluvoxamine maleate) 
               
               
                 Luxiq (betamethasone valerate) Foam 
               
               
                 Luzu (luliconazole) Cream 1% 
               
               
                 Lynparza (olaparib) 
               
               
                 Lyrica (pregabalin) 
               
               
                 Lysteda (tranexamic acid) 
               
               
                 Macugen (pegaptanib) 
               
               
                 Makena (hydroxyprogesterone caproate injection) 
               
               
                 Malarone (atovaquone; proguanil hydrochloride) Tablet 
               
               
                 Marplan Tablets 
               
               
                 Marqibo (vinCRIStine sulfate LIPOSOME injection) 
               
               
                 Mavik (trandolapril) 
               
               
                 Maxalt 
               
               
                 Mekinist (trametinib) 
               
               
                 Mentax (1% butenafine HCl cream) 
               
               
                 Menveo (meningitis vaccine) 
               
               
                 MERIDIA 
               
               
                 Merrem I.V. (meropenem) 
               
               
                 Mesnex 
               
               
                 Metadate CD 
               
               
                 Metaglip (glipizide/metformin HCl) 
               
               
                 Metaprotereol Sulfate Inhalation Solution, 5% 
               
               
                 Metozolv ODT (metoclopramide hydrochloride) 
               
               
                 MetroLotion 
               
               
                 Metronidazole 1.3% Vaginal Gel 
               
               
                 Mevacor (lovastatin) tablets 
               
               
                 Miacalcin (calcitonin-salmon) Nasal Spray 
               
               
                 Micardis (telmisartan) 
               
               
                 Micardis HCT (telmisartan and hydrochlorothiazide) 
               
               
                 Microzide (hydrochlorothiazide) 
               
               
                 Migranal 
               
               
                 Minoxidil Topical Solution 2% for Women 
               
               
                 Miraluma test 
               
               
                 Mirapex 
               
               
                 Mircera (methoxy polyethylene glycol-epoetin beta) 
               
               
                 Mircette 
               
               
                 Mirena (levonorgestrel-releasing intrauterine system) 
               
               
                 Mirvaso (brimonidine) 
               
               
                 Mobic (meloxicam) Tablets 
               
               
                 Monistat 3 (miconazole nitrate) 
               
               
                 Monurol 
               
               
                 Movantik (naloxegol) 
               
               
                 Moxatag (amoxicillin) 
               
               
                 Mozobil (plerixafor injection) 
               
               
                 Multaq (dronedarone) 
               
               
                 Muse 
               
               
                 Myalept (metreleptin for injection) 
               
               
                 Mylotarg (gemtuzumab ozogamicin) 
               
               
                 Myobloc 
               
               
                 Myozyme (alglucosidase alfa) 
               
               
                 Myrbetriq (mirabegron) 
               
               
                 Naglazyme (galsulfase) 
               
               
                 Naltrexone Hydrochloride Tablets 
               
               
                 Namenda (memantine HCl) 
               
               
                 Namzaric (memantine hydrochloride extended-release + donepezil hydrochloride) 
               
               
                 Naprelan (naproxen sodium) 
               
               
                 Nasacort AQ (triamcinolone acetonide) Nasal Spray 
               
               
                 NasalCrom Nasal Spray 
               
               
                 Nascobal Gel (Cyanocobalamin, USP) 
               
               
                 Nasonex Nasal Spray 
               
               
                 Natazia (estradiol valerate + dienogest) 
               
               
                 Natazia (estradiol valerate and estradiol valerate/dienogest) 
               
               
                 Natesto, (testosterone) nasal gel 
               
               
                 Natpara (parathyroid hormone) 
               
               
                 Natrecor (nesiritide) 
               
               
                 Nesina (alogliptin) 
               
               
                 Neulasta 
               
               
                 Neumega 
               
               
                 Neupogen 
               
               
                 Neupro (Rotigotine Transdermal System) 
               
               
                 Neupro (rotigotine) 
               
               
                 Neurontin (gabapentin) 
               
               
                 Neurontin (gabapentin) oral solution 
               
               
                 Neutroval (tbo-filgrastim) 
               
               
                 Nexavar (sorafenib) 
               
               
                 Nexium (esomeprazole magnesium) 
               
               
                 Niaspan 
               
               
                 NicoDerm CQ 
               
               
                 Nicorette (nicotine polacrilex) 
               
               
                 Nicotrol nasal spray 
               
               
                 Nicotrol transdermal patch 
               
               
                 Nitrostat (nitroglycerin) Tablets 
               
               
                 Nolvadex 
               
               
                 NORCO tablets (Hydrocodone Bitartrate/Acetaminophen 10 mg/325 mg) 
               
               
                 Norditropin (somatropin (rDNA origin) for injection) 
               
               
                 Noritate 
               
               
                 Normiflo 
               
               
                 Northera (droxidopa) 
               
               
                 Norvir (ritonavir) 
               
               
                 Novantrone (mitoxantrone hydrochloride) 
               
               
                 NovoLog (insulin aspart) 
               
               
                 Novolog Mix 70/30 
               
               
                 Novothyrox (levothyroxine sodium) 
               
               
                 Noxafil (posaconazole) 
               
               
                 Nplate (romiplostim) 
               
               
                 Nucynta (tapentadol) 
               
               
                 Nuedexta (dextromethorphan hydrobromide and quinidine sulfate) 
               
               
                 Nulojix (belatacept) 
               
               
                 Nutropin (somatropin-rDNA origin) 
               
               
                 NuvaRing 
               
               
                 Nuvigil (armodafmil) 
               
               
                 Nymalize (nimodipine) 
               
               
                 Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] 
               
               
                 Ocuflox (ofloxacin opthalmic solution) 0.3% 
               
               
                 OcuHist 
               
               
                 Odomzo (sonidegib) 
               
               
                 Ofev (nintedanib) 
               
               
                 Oleptro (trazodone hydrochloride) 
               
               
                 Olysio (simeprevir) 
               
               
                 Omidria (phenylephrine and ketorolac injection) 
               
               
                 Omnicef 
               
               
                 Omontys (peginesatide) 
               
               
                 Onfi (clobazam) 
               
               
                 Onglyza (saxagliptin) 
               
               
                 Onsolis (fentanyl buccal) 
               
               
                 Opdivo (nivolumab) 
               
               
                 Opsumit (macitentan) 
               
               
                 Oral Cytovene 
               
               
                 Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass 
               
               
                 Mixed Pollens Allergen Extract) 
               
               
                 Oravig (miconazole) 
               
               
                 Orbactiv (oritavancin) 
               
               
                 Orencia (abatacept) 
               
               
                 Orfadin (nitisinone) 
               
               
                 Orkambi (lumacaftor and ivacaftor) 
               
               
                 Ortho Evra 
               
               
                 Ortho Tri-Cyclen Tablets (norgestimate/ethinyl estradiol) 
               
               
                 Ortho-Prefest 
               
               
                 OsmoCyte Pillow Wound Dressing 
               
               
                 Osphena (ospemifene) 
               
               
                 Otezla (apremilast) 
               
               
                 Ovidrel (gonadotropin, chorionic human recombinant) 
               
               
                 Oxecta (oxycodone HCl) 
               
               
                 Oxtellar XR (oxcarbazepine extended release) 
               
               
                 Oxycodone and Aspirin 
               
               
                 Oxycodone with Acetaminophen 5 mg/325 mg 
               
               
                 OxyContin (oxycodone HCl controlled-release) 
               
               
                 Oxytrol (oxybutynin transdermal system) 
               
               
                 Ozurdex (dexamethasone) 
               
               
                 Pancreaze (pancrelipase) 
               
               
                 Panretin Gel 
               
               
                 Patanase (olopatadine hydrochloride) 
               
               
                 Paxil (paroxetine hydrochloride) 
               
               
                 Paxil CR (paroxetine hydrochloride) 
               
               
                 Pediarix Vaccine 
               
               
                 Pegasys (peginterferon alfa-2a) 
               
               
                 Peg-Intron (peginterferon alfa-2b) 
               
               
                 Pennsaid (diclofenac sodium topical solution) 
               
               
                 Pentoxifylline 
               
               
                 Pepcid Complete 
               
               
                 Periostat (doxycycline hyclate) 
               
               
                 Perjeta (pertuzumab) 
               
               
                 PhosLo 
               
               
                 Photodynamic Therapy 
               
               
                 Photofrin 
               
               
                 Picato (ingenol mebutate) gel 
               
               
                 Pindolol 
               
               
                 Plavix (clopidogrel bisulfate) 
               
               
                 Plegridy (peginterferon beta-1a) 
               
               
                 Plenaxis (abarelix for injectable suspension) 
               
               
                 Pomalyst (pomalidomide) 
               
               
                 Posicor 
               
               
                 Potiga (ezogabine) 
               
               
                 Pradaxa (dabigatran etexilate mesylate) 
               
               
                 Praluent (alirocumab) 
               
               
                 Pramipexole 
               
               
                 Prandin 
               
               
                 Pravachol (pravastatin sodium) 
               
               
                 Precose (acarbose) 
               
               
                 Premarin (conjugated estrogens) 
               
               
                 Prempro 
               
               
                 Prempro &amp; Premphase (conjugated estrogens/medroxyprogesterone acetate tablets) 
               
               
                 Prestalia (perindopril arginine and amlodipine besylate) 
               
               
                 PREVACID(R) (lansopraxole) 
               
               
                 PREVEN; Emergency Contraceptive Kit 
               
               
                 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine) 
               
               
                 Prevpac 
               
               
                 Prezcobix (darunavir and cobicistat) 
               
               
                 Prezista (darunavir) 
               
               
                 Priftin 
               
               
                 Prilosec (omeprazole) 
               
               
                 Prilosec (omeprazole)/Biaxin (clarithromycin) Combination Therapy 
               
               
                 Prinivil or Zestril (Lisinopril) 
               
               
                 ProAmatine (midodrine) 
               
               
                 Procanbid (procainamide hydrochloride extended-release tablets) 
               
               
                 Prochloroperazine 
               
               
                 Prochlorperazine 
               
               
                 Procysbi (cysteamine bitartrate) 
               
               
                 Prograf 
               
               
                 Proleukin 
               
               
                 Prolia (denosumab) 
               
               
                 Promacta (eltrombopag) 
               
               
                 Prometrium 
               
               
                 Propecia 
               
               
                 Proscar 
               
               
                 Protonix (pantoprazole sodium) Delayed Release Tablets 
               
               
                 Protonix (pantoprazole sodium) Delayed-Release Tablets 
               
               
                 Protonix (pantoprazole sodium) Intravenous Formulation 
               
               
                 Protopic (tacrolimus) ointment 
               
               
                 Provenge (sipuleucel-T) 
               
               
                 Proventil HFA Inhalation Aerosol 
               
               
                 Prozac Weekly (fluoxetine HCl) 
               
               
                 Pulmozyme (dornase alfa) 
               
               
                 Qnasl (beclomethasone dipropionate) nasal aerosol 
               
               
                 Qsymia (phentermine + topiramate extended-release) 
               
               
                 Quadramet (Samarium Sm 153 Lexidronam Injection) 
               
               
                 Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) 
               
               
                 Qudexy XR (topiramate) 
               
               
                 Quillivant XR (methylphenidate hydrochloride) 
               
               
                 Quixin (levofloxacin) 
               
               
                 Qutenza (capsaicin) 
               
               
                 Qvar (beclomethasone dipropionate) 
               
               
                 Ragwitek (Short Ragweed Pollen Allergen Extract) 
               
               
                 Ranexa (ranolazine) 
               
               
                 Ranitidine Capsules 
               
               
                 Ranitidine Tablets 
               
               
                 Rapamune (sirolimus) oral solution 
               
               
                 Rapamune (sirolimus) Tablets 
               
               
                 Rapivab (peramivir injection) 
               
               
                 Rapion 
               
               
                 Ravicti (glycerol phenylbutyrate) 
               
               
                 Raxar (grepafloxacin) 
               
               
                 Rayos (prednisone) delayed-release tablets 
               
               
                 Rebetol (ribavirin) 
               
               
                 REBETRON (TM) Combination Therapy 
               
               
                 Rebif (interferon beta-1a) 
               
               
                 Reclast (zoledronic acid) 
               
               
                 Rectiv (nitroglycerin) ointment 0.4% 
               
               
                 Redux (dexfenfluramine hydrochloride) 
               
               
                 Refludan 
               
               
                 REGRANEX (becaplermin) Gel 
               
               
                 Relenza 
               
               
                 Relpax (eletriptan hydrobromide) 
               
               
                 Remeron (Mirtazapine) 
               
               
                 Remeron SolTab (mirtazapine) 
               
               
                 Remicade (infliximab) 
               
               
                 Reminyl (galantamine hydrobromide) 
               
               
                 Remodulin (treprostinil) 
               
               
                 Renagel (sevelamer hydrochloride) 
               
               
                 RenaGelRenagel (sevelamer hydrochloride) 
               
               
                 Renova (tretinoin emollient cream) 
               
               
                 Renvela (sevelamer carbonate) 
               
               
                 ReoPro 
               
               
                 Repatha (evolocumab) 
               
               
                 REPRONEX(menotropins for injection, USP) 
               
               
                 Requip (ropinirole hydrochloride) 
               
               
                 Rescriptor Tablets (delavirdine mesylate tablets) 
               
               
                 Rescula (unoprostone isopropyl ophthalmic solution) 0.15% 
               
               
                 RespiGam (Respiratory Syncitial Virus Immune Globulin Intravenous) 
               
               
                 Restasis (cyclosporine ophthalmic emulsion) 
               
               
                 Retavase (reteplase) 
               
               
                 Retin-A Micro (tretinoin gel) microsphere, 0.1% 
               
               
                 Revlimid (lenalidomide) 
               
               
                 Rexulti (brexpiprazole) 
               
               
                 Reyataz (atazanavir sulfate) 
               
               
                 Rhinocort Aqua Nasal Spray 
               
               
                 Rid Mousse 
               
               
                 Rilutek (riluzole) 
               
               
                 Risperdal Oral Formulation 
               
               
                 Ritalin LA (methylphenidate HCl) 
               
               
                 Rituxan 
               
               
                 Rixubis (Coagulation Factor IX (Recombinant)] 
               
               
                 Rocephin 
               
               
                 Rotarix (Rotavirus Vaccine, Live, Oral) 
               
               
                 Rotateq (rotavirus vaccine, live oral pentavalent) 
               
               
                 Rozerem (ramelteon) 
               
               
                 Ruconest (C1 esterase inhibitor [recombinant]) 
               
               
                 Rytary (carbidopa and levodopa) extended-release capsules 
               
               
                 Rythmol 
               
               
                 Sabril (vigabatrin) 
               
               
                 Saizen 
               
               
                 Salagen Tablets 
               
               
                 Samsca (tolvaptan) 
               
               
                 Sanctura (trospium chloride) 
               
               
                 Sancuso (granisetron) 
               
               
                 Saphris (asenapine) 
               
               
                 Savaysa (edoxaban) 
               
               
                 Savella (milnacipran hydrochloride) 
               
               
                 Saxenda (liraglutide [rDNA origin] injection) 
               
               
                 Sclerosol Intrapleural Aerosol 
               
               
                 Seasonale, Lo Seasonale, Seasonique (ethinylestradiol + levonorgestrel) 
               
               
                 SecreFlo (secretin) 
               
               
                 Selegiline tablets 
               
               
                 Self-examination breast pad 
               
               
                 Selzentry (maraviroc) 
               
               
                 Sensipar (cinacalcet) 
               
               
                 Seprafilm 
               
               
                 Serevent 
               
               
                 Seroquel (R) (quetiapine fumarate) Tablets 
               
               
                 Signifor (pasireotide diaspartate) 
               
               
                 Signifor LAR (pasireotide) 
               
               
                 Silenor (doxepin) 
               
               
                 Simponi (golimumab) 
               
               
                 Simulect 
               
               
                 Singulair 
               
               
                 Sirturo (bedaquiline) 
               
               
                 Sitavig (acyclovir) buccal tablets 
               
               
                 Sivextro (tedizolid phosphate) 
               
               
                 Skelid (tiludronate disodium) 
               
               
                 Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA) 
               
               
                 Sklice (ivermectin) lotion 
               
               
                 Soliris (eculizumab) 
               
               
                 Somatuline Depot (lanreotide acetate) 
               
               
                 Somavert (pegvisomant) 
               
               
                 Sonata 
               
               
                 Soolantra (ivermectin) cream, 1% 
               
               
                 Sovaldi (sofosbuvir) 
               
               
                 Spectracef 
               
               
                 Spiriva HandiHaler (tiotropium bromide) 
               
               
                 SPORANOX (itraconazole) 
               
               
                 Sprix (ketorolac tromethamine) 
               
               
                 Sprycel (dasatinib) 
               
               
                 Stavzor (valproic acid delayed release) 
               
               
                 Stelara (ustekinumab) 
               
               
                 Stendra (avanafil) 
               
               
                 Stiolto Respimat (tiotropium bromide and olodaterol) 
               
               
                 Stivarga (regorafenib) 
               
               
                 Strattera (atomoxetine HCl) 
               
               
                 Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) 
               
               
                 Striverdi Respimat (olodaterol) 
               
               
                 Stromectol (ivermectin) 
               
               
                 Subsys (fentanyl sublingual spray) 
               
               
                 Subutex/Suboxone (buprenorphine/naloxone) 
               
               
                 Sulfamylon 
               
               
                 Supartz 
               
               
                 Supprelin LA (histrelin acetate) 
               
               
                 Surfaxin (lucinactant) 
               
               
                 Sustiva 
               
               
                 Sutent (sunitinib malate) 
               
               
                 Sutent (sunitinib) 
               
               
                 Sylatron (peginterferon alfa-2b) 
               
               
                 Sylvant (siltuximab) 
               
               
                 Symlin (pramlintide) 
               
               
                 Synagis 
               
               
                 Synercid I.V. 
               
               
                 Synjardy (empagliflozin and metformin hydrochloride) 
               
               
                 Synribo (omacetaxine mepesuccinate) 
               
               
                 Synthroid (levothyroxine sodium) 
               
               
                 Synvisc, Synvisc-One (Hylan GF 20) 
               
               
                 Tafinlar (dabrafenib) 
               
               
                 Tamiflu capsule 
               
               
                 Tanzeum (albiglutide) 
               
               
                 Tarceva (erlotinib, OSI 774) 
               
               
                 Targiniq ER (oxycodone hydrochloride + naloxone hydrochloride) extended-release 
               
               
                 tablets 
               
               
                 Tasigna (nilotinib hydrochloride monohydrate) 
               
               
                 Tasmar 
               
               
                 Tavist (clemastine fumarate) 
               
               
                 Taxol 
               
               
                 Taxotere (Docetaxel) 
               
               
                 Tazorac topical gel 
               
               
                 Tecfidera (dimethyl fumarate) 
               
               
                 Technivie, (ombitasvir, paritaprevir and ritonavir) 
               
               
                 Teczem (enalapril maleate/diltiazem malate) 
               
               
                 Teflaro (ceftaroline fosamil) 
               
               
                 Tegretol (carbamazepine) 
               
               
                 Tegretol XR (carbamazepine) 
               
               
                 Tekamlo (aliskiren + amlodipine) 
               
               
                 Tekturna (aliskiren) 
               
               
                 Temodar 
               
               
                 Tequin 
               
               
                 Testim 
               
               
                 Testoderm TTS CIII 
               
               
                 Teveten (eprosartan mesylate plus hydrochlorothiazide) 
               
               
                 Teveten (eprosartan mesylate) 
               
               
                 Thalomid 
               
               
                 Tiazac (diltiazem hydrochloride) 
               
               
                 Tikosyn Capsules 
               
               
                 Tilade (nedocromil sodium) 
               
               
                 Timentin 
               
               
                 Tindamax, tinidazole 
               
               
                 Tivicay (dolutegravir) 
               
               
                 Tivorbex (indomethacin) 
               
               
                 Tobi 
               
               
                 Tolmetin Sodium 
               
               
                 Topamax (topiramate) 
               
               
                 Toprol-XL (metoprolol succinate) 
               
               
                 Torisel (temsirolimus) 
               
               
                 Toviaz (fesoterodine fumarate) 
               
               
                 Tracleer (bosentan) 
               
               
                 Tradjenta (linagliptin) 
               
               
                 Travatan (travoprost ophthalmic solution) 
               
               
                 Trazadone 150 mg 
               
               
                 Treanda (bendamustine hydrochloride) 
               
               
                 Trelstar Depot (triptorelin pamoate) 
               
               
                 Trelstar LA (triptorelin pamoate) 
               
               
                 Tretten (Coagulation Factor XIII A-Subunit [Recombinant]) 
               
               
                 Tribenzor (olmesartan medoxomil + amlodipine + hydrochlorothiazide) 
               
               
                 Tricor (fenofibrate) 
               
               
                 Trileptal (oxcarbazepine) Tablets 
               
               
                 Trilipix (fenofibric acid) 
               
               
                 Tri-Nasal Spray (triamcinolone acetonide spray) 
               
               
                 Tripedia (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed) 
               
               
                 Trisenox (arsenic trioxide) 
               
               
                 Triumeq (abacavir, dolutegravir, and lamivudine) 
               
               
                 Trivagizole 3 (clotrimazole) Vaginal Cream 
               
               
                 Trivora-21 and Trivora-28 
               
               
                 Trizivir (abacavir sulfate; lamivudine; zidovudine AZT) Tablet 
               
               
                 Trokendi XR (topiramate) 
               
               
                 Trovan 
               
               
                 Trulicity (dulaglutide) 
               
               
                 Tudorza Pressair (aclidinium bromide inhalation powder) 
               
               
                 Twinrix 
               
               
                 Tygacil (tigecycline) 
               
               
                 Tykerb (lapatinib) 
               
               
                 Tysabri (natalizumab) 
               
               
                 Tyvaso (treprostinil) 
               
               
                 Tyzeka (telbivudine) 
               
               
                 Uceris (budesonide) 
               
               
                 Uloric (febuxostat) 
               
               
                 Ultracet (acetaminophen and tramadol HCl) 
               
               
                 UltraJect 
               
               
                 Ultresa (pancrelipase) delayed-release capsules 
               
               
                 Unituxin (dinutuximab) 
               
               
                 UroXatral (alfuzosin HCl extended-release tablets) 
               
               
                 Urso 
               
               
                 UVADEX Sterile Solution 
               
               
                 Valchlor (mechlorethamine) gel 
               
               
                 Valcyte (valganciclovir HCl) 
               
               
                 Valstar 
               
               
                 Valtrex (valacyclovir HCl) 
               
               
                 Vancenase AQ 84 mcg Double Strength 
               
               
                 Vanceril 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation 
               
               
                 Aerosol 
               
               
                 Vandetanib (vandetanib) 
               
               
                 Vaprisol (conivaptan) 
               
               
                 Varithena (polidocanol injectable foam) 
               
               
                 VariZIG, Varicella Zoster Immune Globulin (Human) 
               
               
                 Varubi (rolapitant) 
               
               
                 Vascepa (icosapent ethyl) 
               
               
                 Vectibix (panitumumab) 
               
               
                 Velcade (bortezomib) 
               
               
                 Veltin (clindamycin phosphate and tretinoin) 
               
               
                 Venofer (iron sucrose injection) 
               
               
                 Ventolin HFA (albuterol sulfate inhalation aerosol) 
               
               
                 Veramyst (fluticasone furoate) 
               
               
                 Verapamil 
               
               
                 Verdeso (desonide) 
               
               
                 Veregen (kunecatechins) 
               
               
                 VERSED (midazolam HCI) 
               
               
                 Vesicare (solifenacin succinate) 
               
               
                 Vfend (voriconazole) 
               
               
                 Viadur (leuprolide acetate implant) 
               
               
                 Viagra 
               
               
                 Vibativ (telavancin) 
               
               
                 Viberzi (eluxadoline) 
               
               
                 Victoza (liraglutide) 
               
               
                 Victrelis (boceprevir) 
               
               
                 Vidaza (azacitidine) 
               
               
                 Videx (didanosine) 
               
               
                 Viekira Pak (ombitasvir, paritaprevir, ritonavir and dasabuvir) tablets 
               
               
                 Viibryd (vilazodone hydrochloride) 
               
               
                 Vimizim (elosulfase alfa) 
               
               
                 Vimovo (naproxen + esomeprazole) 
               
               
                 Vimpat (lacosamide) 
               
               
                 Viokace (pancrelipase) tablets 
               
               
                 Vioxx (rofecoxib) 
               
               
                 VIRACEPT (nelfinavir mesylate) 
               
               
                 Viramune (nevirapine) 
               
               
                 Viread (tenofovir disoproxil fumarate) 
               
               
                 Viroptic 
               
               
                 Visicol Tablet 
               
               
                 Visipaque (iodixanol) 
               
               
                 Vistide (cidofovir) 
               
               
                 Visudyne (verteporfin for injection) 
               
               
                 Vitrasert Implant 
               
               
                 Vitravene Injection 
               
               
                 Vivelle (estradiol transdermal system) 
               
               
                 Vivelle-Dot (estradiol transdermal system) 
               
               
                 Vivitrol (naltrexone for extended-release injectable suspension) 
               
               
                 Vogelxo (testosterone) gel 
               
               
                 Voraxaze (glucarpidase) 
               
               
                 Votrient (pazopanib) 
               
               
                 Vpriv (velaglucerase alfa for injection) 
               
               
                 Vyvanse (Lisdexamfetamine Dimesylate) 
               
               
                 Warfarin Sodium tablets 
               
               
                 Welchol (colesevelam hydrochloride) 
               
               
                 Western blot confirmatory device 
               
               
                 Wilate (von Willebrand Factor/Coagulation Factor VIII Complex (Human) 
               
               
                 Xalkori (crizotinib) 
               
               
                 Xarelto (rivaroxaban) 
               
               
                 Xartemis XR (oxycodone hydrochloride and acetaminophen) extended release 
               
               
                 Xeljanz (tofacitinib) 
               
               
                 Xeloda 
               
               
                 Xenazine (tetrabenazine) 
               
               
                 Xenical/Orlistat Capsules 
               
               
                 Xeomin (incobotulinumtoxinA) 
               
               
                 Xgeva (denosumab) 
               
               
                 Xiaflex (collagenase clostridium histolyticum) 
               
               
                 Xifaxan (rifaximin) 
               
               
                 Xigduo XR (dapagliflozin + metformin hydrochloride) 
               
               
                 Xigris (drotrecogin alfa [activated]) 
               
               
                 Xofigo (radium Ra 223 dichloride) 
               
               
                 Xolair (omalizumab) 
               
               
                 Xopenex 
               
               
                 Xtandi (enzalutamide) 
               
               
                 Xtoro (finafloxacin otic suspension) 0.3% 
               
               
                 Xyrem (sodium oxybate) 
               
               
                 Xyzal (levocetirizine dihydrochloride) 
               
               
                 Yasmin (drospirenone/ethinyl estradiol) 
               
               
                 Yervoy (ipilimumab) 
               
               
                 ZADITOR 
               
               
                 Zagam (sparfloxacin) tablets 
               
               
                 Zaltrap (ziv-aflibercept) 
               
               
                 Zanaflex (tizanidine hydrochloride) 
               
               
                 Zantac 75 Efferdose 
               
               
                 Zelboraf (vemurafenib) 
               
               
                 Zelnorm (tegaserod maleate) Tablets 
               
               
                 Zemaira (alpha1-proteinase inhibitor) 
               
               
                 Zemplar 
               
               
                 Zenapax 
               
               
                 Zenpep (pancrelipase) 
               
               
                 Zerbaxa (ceftolozane + tazobactam) 
               
               
                 Zerit (stavudine) 
               
               
                 Zevalin (ibritumomab tiuxetan) 
               
               
                 Zingo (lidocaine hydrochloride monohydrate) 
               
               
                 Zioptan (tafluprost ophthalmic solution) 
               
               
                 Ziprasidone (ziprasidone hydrochloride) 
               
               
                 Zipsor (diclofenac potassium) 
               
               
                 Zirgan (ganciclovir ophthalmic gel) 
               
               
                 Zithromax (azithromycin) 
               
               
                 Zocor 
               
               
                 Zofran 
               
               
                 Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules 
               
               
                 Zoladex (10.8 mg goserelin acetate implant) 
               
               
                 Zoloft (sertraline HCl) 
               
               
                 Zometa (zoledronic acid) 
               
               
                 Zomig (zolmitriptan) 
               
               
                 Zonegran (zonisamide) Capsules 
               
               
                 Zontivity (vorapaxar) 
               
               
                 Zortress (everolimus) 
               
               
                 Zosyn (sterile piperacillin sodium/tazobactam sodium) 
               
               
                 Zubsolv (buprenorphine and naloxone) 
               
               
                 Zuplenz (ondansetron oral soluble film) 
               
               
                 Zyban Sustained-Release Tablets 
               
               
                 Zyclara (imiquimod) 
               
               
                 Zydelig (idelalisib) 
               
               
                 Zyflo (Zileuton) 
               
               
                 Zykadia (ceritinib) 
               
               
                 Zymaxid (gatifloxacin ophthalmic solution) 
               
               
                 Zyprexa 
               
               
                 Zyrtec (cetirizine HCl) 
               
               
                 Zytiga (abiraterone acetate) 
               
               
                   
               
            
           
         
       
     
     Table 4 lists sample drugs and their side effects. The listed drugs and their side effects highlight a number side effects that can be used for the development of the Patient Specific Dispensing Algorithm. The following approved drugs in Table 4 and in the following marketed drug compounds and drug compounds in development are encompassed in the embodiment of the invention by reference. Marketed drug compounds of interest are also listed in: Goodman &amp; Gilman&#39;s, The Pharmacological Basis of Therapeutics (12th Ed) (Goodman et al. eds) (McGraw-Hill) (2011); and 2015 Physician&#39;s Desk Reference. Drug compounds in development that are of interest are also listed in: Cortellis™ Competitive Intelligence by Thomson Reuters; Adis R&amp;D; and Pharmaprojects by Citeline. The drug The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     
       
         
           
               
             
               
                 TABLE 4 
               
               
                   
               
               
                 SAMPLE DRUGS AND THEIR SIDE EFFECTS 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
            
               
                 Afinitor 
                 Common: 
               
               
                   
                 Cardiovascular: Hypertension (tumors, 4% to 13%; kidney 
               
               
                   
                 transplant, 30%; liver transplant, 17%), Peripheral edema (tumors, 
               
               
                   
                 13% to 39%; kidney transplant, 45%; liver transplant, 18%) 
               
               
                   
                 Dermatologic: Acne (tumors, 10% to 22%; transplant, 1% to less 
               
               
                   
                 than 10%), Eczema (renal angiomyolipoma, 10%), Rash (tumors, 
               
               
                   
                 5% to 59%) 
               
               
                   
                 Endocrine metabolic: Dyslipidemia (kidney transplant, 15%), 
               
               
                   
                 Hypercholesterolemia (tumors, 66% to 85%; kidney transplant, 
               
               
                   
                 17%), Hyperlipidemia (kidney transplant, 21%; liver transplant, 
               
               
                   
                 24%), Hypertriglyceridemia (tumors, 27% to 73%), 
               
               
                   
                 Hypoalbuminemia (breast cancer, 33%), Hypophosphatemia 
               
               
                   
                 (tumors, 9% to 49%; kidney transplant, 13%), Increased glucose 
               
               
                   
                 level, All grades (tumors, 14% to 75%; kidney transplant, 12%) 
               
               
                   
                 Gastrointestinal: Constipation (tumors, 10% to 14%; kidney 
               
               
                   
                 transplant, 38%), Decrease in appetite (tumors, 6% to 30%; 
               
               
                   
                 transplant, 1% to less than 10%), Diarrhea (tumors, 14% to 50%; 
               
               
                   
                 kidney transplant, 19%; liver transplant, 19%), Nausea (tumors, 
               
               
                   
                 16% to 29%; kidney transplant, 29%; liver transplant, 14%), 
               
               
                   
                 Stomatitis (tumors, 44% to 78%; kidney transplant, 8%), Vomiting 
               
               
                   
                 (tumors, 15% to 29%; kidney transplant, 15%) 
               
               
                   
                 Hematologic: Anemia, All Grades (tumors, 41% to 86%; kidney 
               
               
                   
                 transplant, 26%), Decreased lymphocyte count, All grades (tumors, 
               
               
                   
                 20% to 54%), Partial thromboplastin time increased (subependymal 
               
               
                   
                 giant cell astrocytoma, 72%), Thrombocytopenia, All grades 
               
               
                   
                 (tumors, 19% to 54%; transplant, up to 10%) 
               
               
                   
                 Hepatic: Alkaline phosphatase raised (tumors, 32% to 74%; 
               
               
                   
                 transplant, 1% to less than 10%), ALT/SGPT level raised (tumors, 
               
               
                   
                 18% to 51%), AST/SGOT level raised (tumors, 23% to 69%) 
               
               
                   
                 Immunologic: Impaired wound healing (kidney transplant, 35%; 
               
               
                   
                 liver transplant, 11%) 
               
               
                   
                 Neurologic: Asthenia (tumors, 13% to 33%) 
               
               
                   
                 Otic: Otitis media (renal angiomyolipoma, 6%) 
               
               
                   
                 Psychiatric: Mental disorder (subependymal giant cell 
               
               
                   
                 astrocytoma, 21%) 
               
               
                   
                 Renal: Serum creatinine raised (tumors, 19% to 50%; kidney 
               
               
                   
                 transplant, 18%), Urinary tract infectious disease (tumors, 5% to 
               
               
                   
                 16%; kidney transplant, 22%) 
               
               
                   
                 Reproductive: Amenorrhea (renal angiomyolipoma, 15%), 
               
               
                   
                 Irregular periods (tumors, 10% to 11%), Menorrhagia (renal 
               
               
                   
                 angiomyolipoma, 10%) 
               
               
                   
                 Respiratory: Cough (tumors, 20% to 30%; kidney transplant, 7%), 
               
               
                   
                 Dyspnea (tumors, 20% to 24%), Sinusitis (tumors, 3% to 6%), 
               
               
                   
                 Upper respiratory infection (tumors, 11% to 31%; kidney 
               
               
                   
                 transplant, 16%) 
               
               
                   
                 Other: Fatigue (tumors, 14% to 45%; kidney transplant, 9%), 
               
               
                   
                 Fever (tumors, 15% to 31%; kidney transplant, 19%; liver 
               
               
                   
                 transplant, 13%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Pericardial effusion (Transplant, less than 1%) 
               
               
                   
                 Hematologic: Anemia, Grade 3 or 4 (tumors, 6.6% to 15%), 
               
               
                   
                 Decreased lymphocyte count, Grade 3 or 4 (tumors, 1% to 16%), 
               
               
                   
                 Hemorrhage (renal cell carcinoma, 3%), Leukopenia (tumors, 37% 
               
               
                   
                 to 58%; kidney transplant, 3%; liver transplant, 12%), 
               
               
                   
                 Pancytopenia, All grades (transplant, 1% to less than 10%), 
               
               
                   
                 Thrombosis, Thrombotic microangiopathy (Transplant, less than 
               
               
                   
                 1%), Thrombotic thrombocytopenic purpura (Transplant, less than 
               
               
                   
                 1%), Venous thromboembolism (transplant, 1% to less than 10%) 
               
               
                   
                 Immunologic: Infectious disease (tumors, 37% to 50%; kidney 
               
               
                   
                 transplant, 62%; liver transplant, 50%) 
               
               
                   
                 Neurologic: Seizure (renal angiomyolipoma, 5%) 
               
               
                   
                 Renal: Hemolytic uremic syndrome (Transplant, less than 1%), 
               
               
                   
                 Renal failure (renal cell carcinoma, 3%), Thrombosis of renal 
               
               
                   
                 artery (transplant, 1% to less than 10%) 
               
               
                   
                 Respiratory: Interstitial lung disease (Less than 1%), Non- 
               
               
                   
                 infectious pneumonia (Up to 19%), Pleural effusion (tumors, 7%), 
               
               
                   
                 Pneumocystis pneumonia, Pneumonia (renal cell carcinoma, 6%), 
               
               
                   
                 Pulmonary embolism (PNET, 2.5%; transplant, 1% to less than 
               
               
                   
                 10%) 
               
               
                   
                 Other: Angioedema (Transplant, up to 6.8%), Sepsis (tumors less 
               
               
                   
                 than 1%; transplant, 1% to less than 10%) 
               
               
                 Ampyra 
                 Common 
               
               
                   
                 Gastrointestinal: Abdominal pain (7%), Nausea (7% to 13%), 
               
               
                   
                 Vomiting (13%) 
               
               
                   
                 Musculoskeletal: Abnormal gait (5%), Backache (5%) 
               
               
                   
                 Neurologic: Asthenia (7%), Dizziness (7%), Headache (7%), 
               
               
                   
                 Insomnia (9%) 
               
               
                   
                 Psychiatric: Anxiety (5%) 
               
               
                   
                 Renal: Urinary tract infectious disease (12%) 
               
               
                   
                 Serious 
               
               
                   
                 Immunologic: Anaphylaxis, Hypersensitivity reaction 
               
               
                   
                 Neurologic: Seizure 
               
               
                 Angeliq 
                 Common 
               
               
                   
                 Gastrointestinal: Abdominal pain (3.6% to 6.5%) 
               
               
                   
                 Neurologic: Headache (6%) 
               
               
                   
                 Reproductive: Abnormal vaginal bleeding (3.6% to 14%), Pain of 
               
               
                   
                 breast (3.3% to 17.9%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction 
               
               
                   
                 Gastrointestinal: Disorder of gallbladder 
               
               
                   
                 Hematologic: Deep venous thrombosis 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                   
                 Ophthalmic: Thrombosis of retinal vein 
               
               
                   
                 Reproductive: Breast cancer, Endometrial carcinoma, Ovarian 
               
               
                   
                 cancer 
               
               
                   
                 Respiratory: Pulmonary embolism 
               
               
                 Brisdelle 
                 Common 
               
               
                   
                 Dermatologic: Diaphoresis (1% to 14%) 
               
               
                   
                 Gastrointestinal: Constipation (4.9% to 16%), Diarrhea (7.9% to 
               
               
                   
                 19.2%), Loss of appetite (2% to 9%), Nausea (up to 36.3%), 
               
               
                   
                 Xerostomia (10.8% to 20.6%) 
               
               
                   
                 Neurologic: Asthenia (2.9% to 22%), Dizziness (6% to 14%), 
               
               
                   
                 Headache (psychiatric conditions, 17% to 18%; menopausal 
               
               
                   
                 vasomotor symptoms, 6.3%), Insomnia (11% to 24%), Somnolence 
               
               
                   
                 (12.7% to 24%), Tremor (up to 14.7%) 
               
               
                   
                 Ophthalmic: Blurred vision (2% to 7.8%) 
               
               
                   
                 Reproductive: Abnormal ejaculation (5.8% to 28%), Disorder of 
               
               
                   
                 female genital organs (2% to 9%), Erectile dysfunction (1.9% to 
               
               
                   
                 9%), Reduced libido (males, 6% to 15%; females, 0% to 9%) 
               
               
                   
                 Serious 
               
               
                   
                 Psychiatric: Depression, Exacerbation, Suicidal thoughts, Suicide 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Contrave 
                 Common: 
               
               
                   
                 Gastrointestinal: Constipation (19.2%), Diarrhea (7.1%), Nausea 
               
               
                   
                 (32.5%), Vomiting (10.7%), Xerostomia (8.1%) 
               
               
                   
                 Neurologic: Dizziness (9.9%), Headache (17.6%), Insomnia (9.2%) 
               
               
                   
                 Psychiatric: Anxiety (4.2%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Hypertension (3.2%), Increased heart rate, 
               
               
                   
                 Myocardial infarction (Less than 2%) 
               
               
                   
                 Dermatologic: Erythema multiforme (Rare), Stevens-Johnson 
               
               
                   
                 syndrome (Rare) 
               
               
                   
                 Endocrine metabolic: Hypoglycemia 
               
               
                   
                 Gastrointestinal: Cholecystitis (Less than 2%), Hematochezia (Less 
               
               
                   
                 than 2%) 
               
               
                   
                 Hepatic: Hepatotoxicity 
               
               
                   
                 Immunologic: Anaphylaxis, Delayed hypersensitivity disorder 
               
               
                   
                 Musculoskeletal: Intervertebral disc prolapse (Less than 2%) 
               
               
                   
                 Neurologic: Amnesia (Less than 2%), Seizure (0.1%) 
               
               
                   
                 Ophthalmic: Angle-closure glaucoma 
               
               
                   
                 Psychiatric: Depression (6.3% to 7.1%), Mania, Psychiatric 
               
               
                   
                 symptom, Suicidal thoughts (0.03%) 
               
               
                   
                 Renal: Infectious disorder of kidney (Less than 2%), Serum 
               
               
                   
                 creatinine raised (Less than 2%) 
               
               
                   
                 Respiratory: Pneumonia (Less than 2%) 
               
               
                 Daliresp 
                 Common: 
               
               
                   
                 Endocrine metabolic: Weight decreased (7% to 20%) 
               
               
                   
                 Gastrointestinal: Decrease in appetite (2.1%), Diarrhea (9.5%), 
               
               
                   
                 Nausea (4.7%) 
               
               
                   
                 Immunologic: Influenza (2.8%) 
               
               
                   
                 Musculoskeletal: Backache (3.2%) 
               
               
                   
                 Neurologic: Dizziness (2.1%), Headache (4.4%), Insomnia (2.4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                 Doryx 
                 Common: 
               
               
                   
                 Dermatologic: Rash (4%) 
               
               
                   
                 Gastrointestinal: Diarrhea (3.3%), Loss of appetite, Nausea (8% to 
               
               
                   
                 13.4%), Sensitive dentin, Sore gums, Vomiting (8.1%) 
               
               
                   
                 Musculoskeletal: Myalgia (6.4%) 
               
               
                   
                 Reproductive: Bacterial vaginosis (3.3%) 
               
               
                   
                 Serious: 
               
               
                   
                 Dermatologic: Drug hypersensitivity syndrome, Erythema 
               
               
                   
                 multiforme, Photosensitivity, Stevens-Johnson syndrome, Toxic 
               
               
                   
                 epidermal necrolysis 
               
               
                   
                 Gastrointestinal: Clostridium difficile diarrhea 
               
               
                   
                 Hepatic: Hepatotoxicity (Rare) 
               
               
                   
                 Immunologic: Anaphylaxis, Superinfection 
               
               
                   
                 Musculoskeletal: Arrest of bone development AND/OR growth 
               
               
                   
                 Neurologic: Pseudotumor cerebri 
               
               
                 Ella 
                 Common: 
               
               
                   
                 Gastrointestinal: Abdominal pain (8% to 15%), Nausea (12% to 
               
               
                   
                 13%) 
               
               
                   
                 Neurologic: Headache (18% to 19%) 
               
               
                 Equetro 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Dermatologic: Pruritus (8%), Rash (7%) 
               
               
                   
                 Gastrointestinal: Constipation (10%), Nausea (29%), Vomiting 
               
               
                   
                 (18%), Xerostomia (8%) 
               
               
                   
                 Neurologic: Asthenia (8%), Ataxia (15%), Dizziness (44%), 
               
               
                   
                 Somnolence 
               
               
                   
                 Ophthalmic: Blurred vision (6%), Nystagmus 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block, Cardiac dysrhythmia, 
               
               
                   
                 Congestive heart failure, Eosinophilic myocarditis, 
               
               
                   
                 Hypersensitivity, Syncope 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Endocrine metabolic: Hypocalcemia, Hyponatremia (4% to 21.7%), 
               
               
                   
                 Water intoxication syndrome 
               
               
                   
                 Gastrointestinal: Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Aplastic anemia, Bone marrow 
               
               
                   
                 depression, Eosinophilia, Leukopenia, Pancytopenia, 
               
               
                   
                 Thrombocytopenia 
               
               
                   
                 Hepatic: Hepatitis, Hepatotoxicity, Liver failure, Vanishing bile 
               
               
                   
                 duct syndrome 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome 
               
               
                   
                 Neurologic: Acute intermittent porphyria 
               
               
                   
                 Renal: Azotemia, Renal failure 
               
               
                   
                 Respiratory: Pulmonary hypersensitivity 
               
               
                   
                 Other: Angioedema 
               
               
                 Gabitril 
                 Common: 
               
               
                   
                 Dermatologic: Pruritus (2%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (5% to 7%), Nausea (11%) 
               
               
                   
                 Neurologic: Asthenia (18% to 23%), Ataxia (5% to 9%), Confusion 
               
               
                   
                 (5%), Disturbance in speech (4%), Dizziness (27 to 31%), Feeling 
               
               
                   
                 nervous (10% to 14%), Insomnia (5% to 6%), Somnolence (18% to 
               
               
                   
                 21%), Tremor (9% to 21%), Unable to concentrate (6% to 14%) 
               
               
                   
                 Respiratory: Pharyngitis (7% to 8%) 
               
               
                   
                 Serious: 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Neurologic: Seizure, in patients without epilepsy, Status 
               
               
                   
                 epilepticus, Status epilepticus, in patients without a history of 
               
               
                   
                 seizure 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                 Gilenya 
                 Common: 
               
               
                   
                 Gastrointestinal: Abdominal pain (11%), Diarrhea (13%) 
               
               
                   
                 Hepatic: Increased liver enzymes (All elevations 
               
               
                   
                 (ALT/GGT/AST), 15%; up to 3 times ULN (ALT, AST), 14%; 5 
               
               
                   
                 times ULN or greater (ALT, AST), 4.5%) 
               
               
                   
                 Immunologic: Influenza (11%) 
               
               
                   
                 Musculoskeletal: Backache (10%), Pain, In Extremity (10%) 
               
               
                   
                 Neurologic: Headache (25%) 
               
               
                   
                 Respiratory: Cough (12%), Sinusitis (11%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Atrioventricular block (up to 4.7%), 
               
               
                   
                 Bradyarrhythmia (3%.) 
               
               
                   
                 Dermatologic: Malignant melanoma 
               
               
                   
                 Hematologic: Lymphocytopenia (Severe) (7%) 
               
               
                   
                 Immunologic: Cryptococcosis, Herpesvirus infection (9%), 
               
               
                   
                 Infectious disease (All infections, 72%; serious infections, 2.3%) 
               
               
                   
                 Neurologic: Cryptococcal meningitis, Posterior reversible 
               
               
                   
                 encephalopathy syndrome, Progressive multifocal 
               
               
                   
                 leukoencephalopathy 
               
               
                   
                 Ophthalmic: Macular retinal edema (0.5% to 1.5%) 
               
               
                 Gleevec 
                 Common: 
               
               
                   
                 Cardiovascular: Edema 
               
               
                   
                 Dermatologic: Night sweats (13% to 17%), Rash (Adult, 8.9% to 
               
               
                   
                 38.1%; pediatric, acute lymphocytic leukemia, grade 3 or 4, 4%) 
               
               
                   
                 Endocrine metabolic: Weight increased (5% to 32%) 
               
               
                   
                 Gastrointestinal: Diarrhea (Adult, 25% to 59.3%; pediatric, acute 
               
               
                   
                 lymphoblastic leukemia, grade 3 or 4, 9%), Nausea (Adults, 41.7% 
               
               
                   
                 to 73%; pediatric, acute lymphoblastic leukemia, grade 3 or 4, 
               
               
                   
                 16%), Vomiting (10.8% to 58%) 
               
               
                   
                 Musculoskeletal: Arthralgia (8.8% to 40%), Cramp (28% to 62%), 
               
               
                   
                 Musculoskeletal pain (Chronic myeloid leukemia, 20.5% to 49%), 
               
               
                   
                 Myalgia (Adult, 9% to 33.2%; pediatric, acute lymphoblastic 
               
               
                   
                 leukemia grade 3 or 4, 5%), Spasm (16.3% to 49%) 
               
               
                   
                 Neurologic: Asthenia (12% to 21%), Dizziness (4.6% to 16%), 
               
               
                   
                 Headache (8.2% to 36%), Insomnia (9.8% to 14%) 
               
               
                   
                 Respiratory: Cough (13% to 27%), Nasopharyngitis (1% to 30.5%), 
               
               
                   
                 Pain, Pharyngolaryngeal (Chronic myeloid leukemia, 18.1%), 
               
               
                   
                 Pharyngitis (Chronic myeloid leukemia, 10% to 15%) 
               
               
                   
                 Other: Fatigue (20% to 57%), Fever (6.2% to 41%), Influenza 
               
               
                   
                 (Chronic myeloid leukemia, 0.8% to 13.8%), Rigor (10% to 12%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Cardiac tamponade, Cardiogenic shock, 
               
               
                   
                 Congestive heart failure (0.1% to 1%) 
               
               
                   
                 Dermatologic: Bullous eruption (0.1% to 1%), Erythema 
               
               
                   
                 multiforme (0.01% to 0.1%), Stevens-Johnson syndrome (0.01% to 
               
               
                   
                 0.1%), Toxic epidermal necrolysis 
               
               
                   
                 Gastrointestinal: Gastrointestinal perforation, Pancreatitis (0.1% to 
               
               
                   
                 1%) 
               
               
                   
                 Hematologic: Anemia (Up to 42%), Febrile neutropenia (1% to 
               
               
                   
                 10%), Hemorrhage (All grades, 1% to 53%; grade 3 or 4, 0% to 
               
               
                   
                 19%), Neutropenia (Grade 3 or 4, 3.1% to 64%), Pancytopenia (1% 
               
               
                   
                 to 10%), Thrombocytopenia (Chronic myeloid leukemia (CML), 
               
               
                   
                 grade 3, 8.5% to 30%; CML, grade 4, up to 33%; 
               
               
                   
                 dermatofibrosarcoma protuberans (oral route): 17%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised (grade 3 and above, up to 7%), 
               
               
                   
                 Ascites (0.1% to 1%), AST/SGOT level raised, Hepatic necrosis 
               
               
                   
                 (0.01% to 0.1%), Hepatotoxicity (chronic myeloid leukemia: all 
               
               
                   
                 grades, 6% to 12%), Liver failure (0.01% to 0.1%) 
               
               
                   
                 Neurologic: Cerebral edema, Raised intracranial pressure (0.01% to 
               
               
                   
                 0.1%) 
               
               
                   
                 Ophthalmic: Optic disc edema (0.01% to 0.1%) 
               
               
                   
                 Otic: Sensorineural hearing loss 
               
               
                   
                 Renal: Acute renal failure (0.1% to 1%) 
               
               
                   
                 Respiratory: Acute respiratory failure, Hypoxia (Pediatrics, acute 
               
               
                   
                 lymphoblastic leukemia, grade 3 or 4, 9%), Pleural effusion 
               
               
                   
                 (Pediatrics, acute lymphoblastic leukemia, grade 3 or 4, 7%), 
               
               
                   
                 Pneumonia (Chronic myeloid leukemia, 4% to 13%), Pneumonitis 
               
               
                   
                 (Pediatric, acute lymphoblastic leukemia, grade 3 or 4, 8%) 
               
               
                   
                 Other: Secondary malignant neoplastic disease, Tumor lysis 
               
               
                   
                 syndrome 
               
               
                 Hysingla ER 
                 Common: 
               
               
                   
                 Cardiovascular: Peripheral edema (1% to less than 5%%) 
               
               
                   
                 Dermatologic: Pruritus (0% to less than 5%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1% to less than 5%), 
               
               
                   
                 Constipation (3% to 11%), Nausea (7% to 10%), Vomiting (3% to 
               
               
                   
                 6%), Xerostomia (1% to less than 5%) 
               
               
                   
                 Musculoskeletal: Spasm (1% to less than 5%) 
               
               
                   
                 Neurologic: Dizziness (2% to 3%), Headache (2% to 4%), 
               
               
                   
                 Somnolence (1% to 5%), Tremor (3%) 
               
               
                   
                 Renal: Urinary tract infectious disease (1% to 5%) 
               
               
                   
                 Respiratory: Upper respiratory infection (1% to 3%) 
               
               
                   
                 Other: Fatigue (1% to 4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Hypotension (less than 1%), Orthostatic 
               
               
                   
                 hypotension (less than 1%), Prolonged QT interval, Syncope 
               
               
                   
                 Gastrointestinal: Difficulty swallowing (less than 1%) 
               
               
                   
                 Neurologic: Raised intracranial pressure, Seizure 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug withdrawal syndrome in neonate of dependent mother, 
               
               
                   
                 Opioid withdrawal (less than 1%) 
               
               
                 Kuvan 
                 Common: 
               
               
                   
                 Gastrointestinal: Diarrhea (4% or more), Vomiting (4% or more) 
               
               
                   
                 Neurologic: Headache (4% or greater) 
               
               
                   
                 Respiratory: Cough (4% or more), Nasal congestion (4% or more), 
               
               
                   
                 Nasal discharge (4% or more), Pain in throat (4% or more), Upper 
               
               
                   
                 respiratory infection (17%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Myocardial infarction 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage 
               
               
                   
                 Hematologic: Hemorrhage, Post-procedural 
               
               
                   
                 Neurologic: Seizure 
               
               
                   
                 Respiratory: Respiratory failure 
               
               
                 Lamictal XR 
                 Common: 
               
               
                   
                 Dermatologic: Rash (7% to 14%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (immediate-release, 5% to 10%), 
               
               
                   
                 Diarrhea (immediate-release, 6% to 11%; extended-release, 5%), 
               
               
                   
                 Indigestion (immediate-release, 2% to 7%), Nausea (immediate- 
               
               
                   
                 release, 7% to 25%; extended-release, 7%), Vomiting (immediate- 
               
               
                   
                 release, 5% to 20%; extended-release, 6%)) 
               
               
                   
                 Neurologic: Asthenia (immediate-release, 2% to 8%; extended- 
               
               
                   
                 release, 6%), Ataxia (immediate-release, 2% to 11%), Coordination 
               
               
                   
                 problem (immediate-release, 6% to 7%; extended-release, 3%), 
               
               
                   
                 Dizziness (immediate-release, 7% to 54%; extended release, 14%), 
               
               
                   
                 Headache (immediate-release, 29%), Insomnia (immediate-release, 
               
               
                   
                 5% to 10%), Somnolence (immediate-release, 9% to 17%; 
               
               
                   
                 extended-release, 5%), Tremor (immediate-release, 4% to 10%; 
               
               
                   
                 extended-release, 6%), Vertigo (immediate-release, 2%; extended- 
               
               
                   
                 release, 3%) 
               
               
                   
                 Ophthalmic: Blurred vision (immediate-release, 11% to 25% 
               
               
                   
                 (adults) and 4% (children); extended-release, 3%), Diplopia 
               
               
                   
                 (immediate-release, 24% to 49% (adults) and 5% (children); 
               
               
                   
                 extended-release, 5%) 
               
               
                   
                 Psychiatric: Anxiety (immediate-release, 4%; extended-release, 
               
               
                   
                 3%), Depression (immediate-release, 4%; extended-release, 3%) 
               
               
                   
                 Reproductive: Dysmenorrhea (immediate-release, 5% to 7%) 
               
               
                   
                 Respiratory: Rhinitis (immediate-release, 7% to 14%) 
               
               
                   
                 Other: Pain (immediate-release, 5%) 
               
               
                   
                 Serious: 
               
               
                   
                 Dermatologic: Erythema multiforme (less than 0.1%), Rash, 
               
               
                   
                 Serious (0.08% to 0.8%), Stevens-Johnson syndrome (0.08% to 
               
               
                   
                 0.8%.), Toxic epidermal necrolysis (0.08% to 0.8%) 
               
               
                   
                 Hematologic: Anemia (immediate release, less than 0.1%), 
               
               
                   
                 Disseminated intravascular coagulation, Eosinophilia (immediate 
               
               
                   
                 release, less than 0.1%), Leukopenia (immediate release, 0.1% to 
               
               
                   
                 1%), Thrombocytopenia (immediate release, less than 0.1%) 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome 
               
               
                   
                 Neurologic: Aseptic meningitis 
               
               
                   
                 Other: Angioedema (less than 0.1%), Neuroleptic malignant 
               
               
                   
                 syndrome 
               
               
                 Latuda 
                 Common: 
               
               
                   
                 Gastrointestinal: Diarrhea (3% to 5%), Nausea (10% to 17%), 
               
               
                   
                 Vomiting (2% to 8%) 
               
               
                   
                 Neurologic: Akathisia (5.6% to 22%), Extrapyramidal disease 
               
               
                   
                 (10% to 39%), Parkinsonism (5% to 17%), Somnolence (7.3% to 
               
               
                   
                 26.5%) 
               
               
                   
                 Psychiatric: Anxiety (4% to 5%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Orthostatic hypotension (0.3% to 2.1%), Syncope 
               
               
                   
                 (0.1%) 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Neurologic: Cerebrovascular accident (0.1% to 1%), Seizure (less 
               
               
                   
                 than 1%), Tardive dyskinesia, Transient ischemic attack 
               
               
                   
                 Psychiatric: Suicidal thoughts (0.4% to 1.1%) 
               
               
                   
                 Renal: Serum creatinine raised (2% to 4%) 
               
               
                   
                 Other: Neuroleptic malignant syndrome 
               
               
                 Minastrin 24 FE 
                 Common: 
               
               
                   
                 Dermatologic: Acne (2.7%) 
               
               
                   
                 Endocrine metabolic: Abnormal weight gain (2%) 
               
               
                   
                 Gastrointestinal: Nausea (4.6%), Vomiting (2% to 6%) 
               
               
                   
                 Neurologic: Headache (6.3%) 
               
               
                   
                 Psychiatric: Mood swings (2.2%) 
               
               
                   
                 Reproductive: Abnormal cervical smear (3.1%), Amenorrhea (22% 
               
               
                   
                 to 36%), Bacterial vaginosis (3.1%), Breast tenderness (3.4%), 
               
               
                   
                 Candida vaginitis (6.1%), Intermenstrual bleeding - irregular (24 to 
               
               
                   
                 35%), Menstrual cramp (4.4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Myocardial infarction 
               
               
                   
                 Hematologic: Arterial thrombosis, Venous thromboembolism 
               
               
                   
                 Hepatic: Adenoma of liver, Liver carcinoma 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                   
                 Ophthalmic: Thrombosis of retinal vein 
               
               
                 Nexavar 
                 Common: 
               
               
                   
                 Cardiovascular: Hypertension, All grades (19.1%) 
               
               
                   
                 Dermatologic: Acral erythema (hepatocellular carcinoma, 21%; 
               
               
                   
                 renal cell carcinoma, 30%; thyroid carcinoma, 69%), Alopecia 
               
               
                   
                 (hepatocellular carcinoma, 14%; renal cell carcinoma, 27%; thyroid 
               
               
                   
                 carcinoma, 67%), Peeling of skin, Rash (up to 35%) 
               
               
                   
                 Endocrine metabolic: Hypoalbuminemia (hepatocellular carcinoma, 
               
               
                   
                 59%), Hypocalcemia (hepatocellular carcinoma, 27%; renal cell 
               
               
                   
                 carcinoma, 12%; thyroid carcinoma, 36%), Hypophosphatemia 
               
               
                   
                 (35% to 45%), Raised TSH level (thyroid carcinoma, 41%), Weight 
               
               
                   
                 decreased (hepatocellular carcinoma, 30%; renal cell carcinoma, 
               
               
                   
                 10%; thyroid carcinoma, 49%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (renal cell carcinoma, 11%; 
               
               
                   
                 hepatocellular carcinoma, 31%; thyroid carcinoma, 20%), Decrease 
               
               
                   
                 in appetite (thyroid carcinoma, 30%), Diarrhea (43% to 68%), 
               
               
                   
                 Increased serum lipase level (40% to 41%), Loss of appetite (16% 
               
               
                   
                 to 29%), Nausea (21% to 24%), Serum amylase raised (30% to 
               
               
                   
                 34%) 
               
               
                   
                 Hematologic: Lymphocytopenia (renal cell carcinoma, 23%; 
               
               
                   
                 hepatocellular carcinoma, 47%), Thrombocytopenia (renal cell 
               
               
                   
                 carcinoma; 12%; hepatocellular carcinoma, 46%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised, All grades (thyroid carcinoma, 
               
               
                   
                 59%), AST/SGOT level raised, All grades (thyroid carcinoma, 
               
               
                   
                 54%) 
               
               
                   
                 Immunologic: Infectious disease (10% or greater) 
               
               
                   
                 Other: Fatigue (37% to 46%), Pain (10% or greater) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Congestive heart failure (1.9%), Hypertension, 
               
               
                   
                 Grade 3 or 4 (4.3%), Hypertensive crisis (0.1% to less than 1%), 
               
               
                   
                 Myocardial infarction, Myocardial ischemia, Prolonged QT interval 
               
               
                   
                 (Less than 0.1%) 
               
               
                   
                 Dermatologic: Squamous cell carcinoma of skin (thyroid 
               
               
                   
                 carcinoma, 3%), Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage, Gastrointestinal 
               
               
                   
                 perforation (0.1% to less than 1%), Pancreatitis (0.1% to less than 
               
               
                   
                 1%) 
               
               
                   
                 Hematologic: Hemorrhage (renal cell carcinoma, 15.3%; thyroid 
               
               
                   
                 carcinoma, 17.4%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised, Grade 3 or higher (thyroid 
               
               
                   
                 carcinoma, 4%), AST/SGOT level raised, Grade 3 or 4 (thyroid 
               
               
                   
                 carcinoma, 2%), Hepatitis (less than 0.1%) 
               
               
                   
                 Neurologic: Cerebral hemorrhage (0.1% to less than 1%), Posterior 
               
               
                   
                 reversible encephalopathy syndrome (0.1% to less than 1%) 
               
               
                   
                 Respiratory: Interstitial lung disease (0.1% to less than 1%), 
               
               
                   
                 Respiratory tract hemorrhage 
               
               
                 Noxafil 
                 Common: 
               
               
                   
                 Endocrine metabolic: Hypokalemia (prophylaxis, 22% to 30%) 
               
               
                   
                 Gastrointestinal: Diarrhea (prophylaxis, 29% to 42%; 
               
               
                   
                 oropharyngeal candidiasis, 10%; refractory oropharyngeal 
               
               
                   
                 candidiasis, 13%), Nausea (prophylaxis, 19% to 38%; 
               
               
                   
                 oropharyngeal candidiasis, 9%; refractory oropharyngeal 
               
               
                   
                 candidiasis, 29%), Vomiting (prophylaxis, 12% to 29%; 
               
               
                   
                 oropharyngeal candidiasis, 7%; refractory oropharyngeal 
               
               
                   
                 candidiasis, 28%) 
               
               
                   
                 Neurologic: Headache (prophylaxis, 14% to 28%; oropharyngeal 
               
               
                   
                 candidiasis, 8%; refractory oropharyngeal candidiasis, 20%) 
               
               
                   
                 Other: Fever (prophylaxis, 21% to 45%; oropharyngeal candidiasis, 
               
               
                   
                 6%; refractory oropharyngeal candidiasis, 34%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Prolonged QT interval (1% to 2%), Torsades de 
               
               
                   
                 pointes (less than 5%) 
               
               
                   
                 Hepatic: Cholestasis (rare), Liver failure (rare) 
               
               
                 Pradaxa 
                 Common: 
               
               
                   
                 Gastrointestinal: Esophagitis, Gastritis, Gastroesophageal reflux 
               
               
                   
                 disease (Atrial fibrillation, 5.5%), Gastrointestinal hemorrhage 
               
               
                   
                 (DVT and pulmonary embolism, 0.7% to 3.1%; nonvalvular atrial 
               
               
                   
                 fibrillation, 6.1%), Gastrointestinal ulcer, Indigestion (DVT and 
               
               
                   
                 pulmonary embolism, 7.5%) 
               
               
                   
                 Hematologic: Bleeding (DVT and pulmonary embolism 
               
               
                   
                 prophylaxis, 10.5%; nonvalvular atrial fibrillation, 16.6%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Myocardial infarction (DVT and pulmonary 
               
               
                   
                 embolism, 0.32% to 0.66%; nonvalvular atrial fibrillation, 0.7%) 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage, Major (DVT and 
               
               
                   
                 pulmonary embolism, 0.3% to 0.6%; nonvalvular atrial fibrillation, 
               
               
                   
                 1.6%) 
               
               
                   
                 Hematologic: Bleeding, Major (DVT and pulmonary embolism, 
               
               
                   
                 0.3% to 1.4%; nonvalvular atrial fibrillation, 3.3%), Thrombosis 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Epidural hematoma, Intracranial hemorrhage 
               
               
                   
                 (nonvalvular atrial fibrillation, 0.3%; DVT and pulmonary 
               
               
                   
                 embolism, 0.1%), Traumatic spinal subdural hematoma 
               
               
                   
                 Respiratory: Bleeding, Alveolar 
               
               
                 Promacta 
                 Common: 
               
               
                   
                 Gastrointestinal: Diarrhea (Chronic hepatitis C-associated 
               
               
                   
                 thrombocytopenia, 19%; chronic idiopathic thrombocytopenic 
               
               
                   
                 purpura, adults, 9%, pediatric, 5%; aplastic anemia, 21%), Nausea 
               
               
                   
                 (Chronic hepatitis C-associated thrombocytopenia, 19%; chronic 
               
               
                   
                 idiopathic thrombocytopenic purpura, 4% to 9%; aplastic anemia, 
               
               
                   
                 33%), Pain in throat (Chronic idiopathic thrombocytopenic 
               
               
                   
                 purpura, 4%; aplastic anemia, 14% 4%), Pharyngitis (4%), 
               
               
                   
                 Vomiting (6%) 
               
               
                   
                 Hematologic: Anemia (chronic hepatitis C-associated 
               
               
                   
                 thrombocytopenia, 40%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised (Chronic idiopathic 
               
               
                   
                 thrombocytopenic purpura, 5% to 6%; chronic ITP, pediatric, 6%), 
               
               
                   
                 AST/SGOT level raised (Adult, 4%; pediatric, 5%), 
               
               
                   
                 Hyperbilirubinemia (6% to 8%) 
               
               
                   
                 Musculoskeletal: Myalgia (2% to 12%) 
               
               
                   
                 Neurologic: Headache (Chronic hepatitis C-associated 
               
               
                   
                 thrombocytopenia and aplastic anemia, 21%; chronic idiopathic 
               
               
                   
                 thrombocytopenic purpura, 10%) 
               
               
                   
                 Ophthalmic: Cataract (4% to 7%) 
               
               
                   
                 Renal: Urinary tract infectious disease (5%) 
               
               
                   
                 Respiratory: Cough (Aplastic anemia, 23%; chronic ITP, pediatric, 
               
               
                   
                 9%), Epistaxis (13%) 
               
               
                   
                 Other: Fatigue (Chronic hepatitis C-associated thrombocytopenia 
               
               
                   
                 and aplastic anemia, 28%; chronic idiopathic thrombocytopenic 
               
               
                   
                 purpura, 4%), Fever (Chronic hepatitis C-associated 
               
               
                   
                 thrombocytopenia, 30%; aplastic anemia, 14%) 
               
               
                   
                 Serious: 
               
               
                   
                 Hematologic: Bleeding, Portal vein thrombosis (chronic hepatitis 
               
               
                   
                 C-associated thrombocytopenia, 1%), Thrombosis (chronic 
               
               
                   
                 hepatitis C-associated thrombocytopenia, 3%) 
               
               
                   
                 Hepatic: Hepatotoxicity, Liver failure (chronic hepatitis C- 
               
               
                   
                 associated thrombocytopenia, 7%), Liver function tests abnormal 
               
               
                   
                 (11%) 
               
               
                   
                 Renal: Acute renal failure 
               
               
                 Promacta 
               
               
                 Suboxone 
                 Common: 
               
               
                   
                 Dermatologic: Hyperhidrosis (SL tablet, 14%; buccal film, 1% to 
               
               
                   
                 less than 5%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (SL tablet, 11.2%), Constipation 
               
               
                   
                 (SL tablet, 12.1%; buccal film, 1% to less than 5%), Nausea (SL 
               
               
                   
                 tablet, induction phase, 5%; long-term use, 15%), Vomiting (SL 
               
               
                   
                 tablet, 5% to 7.5%) 
               
               
                   
                 Neurologic: Headache (SL tablet, induction phase, 7%; long-term 
               
               
                   
                 use, 36.4%; buccal film, 5% or greater), Insomnia (SL tablet, 14%; 
               
               
                   
                 buccal film, greater than 1% and less than 5%) 
               
               
                   
                 Other: Drug withdrawal (SL tablet, 25.2%; buccal film, at least 
               
               
                   
                 5%), Pain (SL tablet, 22.4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Hepatic: Hepatitis 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Central nervous system depression 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug dependence (Buccal film, 1% to less than 5%) 
               
               
                 Tekturna HCT 
                 Common: 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (0.8% to 36.9%), 
               
               
                   
                 Hypokalemia (2.2%) 
               
               
                   
                 Gastrointestinal: Diarrhea (1.6%) 
               
               
                   
                 Neurologic: Dizziness (2.3%) 
               
               
                   
                 Renal: Serum blood urea nitrogen raised (11.8%) 
               
               
                   
                 Respiratory: Cough (1.3%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Ophthalmic: Angle-closure glaucoma, acute, Myopia (Acute), 
               
               
                   
                 Transient 
               
               
                 Thalomid 
                 Common: 
               
               
                   
                 Cardiovascular: Edema (multiple myeloma, 13% to 56%), 
               
               
                   
                 Peripheral edema (erythema nodosum leprosum, 3.1% to 8.3%; 
               
               
                   
                 multiple myeloma, 34%) 
               
               
                   
                 Dermatologic: Dry skin (multiple myeloma, 21%), Rash (erythema 
               
               
                   
                 nodosum leprosum, 20.8%) 
               
               
                   
                 Endocrine metabolic: Hypocalcemia (multiple myeloma, 72%), 
               
               
                   
                 Weight gain (multiple myeloma, 3% to 22%), Weight loss 
               
               
                   
                 (multiple myeloma, 23%) 
               
               
                   
                 Gastrointestinal: Constipation (erythema nodosum leprosum, 2.8% 
               
               
                   
                 to 9.4%; multiple myeloma, 50% to 55%), Diarrhea (erythema 
               
               
                   
                 nodosum leprosum, 4.2% to 18.7%), Indigestion (multiple 
               
               
                   
                 myeloma, 11%), Nausea (erythema nodosum leprosum, 4.2%; 
               
               
                   
                 multiple myeloma, 13% to 28%) 
               
               
                   
                 Hematologic: Leukopenia (erythema nodosum, 16.7% to 25%; 
               
               
                   
                 multiple myeloma, 35%) 
               
               
                   
                 Musculoskeletal: Muscle weakness (multiple myeloma, 40%) 
               
               
                   
                 Neurologic: Asthenia (erythema nodosum leprosum, 5.6% to 
               
               
                   
                 21.9%; multiple myeloma, 24%), Confusional state (multiple 
               
               
                   
                 myeloma, 28%), Dizziness (erythema nodosum leprosum, 4.2% to 
               
               
                   
                 19.2%; multiple myeloma, 23%), Somnolence (erythema nodosum 
               
               
                   
                 leprosum, 36.1% to 37.5%; multiple myeloma, 3% or more), 
               
               
                   
                 Tremor (erythema nodosum leprosum, 4.2%; multiple myeloma, 
               
               
                   
                 26%) 
               
               
                   
                 Respiratory: Dyspnea (multiple myeloma, 42%), Pneumonia 
               
               
                   
                 (multiple myeloma, 15%) 
               
               
                   
                 Other: Fatigue (multiple myeloma, 21% to 79%), Fever (erythema 
               
               
                   
                 nodosum leprosum, 19.4% to 21.9%; multiple myeloma, 24%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Atrial fibrillation, Grade 3/4 (multiple myeloma, 
               
               
                   
                 5%), Cardiac dysrhythmia, Ischemic heart disease (11.1%), 
               
               
                   
                 Myocardial infarction (1.3%) 
               
               
                 Tikosyn 
                 Common: 
               
               
                   
                 Cardiovascular: Chest pain (10%) 
               
               
                   
                 Neurologic: Dizziness (8%), Headache (11%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Heart block (up to 1.2%), Prolonged QT interval, 
               
               
                   
                 Torsades de pointes (0.8%), Ventricular arrhythmia (up to 14.5%), 
               
               
                   
                 Ventricular fibrillation (up to 4.8%), Ventricular tachycardia (up to 
               
               
                   
                 12.4%) 
               
               
                 Tradjenta 
                 Common: 
               
               
                   
                 Endocrine metabolic: Hypoglycemia (monotherapy, 6.6%; 
               
               
                   
                 combination therapy, 22.9%) 
               
               
                   
                 Respiratory: Nasopharyngitis (7%) 
               
               
                   
                 Serious: 
               
               
                   
                 Gastrointestinal: Pancreatic cancer, Pancreatitis 
               
               
                   
                 Immunologic: Anaphylaxis, Hypersensitivity reaction 
               
               
                   
                 Other: Angioedema, Pancreatic cancer 
               
               
                 Trokendi XR 
                 Common: 
               
               
                   
                 Dermatologic: Flushing (pediatrics, 5%) 
               
               
                   
                 Endocrine metabolic: Serum bicarbonate level abnormal (25% to 
               
               
                   
                 67%) 
               
               
                   
                 Gastrointestinal: Loss of appetite (10% to 24%), Weight decreased 
               
               
                   
                 (4% to 21%) 
               
               
                   
                 Immunologic: Infectious disease (2% to 8%) 
               
               
                   
                 Neurologic: Confusion (3% to 11%), Dizziness (4% to 25%), 
               
               
                   
                 Impaired cognition (2% to 7%), Impaired psychomotor 
               
               
                   
                 performance (2% to 13%), Memory impairment (3% to 12%), 
               
               
                   
                 Paresthesia (1% to 51%), Reduced concentration span (2% to 
               
               
                   
                 10%), Somnolence (6% to 29%) 
               
               
                   
                 Psychiatric: Feeling nervous (4% to 16%), Mood disorder (4% to 
               
               
                   
                 11%) 
               
               
                   
                 Other: Fatigue (6% to 16%), Fever (1% to 12%) 
               
               
                   
                 Serious: 
               
               
                   
                 Dermatologic: Erythema multiforme, Stevens-Johnson syndrome, 
               
               
                   
                 Toxic epidermal necrolysis 
               
               
                   
                 Endocrine metabolic: Hyperammonemia (Adolescents, 26%), 
               
               
                   
                 Hypohidrosis, Increased body temperature, Metabolic acidosis 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Neurologic: Drug-induced encephalopathy 
               
               
                   
                 Ophthalmic: Glaucoma, Myopia, Visual field defect (epilepsy, 
               
               
                   
                 0.1% to 1%) 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                   
                 Renal: Nephrolithiasis (adults, 1% to 3%) 
               
               
                 Viibryd 
                 Common: 
               
               
                   
                 Gastrointestinal: Diarrhea (26% to 29%), Nausea (22% to 24%), 
               
               
                   
                 Vomiting (4% to 5%) 
               
               
                   
                 Neurologic: Insomnia (6% to 7%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Ventricular premature beats (0.1% to 1%) 
               
               
                   
                 Psychiatric: Suicidal behavior, Suicidal thoughts 
               
               
                   
                 Other: Drug withdrawal, Serotonin syndrome (0.1%) 
               
               
                 Xartemis XR 
                 Common: 
               
               
                   
                 Gastrointestinal: Constipation (extended-release, 4%), Nausea 
               
               
                   
                 (extended-release, 31%), Vomiting (extended-release, 9%) 
               
               
                   
                 Neurologic: Dizziness (extended-release, 13%), Headache 
               
               
                   
                 (extended-release, 10%), Lightheadedness, Sedated, Somnolence 
               
               
                   
                 (extended-release, 4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Disorder of pulmonary circulation, Hypotension, 
               
               
                   
                 Shock 
               
               
                   
                 Dermatologic: Acute generalized exanthematous pustulosis, 
               
               
                   
                 Stevens-Johnson syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Hematologic: Agranulocytosis, Neutropenia 
               
               
                   
                 Hepatic: Hepatic necrosis, Hepatotoxicity, Liver failure 
               
               
                   
                 Immunologic: Anaphylaxis, Hypersensitivity reaction 
               
               
                   
                 Respiratory: Apnea, Respiratory arrest, Respiratory depression 
               
               
                   
                 Other: Neonatal Abstinence Syndrome 
               
               
                 Zohydro ER 
                 Common: 
               
               
                   
                 Cardiovascular: Peripheral edema (1% to less than 5%%) 
               
               
                   
                 Dermatologic: Pruritus (0% to less than 5%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1% to less than 5%), 
               
               
                   
                 Constipation (3% to 11%), Nausea (7% to 10%), Vomiting (3% to 
               
               
                   
                 6%), Xerostomia (1% to less than 5%) 
               
               
                   
                 Musculoskeletal: Spasm (1% to less than 5%) 
               
               
                   
                 Neurologic: Dizziness (2% to 3%), Headache (2% to 4%), 
               
               
                   
                 Somnolence (1% to 5%), Tremor (3%) 
               
               
                   
                 Renal: Urinary tract infectious disease (1% to 5%) 
               
               
                   
                 Respiratory: Upper respiratory infection (1% to 3%) 
               
               
                   
                 Other: Fatigue (1% to 4%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Hypotension (less than 1%), Orthostatic 
               
               
                   
                 hypotension (less than 1%), Prolonged QT interval, Syncope 
               
               
                   
                 Gastrointestinal: Difficulty swallowing (less than 1%) 
               
               
                   
                 Neurologic: Raised intracranial pressure, Seizure 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug withdrawal syndrome in neonate of dependent mother, 
               
               
                   
                 Opioid withdrawal (less than 1%) 
               
               
                 Zorvolex 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation (5% to 8%), Diarrhea (6%), Nausea 
               
               
                   
                 (6% to 7%) 
               
               
                   
                 Hepatic: Increased liver function test (15%) 
               
               
                   
                 Neurologic: Headache (4% to 8%) 
               
               
                   
                 Renal: Urinary tract infectious disease (7%) 
               
               
                   
                 Respiratory: Nasopharyngitis (6%), Sinusitis (3% to 5%), Upper 
               
               
                   
                 respiratory infection (8%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction, Thrombosis 
               
               
                   
                 Dermatologic: Erythema multiforme, Erythroderma, Stevens- 
               
               
                   
                 Johnson syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage, Gastrointestinal 
               
               
                   
                 perforation 
               
               
                   
                 Hematologic: Aplastic anemia, Blood coagulation disorder, 
               
               
                   
                 Hemolytic anemia, Thrombocytopenia 
               
               
                   
                 Hepatic: Increased liver enzymes, Jaundice, Liver failure 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                   
                 Renal: Acute renal failure 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                 Zytiga 
                 Common 
               
               
                   
                 Dermatologic: Contusion (13.3%), Flushing (19% to 22.3%) 
               
               
                   
                 Endocrine metabolic: Hypercholesterolemia (Greater than 20%), 
               
               
                   
                 Hyperglycemia (56.6%), Hypertriglyceridemia (62.5%), 
               
               
                   
                 Hypophosphatemia (23.8%) 
               
               
                   
                 Gastrointestinal: Diarrhea (17.6% to 21.6%), Vomiting (10% or 
               
               
                   
                 higher) 
               
               
                   
                 Hematologic: Anemia (Greater than 20%), Lymphocytopenia, All 
               
               
                   
                 grades (38.2%) 
               
               
                   
                 Hepatic: Alkaline phosphatase raised (Greater than 20%) 
               
               
                   
                 Musculoskeletal: Joint swelling (29.5% to 30.3%) 
               
               
                   
                 Renal: Urinary tract infectious disease (11.5%) 
               
               
                   
                 Respiratory: Cough (10.6% to 17.3%), Dyspnea (11.8%) 
               
               
                   
                 Other: Fatigue (39.1%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia (7.2%), Cardiorespiratory 
               
               
                   
                 arrest (0.5%), Chest discomfort, Chest pain, Edema (25.1% to 
               
               
                   
                 26.7%), Heart failure (2.1% to 2.3%), Hypertension (8.5% to 
               
               
                   
                 21.6%), Myocardial infarction, Sudden cardiac death 
               
               
                   
                 Endocrine metabolic: Adrenal insufficiency (0.5%), Hypokalemia 
               
               
                   
                 (17.2% to 28.3%) 
               
               
                   
                 Hematologic: Lymphocytopenia, Grade 3 or 4 (8.7%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised (11.1% to 41.9%), AST/SGOT 
               
               
                   
                 level raised (30.6% to 37.3%), Serum bilirubin raised (6.6%) 
               
               
                 Seroquel (Quetiapine) 
                 Common: 
               
               
                   
                 Cardiovascular: Increased diastolic arterial pressure (Pediatric, 
               
               
                   
                 40.6%), Increased systolic arterial pressure (Pediatric, 15.2%), 
               
               
                   
                 Orthostatic hypotension (Up to 7%), Tachycardia (Up to 6%) 
               
               
                   
                 Endocrine metabolic: Serum cholesterol raised (7% to 18%), Serum 
               
               
                   
                 triglycerides raised (8% to 28%), Weight gain (3% to 28%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (3% to 7%), Constipation (2% to 
               
               
                   
                 11%), Increased appetite (2% to 12%), Indigestion (2% to 7%), 
               
               
                   
                 Nausea (Pediatric, 6% to 10%), Vomiting (Pediatric, 7% to 8%), 
               
               
                   
                 Xerostomia (Adult, 9% to 44%; pediatric, 4% to 10%) 
               
               
                   
                 Hepatic: Increased liver enzymes (1% to 6%) 
               
               
                   
                 Musculoskeletal: Backache (3% to 5%) 
               
               
                   
                 Neurologic: Asthenia (Up to 10%), Dizziness (8% to 19%), 
               
               
                   
                 Extrapyramidal disease (1.1% to 12.9%), Headache (17% to 21%), 
               
               
                   
                 Insomnia (8% to 12%), Lethargy (1% to 5%), Somnolence (18% to 
               
               
                   
                 57%), Tremor (2% to 8%) 
               
               
                   
                 Psychiatric: Agitation (6% to 20%) 
               
               
                   
                 Respiratory: Nasal congestion (3% to 5%), Pharyngitis (4% to 6%) 
               
               
                   
                 Other: Fatigue (3% to 14%), Pain (7%) 
               
               
                   
                 Serious: 
               
               
                   
                 Cardiovascular: Prolonged QT interval (0.1% to less than 1%), 
               
               
                   
                 Sudden cardiac death, Syncope (0.3% to 1%) 
               
               
                   
                 Endocrine metabolic: Diabetic ketoacidosis 
               
               
                   
                 Gastrointestinal: Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Leukopenia, Neutropenia (0.3% to 
               
               
                   
                 1.5%) 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Seizure (0.05% to 0.5%), Tardive dyskinesia 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                   
                 Reproductive: Priapism 
               
               
                   
                 Other: Neuroleptic malignant syndrome 
               
               
                 Pain Relievers 
               
               
                 Opioids 
               
               
                 Codeine 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation, Nausea, Vomiting 
               
               
                   
                 Neurologic: Dizziness, Lightheadedness, Sedated, Somnolence 
               
               
                   
                 Respiratory: Dyspnea 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Gastrointestinal: Bowel obstruction, Pancreatitis 
               
               
                   
                 Neurologic: CSF pressure: raised, Seizure 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                 Fentanyl and Analogs 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (up to 5% (buccal film)), Peripheral 
               
               
                   
                 edema (1% or greater (nasal spray); 5% to 32% (buccal tablet)) 
               
               
                   
                 Dermatologic: Application site reaction (10% (buccal tablet)), Rash 
               
               
                   
                 (3% to 8% (lozenge)) 
               
               
                   
                 Endocrine metabolic: Abnormal weight loss (up to 13% (buccal 
               
               
                   
                 tablet/film)), Hypokalemia (up to 15% (buccal tablet)) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1% or greater (nasal spray); up 
               
               
                   
                 to 15%), Constipation (4% to 26%), Diarrhea (up to 16% (buccal 
               
               
                   
                 tablet/film)), Loss of appetite (2% to 11% (buccal tablet/film)), 
               
               
                   
                 Nausea (5.6% to 42%), Vomiting (4% to 37%) 
               
               
                   
                 Hematologic: Anemia (1% or greater (nasal spray); 9% to 32% 
               
               
                   
                 (buccal tablet)), Neutropenia (1% or greater (nasal spray); up to 8% 
               
               
                   
                 (buccal tablet)) 
               
               
                   
                 Musculoskeletal: Arthralgia (up to 8% (buccal tablet)), Backache 
               
               
                   
                 (up to 11% (buccal tablet)) 
               
               
                   
                 Neurologic: Asthenia (up to 30% (lozenge, buccal tablet/film)), 
               
               
                   
                 Confusion (up to 16%), Dizziness (6% (nasal spray); up to 26% 
               
               
                   
                 (lozenge, sublingual, buccal tablet/film)), Headache (1% or greater 
               
               
                   
                 (nasal spray); up to 17% (lozenge, sublingual, buccal tablet/film)), 
               
               
                   
                 Insomnia (up to 11% (lozenge, buccal tablet/film)), Somnolence 
               
               
                   
                 (up to 15% (sublingual, buccal tablet)) 
               
               
                   
                 Psychiatric: Anxiety (3% to 9% (buccal film, lozenge)), Depression 
               
               
                   
                 (up to 11% (buccal tablet)) 
               
               
                   
                 Respiratory: Cough (up to 9%), Pneumonia (1% to 16% (buccal 
               
               
                   
                 tablet, nasal spray)) 
               
               
                   
                 Other: Dehydration (up to 21% (buccal tablet, film)), Fatigue (1% 
               
               
                   
                 to 20% (buccal tablet, film)) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Bradyarrhythmia (1% or greater (sublingual 
               
               
                   
                 tablet)), Cardiorespiratory arrest (1% or greater (nasal spray)), 
               
               
                   
                 Tachyarrhythmia (1% or greater (sublingual, buccal tablet/film)) 
               
               
                   
                 Gastrointestinal: Bowel obstruction (1% or greater (buccal film); up 
               
               
                   
                 to 4% (lozenge)) 
               
               
                   
                 Hematologic: Deep venous thrombosis (1% or greater (nasal 
               
               
                   
                 spray)) 
               
               
                   
                 Musculoskeletal: Muscle rigidity 
               
               
                   
                 Respiratory: Dyspnea (up to 19% (lozenge, buccal tablet/film)), 
               
               
                   
                 Respiratory depression 
               
               
                 (Causing Overdoses) 
               
               
                 Hydrocodone 
                 Common 
               
               
                   
                 Cardiovascular: Peripheral edema (1% to less than 5%%) 
               
               
                   
                 Dermatologic: Pruritus (0% to less than 5%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1% to less than 5%), 
               
               
                   
                 Constipation (3% to 11%), Nausea (7% to 10%), Vomiting (3% to 
               
               
                   
                 6%), Xerostomia (1% to less than 5%) 
               
               
                   
                 Musculoskeletal: Spasm (1% to less than 5%) 
               
               
                   
                 Neurologic: Dizziness (2% to 3%), Headache (2% to 4%), 
               
               
                   
                 Somnolence (1% to 5%), Tremor (3%) 
               
               
                   
                 Renal: Urinary tract infectious disease (1% to 5%) 
               
               
                   
                 Respiratory: Upper respiratory infection (1% to 3%) 
               
               
                   
                 Other: Fatigue (1% to 4%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypotension (less than 1%), Orthostatic 
               
               
                   
                 hypotension (less than 1%), Prolonged QT interval, Syncope 
               
               
                   
                 Gastrointestinal: Difficulty swallowing (less than 1%) 
               
               
                   
                 Neurologic: Raised intracranial pressure, Seizure 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug withdrawal syndrome in neonate of dependent mother, 
               
               
                   
                 Opioid withdrawal (less than 1%) 
               
               
                 Hydromorphone 
                 Common 
               
               
                   
                 Dermatologic: Flushing (extended-release, less than 2%), Pruritus 
               
               
                   
                 (extended-release, 1% to 8%), Sweating 
               
               
                   
                 Gastrointestinal: Constipation (extended-release, 7% to 31%), 
               
               
                   
                 Nausea (extended-release, 9% to 28%.), Vomiting (extended- 
               
               
                   
                 release, 6% to 14%) 
               
               
                   
                 Neurologic: Asthenia (1% to 11%), Dizziness (1% to 11%), 
               
               
                   
                 Headache (1% to 12%), Somnolence (less than 2%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypotension (less than 2%), Syncope (less than 
               
               
                   
                 2%) 
               
               
                   
                 Neurologic: Coma, Myoclonus (less than 2%), Raised intracranial 
               
               
                   
                 pressure, Seizure (less than 2%) 
               
               
                   
                 Psychiatric: Suicidal thoughts (extended-release, less than 2%) 
               
               
                   
                 Respiratory: Apnea (less than 1%), Respiratory arrest, Respiratory 
               
               
                   
                 depression (less than 2%) 
               
               
                   
                 Other: Drug dependence (less than 1%), Drug withdrawal (less than 
               
               
                   
                 1%), Neonatal Abstinence Syndrome 
               
               
                 Methadone 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Endocrine metabolic: Diaphoresis 
               
               
                   
                 Gastrointestinal: Constipation, Nausea, Vomiting 
               
               
                   
                 Neurologic: Asthenia, Dizziness, Lightheadedness, Sedated 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Decreased vascular flow, left ventricle, Prolonged 
               
               
                   
                 QT interval, Torsades de pointes 
               
               
                   
                 Endocrine metabolic: Hypoglycemia 
               
               
                   
                 Respiratory: Respiratory acidosis, Respiratory arrest, Respiratory 
               
               
                   
                 depression 
               
               
                   
                 Other: Drug dependence 
               
               
                 Oxycodone 
                 Common 
               
               
                   
                 Dermatologic: Pruritus (Adults, controlled-release, 13%; 
               
               
                   
                 immediate-release, 3% or greater; pediatrics, 6%), Sweating 
               
               
                   
                 (controlled-release, 5%; immediate-release, less than 3%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (up to 5%), Constipation (Adults, 
               
               
                   
                 controlled-release, 23%; immediate-release, 3% or greater; 
               
               
                   
                 pediatrics, 9%), Nausea (Adults, controlled-release, 23%; 
               
               
                   
                 immediate-release, 3% or greater; pediatrics, 15%), Vomiting 
               
               
                   
                 (Adults, controlled-release, 12%; immediate-release, 3% or greater; 
               
               
                   
                 pediatrics, 21%), Xerostomia (controlled-release, 6%; immediate- 
               
               
                   
                 release, less than 3%) 
               
               
                   
                 Neurologic: Asthenia (controlled-release, 6%; immediate-release, 
               
               
                   
                 3% or greater), Dizziness (Adults, controlled-release, 13%; 
               
               
                   
                 immediate-release, 3% or greater; pediatrics, 9%), Headache 
               
               
                   
                 (Adults, 3% or greater; pediatrics, 14%), Somnolence (controlled- 
               
               
                   
                 release, 23%; immediate-release, 3% or greater) 
               
               
                   
                 Other: Fever (Adults, up to 5%; pediatrics, 11%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac arrest, Chest pain (less than 1%), Heart 
               
               
                   
                 failure (less than 3%), Hypotension (less than 3%), Shock, ST 
               
               
                   
                 segment depression (less than 1%), Syncope (less than 1%) 
               
               
                   
                 Gastrointestinal: Bowel obstruction, Diverticulitis, Exacerbation 
               
               
                   
                 Immunologic: Hypersensitivity reaction (less than 3%) 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug withdrawal syndrome in neonate of dependent mother, 
               
               
                   
                 Opioid withdrawal (1% to 5%) 
               
               
                 Oxymorphone 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (less than 10%) 
               
               
                   
                 Dermatologic: Pruritus (less than or equal to 15.2%), Sweating 
               
               
                   
                 symptom (1% to less than 10%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1% to less than 10%), 
               
               
                   
                 Constipation (4.1% to 27.6%), Nausea (2.9% to 33.1%), Vomiting 
               
               
                   
                 (less than or equal to 15.6%), Xerostomia (1% to less than 10%) 
               
               
                   
                 Neurologic: Confusion (1% to less than 10%), Dizziness (5% to 
               
               
                   
                 17%), Headache (4% to 12%), Somnolence (2% to 19%) 
               
               
                   
                 Respiratory: Dyspnea (1% to less than 10%), Hypoxia (less than 
               
               
                   
                 10%) 
               
               
                   
                 Other: Fatigue (1% to less than 10%), Fever (1% to 14.2%) 
               
               
                   
                 Serious 
               
               
                   
                 Gastrointestinal: Bowel obstruction (less than 1%) 
               
               
                   
                 Neurologic: Coma 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Drug dependence, Drug withdrawal syndrome in neonate of 
               
               
                   
                 dependent mother 
               
               
                 Amytal (amobarbital) 
                 Common 
               
               
                   
                 Neurologic: Confusion, Dizziness, Headache, Somnolence 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome (rare) 
               
               
                   
                 Hematologic: Agranulocytosis (rare), Megaloblastic anemia, With 
               
               
                   
                 prolonged use (rare) 
               
               
                   
                 Hepatic: Injury of liver, With prolonged use (rare) 
               
               
                   
                 Respiratory: Apnea, Hypoventilation 
               
               
                 Nembutal (pentobarbital) 
                 Common 
               
               
                   
                 Neurologic: Confusion (less than 1%), Dizziness (less than 1%), 
               
               
                   
                 Somnolence (1% to 3%) 
               
               
                   
                 Psychiatric: Agitation (less than 1%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome (less than 1%) 
               
               
                   
                 Hematologic: Megaloblastic anemia (less than 1%) 
               
               
                   
                 Hepatic: Injury of liver (less than 1%) 
               
               
                   
                 Respiratory: Apnea (less than 1%), Hypoventilation (less than 1%) 
               
               
                 Seconal (secobarbital) 
                 Common 
               
               
                   
                 Neurologic: Somnolence (1% to 3%) 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Megaloblastic anemia, With prolonged use (less than 
               
               
                   
                 1%) 
               
               
                   
                 Hepatic: Liver damage (less than 1%) 
               
               
                   
                 Psychiatric: Complex mannerisms - behavior (Less than 1%.) 
               
               
                   
                 Other: Drug dependence, Withdrawal sign or symptom 
               
               
                 Adderall (Amphetamine) 
                 Common 
               
               
                   
                 Cardiovascular: Increased systolic arterial pressure (extended- 
               
               
                   
                 release: pediatrics, 7% to 35%) 
               
               
                   
                 Endocrine metabolic: Weight loss (extended-release: adults, 10%; 
               
               
                   
                 pediatrics, 4% to 9%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (extended-release: pediatrics, 
               
               
                   
                 11% to 14%), Loss of appetite (extended-release capsules: adults, 
               
               
                   
                 33%; pediatrics, 22% to 36%), Xerostomia (extended-release: 
               
               
                   
                 adults, 35%; pediatrics, 2% to 4%) 
               
               
                   
                 Neurologic: Dizziness, Headache (extended-release: adults, 26%), 
               
               
                   
                 Insomnia (extended-release: adults, 27%; pediatrics, 12% to 17%) 
               
               
                   
                 Psychiatric: Feeling nervous (extended release: adults, 13%; 
               
               
                   
                 pediatrics, 6%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiomyopathy, Myocardial infarction, Peripheral 
               
               
                   
                 vascular disease, Raynaud&#39;s disease, Sudden cardiac death 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Neurologic: Cerebrovascular accident, Seizure 
               
               
                   
                 Psychiatric: Psychotic disorder 
               
               
                 Methylphenidate 
                 Common 
               
               
                   
                 Cardiovascular: Tachycardia (Adult, 4.8%) 
               
               
                   
                 Dermatologic: Diaphoresis (Adult, 5.1%) 
               
               
                   
                 Endocrine metabolic: Weight decreased (Adult, 6.5%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (2% or greater), Decrease in 
               
               
                   
                 appetite (Adult, 25.3%; pediatric, 2% to 9% or greater), Loss of 
               
               
                   
                 appetite (Adult, 1.7%; pediatric, 3.1% to 9% or greater), Nausea 
               
               
                   
                 (Adult, 12.8%), Vomiting (2% or greater), Xerostomia (Adult, 
               
               
                   
                 14%) 
               
               
                   
                 Neurologic: Dizziness (Adult, 6.7%; pediatric, 1.9%.), Headache 
               
               
                   
                 (Adult, 22.2%; pediatric, up to 12%), Insomnia (Adult, 12.3%; 
               
               
                   
                 pediatric, 2.8% to 5%) 
               
               
                   
                 Psychiatric: Anxiety (Adult, 8.2%), Depression (Adult, 1.7% to 
               
               
                   
                 3.9%), Irritability (Adult, 5.8%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction, Raynaud&#39;s phenomenon, 
               
               
                   
                 Sudden cardiac death 
               
               
                   
                 Endocrine metabolic: Decreased body growth 
               
               
                   
                 Gastrointestinal: Gastrointestinal obstruction, With preexisting 
               
               
                   
                 severe gastrointestinal narrowing and use of controlled-release 
               
               
                   
                 formulations 
               
               
                   
                 Hepatic: Abnormal liver function 
               
               
                   
                 Neurologic: Cerebral artery occlusion, Cerebral hemorrhage, 
               
               
                   
                 Cerebrovascular accident, Seizure 
               
               
                   
                 Ophthalmic: Blurred vision (1.7% to 2% or greater) 
               
               
                   
                 Psychiatric: Aggressive behavior (Adult, 1.7%), Mania, Psychotic 
               
               
                   
                 disorder 
               
               
                   
                 Reproductive: Priapism 
               
               
                 Daytrana 
                 See Methylphenidate 
               
               
                 Concerta 
                 See Methylphenidate 
               
               
                 Ritalin 
                 See Methylphenidate 
               
               
                 Klonopin (clonazepam) 
                 Common 
               
               
                   
                 Neurologic: Ataxia (5% to 30%), Coordination problem (6%), 
               
               
                   
                 Dizziness (8%), Somnolence (37% to 50%) 
               
               
                   
                 Psychiatric: Problem behavior (25%) 
               
               
                   
                 Respiratory: Upper respiratory infection (8%) 
               
               
                   
                 Other: Fatigue (7%) 
               
               
                   
                 Serious 
               
               
                   
                 Psychiatric: Depression (7%), Suicidal thoughts 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                 Valium (diazepam) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Dermatologic: Rash (3%, rectal gel) 
               
               
                   
                 Gastrointestinal: Diarrhea (4%, rectal gel) 
               
               
                   
                 Musculoskeletal: Muscle weakness 
               
               
                   
                 Neurologic: Ataxia, Incoordination (3%, rectal gel), Somnolence 
               
               
                   
                 Psychiatric: Euphoria (3%, rectal gel) 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                   
                 Other: Fatigue 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Neutropenia 
               
               
                 Xanax (alprazolam) 
                 Common 
               
               
                   
                 Endocrine metabolic: Decrease in appetite (7.3% to 27.8%), 
               
               
                   
                 Increased appetite (7% to 32.7%), Weight increase (2.7% to 27.2%) 
               
               
                   
                 Gastrointestinal: Constipation (8.1% to 26.2%), Reduced salivation 
               
               
                   
                 (32.8%), Xerostomia (10.2% to 14.7%) 
               
               
                   
                 Neurologic: Cognitive disorder (28.8%), Confusion (1.5% to 
               
               
                   
                 10.4%), Dysarthria (10.9% to 23.3%), Incoordination (9.4% to 
               
               
                   
                 40.1%), Lightheadedness (20.8%), Memory impairment (15.4% to 
               
               
                   
                 33.1%), Sedated (45.2%), Somnolence (23% to 76.8%) 
               
               
                   
                 Psychiatric: Irritability (immediate-release, 33.1%; extended- 
               
               
                   
                 release 1% or more) 
               
               
                   
                 Reproductive: Reduced libido (6% to 14.4%) 
               
               
                   
                 Other: Fatigue (13.9% to 48.6%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                 Ambien (zolpidem) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea (1% to 3%), Nausea (1% to 7%) 
               
               
                   
                 Immunologic: Allergic reaction (4%) 
               
               
                   
                 Neurologic: Dizziness (1% to 23.5%), Drugged state (3%), 
               
               
                   
                 Headache (1% to 19%), Somnolence (2% to 15%) 
               
               
                   
                 Ophthalmic: Visual disturbance (3%) 
               
               
                   
                 Other: Fatigue (0.1% to 3%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Chest pain (1%), Tachycardia (0.1% to 1%) 
               
               
                   
                 Immunologic: Anaphylaxis (rare) 
               
               
                   
                 Neurologic: Hepatic encephalopathy 
               
               
                   
                 Psychiatric: Complex mannerisms - behavior, Depression, 
               
               
                   
                 worsening, Suicidal thoughts 
               
               
                   
                 Other: Angioedema (rare) 
               
               
                 Lunesta (eszopiclone) 
                 Common 
               
               
                   
                 Gastrointestinal: Disorder of taste (8% to 34%), Vomiting (3%) 
               
               
                   
                 Neurologic: Dizziness (1% to 7%), Headache (13% to 21%), 
               
               
                   
                 Migraine (1% or greater) 
               
               
                   
                 Respiratory: Respiratory tract infection (5% to 10%) 
               
               
                   
                 Serious 
               
               
                   
                 Other: Angioedema (rare) 
               
               
                 Sonata (zaleplon) 
                 Common 
               
               
                   
                 Neurologic: Dizziness (7% to 9%), Headache (30% to 42%) 
               
               
                   
                 Serious 
               
               
                   
                 Immunologic: Anaphylaxis (rare) 
               
               
                   
                 Neurologic: Drug withdrawal seizure (rare) 
               
               
                   
                 Psychiatric: Abnormal behavior, Complex mannerisms - behavior, 
               
               
                   
                 Depression (at least 1%), Suicidal behavior, Suicidal thoughts 
               
               
                   
                 Other: Angioedema (rare) 
               
               
                 Chantix 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation (5% to 8%), Flatulence (6% to 9%), 
               
               
                   
                 Nausea (30%), Vomiting (5% to 11%) 
               
               
                   
                 Neurologic: Dream disorder (9% to 13%), Headache (11% to 19%), 
               
               
                   
                 Insomnia (10% to 19%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Angina (2.3%), Myocardial infarction (2%) 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                   
                 Ophthalmic: Acquired night blindness (rare), Blurred vision 
               
               
                   
                 (infrequent), Retinal vascular disorder (rare), Subcapsular cataract 
               
               
                   
                 (rare), Transient blindness (rare), Visual disturbance (infrequent) 
               
               
                   
                 Psychiatric: Abnormal behavior, Depression (3.5% to 11%), 
               
               
                   
                 Hostile behavior (2%), Mood disorder (2.3%), Suicidal behavior, 
               
               
                   
                 and/or ideation (6% to 11%) 
               
               
                 Revlimid 
                 Common 
               
               
                   
                 Cardiovascular: Peripheral edema (multiple myeloma, 26.3%; 
               
               
                   
                 myelodysplastic syndrome, 20.3%; mantle cell lymphoma, 16%) 
               
               
                   
                 Dermatologic: Pruritus (Multiple myeloma, 7.6%; myelodysplastic 
               
               
                   
                 syndrome, 41.9%; mantle cell lymphoma, 17%), Rash (Multiple 
               
               
                   
                 myeloma, up to 26.1%; myelodysplastic syndrome, 35.8%; mantle 
               
               
                   
                 cell lymphoma, 22%) 
               
               
                   
                 Endocrine metabolic: Hypokalemia (Multiple myeloma, 13.6% to 
               
               
                   
                 17.1%; myelodysplastic syndrome, 10.8%; mantle cell lymphoma, 
               
               
                   
                 13%), Weight decreased (13% to 19.5%) 
               
               
                   
                 Gastrointestinal: Constipation (Multiple myeloma, 40.5%; 
               
               
                   
                 myelodysplastic syndrome, 23.6%; mantle cell lymphoma, 16%), 
               
               
                   
                 Diarrhea (Multiple myeloma, 38.5% to 45.5%; myelodysplastic 
               
               
                   
                 syndrome, 48.6%; mantle cell lymphoma, 31%), Nausea (23.6% to 
               
               
                   
                 30%&#39;) 
               
               
                   
                 Hematologic: Anemia, All grades (Multiple myeloma, 31.4% to 
               
               
                   
                 43.8%; myelodysplastic syndrome, 11.5%; mantle cell lymphoma, 
               
               
                   
                 31%), Leukopenia, All grades (7.9% to 15%), Neutropenia, All 
               
               
                   
                 grades (Multiple myeloma, 35% to 42.2%; myelodysplastic 
               
               
                   
                 syndrome, 58.8%; mantle cell lymphoma, 49%), 
               
               
                   
                 Thrombocytopenia, All grades (Multiple myeloma, 19.5% to 
               
               
                   
                 21.5%; myelodysplastic syndrome, 61.5%; mantle cell lymphoma, 
               
               
                   
                 36%) 
               
               
                   
                 Musculoskeletal: Arthralgia (Multiple myeloma, 19%; 
               
               
                   
                 myelodysplastic syndrome, 21.6%; mantle cell lymphoma, 8%), 
               
               
                   
                 Backache (Multiple myeloma, 25.8% to 32%; myelodysplastic 
               
               
                   
                 syndrome, 20.9%; mantle cell lymphoma, 13%), Cramp (Multiple 
               
               
                   
                 myeloma, 33.4%; myelodysplastic syndrome, 18.2%) 
               
               
                   
                 Neurologic: Asthenia (Multiple myeloma, 28.2%; myelodysplastic 
               
               
                   
                 syndrome, 14.9%; mantle cell lymphoma, 14%), Dizziness (19.6% 
               
               
                   
                 to 23.2%), Headache (Myelodysplastic syndrome, 19.6%), 
               
               
                   
                 Insomnia (Multiple myeloma, 27.6%; myelodysplastic syndrome, 
               
               
                   
                 10.1%), Tremor (Multiple myeloma, 21.2%) 
               
               
                   
                 Ophthalmic: Blurred vision (Multiple myeloma, 17.3%) 
               
               
                   
                 Respiratory: Cough (Multiple myeloma, 22.7%; myelodysplastic 
               
               
                   
                 syndrome, 19.6%; mantle cell lymphoma, 28%), Dyspnea (Multiple 
               
               
                   
                 myeloma, 22% to 23.5%; myelodysplastic syndrome, 6.8% to 
               
               
                   
                 16.9%; mantle cell lymphoma, 18%), Epistaxis (Myelodysplastic 
               
               
                   
                 syndrome, 14.9%), Nasopharyngitis (Multiple myeloma, 15% to 
               
               
                   
                 17.6%; myelodysplastic syndrome, 23%), Pharyngitis (13.6% to 
               
               
                   
                 15.5%), Upper respiratory infection (Multiple myeloma, 24.6%; 
               
               
                   
                 myelodysplastic syndrome, 14.9%; mantle cell lymphoma, 13%) 
               
               
                   
                 Other: Fatigue (Multiple myeloma, 32.5% to 43.9%; 
               
               
                   
                 myelodysplastic syndrome, 31.1%; mantle cell lymphoma, 34%), 
               
               
                   
                 Fever (Multiple myeloma, 21.4% to 27.5%; myelodysplastic 
               
               
                   
                 syndrome, 20.9%; mantle cell lymphoma, 23%), Infectious disease 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrial fibrillation, Grade 3 or 4 (multiple myeloma, 
               
               
                   
                 3.7%), Cerebrovascular accident (1.4% to 2.3%), Congestive heart 
               
               
                   
                 failure, Grade 3 or 4 (multiple myeloma, 1.4%), Myocardial 
               
               
                   
                 infarction (Less than 5%), Syncope, Grade 3 or 4 (1.4% to 2.8%) 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Hematologic: Anemia, Grade 3 or 4 (Multiple myeloma, 9.9% to 
               
               
                   
                 18.2%; myelodysplastic syndrome, 6.1%; mantle cell lymphoma, 
               
               
                   
                 11%), Deep venous thrombosis, All grades (9.3% to 10.3%), Deep 
               
               
                   
                 venous thrombosis, Grade 3 or 4 (4% to 8.2%), Febrile neutropenia, 
               
               
                   
                 Grade 3 or 4 (2.3% to 6%), Leukopenia, Grade 3 or 4 (4% to 7%), 
               
               
                   
                 Neutropenia, Grade 3 or 4 (Multiple myeloma, 16% to 33.4% 
               
               
                   
                 myelodysplastic syndrome, 53.4%; mantle cell lymphoma, 43%.), 
               
               
                   
                 Thrombocytopenia, Grade 3 or 4 (Multiple myeloma, 8.3% to 
               
               
                   
                 12.2%; myelodysplastic syndrome, 50%; mantle cell lymphoma, 
               
               
                   
                 28%), Thrombosis 
               
               
                   
                 Hepatic: Hepatotoxicity (15%), Liver failure 
               
               
                   
                 Ophthalmic: Cataract, Grade 3 or 4 (Multiple myeloma, 9.6%; 
               
               
                   
                 1.4% (grade 3.4)) 
               
               
                   
                 Renal: Interstitial nephritis, acute 
               
               
                   
                 Respiratory: Hypoxia (Mantle cell lymphoma, 2%), Pleural 
               
               
                   
                 effusion (Mantle cell lymphoma, 7%), Pneumonia (Multiple 
               
               
                   
                 myeloma, 13.6% to 17.5%; myelodysplastic syndrome, 11.5%; 
               
               
                   
                 mantle cell lymphoma, 14%), Pneumonitis (Myelodysplastic 
               
               
                   
                 syndrome, grade 3 or 4, 1.4%), Pulmonary embolism, Grade 3 or 4 
               
               
                   
                 (2% to 4%), Pulmonary hypertension (Myelodysplastic syndrome, 
               
               
                   
                 grade 3 or 4, 1.4%), Respiratory distress (Grade 3 or 4, 1% to 2%) 
               
               
                   
                 Other: Angioedema, Multiple organ failure (Myelodysplastic 
               
               
                   
                 syndrome, grade 3 or 4, 1.4%), Secondary malignant neoplastic 
               
               
                   
                 disease, Tumor flare (Mantle cell lymphoma, 10%), Tumor lysis 
               
               
                   
                 syndrome 
               
               
                 Tracleer 
                 Common 
               
               
                   
                 Cardiovascular: Edema of lower extremity (5% to 8%), 
               
               
                   
                 Hypotension (7%), Palpitations (5%) 
               
               
                   
                 Dermatologic: Flushing (7% to 14%) 
               
               
                   
                 Hematologic: Decreased hemoglobin (6%) 
               
               
                   
                 Neurologic: Headache (up to 24%) 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Decreased hemoglobin (Severe) (3%) 
               
               
                   
                 Hepatic: Cirrhosis of liver, Increased liver aminotransferase level 
               
               
                   
                 (Up to 11%), Liver failure 
               
               
                   
                 Other: Angioedema 
               
               
                 Xeljanz (Jak Compounds) 
                 Common 
               
               
                   
                 Endocrine metabolic: Increased HDL level (10% to 12%), Raised 
               
               
                   
                 low density lipoprotein cholesterol (15% to 19%) 
               
               
                   
                 Neurologic: Headache (3.4% to 4.3%) 
               
               
                   
                 Renal: Urinary tract infectious disease (2%) 
               
               
                   
                 Respiratory: Nasopharyngitis (2.8% to 3.8%), Upper respiratory 
               
               
                   
                 infection (3.8% to 4.5%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Skin cancer, Non-melanoma 
               
               
                   
                 Gastrointestinal: Gastrointestinal perforation 
               
               
                   
                 Hematologic: Anemia, Decreased lymphocyte count (0.04%), 
               
               
                   
                 Neutropenia (0.07%) 
               
               
                   
                 Hepatic: Injury of liver 
               
               
                   
                 Immunologic: Infectious disease (20% to 22%), Opportunistic 
               
               
                   
                 infection, Post-transplant lymphoproliferative disorder, Epstein 
               
               
                   
                 Barr virus associated (2.3%), Tuberculosis 
               
               
                   
                 Other: Cancer 
               
               
                 Atomoxetine (Strattera) 
                 Common 
               
               
                   
                 Cardiovascular: Increased diastolic arterial pressure (adult, 4.8% to 
               
               
                   
                 12.6%; pediatric, 9.3% to 21.5%), Increased systolic arterial 
               
               
                   
                 pressure (adult, 4.2% to 12.4%; pediatric, 4.9% to 12.5%), 
               
               
                   
                 Tachycardia (adult, 1.5% to 22.4%; pediatric, 0.3% to 23.4%) 
               
               
                   
                 Endocrine metabolic: Weight decreased (adults, 2%; pediatric, 3% 
               
               
                   
                 to 29.1%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (adult, 7%; pediatric, 17% to 
               
               
                   
                 18%), Constipation (adult, 8%; pediatric, 1% to 2%), Decrease in 
               
               
                   
                 appetite (adult, 16%; pediatric, 16%), Nausea (adult, 26%; 
               
               
                   
                 pediatric, 7% to 13%), Vomiting (adult, 4%; pediatric, 11%), 
               
               
                   
                 Xerostomia (adult, 20%) 
               
               
                   
                 Neurologic: Headache (pediatric, 19%), Insomnia (adult, 15%; 
               
               
                   
                 pediatric, at least 2%), Somnolence (adult, 8%; pediatric, 11%) 
               
               
                   
                 Renal: Delay when starting to pass urine (adult, 6%) 
               
               
                   
                 Reproductive: Dysmenorrhea (adult, 3%), Erectile dysfunction 
               
               
                   
                 (adult, 8%) 
               
               
                   
                 Other: Menopausal flushing (adult, 3%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction, Sudden cardiac death 
               
               
                   
                 Hepatic: Injury of liver (Severe), Liver failure 
               
               
                   
                 Neurologic: Cerebrovascular accident, Dyskinesia, Seizure (adult, 
               
               
                   
                 0.1%; pediatric, 0.2%) 
               
               
                   
                 Psychiatric: Mania, Psychotic disorder, Suicidal thoughts 
               
               
                   
                 (pediatric, 0.4%) 
               
               
                   
                 Reproductive: Priapism (rare) 
               
               
                 Quetiapine (Seroquel) 
                 See Seroquel above 
               
               
                 Eszopiclone (Lunesta) 
                 See Lunesta above 
               
               
                 Gabapentin (Neurontin) 
                 Common 
               
               
                   
                 Cardiovascular: Peripheral edema (1.7% to 8.3%) 
               
               
                   
                 Gastrointestinal: Nausea (greater than 1%), Vomiting (3.3%) 
               
               
                   
                 Immunologic: Viral disease (10.9%) 
               
               
                   
                 Neurologic: Ataxia (Adult, 3%; adult and adolescent, 13%), 
               
               
                   
                 Nystagmus (Adult and adolescent, 8%) 
               
               
                   
                 Other: Fatigue (3% to 11%), Fever (Pediatric, 10%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome 
               
               
                   
                 Neurologic: Dizziness (Adults, 28%; adults and adolescents, 17%; 
               
               
                   
                 pediatrics, 3%), Somnolence (Adults, 21%; adults and adolescents, 
               
               
                   
                 19%; pediatrics, 8%) 
               
               
                   
                 Psychiatric: Disorder of form of thought (Pediatric, 1.7%), 
               
               
                   
                 Disturbance in thinking (2% to 3%), Hostile behavior (Pediatric, 
               
               
                   
                 5.2%), Hyperactive behavior (Pediatric, 4.7%), Mood swings 
               
               
                   
                 (Pediatric, 6%), Suicidal thoughts 
               
               
                 Topiramate (Topamax) 
                 Common 
               
               
                   
                 Dermatologic: Flushing (pediatrics, 5%) 
               
               
                   
                 Endocrine metabolic: Serum bicarbonate level abnormal (25% to 
               
               
                   
                 67%) 
               
               
                   
                 Gastrointestinal: Loss of appetite (10% to 24%), Weight decreased 
               
               
                   
                 (4% to 21%) 
               
               
                   
                 Immunologic: Infectious disease (2% to 8%) 
               
               
                   
                 Neurologic: Confusion (3% to 11%), Dizziness (4% to 25%), 
               
               
                   
                 Impaired cognition (2% to 7%), Impaired psychomotor 
               
               
                   
                 performance (2% to 13%), Memory impairment (3% to 12%), 
               
               
                   
                 Paresthesia (1% to 51%), Reduced concentration span (2% to 
               
               
                   
                 10%), Somnolence (6% to 29%) 
               
               
                   
                 Psychiatric: Feeling nervous (4% to 16%), Mood disorder (4% to 
               
               
                   
                 11%) 
               
               
                   
                 Other: Fatigue (6% to 16%), Fever (1% to 12%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Erythema multiforme, Stevens-Johnson syndrome, 
               
               
                   
                 Toxic epidermal necrolysis 
               
               
                   
                 Endocrine metabolic: Hyperammonemia (Adolescents, 26%), 
               
               
                   
                 Hypohidrosis, Increased body temperature, Metabolic acidosis 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Neurologic: Drug-induced encephalopathy 
               
               
                   
                 Ophthalmic: Glaucoma, Myopia, Visual field defect (epilepsy, 
               
               
                   
                 0.1% to 1%) 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                   
                 Renal: Nephrolithiasis (adults, 1% to 3%) 
               
               
                 Lamotrigine (Lamictal) 
                 Common 
               
               
                   
                 Dermatologic: Rash (7% to 14%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (immediate-release, 5% to 10%), 
               
               
                   
                 Diarrhea (immediate-release, 6% to 11%; extended-release, 5%), 
               
               
                   
                 Indigestion (immediate-release, 2% to 7%), Nausea (immediate- 
               
               
                   
                 release, 7% to 25%; extended-release, 7%), Vomiting (immediate- 
               
               
                   
                 release, 5% to 20%; extended-release, 6%)) 
               
               
                   
                 Neurologic: Asthenia (immediate-release, 2% to 8%; extended- 
               
               
                   
                 release, 6%), Ataxia (immediate-release, 2% to 11%), Coordination 
               
               
                   
                 problem (immediate-release, 6% to 7%; extended-release, 3%), 
               
               
                   
                 Dizziness (immediate-release, 7% to 54%; extended release, 14%), 
               
               
                   
                 Headache (immediate-release, 29%), Insomnia (immediate-release, 
               
               
                   
                 5% to 10%), Somnolence (immediate-release, 9% to 17%; 
               
               
                   
                 extended-release, 5%), Tremor (immediate-release, 4% to 10%; 
               
               
                   
                 extended-release, 6%), Vertigo (immediate-release, 2%; extended- 
               
               
                   
                 release, 3%) 
               
               
                   
                 Ophthalmic: Blurred vision (immediate-release, 11% to 25% 
               
               
                   
                 (adults) and 4% (children); extended-release, 3%), Diplopia 
               
               
                   
                 (immediate-release, 24% to 49% (adults) and 5% (children); 
               
               
                   
                 extended-release, 5%) 
               
               
                   
                 Psychiatric: Anxiety (immediate-release, 4%; extended-release, 
               
               
                   
                 3%), Depression (immediate-release, 4%; extended-release, 3%) 
               
               
                   
                 Reproductive: Dysmenorrhea (immediate-release, 5% to 7%) 
               
               
                   
                 Respiratory: Rhinitis (immediate-release, 7% to 14%) 
               
               
                   
                 Other: Pain (immediate-release, 5%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Erythema multiforme (less than 0.1%), Rash, 
               
               
                   
                 Serious (0.08% to 0.8%), Stevens-Johnson syndrome (0.08% to 
               
               
                   
                 0.8%.), Toxic epidermal necrolysis (0.08% to 0.8%) 
               
               
                   
                 Hematologic: Anemia (immediate release, less than 0.1%), 
               
               
                   
                 Disseminated intravascular coagulation, Eosinophilia (immediate 
               
               
                   
                 release, less than 0.1%), Leukopenia (immediate release, 0.1% to 
               
               
                   
                 1%), Thrombocytopenia (immediate release, less than 0.1%) 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome 
               
               
                   
                 Neurologic: Aseptic meningitis 
               
               
                   
                 Other: Angioedema (less than 0.1%), Neuroleptic malignant 
               
               
                   
                 syndrome 
               
               
                 Levetiracetam (Keppra) 
                 Common 
               
               
                   
                 Gastrointestinal: Loss of appetite (3% to 8%), Vomiting (15%) 
               
               
                   
                 Immunologic: Infectious disease (13%) 
               
               
                   
                 Musculoskeletal: Decreased bone mineral density (70%), Neck pain 
               
               
                   
                 (2% to 8%) 
               
               
                   
                 Neurologic: Asthenia (15%), Dizziness (5% to 9%), Headache 
               
               
                   
                 (14% to 19%) 
               
               
                   
                 Psychiatric: Abnormal behavior (7% to 37.6%), Irritability (6% to 
               
               
                   
                 12%) 
               
               
                   
                 Respiratory: Cough (2% to 9%), Nasopharyngitis (7% to 15%) 
               
               
                   
                 Other: Fatigue (10% to 11%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis due to drug 
               
               
                   
                 Hematologic: Decreased erythrocyte production, Decreased white 
               
               
                   
                 blood cell count (2.4% to 3.2%), Eosinophilia (8.6%), Neutropenia 
               
               
                   
                 (partial onset seizures, adults, 2.4%), Pancytopenia, 
               
               
                   
                 Thrombocytopenia 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Neurologic: Somnolence (8% to 45%) 
               
               
                   
                 Psychiatric: Suicidal intent (0.5%), Suicide 
               
               
                 Olanzapine (Zyprexa) 
                 Common 
               
               
                   
                 Cardiovascular: Orthostatic hypotension (More than 5%), 
               
               
                   
                 Peripheral edema (3% to 6%) 
               
               
                   
                 Endocrine metabolic: Hypercholesterolemia (Adult, up to 26%; 
               
               
                   
                 adolescent, up to 53%), Hyperglycemia (Adult, up to 20%; 
               
               
                   
                 adolescent, up to 14%), Hyperprolactinemia (30% to 61.1%), 
               
               
                   
                 Increased appetite (Adult, 3% to 24%; adolescent, 17% to 29%), 
               
               
                   
                 Serum triglycerides raised (20.8% to 40%), Weight increased, 7% 
               
               
                   
                 or greater (Adult, 22.2% to 64%; adolescent, 40.6% to 89%) 
               
               
                   
                 Gastrointestinal: Constipation (4% to 11%), Xerostomia (Adult, up 
               
               
                   
                 to 32%; adolescent, 4% to 7%) 
               
               
                   
                 Neurologic: Akathisia (5% to 27%), Asthenia (2% to 20%), 
               
               
                   
                 Dizziness (Adult, 1.6% to 18%; adolescent, 7% to 8%), 
               
               
                   
                 Somnolence (IM, 6%; oral, 20% to 52%), Tremor (1% to 23%) 
               
               
                   
                 Psychiatric: Personality disorder (8%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Sudden cardiac death 
               
               
                   
                 Endocrine metabolic: Diabetes mellitus, Diabetic coma with 
               
               
                   
                 ketoacidosis, Diabetic ketoacidosis, Hyperglycemic hyperosmolar 
               
               
                   
                 state 
               
               
                   
                 Gastrointestinal: Acute hemorrhagic pancreatitis 
               
               
                   
                 Hematologic: Leukopenia, Venous thromboembolism 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                 Risperidone (Risperdal) 
                 Common 
               
               
                   
                 Dermatologic: Rash (oral, adults, 1% to 4%; pediatrics, up to 11%; 
               
               
                   
                 IM, less than 4%) 
               
               
                   
                 Endocrine metabolic: Hyperprolactinemia (oral, adults, less than 
               
               
                   
                 1%; pediatrics, 49% to 87%; IM, less than 4%), Weight increased 
               
               
                   
                 (oral, adult, 8.7% to 20.9%; pediatric, 14% to 32.6%; IM, adult, 8% 
               
               
                   
                 to 10%) 
               
               
                   
                 Gastrointestinal: Constipation (oral, 8% to 21%; IM, 5% to 7%), 
               
               
                   
                 Diarrhea (oral, 1% to 8%; IM, less than 4%), Excessive salivation 
               
               
                   
                 (oral, 1% to 10%; IM, 1% to 4%), Increased appetite (oral, adult, 
               
               
                   
                 more than 5%; pediatric, 4% to 47%; IM, 4%), Indigestion (oral, 
               
               
                   
                 2% to 10%; IM, 6%), Nausea (oral, 4% to 16%; IM, 3% to 4%), 
               
               
                   
                 Upper abdominal pain (oral, adult, more than 5%; pediatric, 13% to 
               
               
                   
                 16%), Vomiting (oral, 10% to 25%; IM, less than 4%), Xerostomia 
               
               
                   
                 (oral, 4% to 15%; IM, up to 7%) 
               
               
                   
                 Neurologic: Akathisia (oral, up to 10%; IM, 4% to 11%), Dizziness 
               
               
                   
                 (oral, 4% to 16%; IM, 3% to 11%), Dystonia (oral, adult, 3% to 
               
               
                   
                 5%; pediatric, 2% to 6%; IM, adult, less than 4%), Parkinsonism 
               
               
                   
                 (oral, 6% to 28%; IM, 8% to 15%), Sedated (oral, adult, 3% to 6%; 
               
               
                   
                 pediatric, 8% to 29%), Tremor (oral, 2% to 12%; IM, 3% to 24%) 
               
               
                   
                 Ophthalmic: Blurred vision (oral, 1% to 7%; IM, 2% to 3%) 
               
               
                   
                 Psychiatric: Anxiety (oral, up to 16% IM, less than 4%) 
               
               
                   
                 Respiratory: Cough (oral, adults, 2%; pediatrics, 24%; IM, 2% to 
               
               
                   
                 4%), Nasal congestion (oral, adult, 4% to 6%; pediatric, 13%), 
               
               
                   
                 Nasopharyngitis (oral, adult, 3% to 4%; pediatric, 21%), Pain in 
               
               
                   
                 throat (oral, adult, more than 5%; pediatric, 3% to 10%), Upper 
               
               
                   
                 respiratory infection (oral, 2% to 8%; IM, 2% and 6%) 
               
               
                   
                 Other: Fatigue (oral, adult, 1% to 3%; pediatric, 18% to 42%; IM, 
               
               
                   
                 3% to 9%), Pain, General (IM, 1% to 4%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Prolonged QT interval, Sudden cardiac death, 
               
               
                   
                 Syncope (oral, up to 1%; IM, up to 2%) 
               
               
                   
                 Endocrine metabolic: Diabetic ketoacidosis, Hypothermia 
               
               
                   
                 Gastrointestinal: Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Leukopenia, Neutropenia, 
               
               
                   
                 Thrombocytopenia, Thrombotic thrombocytopenic purpura 
               
               
                   
                 Neurologic: Cerebrovascular accident (oral, less than 5%; IM, less 
               
               
                   
                 than 4%), Seizure (oral, 0.3%; IM, 0.3%), Tardive dyskinesia (oral, 
               
               
                   
                 less than 5%; IM, less than 4%) 
               
               
                   
                 Reproductive: Priapism 
               
               
                   
                 Respiratory: Pulmonary embolism 
               
               
                   
                 Other: Neuroleptic malignant syndrome (oral, adults, less than 1%; 
               
               
                   
                 pediatrics, less than 5%) 
               
               
                 Hydrocodone/ 
                 Common 
               
               
                 APAP (Generics) 
                 Gastrointestinal: Nausea and vomiting 
               
               
                   
                 Neurologic: Dizziness, Lightheadedness, Sedated 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Acute generalized exanthematous pustulosis, 
               
               
                   
                 Stevens-Johnson syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Hematologic: Agranulocytosis, Thrombocytopenia 
               
               
                   
                 Hepatic: Hepatotoxicity, Liver failure 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                 Tramadol (Ultram) 
                 Common 
               
               
                   
                 Dermatologic: Flushing (7.7% to 15.8%), Pruritus (3% to 11.9%) 
               
               
                   
                 Gastrointestinal: Constipation (10% to 46%), Nausea (13% to 
               
               
                   
                 40%), Vomiting (3% to 17%), Xerostomia (1% to 10%) 
               
               
                   
                 Neurologic: Dizziness (7% to 33%), Headache (3% to 32%), 
               
               
                   
                 Insomnia (1% to 10.9%), Somnolence (4% to 25%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction (0.5% to less than 1%) 
               
               
                   
                 Endocrine metabolic: Hypoglycemia (Very rare) 
               
               
                   
                 Gastrointestinal: Pancreatitis (0.5% to less than 1%) 
               
               
                   
                 Immunologic: Anaphylactoid reaction (less than 1%) 
               
               
                   
                 Neurologic: Seizure 
               
               
                   
                 Respiratory: Dyspnea (less than 5%), Respiratory depression 
               
               
                   
                 Other: Serotonin syndrome (less than 1%) 
               
               
                 Oxycodone/APAP (Percocet) 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation (extended-release, 4%), Nausea 
               
               
                   
                 (extended-release, 31%), Vomiting (extended-release, 9%) 
               
               
                   
                 Neurologic: Dizziness (extended-release, 13%), Headache 
               
               
                   
                 (extended-release, 10%), Lightheadedness, Sedated, Somnolence 
               
               
                   
                 (extended-release, 4%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Disorder of pulmonary circulation, Hypotension, 
               
               
                   
                 Shock 
               
               
                   
                 Dermatologic: Acute generalized exanthematous pustulosis, 
               
               
                   
                 Stevens-Johnson syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Hematologic: Agranulocytosis, Neutropenia 
               
               
                   
                 Hepatic: Hepatic necrosis, Hepatotoxicity, Liver failure 
               
               
                   
                 Immunologic: Anaphylaxis, Hypersensitivity reaction 
               
               
                   
                 Respiratory: Apnea, Respiratory arrest, Respiratory depression 
               
               
                   
                 Other: Neonatal Abstinence Syndrome 
               
               
                 Oxycodone (OxyContin) 
                 See Oxycodone above 
               
               
                 Codeine/APAP (Tylenol #2) 
                 Common 
               
               
                   
                 Gastrointestinal: Nausea, Vomiting 
               
               
                   
                 Neurologic: Dizziness, Lightheadedness, Sedated, Somnolence 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Acute generalized exanthematous pustulosis, 
               
               
                   
                 Stevens-Johnson syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Hematologic: Agranulocytosis, Thrombocytopenia 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Respiratory: Respiratory depression 
               
               
                 Alprazolam (Xanax) 
                 See Alprazolam above 
               
               
                 Clonazepam (Klonopin) 
                 See Clonazepam above 
               
               
                 Diazepam (Valium) 
                 See Diazepam above 
               
               
                 Lorazepam (Ativan) 
                 Common 
               
               
                   
                 Neurologic: Asthenia (4.2%), Dizziness (6.9%), Sedated (15.9%), 
               
               
                   
                 Unsteadiness present (3.4%) 
               
               
                   
                 Psychiatric: Depression 
               
               
                   
                 Serious 
               
               
                   
                 Endocrine metabolic: Acidosis (less than 1%) 
               
               
                   
                 Psychiatric: Delirium 
               
               
                 Buspirone (Buspar) 
                 Common 
               
               
                   
                 Gastrointestinal: Nausea (8%) 
               
               
                   
                 Neurologic: Dizziness (12%), Headache (6%), Somnolence (10%) 
               
               
                   
                 Psychiatric: Feeling nervous (5%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Congestive heart failure (less than 0.1%), 
               
               
                   
                 Myocardial infarction (less than 0.1%) 
               
               
                   
                 Neurologic: Cerebrovascular accident (less than 0.1%) 
               
               
                 Hydroxyzine (Vistaril) 
                 Common 
               
               
                   
                 Gastrointestinal: Xerostomia 
               
               
                   
                 Neurologic: Headache, Somnolence 
               
               
                 Escitalopram (Lexapro) 
                 Common 
               
               
                   
                 Dermatologic: Diaphoresis (3% to 8%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (2%), Constipation (3% to 6%), 
               
               
                   
                 Diarrhea (6% to 14%), Indigestion (2% to 6%), Nausea (15% to 
               
               
                   
                 18%), Vomiting (up to 3%), Xerostomia (4% to 9%) 
               
               
                   
                 Neurologic: Dizziness (4% to 7%), Headache (24%), Insomnia (7% 
               
               
                   
                 to 14%), Somnolence (4% to 13%) 
               
               
                   
                 Reproductive: Disorder of ejaculation (9% to 14%), Erectile 
               
               
                   
                 dysfunction (3%), Orgasm incapacity (females, 2% to 6%), 
               
               
                   
                 Reduced libido (3% to 7%) 
               
               
                   
                 Other: Fatigue (5% to 8%) 
               
               
                   
                 Serious 
               
               
                   
                 Psychiatric: Depression, worsening, Suicidal thoughts, Suicide 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Sertraline (Zoloft) 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation (3% to 8%), Diarrhea (13% to 24%), 
               
               
                   
                 Indigestion (6% to 13%), Nausea (13% to 30%), Nausea and 
               
               
                   
                 vomiting (2% to 30%) 
               
               
                   
                 Neurologic: Dizziness (6% to 17%), Headache (25%), Insomnia 
               
               
                   
                 (12% to 28%), Somnolence (2% to 15%), Tremor (5% to 11%) 
               
               
                   
                 Reproductive: Abnormal ejaculation (7% to 19%), Reduced libido 
               
               
                   
                 (up to 11%) 
               
               
                   
                 Other: Fatigue (10% to 16%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Endocrine metabolic: Hyponatremia 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis 
               
               
                   
                 Neurologic: Seizure (rare) 
               
               
                   
                 Psychiatric: Depression, Exacerbation, Mania (rare), Suicidal 
               
               
                   
                 thoughts (rare), Suicide (rare) 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Trazodone (Desyrel) 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation (7% to 8%), Diarrhea (up to 9%), 
               
               
                   
                 Nausea (21%), Vomiting (at least 1%), Xerostomia (14% to 33.8%) 
               
               
                   
                 Musculoskeletal: Backache (5%) 
               
               
                   
                 Neurologic: Confusion (up to 5.7%), Dizziness (25%), Headache 
               
               
                   
                 (9.9% to 33%), Insomnia (6.4% to 9.9%), Somnolence (23.9% to 
               
               
                   
                 46%) 
               
               
                   
                 Ophthalmic: Blurred vision (5% to 14.7%) 
               
               
                   
                 Psychiatric: Dream disorder (up to 5.1%), Feeling nervous (6.4% to 
               
               
                   
                 14.8%) 
               
               
                   
                 Other: Fatigue (5.7% to 15%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia, Hypotension (3.8% to 7%), 
               
               
                   
                 Prolonged QT interval, Torsades de pointes 
               
               
                   
                 Immunologic: Hypersensitivity reaction (less than 1%) 
               
               
                   
                 Neurologic: Seizure (rare), Serotonin syndrome 
               
               
                   
                 Psychiatric: Suicidal thoughts (rare), Suicide 
               
               
                   
                 Reproductive: Priapism 
               
               
                 Duloxetine (Cymbalta) 
                 Common 
               
               
                   
                 Cardiovascular: Hypertension (2%) 
               
               
                   
                 Dermatologic: Diaphoresis (Adult, 6%; pediatric, less than 2%) 
               
               
                   
                 Gastrointestinal: Constipation (9% to 10%), Decrease in appetite 
               
               
                   
                 (6% to 10%), Diarrhea (Adult, 9%; pediatric, 6%), Nausea (18% to 
               
               
                   
                 23%), Xerostomia (Adult, 11% to 14%; pediatric, 2%) 
               
               
                   
                 Neurologic: Asthenia, Dizziness (Adult, 9%; pediatric, 8%), 
               
               
                   
                 Headache (Adult, 13% to 14%; pediatric, 18%), Hypersomnia, 
               
               
                   
                 Insomnia (7% to 10%), Sedated, Somnolence 
               
               
                   
                 Other: Fatigue 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypertensive crisis, Myocardial infarction (0.01% 
               
               
                   
                 to 0.001%), Orthostatic hypotension 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage 
               
               
                   
                 Hematologic: Bleeding, Abnormal 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Psychiatric: Suicidal thoughts 
               
               
                   
                 Other: Serotonin syndrome, Withdrawal sign or symptom (1% or 
               
               
                   
                 greater) 
               
               
                 Citalopram (Celexa) 
                 Common 
               
               
                   
                 Dermatologic: Diaphoresis (5% to 18%) 
               
               
                   
                 Gastrointestinal: Constipation (13%), Diarrhea (8%), Nausea (20% 
               
               
                   
                 to 21%), Vomiting (4% to 20%), Xerostomia (17% to 20%) 
               
               
                   
                 Neurologic: Dizziness (14%), Headache (18%), Insomnia (15%), 
               
               
                   
                 Sedated (15%), Somnolence (18%), Tremor (8% to 16%) 
               
               
                   
                 Psychiatric: Agitation (3% to 10%) 
               
               
                   
                 Reproductive: Disorder of ejaculation (6.1%) 
               
               
                   
                 Other: Fatigue (5%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction (0.1% to 1%), Prolonged QT 
               
               
                   
                 interval (0.5% to 1.9%), Torsades de pointes 
               
               
                   
                 Neurologic: Cerebrovascular accident (0.1% to less than 1%) 
               
               
                   
                 Psychiatric: Suicidal thoughts, Suicide 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Aripiprazole (Abilify) 
                 Common 
               
               
                   
                 Endocrine metabolic: Weight increased, 7% or greater (2.5% to 
               
               
                   
                 21.5%) 
               
               
                   
                 Gastrointestinal: Constipation (5% to 11%), Nausea (8% to 15%), 
               
               
                   
                 Vomiting (3% to 11%) 
               
               
                   
                 Neurologic: Akathisia (2% to 25%), Dizziness (4% to 10%), 
               
               
                   
                 Extrapyramidal sign (2% to 27.3%), Headache (10% to 27%), 
               
               
                   
                 Insomnia (8% to 18%), Sedated (3% to 21%), Somnolence (6% to 
               
               
                   
                 26.3%), Tremor (2% to 11.8%) 
               
               
                   
                 Ophthalmic: Blurred vision (3% to 8%) 
               
               
                   
                 Psychiatric: Anxiety (4% to 17%), Restlessness (2% to 12%) 
               
               
                   
                 Other: Fatigue (2% to 17%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiorespiratory arrest (0.1% to 1%), 
               
               
                   
                 Cardiorespiratory failure (0.1% to 1%), Myocardial infarction 
               
               
                   
                 (0.1% to 1%), Prolonged QT interval (0.1% to 1%) 
               
               
                   
                 Endocrine metabolic: Diabetic ketoacidosis (Less than 0.1%) 
               
               
                   
                 Gastrointestinal: Pancreatitis (Lss than 0.1%) 
               
               
                   
                 Hematologic: Agranulocytosis, Leukopenia (Less than 1%), 
               
               
                   
                 Neutropenia (Less than 1%) 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis (Less than 0.1%) 
               
               
                   
                 Neurologic: Cerebrovascular accident, Seizure (Up to 0.3%), 
               
               
                   
                 Tardive dyskinesia, Transient ischemic attack 
               
               
                   
                 Psychiatric: At risk for suicide, Suicidal behavior 
               
               
                   
                 Other: Angioedema (0.1% to less than 1%), Increased body 
               
               
                   
                 temperature, Neuroleptic malignant syndrome 
               
               
                 Paroxetine (Paxil) 
                 Common 
               
               
                   
                 Cardiovascular: Palpitations (up to 3%), Vasodilatation (2% to 4%) 
               
               
                   
                 Dermatologic: Diaphoresis (5% to 14%) 
               
               
                   
                 Gastrointestinal: Constipation (up to 16%), Diarrhea (up to 18%), 
               
               
                   
                 Loss of appetite (up to 9%), Nausea (up to 26%), Xerostomia (9% 
               
               
                   
                 to 18%) 
               
               
                   
                 Neurologic: Asthenia (up to 22%), Dizziness (6% to 14%), 
               
               
                   
                 Headache (17% to 27%), Insomnia (up to 24%), Somnolence (up to 
               
               
                   
                 24%), Tremor (4% to 11%) 
               
               
                   
                 Ophthalmic: Blurred vision (up to 5%) 
               
               
                   
                 Reproductive: Abnormal ejaculation (13% to 28%), Erectile 
               
               
                   
                 dysfunction (2% to 9%), Orgasm disorder (females; 2% to 9%), 
               
               
                   
                 Reduced libido (males: 6% to 15%; females: 0% to 9%) 
               
               
                   
                 Respiratory: Yawning (4%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Hepatic: Acute hepatitis (rare) 
               
               
                   
                 Neurologic: Seizure (0.1%) 
               
               
                   
                 Psychiatric: Depression, exacerbation, Suicidal thoughts (rare), 
               
               
                   
                 Suicide (rare) 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Fluoxetine (Prozac) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea (8% to 18%), Indigestion (6% to 10%), 
               
               
                   
                 Loss of appetite (3.8% to 17%), Nausea (12% to 29%), Xerostomia 
               
               
                   
                 (4% to 12%) 
               
               
                   
                 Neurologic: Asthenia (7% to 21%), Dizziness (2% to 11%), 
               
               
                   
                 Insomnia (9% to 33%), Somnolence (5% to 17%), Tremor (3% to 
               
               
                   
                 13%) 
               
               
                   
                 Psychiatric: Anxiety (3% to 15%), Feeling nervous (3% to 14%) 
               
               
                   
                 Respiratory: Pharyngitis (3% to 11%), Rhinitis (16% to 23%) 
               
               
                   
                 Other: Influenza-like symptoms (3% to 12%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Prolonged QT interval 
               
               
                   
                 Dermatologic: Erythema multiforme 
               
               
                   
                 Endocrine metabolic: Hyponatremia 
               
               
                   
                 Hematologic: Bleeding 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Neurologic: Seizure (0.2%) 
               
               
                   
                 Psychiatric: Depression, worsening, Mania, Suicidal thoughts, 
               
               
                   
                 Suicide 
               
               
                   
                 Other: Serotonin syndrome 
               
               
                 Venlafaxine (Effexor) 
                 Common 
               
               
                   
                 Cardiovascular: Hypertension (3% to 13%) 
               
               
                   
                 Dermatologic: Sweating symptom (6.7% to 25%) 
               
               
                   
                 Endocrine metabolic: Weight loss (3% to 47%) 
               
               
                   
                 Gastrointestinal: Constipation (8% to 15%), Loss of appetite (8% to 
               
               
                   
                 22%), Nausea (21% to 58%), Xerostomia (12% to 22%) 
               
               
                   
                 Neurologic: Asthenia (8% to 19%), Dizziness (11% to 23.9%), 
               
               
                   
                 Dream disorder (3% to 7%), Headache (25% to 38%), Insomnia 
               
               
                   
                 (14% to 24%), Somnolence (14% to 26%), Tremor (1.1% to 
               
               
                   
                 10.2%) 
               
               
                   
                 Ophthalmic: Blurred vision (4% to 6%) 
               
               
                   
                 Psychiatric: Feeling nervous (4% to 21.3%) 
               
               
                   
                 Reproductive: Abnormal ejaculation (2.2% to 19%), Erectile 
               
               
                   
                 dysfunction (2.1% to 6%), Orgasm disorder (2% to 5%) 
               
               
                   
                 Serious 
               
               
                   
                 Endocrine metabolic: Hyponatremia 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage (rare) 
               
               
                   
                 Hematologic: Bleeding, Abnormal 
               
               
                   
                 Hepatic: Hepatitis 
               
               
                   
                 Neurologic: Seizure (0.3%) 
               
               
                   
                 Psychiatric: Depression, exacerbation (rare), Hypomania, Mania, 
               
               
                   
                 Suicidal thoughts (rare), Suicide 
               
               
                   
                 Other: Neuroleptic malignant syndrome, Serotonin syndrome 
               
               
                 Amitriptyline (Elavil) 
                 Common 
               
               
                   
                 Endocrine metabolic: Weight gain 
               
               
                   
                 Gastrointestinal: Constipation, Xerostomia 
               
               
                   
                 Neurologic: Dizziness, Headache, Somnolence 
               
               
                   
                 Ophthalmic: Blurred vision 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia, Electrocardiogram abnormal, 
               
               
                   
                 Myocardial infarction, Prolonged QT interval, Sudden cardiac 
               
               
                   
                 death 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Hepatic: Hepatotoxicity, Jaundice (rare) 
               
               
                   
                 Neurologic: Neuroleptic malignant syndrome, Seizure 
               
               
                   
                 Psychiatric: Depression, worsening, Suicidal thoughts, Suicide 
               
               
                 Bupropion (Wellbutrin) 
                 Common 
               
               
                   
                 Cardiovascular: Tachycardia (major depressive disorder, 11%) 
               
               
                   
                 Endocrine metabolic: Weight gain (2% to 9%), Weight loss (major 
               
               
                   
                 depressive disorder, 14% to 19%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (2% to 9%), Constipation (5% to 
               
               
                   
                 10%), Nausea (13% to 18%), Xerostomia (17% to 26%) 
               
               
                   
                 Neurologic: Confusion (major depressive disorder, 8%), Dizziness 
               
               
                   
                 (6% to 11%), Headache (25% to 34%), Insomnia (11% to 20%) 
               
               
                   
                 Psychiatric: Agitation (2% to 9%) 
               
               
                   
                 Respiratory: Nasopharyngitis (seasonal affective disorder, 13%), 
               
               
                   
                 Pharyngitis (major depressive disorder, 3% to 11%), Upper 
               
               
                   
                 respiratory infection (seasonal affective disorder, 9%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Complete atrioventricular block, Myocardial 
               
               
                   
                 infarction 
               
               
                   
                 Gastrointestinal: Colitis, Pancreatitis 
               
               
                   
                 Hematologic: Pancytopenia 
               
               
                   
                 Hepatic: Abnormal liver function, Hepatitis, Jaundice, Liver 
               
               
                   
                 damage 
               
               
                   
                 Immunologic: Anaphylactoid reaction, Anaphylaxis, Delayed 
               
               
                   
                 hypersensitivity disorder 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis 
               
               
                   
                 Neurologic: Seizure (major depressive disorder, 0.1% to 0.4%) 
               
               
                   
                 Psychiatric: Delusional disorder, Depression, Worsening, 
               
               
                   
                 Hallucinations, Hostile behavior (major depressive disorder, 6%), 
               
               
                   
                 Hypomania, Mania, Precipitation of episode, Paranoid ideation, 
               
               
                   
                 Psychotic disorder, Activation, Suicidal behavior, Suicidal thoughts 
               
               
                   
                 Respiratory: Pulmonary embolism 
               
               
                   
                 Other: Angioedema 
               
               
                 Nortriptyline (Pamelor) 
                 Common 
               
               
                   
                 Gastrointestinal: Constipation 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia, Heart block, Myocardial 
               
               
                   
                 infarction, Prolonged QT interval, Sudden cardiac death 
               
               
                   
                 Endocrine metabolic: Syndrome of inappropriate antidiuretic 
               
               
                   
                 hormone secretion 
               
               
                   
                 Gastrointestinal: Paralytic ileus 
               
               
                   
                 Hematologic: Bone marrow depression 
               
               
                   
                 Hepatic: Fulminant hepatic failure, Jaundice (rare) 
               
               
                   
                 Neurologic: Cerebrovascular accident, Myoclonus, Seizure 
               
               
                   
                 Psychiatric: Depression, worsening, Mania, Psychotic disorder, 
               
               
                   
                 exacerbation, Suicidal thoughts, Suicide 
               
               
                   
                 Other: Angioedema 
               
               
                 Mirtazepine (Remeron) 
                 Common 
               
               
                   
                 Endocrine metabolic: Increased appetite (17%), Serum triglycerides 
               
               
                   
                 raised (increases to 500 mg/dL or greater: 6%), Weight gain (body 
               
               
                   
                 weight increase of 7% or greater: adults 7.5%; pediatrics 49%) 
               
               
                   
                 Gastrointestinal: Constipation (13%), Xerostomia (25%) 
               
               
                   
                 Hepatic: ALT/SGPT level raised (2%) 
               
               
                   
                 Neurologic: Asthenia (8%), Dizziness (7%), Somnolence (54%) 
               
               
                   
                 Psychiatric: Disturbance in thinking (3%) 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Agranulocytosis, Neutropenia 
               
               
                   
                 Hepatic: Cirrhosis of liver (less than 0.1%) 
               
               
                   
                 Neurologic: Grand mal seizure (less than 0.1%), Status epilepticus 
               
               
                   
                 Psychiatric: Depression, exacerbation, Suicidal thoughts, Suicide 
               
               
                   
                 Other: Neuroleptic malignant syndrome, Serotonin syndrome (less 
               
               
                   
                 than 0.1%) 
               
               
                 Olanzapine (Zyprexa) 
                 See Olanzapine above 
               
               
                 Risperidone (Risperdal) 
                 See Resperidone above 
               
               
                 Antiepileptics 
               
               
                 Divalproex (Depakote) 
                 Common 
               
               
                   
                 Gastrointestinal: Abdominal pain (9% to 23%), Diarrhea (13% to 
               
               
                   
                 23%), Indigestion (8% to 11%), Loss of appetite (4% to 12%), 
               
               
                   
                 Nausea (26% to 48%), Vomiting (15% to 27%) 
               
               
                   
                 Musculoskeletal: Backache (Complex partial seizures, greater than 
               
               
                   
                 1% to less than 5%; migraine, 8%) 
               
               
                   
                 Neurologic: Asthenia (6% to 27%), Dizziness (up to 25%), Feeling 
               
               
                   
                 nervous (up to 11%), Headache (31%), Insomnia (up to 15%), 
               
               
                   
                 Somnolence (Adult, 7% to 30%; pediatric, greater than 5%), 
               
               
                   
                 Tremor (1% to 57%) 
               
               
                   
                 Ophthalmic: Amblyopia, Blurred vision, Diplopia (16%) 
               
               
                   
                 Other: Infectious disease (12% to 20%), Influenza (12%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Palpitations (greater than 1% to less than 5%), 
               
               
                   
                 Tachycardia (greater than 1% to less than 5%) 
               
               
                   
                 Endocrine metabolic: Hyperammonemia 
               
               
                   
                 Gastrointestinal: Pancreatitis (greater than 1% to less than 5%) 
               
               
                   
                 Hematologic: Myelodysplastic syndrome, Thrombocytopenia, 
               
               
                   
                 Dose-related (1% to 27%) 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome (rare) 
               
               
                   
                 Neurologic: Hyperammonemic encephalopathy 
               
               
                   
                 Otic: Ototoxicity - deafness (greater than 1% to less than 5%) 
               
               
                 Ropinirole (Requip) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (2% to 25%), Orthostatic hypotension 
               
               
                   
                 (Up to 23%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (6% to 7%), Constipation (4% to 
               
               
                   
                 5%), Nausea (11% to 60%), Vomiting (7% to 12%) 
               
               
                   
                 Neurologic: Dizziness (Parkinson disease, 6% to 40%; restless legs 
               
               
                   
                 syndrome, 11%), Dyskinesia (13% to 34%), Headache (6%), 
               
               
                   
                 Somnolence (Parkinson disease, 7% to 40%; restless leg syndrome, 
               
               
                   
                 12%) 
               
               
                   
                 Other: Fatigue (8% to 11%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Sinus node dysfunction, Syncope (Parkinson 
               
               
                   
                 disease, 1% to 12%; restless leg syndrome, 1%) 
               
               
                   
                 Neurologic: Sleep attack 
               
               
                   
                 Psychiatric: Hallucinations (5% to 10%) 
               
               
                 Pramipexole (Mirapex) 
                 Common 
               
               
                   
                 Cardiovascular: Orthostatic hypotension (Immediate release, 53%; 
               
               
                   
                 extended-release, 3%) 
               
               
                   
                 Gastrointestinal: Constipation (immediate-release, 4% to 14%; 
               
               
                   
                 extended-release, 7% to 14%), Nausea (immediate-release, 11% to 
               
               
                   
                 28%; extended-release, 11% to 22%) 
               
               
                   
                 Neurologic: Amnesia (4% to 6%), Asthenia (Immediate-release, 
               
               
                   
                 10% to 14%; extended-release, 3%), Confusion (4% to 10%), 
               
               
                   
                 Dizziness (Immediate-release, 3% to 26%; extended-release, 2% to 
               
               
                   
                 12%), Dream disorder (Up to 11%), Dyskinesia (Immediate- 
               
               
                   
                 release, 18% to 47%; extended-release, 17%), Extrapyramidal 
               
               
                   
                 movements (28%), Headache (Immediate-release, 4% to 16%; 
               
               
                   
                 extended-release, 7%), Insomnia (Immediate-release, 4% to 27%; 
               
               
                   
                 extended-release, 4%) 
               
               
                   
                 Psychiatric: Hallucinations (5% to 17%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Heart failure 
               
               
                   
                 Dermatologic: Malignant melanoma 
               
               
                   
                 Neurologic: Sleep attack (2% to 6%), Somnolence (Immediate- 
               
               
                   
                 release, 6% to 33%;; extended-release, 15% to 36%) 
               
               
                   
                 Psychiatric: Disturbance in thinking, Psychotic disorder 
               
               
                   
                 Other: Malignant melanoma, Neuroleptic malignant syndrome 
               
               
                 Methylphenidate (Concerta) 
                 See Methylphenidate above 
               
               
                 Lisdexamfetamine (Vyvanse) 
                 Common 
               
               
                   
                 Dermatologic: Rash (pediatrics, 3%) 
               
               
                   
                 Endocrine metabolic: Decreased body growth, Weight decreased 
               
               
                   
                 (pediatrics, 9%) 
               
               
                   
                 Gastrointestinal: Diarrhea (adults, 7%), Loss of appetite (adults, 8% 
               
               
                   
                 to 27%; pediatrics, 34% to 39%), Nausea (adults, 7%; pediatrics, 
               
               
                   
                 6%), Upper abdominal pain (pediatrics, 12%), Vomiting 
               
               
                   
                 (pediatrics, 9%), Xerostomia (Adults, 26% to 36%; pediatrics, 4% 
               
               
                   
                 to 5%) 
               
               
                   
                 Neurologic: Dizziness (pediatrics, 5%), Insomnia (Adults, 20% to 
               
               
                   
                 27%; pediatrics, 13% to 23%) 
               
               
                   
                 Psychiatric: Anxiety (Adults, 5% to 6%), Irritability (pediatrics, 
               
               
                   
                 10%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Chest pain, Myocardial infarction, Peripheral 
               
               
                   
                 vascular disease, Raynaud&#39;s disease, Sudden cardiac death, 
               
               
                   
                 Tachycardia, Ventricular hypertrophy 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Cerebrovascular accident, Seizure 
               
               
                 Amphetamine/Dextro- 
                 See Adderall above 
               
               
                 amphetamine (Adderall) 
               
               
                 Dalteparin (Fragmin), 
                 Common 
               
               
                 Danaparoid (Orgaran) 
                 Dermatologic: Hematoma, Injection site (7% to 35%), Injection site 
               
               
                   
                 pain (4.5% to 12%) 
               
               
                   
                 Other: Irritation symptom, Local 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Epidural hematoma, Hematoma, Spinal, 
               
               
                   
                 Hemorrhage, Major (up to 13.6%), Hemorrhagic cerebral infarction 
               
               
                   
                 (8%), Intracranial hemorrhage, Subdural hemorrhage, Intrauterine, 
               
               
                   
                 Thrombocytopenia (Non-cancer indications, less than 1%; patients 
               
               
                   
                 with cancer, 10.9% to 13.6%) 
               
               
                   
                 Hepatic: Increased liver function test (up to 4.3%) 
               
               
                   
                 Immunologic: Anaphylactoid reaction (rare) 
               
               
                   
                 Neurologic: Paralysis 
               
               
                 Enoxaparin (Lovenox) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea (2.2%), Nausea (2.5% to 3%) 
               
               
                   
                 Hematologic: Anemia (up to 16%), Bleeding, Major (up to 4%), 
               
               
                   
                 Thrombocytopenia (less than 3%) 
               
               
                   
                 Hepatic: Increased liver function test (5.9% to 6.1%) 
               
               
                   
                 Other: Fever (up to 8%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrial fibrillation (0.7%), Heart failure (0.95%) 
               
               
                   
                 Dermatologic: Eczematous drug eruption, Skin necrosis 
               
               
                   
                 Hematologic: Hematoma, Hemorrhage (4% to 13%) 
               
               
                   
                 Neurologic: Intracranial hemorrhage (0.8%), Paraplegia 
               
               
                   
                 Respiratory: Pneumonia (0.82%) 
               
               
                 Heparin (various) 
                 Common 
               
               
                   
                 Hematologic: Thrombocytopenia (up to 30%) 
               
               
                   
                 Hepatic: Increased liver aminotransferase level 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Hemorrhage (5% to 10%), Heparin-induced 
               
               
                   
                 thrombocytopenia (1% to 10%), Heparin-induced 
               
               
                   
                 thrombocytopenia with thrombosis (less than 1%) 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Neurologic: Non-traumatic spinal subdural hematoma 
               
               
                 Tinzaparin (Innohep) 
                 Common 
               
               
                   
                 Dermatologic: Erythema (16%) 
               
               
                   
                 Hepatic: Increased liver function test, Asymptomatic (9% to 13%) 
               
               
                   
                 Neurologic: Pain, Local (16%) 
               
               
                   
                 Other: Irritation symptom, Local (16%) 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Bleeding, Major (0.8%), Granulocytopenic disorder 
               
               
                   
                 (rare), Hematoma, spinal/epidural, Pancytopenia (rare), 
               
               
                   
                 Thrombocytopenia (1%), Thrombocytopenia (Severe) (0.13%) 
               
               
                   
                 Immunologic: Anaphylaxis (rare) 
               
               
                   
                 Neurologic: Paralysis 
               
               
                   
                 Reproductive: Priapism (rare) 
               
               
                 Warfarin (Coumadin) 
                 Common 
               
               
                   
                 Dermatologic: Alopecia 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cholesterol embolus syndrome, Gangrenous 
               
               
                   
                 disorder (less than 0.1%) 
               
               
                   
                 Dermatologic: Tissue necrosis (less than 0.1%) 
               
               
                   
                 Hematologic: Bleeding, Hemorrhage 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Musculoskeletal: Compartment syndrome 
               
               
                   
                 Neurologic: Intracranial hemorrhage 
               
               
                   
                 Ophthalmic: Intraocular hemorrhage 
               
               
                 Dabigatran (Pradaxa) 
                 Common 
               
               
                   
                 Gastrointestinal: Esophagitis, Gastritis, Gastroesophageal reflux 
               
               
                   
                 disease (Atrial fibrillation, 5.5%), Gastrointestinal hemorrhage 
               
               
                   
                 (DVT and pulmonary embolism, 0.7% to 3.1%; nonvalvular atrial 
               
               
                   
                 fibrillation, 6.1%), Gastrointestinal ulcer, Indigestion (DVT and 
               
               
                   
                 pulmonary embolism, 7.5%) 
               
               
                   
                 Hematologic: Bleeding (DVT and pulmonary embolism 
               
               
                   
                 prophylaxis, 10.5%; nonvalvularatrial fibrillation, 16.6%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction (DVT and pulmonary 
               
               
                   
                 embolism, 0.32% to 0.66%; nonvalvular atrial fibrillation, 0.7%) 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage, Major (DVT and 
               
               
                   
                 pulmonary embolism, 0.3% to 0.6%; nonvalvular atrial fibrillation, 
               
               
                   
                 1.6%) 
               
               
                   
                 Hematologic: Bleeding, Major (DVT and pulmonary embolism, 
               
               
                   
                 0.3% to 1.4%; nonvalvular atrial fibrillation, 3.3%), Thrombosis 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Epidural hematoma, Intracranial hemorrhage 
               
               
                   
                 (nonvalvular atrial fibrillation, 0.3%; DVT and pulmonary 
               
               
                   
                 embolism, 0.1%), Traumatic spinal subdural hematoma 
               
               
                   
                 Respiratory: Bleeding, Alveolar 
               
               
                 Rivaroxaban (Xarelto) 
                 Common 
               
               
                   
                 Hematologic: Bleeding (Hip/knee replacement, 5.8%; 
               
               
                   
                 DVT/pulmonary embolism, 17.4% to 28.3%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Syncope (1.2%) 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage (nonvalvular atrial 
               
               
                   
                 fibrillation, 3.1%) 
               
               
                   
                 Hematologic: Bleeding, Major (Nonvalvular atrial fibrillation, 
               
               
                   
                 5.6%; hip/knee replacement, 0.3%; DVT/pulmonary embolism, 
               
               
                   
                 1%), Epidural hematoma, Hematoma, Spinal 
               
               
                   
                 Immunologic: Anaphylaxis, Hypersensitivity reaction 
               
               
                   
                 Other: Drug withdrawal, Stroke and non-CNS embolism 
               
               
                 Apixaban (Eliquis) 
                 Common 
               
               
                   
                 Dermatologic: Contusion (1.4% to 2.2%) 
               
               
                   
                 Gastrointestinal: Bleeding gums (Less than 0.1% to 1.4%) 
               
               
                   
                 Hematologic: Hematoma (DVT, 1.3% to 1.5%) 
               
               
                   
                 Reproductive: Menorrhagia (1.4%) 
               
               
                   
                 Respiratory: Epistaxis (DVT and pulmonary embolism, 1.5% to 
               
               
                   
                 3.6%; DVT prophylaxis, 0.1% to less than 1%), Hemoptysis (Less 
               
               
                   
                 than 0.1% to 1.2%) 
               
               
                   
                 Serious 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage (atrial fibrillation, 
               
               
                   
                 0.83%/year; DVT prophylaxis, 0.1% to less than 1%; DVT and 
               
               
                   
                 pulmonary embolism, 0.1% to less than 1%), Hematochezia (0.1% 
               
               
                   
                 to less than 1%), Rectal hemorrhage (Less than 0.1% to 1%) 
               
               
                   
                 Hematologic: Bleeding (atrial fibrillation, 2.08%/year; DVT 
               
               
                   
                 prophylaxis, 2.88% to 4.83%), Bleeding, Major (0.1% to 2.13%), 
               
               
                   
                 Hemorrhage (0.1% to 1.4%), Hemorrhage, Operative (DVT 
               
               
                   
                 prophylaxis, 0.1% to less than 1%) 
               
               
                   
                 Hepatic: Alkaline phosphatase raised (DVT prophylaxis, 0.1% to 
               
               
                   
                 less than 1%), Liver function tests abnormal (DVT prophylaxis, 
               
               
                   
                 0.1% to less than 1%), Serum bilirubin raised (DVT prophylaxis, 
               
               
                   
                 0.1% to less than 1%) 
               
               
                   
                 Immunologic: Hypersensitivity reaction (atrial fibrillation, less than 
               
               
                   
                 1%) 
               
               
                   
                 Musculoskeletal: Hemorrhage of muscle (Less than 0.1% to less 
               
               
                   
                 than 1%) 
               
               
                   
                 Neurologic: Epidural hematoma, Intracranial hemorrhage (atrial 
               
               
                   
                 fibrillation, 0.33% to 0.34%/year), Non-traumatic spinal subdural 
               
               
                   
                 hematoma, Traumatic spinal subdural hematoma 
               
               
                   
                 Ophthalmic: Conjunctival hemorrhage (0.1% to less than 1%), 
               
               
                   
                 Intraocular hemorrhage (Less than 0.1% to less than 1%), Retinal 
               
               
                   
                 hemorrhage (0.1% to less than 1%) 
               
               
                   
                 Renal: Hematuria (DVT, 1.4% to 2.1%; DVT prophylaxis, 0.1% to 
               
               
                   
                 less than 1%) 
               
               
                 Edoxaban (Savaysa) 
                 Common 
               
               
                   
                 Dermatologic: Rash (3.6% to 4.2%) 
               
               
                   
                 Hematologic: Anemia (Nonvalvular atrial fibrillation, 9.6%; DVT 
               
               
                   
                 or pulmonary embolism, 1.7%), Bleeding, Clinically Relevant, 
               
               
                   
                 Nonmajor (Nonvalvular atrial fibrillation, 9.4%; DVT or 
               
               
                   
                 pulmonary embolism, 7.2%) 
               
               
                   
                 Hepatic: Liver function tests abnormal (Nonvalvular atrial 
               
               
                   
                 fibrillation, 4.8%; DVT or pulmonary embolism, 7.8%) 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Bleeding, Major (Nonvalvular atrial fibrillation, 
               
               
                   
                 3.1%; DVT or pulmonary embolism, 1.4%) 
               
               
                   
                 Neurologic: Hemorrhagic cerebral infarction (Nonvalvular atrial 
               
               
                   
                 fibrillation, 0.3%), Intracranial hemorrhage (Nonvalvular atrial 
               
               
                   
                 fibrillation, 0.5%; DVT or pulmonary embolism, 0.1%) 
               
               
                   
                 Respiratory: Interstitial lung disease (Nonvalvular atrial fibrillation, 
               
               
                   
                 0.2%) 
               
               
                 Aspirin 
                 Serious 
               
               
                   
                 Gastrointestinal: Gastrointestinal ulcer 
               
               
                   
                 Hematologic: Bleeding 
               
               
                   
                 Ophthalmic: Exudative age-related macular degeneration 
               
               
                   
                 Otic: Tinnitus 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                   
                 Other: Angioedema, Reye&#39;s syndrome 
               
               
                 Ticlopidine 
                 Common 
               
               
                   
                 Dermatologic: Rash (1% to 11.8%) 
               
               
                   
                 Gastrointestinal: Abdominal pain, Diarrhea, Indigestion, Loss of 
               
               
                   
                 appetite, Nausea 
               
               
                   
                 Hematologic: Hemorrhage, Leukopenia 
               
               
                   
                 Hepatic: Liver function tests abnormal 
               
               
                   
                 Neurologic: Dizziness 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Agranulocytosis, Aplastic anemia (rare), 
               
               
                   
                 Granulocytopenic disorder, Neutropenia (2.4%), Pancytopenia, 
               
               
                   
                 Thrombocytopenia, Thrombotic thrombocytopenic purpura (rare) 
               
               
                 Clopidogrel (Plavix ®) 
                 Common 
               
               
                   
                 Hematologic: Bleeding, Non-major (3.6% to 5.1%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Coronary artery stent thrombosis 
               
               
                   
                 Dermatologic: Fixed drug eruption 
               
               
                   
                 Gastrointestinal: Colitis, Gastrointestinal hemorrhage (2%; 2.7% 
               
               
                   
                 with aspirin) 
               
               
                   
                 Hematologic: Agranulocytosis (Less than 1%), Aplastic anemia 
               
               
                   
                 (less then 1%), Bleeding, Major (0.8% to 3.7%), Pancytopenia 
               
               
                   
                 (Severe), Thrombotic thrombocytopenic purpura 
               
               
                   
                 Hepatic: Hepatitis, Hepatotoxicity, Liver failure 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Neurologic: Epidural hematoma, Intracranial hemorrhage 
               
               
                   
                 Ophthalmic: Intraocular hemorrhage (0.05%) 
               
               
                   
                 Other: Drug withdrawal, Rebound effect 
               
               
                 Dipyridamole 
                 Common 
               
               
                   
                 Cardiovascular: Chest pain (IV, up to 30%), Electrocardiogram 
               
               
                   
                 abnormal (IV, 0.8% to 7.5%) 
               
               
                   
                 Dermatologic: Flushing (IV, 3.4%), Rash (oral, 2.3%) 
               
               
                   
                 Gastrointestinal: Abdominal discomfort (oral, 6.1%) 
               
               
                   
                 Neurologic: Dizziness (oral, 13.6%; IV, 11.8%), Headache (oral, 
               
               
                   
                 2.3%; IV, 12.2% to 20%) 
               
               
                   
                 Respiratory: Dyspnea (IV, 2.6% to 25%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Angina, Cardiac arrest, Myocardial infarction (IV, 
               
               
                   
                 0.1%), Myocardial ischemia, Ventricular fibrillation, Ventricular 
               
               
                   
                 tachycardia (IV, 0.2%) 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Neurologic: Cerebrovascular accident, Seizure 
               
               
                   
                 Respiratory: Bronchospasm (IV, 0.2%) 
               
               
                 Benazepril (Lotensin) 
                 Common 
               
               
                   
                 Neurologic: Dizziness (3.6%), Headache (6.2%) 
               
               
                   
                 Respiratory: Cough (1.2%) 
               
               
                   
                 Other: Fatigue (2.4%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome (less than 1%) 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis, Neutropenia 
               
               
                   
                 Hepatic: Hepatic necrosis (rare), Increased liver enzymes (rare), 
               
               
                   
                 Jaundice (rare) 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Renal: Renal impairment 
               
               
                   
                 Other: Angioedema, head and neck (0.5%) 
               
               
                 Captopril (Capoten) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Dermatologic: Rash 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (11%) 
               
               
                   
                 Gastrointestinal: Disorder of taste 
               
               
                   
                 Respiratory: Cough (0.5% to 2%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis (0.1% to 0.2%), Neutropenia (0.1% 
               
               
                   
                 to 0.2%) 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Other: Angioedema (0.1%) 
               
               
                 Enalapril (Vasotec) 
                 Common 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (1% to 3.8%) 
               
               
                   
                 Neurologic: Dizziness (4.3% to 7.9%) 
               
               
                   
                 Renal: Serum blood urea nitrogen raised (0.2% (hypertension) to 
               
               
                   
                 20% (hypertension with renal artery stenosis)), Serum creatinine 
               
               
                   
                 raised (0.2% (hypertension) to 20% (hypertension with renal artery 
               
               
                   
                 stenosis)) 
               
               
                   
                 Other: Fatigue (3%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypotension (0.9% to 6.7%) 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Hepatic: Hepatotoxicity, Liver failure 
               
               
                   
                 Immunologic: Anaphylactoid reaction, during desensitization 
               
               
                   
                 Renal: Acute renal failure, Renal impairment 
               
               
                   
                 Other: Angioedema (0.1% to 1%) 
               
               
                 Fosinopril (Monopril) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (2.4% to 4.4%) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (2.6%) 
               
               
                   
                 Gastrointestinal: Nausea and vomiting (1.2% to 2.2%) 
               
               
                   
                 Neurologic: Dizziness (1.6% to 11.9%) 
               
               
                   
                 Respiratory: Cough (2.2% to 9.7%) 
               
               
                   
                 Serious 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Renal: Acute renal failure, Azotemia, Oliguria 
               
               
                   
                 Other: Angioedema, Head and Neck 
               
               
                 Lisinopril (Prinivil, Zestril) 
                 Common 
               
               
                   
                 Cardiovascular: Chest pain, Hypotension (up to 11%), Syncope 
               
               
                   
                 (5% to 7%) 
               
               
                   
                 Neurologic: Dizziness (12% to 19%), Headache 
               
               
                   
                 Respiratory: Cough 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Hypotension (Severe) (9%) 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome (1% or more), Toxic 
               
               
                   
                 epidermal necrolysis (1% or more) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (2.2% to 6%) 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Immunologic: Anaphylaxis due to hymenoptera venom, Dialysis 
               
               
                   
                 membrane-induced anaphylactoid reaction 
               
               
                   
                 Renal: Acute renal failure, Renal impairment (2.4%) 
               
               
                   
                 Other: Angioedema, Head and Neck 
               
               
                 Moexipril (Univasc) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea (3.1%) 
               
               
                   
                 Neurologic: Dizziness (4.3%) 
               
               
                   
                 Respiratory: Cough (6.1%) 
               
               
                   
                 Other: Influenza-like symptoms 
               
               
                   
                 Serious 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Immunologic: Anaphylaxis due to hymenoptera venom, Dialysis 
               
               
                   
                 membrane-induced anaphylactoid reaction 
               
               
                   
                 Renal: Abnormal renal function 
               
               
                   
                 Other: Angioedema, Head and Neck 
               
               
                 Perindopril (Aceon) 
                 Common 
               
               
                   
                 Endocrine metabolic: Hyperkalemia 
               
               
                   
                 Musculoskeletal: Backache (5.8%) 
               
               
                   
                 Neurologic: Asthenia, Dizziness (8.2%), Headache 
               
               
                   
                 Respiratory: Cough (12%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac arrest, Orthostatic hypotension (0.8%) 
               
               
                   
                 Gastrointestinal: Intestinal angioedema, Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Bone marrow depression, 
               
               
                   
                 Neutropenia 
               
               
                   
                 Hepatic: Liver failure 
               
               
                   
                 Renal: Acute renal failure 
               
               
                   
                 Other: Angioedema (0.1% to 0.5%) 
               
               
                 Quinapril (Accupril) 
                 Common 
               
               
                   
                 Cardiovascular: Chest pain (2.4%), Hypotension (2.9%) 
               
               
                   
                 Gastrointestinal: Nausea and vomiting (1.4% to 2.4%) 
               
               
                   
                 Neurologic: Dizziness (3.9% to 7.7%), Headache (1.7% to 6.9%) 
               
               
                   
                 Respiratory: Cough (2% to 4.3%) 
               
               
                   
                 Other: Fatigue (2.6%) 
               
               
                   
                 Serious 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Immunologic: Anaphylactoid reaction (rare), Anaphylaxis due to 
               
               
                   
                 hymenoptera venom, Dialysis membrane-induced anaphylactoid 
               
               
                   
                 reaction 
               
               
                   
                 Renal: Serum blood urea nitrogen raised (2% to 8%), Serum 
               
               
                   
                 creatinine raised (2% to 11%) 
               
               
                   
                 Other: Angioedema 
               
               
                 Ramipril (Altace) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (11%) 
               
               
                   
                 Neurologic: Asthenia, Dizziness (2.2% to 4%), Headache (5.4%) 
               
               
                   
                 Respiratory: Cough (8% to 12%) 
               
               
                   
                 Other: Fatigue 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Gastrointestinal: Intestinal angioedema, Pancreatitis 
               
               
                   
                 Hepatic: Hepatic necrosis, Hepatotoxicity 
               
               
                   
                 Immunologic: Anaphylactoid reaction 
               
               
                   
                 Other: Angioedema, Head and Neck 
               
               
                 Trandolapril (Mavik) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (0.6% to 11%), Syncope (5.9%) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (0.3% to 5.3%) 
               
               
                   
                 Gastrointestinal: Indigestion (0.3% to 6.4%) 
               
               
                   
                 Neurologic: Dizziness (1.3% to 23%) 
               
               
                   
                 Renal: Serum blood urea nitrogen raised (9%) 
               
               
                   
                 Respiratory: Cough (1.9% to 35%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiogenic shock (3.8%), Intermittent 
               
               
                   
                 claudication (3.8%) 
               
               
                   
                 Gastrointestinal: Intestinal angioedema 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Immunologic: Anaphylaxis due to hymenoptera venom, Dialysis 
               
               
                   
                 membrane-induced anaphylactoid reaction 
               
               
                   
                 Other: Angioedema 
               
               
                 Candesartan (Atacand) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (18.8%) 
               
               
                   
                 Musculoskeletal: Backache (3%.) 
               
               
                   
                 Neurologic: Dizziness (less than 5%) 
               
               
                   
                 Respiratory: Pharyngitis (2%), Rhinitis (2%), Upper respiratory 
               
               
                   
                 infection (6%) 
               
               
                 Eprosartan (Teveten) 
                 Common 
               
               
                   
                 Gastrointestinal: Abdominal pain 
               
               
                   
                 Musculoskeletal: Myalgia (1.9%) 
               
               
                   
                 Neurologic: Dizziness (3.8%) 
               
               
                   
                 Respiratory: Upper respiratory infection 
               
               
                   
                 Other: Fatigue (1.4%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Edema of face (rare) 
               
               
                   
                 Hematologic: Neutropenia (1.3%) 
               
               
                 Irbesartan (Avapro) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea, Heartbum 
               
               
                   
                 Neurologic: Headache 
               
               
                   
                 Respiratory: Upper respiratory infection 
               
               
                   
                 Other: Fatigue 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Thrombocytopenia 
               
               
                   
                 Hepatic: Cholestasis, Hepatitis 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis 
               
               
                   
                 Renal: Renal failure 
               
               
                   
                 Other: Angioedema, face, lips, throat 
               
               
                 Losartan (Cozaar) 
                 Common 
               
               
                   
                 Cardiovascular: Chest pain (12%), Hypotension (7%) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (7%), Hypoglycemia (14%) 
               
               
                   
                 Gastrointestinal: Diarrhea (15%) 
               
               
                   
                 Hematologic: Anemia (14%) 
               
               
                   
                 Neurologic: Asthenia, Dizziness (3%) 
               
               
                   
                 Respiratory: Cough (10%) 
               
               
                   
                 Other: Fatigue 
               
               
                   
                 Serious 
               
               
                   
                 Hepatic: Hepatotoxicity 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis 
               
               
                   
                 Renal: Acute renal failure 
               
               
                   
                 Other: Angioedema 
               
               
                 Telmisartan (Micardis)) 
                 Common 
               
               
                   
                 Respiratory: Cough (1.6% to 15.6%), Upper respiratory infection 
               
               
                   
                 (7%) 
               
               
                   
                 Serious 
               
               
                   
                 Musculoskeletal: Rhabdomyolysis (rare) 
               
               
                 Valsartan (Diovan) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (5.5% to 6.9%) 
               
               
                   
                 Neurologic: Dizziness (2% to 17%), Headache (greater than 1%) 
               
               
                   
                 Renal: Serum blood urea nitrogen raised (heart failure, 16.6%), 
               
               
                   
                 Serum creatinine raised (hypertension, 0.8%; heart failure, 3.9%; 
               
               
                   
                 post-myocardial infarction, 4.2%) 
               
               
                   
                 Respiratory: Cough 
               
               
                   
                 Serious 
               
               
                   
                 Renal: Acute renal failure 
               
               
                   
                 Other: Angioedema, Face, lips, throat 
               
               
                 Sacubitril/valsartan (Entresto) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (18%) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (12%) 
               
               
                   
                 Neurologic: Dizziness (6%) 
               
               
                   
                 Serious 
               
               
                   
                 Renal: Renal failure (5%) 
               
               
                   
                 Other: Angioedema (0.5%) 
               
               
                 Acebutolol (Sectral) 
                 Common 
               
               
                   
                 Neurologic: Dizziness (6%), Headache (6%) 
               
               
                   
                 Other: Fatigue (11%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Angina (2%), Bradyarrhythmia (2%), Heart failure 
               
               
                   
                 (2%) 
               
               
                   
                 Hepatic: Hepatotoxicity (rare) 
               
               
                   
                 Immunologic: Anaphylaxis, Systemic lupus erythematosus (rare.) 
               
               
                 Atenolol (Tenormin) 
                 Common 
               
               
                   
                 Cardiovascular: Bradyarrhythmia (3% to 18%), Cold extremities 
               
               
                   
                 (12%), Hypotension (4% to 25%) 
               
               
                   
                 Neurologic: Dizziness (13%) 
               
               
                   
                 Psychiatric: Depression (up to 12%) 
               
               
                   
                 Other: Fatigue (up to 26%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Heart failure, Myocardial infarction, Ventricular 
               
               
                   
                 arrhythmia 
               
               
                   
                 Endocrine metabolic: Thyrotoxicosis 
               
               
                   
                 Immunologic: Anaphylaxis, Systemic lupus erythematosus 
               
               
                   
                 Respiratory: Pulmonary embolism (1.2%) 
               
               
                   
                 Other: Withdrawal sign or sy 
               
               
                 Betaxolol (Kerlone) 
                 Common 
               
               
                   
                 Cardiovascular: Bradyarrhythmia (5.8% to 8.1%) 
               
               
                   
                 Gastrointestinal: Indigestion (3.9% to 4.7%), Nausea (1.6% to 
               
               
                   
                 5.8%) 
               
               
                   
                 Musculoskeletal: Arthralgia (3.1% to 5.2%), Chest pain (2.4% to 
               
               
                   
                 7.1%) 
               
               
                   
                 Ophthalmic: Burning sensation in eye (30%, ophthalmic) 
               
               
                   
                 Other: Fatigue (2.9% to 9.7%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block, Myocardial infarction 
               
               
                 Bisoprolol/hydrochlorothiazide 
                 Common 
               
               
                 (Ziac) 
                 Gastrointestinal: Diarrhea (4.3%) 
               
               
                   
                 Neurologic: Dizziness (5.1%), Headache (4.5%) 
               
               
                   
                 Other: Fatigue (4.6%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Heart failure 
               
               
                   
                 Ophthalmic: Angle-closure glaucoma, acute, Myopia, Acute 
               
               
                   
                 transient 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                 Bisoprolol (Zebeta) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea (2.6% to 3.5%) 
               
               
                   
                 Neurologic: Headache (8.8% to 10.9%) 
               
               
                   
                 Respiratory: Rhinitis (2.9% to 4%), Upper respiratory infection 
               
               
                   
                 (4.8% to 5%.) 
               
               
                   
                 Other: Fatigue (6.6% to 8.2%) 
               
               
                 Carteolol (Cartrol) 
                 Common 
               
               
                   
                 Cardiovascular: Angina 
               
               
                   
                 Neurologic: Asthenia (7%.), Dizziness (4% to 15%.), Headache 
               
               
                   
                 (4% to 17%.), Insomnia (2% to 12%.) 
               
               
                   
                 Ophthalmic: Blurred vision, Burning sensation in eye (25%), 
               
               
                   
                 Conjunctival edema (25%), Conjunctival hyperemia (25%), 
               
               
                   
                 Epiphora (25%), Eye irritation (25%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia, Heart failure 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                 Metoprolol (Lopressor, Toprol 
                 Common 
               
               
                 XL) 
                 Cardiovascular: Bradyarrhythmia (3%), Cold extremities (1%), 
               
               
                   
                 Heart failure (1%), Hypotension (1%) 
               
               
                   
                 Dermatologic: Pruritus (5%), Rash (5%) 
               
               
                   
                 Gastrointestinal: Constipation (1%), Diarrhea (5%), Indigestion 
               
               
                   
                 (1%), Nausea (1%) 
               
               
                   
                 Neurologic: Dizziness (10%), Fatigue (10%), Headache 
               
               
                   
                 Psychiatric: Depression (5%) 
               
               
                   
                 Respiratory: Dyspnea (3%), Wheezing (1%) 
               
               
                   
                 Serious 
               
               
                   
                 Respiratory: Bronchospasm (1%) 
               
               
                 Nadolol (Corgard) 
                 Common 
               
               
                   
                 Cardiovascular: Bradyarrhythmia (2%) 
               
               
                   
                 Neurologic: Dizziness (2%) 
               
               
                   
                 Other: Fatigue (2%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block, Cardiac dysrhythmia (1%), 
               
               
                   
                 Heart failure (1%) 
               
               
                 Propranolol (Inderal) 
                 Common 
               
               
                   
                 Gastrointestinal: Diarrhea, Vomiting 
               
               
                   
                 Neurologic: Dizziness (Hypertension, 4% to 7%), Sleep disorder 
               
               
                   
                 Other: Fatigue (5% to 7%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Bradyarrhythmia, Cardiogenic shock, Congestive 
               
               
                   
                 heart failure, Heart block, Heart failure, Hypotension, Prolonged 
               
               
                   
                 PR interval, Shortened QT interval 
               
               
                   
                 Dermatologic: Erythroderma, Stevens-Johnson syndrome, Toxic 
               
               
                   
                 epidermal necrolysis 
               
               
                   
                 Endocrine metabolic: Hypoglycemia 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                   
                 Other: Withdrawal sign or symptom 
               
               
                 Sotalol (Betapace) 
                 Common 
               
               
                   
                 Cardiovascular: Chest pain (Adult, 16%; pediatric, 4%), 
               
               
                   
                 Lightheadedness (12%) 
               
               
                   
                 Dermatologic: Rash (5%) 
               
               
                   
                 Neurologic: Disturbance of consciousness (4%), Dizziness (13.1% 
               
               
                   
                 to 20%), Headache (3.3% to 11.5%) 
               
               
                   
                 Respiratory: Dyspnea (9.2% to 21%) 
               
               
                   
                 Other: Fatigue (18.9% to 20%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block, Bradyarrhythmia (Adult, 
               
               
                   
                 12.3% to 16%; pediatric, 4%), Cardiac dysrhythmia (5%), 
               
               
                   
                 Congestive heart failure (1.2% to 3.3%), Heart failure (5%), 
               
               
                   
                 Prolonged QT interval, Torsades de pointes (0.5% to 4%) 
               
               
                   
                 Neurologic: Cerebrovascular accident (1%) 
               
               
                 Timolol (Blocadren) 
                 Common 
               
               
                   
                 Cardiovascular: Angina, Bradyarrhythmia (5% to 9.1%, oral), 
               
               
                   
                 Heart failure (8%, oral), Hypotension 
               
               
                   
                 Dermatologic: Pruritus, Rash, Urticaria 
               
               
                   
                 Gastrointestinal: Abdominal pain, Diarrhea, Indigestion, Nausea, 
               
               
                   
                 Vomiting 
               
               
                   
                 Musculoskeletal: Cramp 
               
               
                   
                 Neurologic: Confusion (13%), Dizziness (2.3% to 6%, oral), 
               
               
                   
                 Headache (1.7%, oral; 1% to 5%, ophthalmic) 
               
               
                   
                 Ophthalmic: Blurred vision (Ophthalmic, 15% to 33%), Burning 
               
               
                   
                 sensation in eye (Ophthalmic, 12.5% to 20%), Dry eyes 
               
               
                   
                 Psychiatric: Depression (9.2%, ophthalmic), Hallucinations (11%), 
               
               
                   
                 Psychotic disorder (3%) 
               
               
                   
                 Respiratory: Cough, Dyspnea (1.7%, oral) 
               
               
                   
                 Other: Fatigue (3.4% to 5%, oral), Infectious disease 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia (1%), Myocardial infarction 
               
               
                   
                 (rare) 
               
               
                   
                 Respiratory: Bronchospasm (0.6%, oral) 
               
               
                 carvedilol, Common brand 
                 Common 
               
               
                 names - Coreg* 
                 Cardiovascular: Bradyarrhythmia (3% to 10%), Hypotension (1.8% 
               
               
                   
                 to 20.2%), Peripheral edema (1% to 7%) 
               
               
                   
                 Endocrine metabolic: Abnormal weight gain (10% to 12%), 
               
               
                   
                 Hyperglycemia (5% to 12%) 
               
               
                   
                 Gastrointestinal: Diarrhea (2% to 12%) 
               
               
                   
                 Neurologic: Dizziness (6% to 33%) 
               
               
                   
                 Reproductive: Erectile dysfunction (13.5%) 
               
               
                   
                 Other: Fatigue (24%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block (greater than 1% to 3%) 
               
               
                   
                 Dermatologic: Erythema multiforme, Stevens-Johnson syndrome, 
               
               
                   
                 Toxic epidermal necrolysis 
               
               
                   
                 Hematologic: Aplastic anemia 
               
               
                   
                 Ophthalmic: Intraoperative floppy iris syndrome 
               
               
                   
                 Respiratory: Asthma with status asthmaticus (rare) 
               
               
                 labetolol hydrochloride, 
                 Common 
               
               
                 Common brand names 
                 Cardiovascular: Orthostatic hypotension (1%, oral; 58%, IV) 
               
               
                 Normodyne*, Trandate* 
                 Dermatologic: Has tingling sensation (7%.) 
               
               
                   
                 Gastrointestinal: Nausea (14%) 
               
               
                   
                 Neurologic: Dizziness (9% to 20%) 
               
               
                   
                 Respiratory: Nasal congestion (3%) 
               
               
                   
                 Other: Fatigue (11%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Heart failure 
               
               
                   
                 Endocrine metabolic: Hyperkalemia 
               
               
                   
                 Hepatic: Hepatotoxicity 
               
               
                   
                 Respiratory: Bronchospasm 
               
               
                 Amlodipine (Norvasc, Lotrel) 
                 Common 
               
               
                   
                 Cardiovascular: Flushing (0.7% to 2.6%), Palpitations (Up to 
               
               
                   
                 4.5%), Peripheral edema (Up to 10.8%) 
               
               
                   
                 Gastrointestinal: Abdominal pain (1.6%), Nausea (2.9%.) 
               
               
                   
                 Neurologic: Dizziness (Up to 3.4%), Headache (7.3%), 
               
               
                   
                 Somnolence (1.4%) 
               
               
                   
                 Other: Fatigue (4.5%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Acute myocardial infarction, Angina 
               
               
                   
                 Other: Angioedema 
               
               
                 Bepridil (Vascor) 
                 Common 
               
               
                   
                 Diarrhea 
               
               
                   
                 Dizzy 
               
               
                   
                 Feel Like Throwing Up 
               
               
                   
                 Infrequent side effects of Vascor: 
               
               
                   
                 Abnormal Heart Rhythm 
               
               
                   
                 Chronic Heart Failure 
               
               
                   
                 Fluid in the Lungs 
               
               
                   
                 Prolonged Q-T Interval on EKG 
               
               
                   
                 Slow Heartbeat 
               
               
                   
                 Very Rapid Heartbeat - Torsades de Pointes 
               
               
                   
                 Head Pain 
               
               
                   
                 Incomplete or Infrequent Bowel Movements 
               
               
                   
                 Low Energy 
               
               
                   
                 Rare side effects of Vascor: 
               
               
                   
                 Deficiency of Granulocytes a Type of White Blood Cell 
               
               
                   
                 Fluid Retention in the Legs, Feet, Arms or Hands 
               
               
                   
                 Inflammation of Skin caused by an Allergy 
               
               
                   
                 Rash 
               
               
                   
                 Reaction due to an Allergy 
               
               
                   
                 Low Blood Pressure 
               
               
                 Diltiazem (Cardizem, Tiazac) 
                 Common 
               
               
                   
                 Cardiovascular: Bradyarrhythmia (1.7% to 3.6%), Peripheral 
               
               
                   
                 edema (4.6% to 8%) 
               
               
                   
                 Neurologic: Dizziness (3.5% to 6.4%), Headache (4.6%) 
               
               
                   
                 Respiratory: Cough (2%) 
               
               
                   
                 Other: Fatigue (4.8%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Congestive heart failure (less than 2%), Heart 
               
               
                   
                 block, Myocardial infarction 
               
               
                   
                 Hepatic: Hepatotoxicity 
               
               
                 Felodipine (Plendil) 
                 Common 
               
               
                   
                 Cardiovascular: Peripheral edema (2% to 17.4%) 
               
               
                   
                 Dermatologic: Flushing (3.9% to 6.9%) 
               
               
                   
                 Gastrointestinal: Indigestion (0.5% to 3.9%) 
               
               
                   
                 Neurologic: Headache (10.6% to 14.7%) 
               
               
                   
                 Respiratory: Upper respiratory infection (0.7% to 3.9%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Angina, Hypotension (less than 0.5%), Myocardial 
               
               
                   
                 infarction, Tachycardia 
               
               
                   
                 Neurologic: Cerebrovascular accident 
               
               
                 Nifedipine (Adalat, Procardia) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (up to 5%), Palpitations (up to 7%), 
               
               
                   
                 Peripheral edema (7% to 29%) 
               
               
                   
                 Dermatologic: Flushing (4% to 25%) 
               
               
                   
                 Gastrointestinal: Nausea (up to 10%) 
               
               
                   
                 Neurologic: Dizziness (4% to 10%), Headache (19% to 23%) 
               
               
                   
                 Psychiatric: Feeling nervous 
               
               
                   
                 Respiratory: Cough, Dyspnea 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction (up to 4%), Ventricular 
               
               
                   
                 arrhythmia (less than 0.5%) 
               
               
                   
                 Gastrointestinal: Gastrointestinal obstruction, Gastrointestinal ulcer 
               
               
                   
                 Hematologic: Aplastic anemia 
               
               
                 Nimodipine (Nimotop) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (up to 8.1%) 
               
               
                   
                 Gastrointestinal: Diarrhea (up to 4.2%), Nausea (0.6% to 1.4%) 
               
               
                   
                 Neurologic: Headache (up to 4.1%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Congestive heart failure (less than 1%) 
               
               
                   
                 Gastrointestinal: Gastrointestinal hemorrhage (less than 1%) 
               
               
                   
                 Hematologic: Bleeding, Disseminated intravascular coagulation 
               
               
                   
                 (less than 1%), Hematoma (less than 1%) 
               
               
                 Nisoldipine (Sular) 
                 Common 
               
               
                   
                 Cardiovascular: Palpitations (3%), Peripheral edema (22%), 
               
               
                   
                 Vasodilatation (4%) 
               
               
                   
                 Dermatologic: Flushing 
               
               
                   
                 Neurologic: Dizziness (5%), Headache (22%) 
               
               
                   
                 Respiratory: Pharyngitis (5%), Sinusitis 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Myocardial infarction 
               
               
                 Verapamil (Calan, Isoptin, 
                 Common 
               
               
                 Verelan) 
                 Cardiovascular: Edema (up to 3.7%), Hypotension (1.5% to 3%) 
               
               
                   
                 Gastrointestinal: Constipation (7.3% to 13%) 
               
               
                   
                 Neurologic: Dizziness (3% to 5.9%), Headache (2.2% to 12.1%) 
               
               
                   
                 Respiratory: Pharyngitis (3%), Sinusitis (3%) 
               
               
                   
                 Other: Influenza-like symptoms (3.7%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Atrioventricular block, Myocardial infarction 
               
               
                   
                 Respiratory: Pulmonary edema 
               
               
                 Digoxin 
                 Common 
               
               
                   
                 Gastrointestinal: Nausea and vomiting 
               
               
                   
                 Neurologic: Dizziness, Headache 
               
               
                   
                 Psychiatric: Mental disorder 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia, Ischemia, Sinoatrial block, 
               
               
                   
                 Sinus bradycardia, Vasoconstriction 
               
               
                   
                 Hematologic: Thrombocytopenia 
               
               
                 Digitoxin 
                 Common 
               
               
                   
                 Enlarged BreastsLCommon side effects of digitoxin: 
               
               
                   
                 Enlarged Breasts 
               
               
                   
                 Infrequent side effects of digitoxin: 
               
               
                   
                 Sinus Bradycardia 
               
               
                   
                 Rare side effects of digitoxin: 
               
               
                   
                 Abnormal Heart Electrical Signals 
               
               
                   
                 Atrioventricular Heart Block 
               
               
                   
                 Decreased Blood Platelets 
               
               
                   
                 Delirium 
               
               
                   
                 Diarrhea 
               
               
                   
                 Fast Heartbeat 
               
               
                   
                 Gangrene of Intestine caused by Blood Supply ProblemSevere 
               
               
                   
                 Heart Block 
               
               
                   
                 Inflammation of Skin caused by an Allergy 
               
               
                   
                 Loss of Appetite 
               
               
                   
                 Rapid Ventricular Heartbeat 
               
               
                   
                 Rash 
               
               
                   
                 Reaction due to an Allergy 
               
               
                   
                 Throwing Up 
               
               
                   
                 Ventricular Fibrillation 
               
               
                   
                 Ventricular Premature Beats 
               
               
                   
                 Visual Halos Around Lights 
               
               
                   
                 Anxious 
               
               
                   
                 Blurred Vision 
               
               
                   
                 Confused 
               
               
                   
                 Depression E194 
               
               
                   
                 Discolored Spots and Small Elevations of the SkinLess 
               
               
                   
                 DizzyLess 
               
               
                   
                 Feel Like Throwing Up 
               
               
                   
                 Feeling Weak 
               
               
                   
                 Hallucination 
               
               
                   
                 Head Pain 
               
               
                 Lanoxin 
                 See Digoxin above 
               
               
                 Amiloride (Midamor) 
                 Common 
               
               
                   
                 Dermatologic: Rash (1% or less) 
               
               
                   
                 Gastrointestinal: Diarrhea (3% to 8%), Loss of appetite (3% to 8%), 
               
               
                   
                 Nausea (3% to 8%), Vomiting (3% to 8%) 
               
               
                   
                 Musculoskeletal: Asthenia (greater than 1% to less than 3%), 
               
               
                   
                 Cramp (greater than 1% to less than 3%) 
               
               
                   
                 Neurologic: Dizziness (greater than 1% to less than 3%), Headache 
               
               
                   
                 (3% to 8%) 
               
               
                   
                 Respiratory: Cough (greater than 1% to less than 3%), Dyspnea 
               
               
                   
                 (greater than 1% to less than 3%) 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia (1% or less), Palpitations (1% 
               
               
                   
                 or less) 
               
               
                   
                 Endocrine metabolic: Hyperkalemia (10%) 
               
               
                   
                 Hematologic: Aplastic anemia, Neutropenia 
               
               
                   
                 Neurologic: Encephalopathy (greater than 1% to less than 3%) 
               
               
                   
                 Ophthalmic: Raised intraocular pressure (1% or less) 
               
               
                 Bumetanide (Bumex) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (0.8%) 
               
               
                   
                 Endocrine metabolic: Hyperuricemia (18.4%), Hypochloremia 
               
               
                   
                 (14.9%), Hypokalemia (14.7%) 
               
               
                   
                 Gastrointestinal: Nausea (0.6%) 
               
               
                   
                 Musculoskeletal: Cramp (1.1%) 
               
               
                   
                 Neurologic: Dizziness (1.1%), Headache (0.6%) 
               
               
                   
                 Renal: Azotemia (10.6%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Hematologic: Thrombocytopenia (0.2%) 
               
               
                   
                 Neurologic: Encephalopathy (0.6%) 
               
               
                 Chlorothiazide (Diuril) 
                 Common 
               
               
                   
                 Dermatologic: Photosensitivity 
               
               
                   
                 Endocrine metabolic: Hyperglycemia, Hyperuricemia 
               
               
                   
                 Gastrointestinal: Diarrhea, Loss of appetite, Nausea, Vomiting 
               
               
                   
                 Neurologic: Dizziness 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Cutaneous lupus erythematosus, Stevens-Johnson 
               
               
                   
                 syndrome, Toxic epidermal necrolysis 
               
               
                   
                 Endocrine metabolic: Electrolytes abnormal 
               
               
                   
                 Gastrointestinal: Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Aplastic anemia, Hemolytic anemia 
               
               
                   
                 Hepatic: Hepatotoxicity, Jaundice 
               
               
                   
                 Immunologic: Anaphylaxis, Systemic lupus erythematosus 
               
               
                   
                 Neurologic: Coma 
               
               
                   
                 Renal: Renal failure 
               
               
                   
                 Respiratory: Pulmonary edema, Noncardiogenic 
               
               
                 Chlorthalidone (Hygroton) 
                 Common 
               
               
                   
                 Endocrine metabolic: Hyperuricemia 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia 
               
               
                   
                 Dermatologic: Toxic epidermal necrolysis 
               
               
                   
                 Gastrointestinal: Pancreatitis (rare) 
               
               
                   
                 Hepatic: Cholestatic jaundice syndrome 
               
               
                   
                 Respiratory: Pulmonary edema (rare) 
               
               
                 Furosemide (Lasix) 
                 Common 
               
               
                   
                 Endocrine metabolic: Hyperuricemia (40%), Hypomagnesemia 
               
               
                   
                 Gastrointestinal: Loss of appetite 
               
               
                   
                 Renal: Spasm of bladder 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Orthostatic hypotension 
               
               
                   
                 Dermatologic: Drug hypersensitivity syndrome, Erythema 
               
               
                   
                 multiforme, Erythroderma, Stevens-Johnson syndrome, Toxic 
               
               
                   
                 epidermal necrolysis due to drug 
               
               
                   
                 Gastrointestinal: Pancreatitis 
               
               
                   
                 Hematologic: Agranulocytosis, Aplastic anemia, 
               
               
                   
                 Thrombocytopenia 
               
               
                   
                 Immunologic: Anaphylactoid reaction, Anaphylaxis 
               
               
                 Hydro-chlorothiazide (Esidrix, 
                 Common 
               
               
                 Hydrodiuril) 
                 Cardiovascular: Hypotension 
               
               
                   
                 Dermatologic: Phototoxicity 
               
               
                   
                 Neurologic: Vertigo 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Cardiac dysrhythmia 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Endocrine metabolic: Dilutional hyponatremia, Hypercalcemia, 
               
               
                   
                 Hyperglycemia, Hypokalemia, Hypomagnesemia, Hyponatremia, 
               
               
                   
                 Hypophosphatemia 
               
               
                   
                 Gastrointestinal: Cholecystitis, Pancreatitis 
               
               
                   
                 Hepatic: Cholestatic jaundice syndrome 
               
               
                   
                 Ophthalmic: Angle-closure glaucoma, acute, Myopia, Acute 
               
               
                   
                 transient 
               
               
                   
                 Renal: Renal failure, Renal impairment 
               
               
                 Indapamide (Lozol) 
                 Common 
               
               
                   
                 Endocrine metabolic: Hypokalemia (3% to 7%) 
               
               
                   
                 Musculoskeletal: Cramp 
               
               
                   
                 Neurologic: Asthenia, Dizziness (Greater than or equal to 5%), 
               
               
                   
                 Headache (Greater than or equal to 5%), Lethargy, Numbness 
               
               
                   
                 Other: Fatigue, Malaise 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Hematologic: Agranulocytosis, Aplastic anemia 
               
               
                   
                 Hepatic: Hepatitis 
               
               
                   
                 Immunologic: Anaphylaxis 
               
               
                 Spironolactone (Aldactone) 
                 Common 
               
               
                   
                 Endocrine metabolic: Gynecomastia 
               
               
                   
                 Gastrointestinal: Diarrhea, Nausea and vomiting 
               
               
                   
                 Neurologic: Somnolence 
               
               
                   
                 Reproductive: Disorder of menstruation, Erectile dysfunction 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome, Toxic epidermal 
               
               
                   
                 necrolysis 
               
               
                   
                 Endocrine metabolic: Breast cancer, Disorder of electrolytes, 
               
               
                   
                 Hyperkalemia, Metabolic acidosis 
               
               
                   
                 Gastrointestinal: Gastric hemorrhage, Gastritis 
               
               
                   
                 Hematologic: Agranulocytosis 
               
               
                   
                 Immunologic: Drug hypersensitivity syndrome, Systemic lupus 
               
               
                   
                 erythematosus 
               
               
                   
                 Other: Breast cancer 
               
               
                 Isosorbide dinitrate (Isordil) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension, Lightheadedness 
               
               
                   
                 Neurologic: Headache 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Syncope 
               
               
                   
                 Hematologic: Methemoglobinemia 
               
               
                 Nesiritide (Natrecor) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (4% to 17%) 
               
               
                   
                 Gastrointestinal: Nausea (3%) 
               
               
                   
                 Neurologic: Dizziness (2%), Headache (7%) 
               
               
                   
                 Renal: Serum creatinine raised (17% to 31.4%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Injection site extravasation 
               
               
                   
                 Immunologic: Hypersensitivity reaction 
               
               
                   
                 Other: Death, Increased risk 
               
               
                 Hydralazine (Apresoline) 
                 Common 
               
               
                   
                 Cardiovascular: Angina, Edema, Palpitations, Tachycardia 
               
               
                   
                 Gastrointestinal: Diarrhea, Loss of appetite, Nausea, Vomiting 
               
               
                   
                 Neurologic: Headache 
               
               
                   
                 Serious 
               
               
                   
                 Hematologic: Agranulocytosis, Leukopenia 
               
               
                   
                 Hepatic: Hepatotoxicity 
               
               
                   
                 Immunologic: Lupus pneumonia (Acute), Systemic lupus 
               
               
                   
                 erythematosus 
               
               
                 Nitrates (Nitroglycerin) 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension (4%) 
               
               
                   
                 Dermatologic: Flushing 
               
               
                   
                 Neurologic: Dizziness (5%), Headache (63% to 64%), 
               
               
                   
                 Lightheadedness (6%) 
               
               
                   
                 Serious 
               
               
                   
                 Dermatologic: Anaphylactoid reaction 
               
               
                   
                 Hematologic: Methemoglobinemia 
               
               
                   
                 Neurologic: Raised intracranial pressure 
               
               
                 Minoxidil 
                 Common 
               
               
                   
                 Cardiovascular: Hypotension 
               
               
                   
                 Dermatologic: Hirsutism, Hypertrichosis 
               
               
                   
                 Endocrine metabolic: Body fluid retention (7%), Hypernatremia 
               
               
                   
                 Serious 
               
               
                   
                 Cardiovascular: Angina, Cardiac tamponade, Electrocardiogram 
               
               
                   
                 abnormal (60%), Pericardial effusion (3%), Pericarditis, 
               
               
                   
                 Tachyarrhythmia 
               
               
                   
                 Dermatologic: Stevens-Johnson syndrome 
               
               
                   
                 Hematologic: Leukopenia, Thrombocytopenia 
               
               
                   
               
            
           
         
       
     
     Table 5 is included by reference as the drugs that are listed as in development in the following databases: Cortellis™ Competitive Intelligence by Thomson Reuters; Adis R&amp;D; and Pharmaprojects by Citeline. The drugs in the development pipeline can utilize the Invention to capture required clinical trial information and control drug dispensing for regulatory drug approval as well as to control drug dispensing after regulatory approval. The drugs are encompassed in the embodiment of the invention by reference. The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     Table 6 is included by reference as the mechanisms of action for marketed drugs, drugs in developed, and efficacious drugs whose development was stopped due to a side effect(s) that can be addressed by the embodiment and thereby made approvable. The listed drugs in the following databases are encompassed in the embodiment of the invention by reference: Cortellis™ Competitive Intelligence by Thomson Reuters; Adis R&amp;D; and Pharmaprojects by Citeline. The listing for each includes by definition each respective drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     Table 7 is included by reference as the oral drugs listed in the following databases that (i) were in development but were disconintued due to dose related side effects whose safety concerns can be addressed by the Invention or (ii) drugs that were withdrawn from the market after approval due to dose related side effects whose safety concerns can be addressed by the Invention: Cortellis™ Competitive Intelligence by Thomson Reuters; Adis R&amp;D; and Pharmaprojects by Citeline. These drugs are encompassed in the embodiment of the invention by reference. The listing for each drug includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     Table 8 is a sample list of diseases encompassed in the embodiment of the invention by reference. The listing for each encompasses drugs used to treat the disease and for each includes by definition each drug&#39;s respective indication(s), strength, dosage form, route of administration, side effect profile, drug interactions, etc. 
     
       
         
           
               
             
               
                 TABLE 8 
               
               
                   
               
               
                 Diseases 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
            
               
                 Abdominal Aortic Aneurysm - see Aortic Aneurysm 
               
               
                 ACE (Adverse Childhood Experiences) 
               
               
                 Acinetobacter Infection 
               
               
                 Acquired Immune Deficiency Syndrome (AIDS) - see HIV/AIDS 
               
               
                 Acquired Immunodeficiency Syndrome (AIDS) - see HIV/AIDS 
               
               
                 Adenovirus Infection 
               
               
                 Adenovirus Vaccination 
               
               
                 ADHD [Attention Deficit/Hyperactivity Disorder] 
               
               
                 Adult Vaccinations 
               
               
                 Adverse Childhood Experiences (ACE) 
               
               
                 African Trypanosomiasis - see Sleeping Sickness 
               
               
                 Agricultural Safety - see Farm Worker Injuries 
               
               
                 AHF (Alkhurma hemorrhagic fever) 
               
               
                 AIDS (Acquired Immune Deficiency Syndrome) 
               
               
                 AIDS (Acquired Immunodeficiency Syndrome) 
               
               
                 Alkhurma hemorrhagic fever (AHF) 
               
               
                 ALS [Amyotrophic Lateral Sclerosis] 
               
               
                 Alzheimer&#39;s Disease 
               
               
                 Amebiasis, Intestinal [ Entamoeba histolytica  infection] 
               
               
                 American Indian and Alaska Native Vaccination 
               
               
                 American Trypanosomiasis - see Chagas Disease 
               
               
                 Amphibians and Fish, Infections from - see Fish and Amphibians, 
               
               
                 Infections from 
               
               
                 Amyotrophic Lateral Sclerosis - see ALS 
               
               
                 Anaplasmosis, Human 
               
               
                   Ancylostoma duodenale  Infection,  Necator americanus  Infection - 
               
               
                 see Human Hookworm 
               
               
                 Anemia 
               
               
                   Angiostrongylus  Infection 
               
               
                 Animal-Related Diseases 
               
               
                 Anisakiasis - see  Anisakis  Infection 
               
               
                   Anisakis  Infection [Anisakiasis] 
               
               
                 Anthrax [ Bacillus anthracis  Infection] 
               
               
                 Anthrax Emergency Vaccination 
               
               
                 Antibiotic and Antimicrobial Resistance 
               
               
                 Antibiotic Use, Appropriate 
               
               
                 Aortic Aneurysm 
               
               
                 Aortic Dissection - see Aortic Aneurysm 
               
               
                 Arenavirus Infection 
               
               
                 Arthritis 
               
               
                 Ascariasis - see  Ascaris  Infection 
               
               
                   Ascaris  Infection [Ascariasis] 
               
               
                 ASDs (Autism and Genetics) 
               
               
                 Aseptic Meningitis - see Viral Meningitis 
               
               
                 Aspergillosis - see  Aspergillus  Infection 
               
               
                   Aspergillus  Infection [Aspergillosis] 
               
               
                 Asthma 
               
               
                 Attention Deficit/Hyperactivity Disorder - see ADHD 
               
               
                 Autism 
               
               
                 Autism and Genetics (ASDs) [autism spectrum disorders] 
               
               
                 autism spectrum disorders - see Autism and Genetics 
               
               
                 Avian Influenza 
               
               
                 B virus Infection [Herpes B virus] 
               
               
                   B. cepacia  infection ( Burkholderia cepacia  Infection) 
               
               
                   Babesia  Infection - see Babesiosis 
               
               
                 Babesiosis [ Babesia  Infection] 
               
               
                   Bacillus anthracis  - see Anthrax 
               
               
                   Bacillus anthracis  Infection - see Anthrax 
               
               
                 Back Belts - see Ergonomic and Musculoskeletal Disorders 
               
               
                 Bacterial Meningitis 
               
               
                 Bacterial Vaginosis (BV) 
               
               
                   Balamuthia mandrillaris  Infection - see  Balamuthia  Infection 
               
               
                   Balamuthia  Infection [ Balamuthia mandrillaris  Infection] 
               
               
                 Balantidiasis - see  Balantidium  Infection 
               
               
                   Balantidium  Infection [Balantidiasis] 
               
               
                   Bartonella bacilliformis  Infection - see Carrión&#39;s disease 
               
               
                   Bartonella quintana  Infection - see Trench fever 
               
               
                   Baylisascaris  Infection - see Raccoon Roundworm Infection 
               
               
                 BCG (Tuberculosis Vaccine) 
               
               
                 Bilharzia - see Schistosomiasis 
               
               
                 Bioterrorism Agents/Diseases 
               
               
                 Bird Flu - see Avian Influenza 
               
               
                 Birth Defects 
               
               
                 Black Lung [Coal Workers&#39; Pneumoconioses] 
               
               
                 Blast Injuries 
               
               
                   Blastocystis hominis  Infection - see  Blastocystis  Infection 
               
               
                   Blastocystis  Infection [ Blastocystis hominis  Infection] 
               
               
                 Blastomycosis [ Blastomyces dermatitidis  Infection] 
               
               
                 Bleeding Disorders 
               
               
                 blood clot 
               
               
                 Blood Disorders 
               
               
                 Body Lice [ Pediculus humanus  corporis] 
               
               
                 Bone Health 
               
               
                   Borrelia burgdorferi  Infection - see Lyme Disease 
               
               
                 Botulism [ Clostridium botulinim  Infection] 
               
               
                 Bovine Spongiform Encephalopathy (BSE) 
               
               
                 Brainerd Diarrhea 
               
               
                 Breast and Ovarian Cancer and Family Health History 
               
               
                 Breast Cancer 
               
               
                 Breastfeeding 
               
               
                 Bronchiolitis - see Respiratory Syncytial Virus Infection 
               
               
                 Bronchitis 
               
               
                   Brucella  Infection [Brucellosis] 
               
               
                 Brucellosis - see  Brucella  Infection 
               
               
                 BSE (Bovine Spongiform Encephalopathy) 
               
               
                 BSE (Mad Cow Disease) 
               
               
                   Burkholderia cepacia  Infection ( B. cepacia  infection) 
               
               
                   Burkholderia mallei  - see Glanders 
               
               
                   Burkholderia pseudomallei  Infection - see Melioidosis 
               
               
                 BV (Bacterial Vaginosis) 
               
               
                   C. diff.  Infection [ Clostridium difficile  Infection] 
               
               
                   C. gattii  cryptococcosis 
               
               
                   C. neoformans  cryptococcosis 
               
               
                   Campylobacter  Infection [Campylobacteriosis] 
               
               
                 Campylobacteriosis - see  Campylobacter  Infection 
               
               
                 Cancer 
               
               
                 Cancer and Flu 
               
               
                 Cancer Health Disparities - see Health Disparities in Cancer 
               
               
                   Candida  Infection [Candidiasis] 
               
               
                 Candidiasis - see  Candida  Infection 
               
               
                 Canine Flu 
               
               
                   Capillaria  Infection [Capillariasis] 
               
               
                 Capillariasis - see  Capillaria  Infection 
               
               
                 Carbapenem resistant  Klebsiella pneumonia  (CRKP) see 
               
               
                 
                   Klebsiella pneumoniae 
                 
               
               
                 Carbapenem-resistant Enterobacteriaceae (CRE) 
               
               
                 Cardiovascular Health - see Heart Disease 
               
               
                 Carpal Tunnel Syndrome - see Ergonomic and Musculoskeletal 
               
               
                 Disorders 
               
               
                 Carrión&#39;s disease [ Bartonella bacilliformis  Infection] 
               
               
                 Cat Flea Tapeworm - see Tapeworm, Dog and Cat Flea 
               
               
                 Cats, Infections from 
               
               
                 CCHF (Crimean-Congo hemorrhagic fever) 
               
               
                 Cercarial Dermatitis - see Swimmer&#39;s Itch 
               
               
                 Cerebral Palsy 
               
               
                 Cervical Cancer 
               
               
                 CFS (Chronic Fatigue Syndrome) 
               
               
                 Chagas Disease [ Trypanosoma cruzi  Infection] 
               
               
                 Chapare Hemorrhagic Fever (CHHF) 
               
               
                 Chest Cold - see Bronchitis 
               
               
                 CHHF (Chapare Hemorrhagic Fever) 
               
               
                 Chickenpox [Varicella Disease] 
               
               
                 Chickenpox Vaccination 
               
               
                 Chikungunya Fever (CHIKV) 
               
               
                 CHIKV (Chikungunya Fever) 
               
               
                 Childhood Arthritis 
               
               
                 Childhood Injuries 
               
               
                 Childhood Overweight and Obesity 
               
               
                 Children&#39;s Cough and Cold Medicines - see Cough and Cold 
               
               
                 Medicines 
               
               
                   Chlamydia  [ Chlamydia trachomatis  Disease] 
               
               
                   Chlamydia trachomatis  Disease - see  Chlamydia   
               
               
                   Chlamydophila  ( Chlamydia )  pneumoniae  Infection 
               
               
                 Cholera [ Vibrio cholerae  Infection] 
               
               
                 Chronic Disease Prevention 
               
               
                 Chronic Fatigue Syndrome (CFS) 
               
               
                 Chronic Kidney Disease (CKD) 
               
               
                 Chronic Obstructive Pulmonary Disease (COPD) 
               
               
                 Chronic Wasting Disease (CWD) 
               
               
                 Ciguatera Fish Poisoning 
               
               
                 Ciguatoxin - see Marine Toxins 
               
               
                 CJD, Classic (Classic Creutzfeldt-Jakob Disease) 
               
               
                 CKD (Chronic Kidney Disease) 
               
               
                 CKD (Kidney Disease) 
               
               
                 Classic Creutzfeldt-Jakob Disease (CJD, Classic) 
               
               
                 Clonorchiasis - see  Clonorchis  Infection 
               
               
                   Clonorchis  Infection [Clonorchiasis] 
               
               
                   Clostridium botulinim  Infection - see Botulism 
               
               
                   Clostridium difficile  Infection - see  C. diff.  Infection 
               
               
                   Clostridium perfringens  infection 
               
               
                   Clostridium perfringens  infection 
               
               
                   Clostridium tetani  Infection - see Tetanus Disease 
               
               
                 Clotting Disorders 
               
               
                 CMV (Cytomegalovirus Infection) 
               
               
                 Coal Workers&#39; Pneumoconioses - see Black Lung 
               
               
                 Coccidioidomycosis - see Valley Fever 
               
               
                 Cold, Common 
               
               
                 Colorado Tick Fever (CTF) 
               
               
                 Colorectal (Colon) Cancer 
               
               
                 Colorectal Cancer and Genetics 
               
               
                 Colorectal Cancer Control Program (CRCCP) 
               
               
                 Common Cold - see Cold, Common 
               
               
                 Concussion - see Traumatic Brain Injury 
               
               
                 Congenital Hearing Loss - see Hearing Loss in Children 
               
               
                 Conjunctivitis - see Pink Eye 
               
               
                 Cooleys Anemia 
               
               
                 COPD (Chronic Obstructive Pulmonary Disease) 
               
               
                   Corynebacterium diphtheriae  Infection - see Diphtheria 
               
               
                 Cough and Cold Medicines 
               
               
                   Coxiella burnetii  Infection - see Q Fever 
               
               
                 CRE (Carbapenem-resistant Enterobacteriaceae) 
               
               
                 Creutzfeldt-Jakob Disease, Classic - see Classic Creutzfeldt-Jakob 
               
               
                 Disease 
               
               
                 Crimean-Congo hemorrhagic fever (CCHF) [Nairovirus Infection] 
               
               
                 CRKP (Carbapenem resistant  Klebsiella pneumonia ) 
               
               
                 Crohn&#39;s Disease - see Inflammatory Bowel Disease 
               
               
                   Cronobacter  Infection 
               
               
                 Cryptococcosis,  C. gattii.  - see  C. gattii  cryptococcosis 
               
               
                 Cryptococcosis,  C. neoformans  - see  C. neoformans  cryptococcosis 
               
               
                 Cryptosporidiosis - see  Cryptosporidium  Infection 
               
               
                   Cryptosporidium  Infection [Cryptosporidiosis] 
               
               
                 CTF (Colorado Tick Fever) 
               
               
                 CWD (Chronic Wasting Disease) 
               
               
                   Cyclospora  Infection [Cyclosporiasis] 
               
               
                 Cyclosporiasis - see  Cyclospora  Infection 
               
               
                 Cysticercosis 
               
               
                   Cystoisospora  Infection [Cystoisosporiasis] 
               
               
                 Cystoisosporiasis - see  Cystoisospora  Infection 
               
               
                 Cytomegalovirus Infection (CMV) 
               
               
                 DBA (Diamond Blackfan Anemia) 
               
               
                 Deep Vein Thrombosis (DVT) 
               
               
                 Dengue Fever (DF) 
               
               
                 Dengue Hemorrhagic Fever (DHF) - see Dengue Fever 
               
               
                 Dermatophyte Infection - see Ringworm 
               
               
                 Dermatophytes - see Ringworm 
               
               
                 Developmental Disabilities 
               
               
                 DF (Dengue Fever) 
               
               
                 DHF (Dengue Hemorrhagic Fever) 
               
               
                 Diabetes 
               
               
                 Diamond Blackfan Anemia (DBA) 
               
               
                   Dientamoeba fragilis  Infection 
               
               
                 Diet and Nutrition - see Nutrition 
               
               
                 Diphtheria [ Corynebacterium diphtheriae  Infection] 
               
               
                 Diphtheria Vaccination 
               
               
                 Diphyllobothriasis - see  Diphyllobothrium  Infection 
               
               
                   Diphyllobothrium  Infection [Diphyllobothriasis] 
               
               
                   Dipylidium  Infection - see Tapeworm, Dog and Cat Flea 
               
               
                 Dirofilariasis (Dog Heartworm) 
               
               
                 Division of Public Health Systems and Workforce Development 
               
               
                 (DPHSWD) 
               
               
                 Division of Public Health Systems and Workforce Development 
               
               
                 (DPHSWD) - see Division of Public Health Systems and Workforce 
               
               
                 Development 
               
               
                 Dog Flea Tapeworm - see Tapeworm, Dog and Cat Flea 
               
               
                 Dog Heartworm [ Dirofilaria ] - see Dirofilariasis (Dog Heartworm) 
               
               
                 Dogs, Infections from 
               
               
                 Down Syndrome [Trisomy 21] 
               
               
                 DPHSWD (Division of Public Health Systems and Workforce 
               
               
                 Development) 
               
               
                 Dracunculiasis - see Guinea Worm Disease 
               
               
                 Drug Resistance - see Antibiotic and Antimicrobial Resistance 
               
               
                 DVT (Deep Vein Thrombosis) 
               
               
                 Dwarf Tapeworm [ Hymenolepis  Infection] 
               
               
                   E. coli  Infection [ Escherichia coli  Infection] 
               
               
                 Ear Infection [Otitis Media] 
               
               
                 Early Hearing Detection and Intervention (EHDI) - see Hearing, 
               
               
                 Early Detection &amp; Intervention 
               
               
                 Eastern Equine Encephalitis (EEE) 
               
               
                 Ebola Virus Disease (EVD) 
               
               
                 EBV Infection (Epstein-Barr Virus Infection) 
               
               
                 Echinococcosis 
               
               
                 EEE (Eastern Equine Encephalitis) 
               
               
                 EHDI (Early Hearing Detection and Intervention) 
               
               
                 Ehrlichiosis, Human 
               
               
                 Elephantiasis - see Lymphatic Filariasis 
               
               
                 Emerging Infectious Diseases 
               
               
                   Entamoeba histolytica  infection - see Amebiasis, Intestinal 
               
               
                 Enteric Diseases from Animals - see Gastrointestinal Diseases from 
               
               
                 Animals 
               
               
                   Enterobius vermicularis  Infection - see Pinworm Infection 
               
               
                 Enterovirus D68 
               
               
                 Enterovirus Infections (Non-Polio) - see Non-Polio Enterovirus 
               
               
                 Infections 
               
               
                 Epidemic Typhus - see Typhus Fevers 
               
               
                 Epilepsy 
               
               
                 Epstein-Barr Virus Infection (EBV Infection) 
               
               
                 Ergonomic and Musculoskeletal Disorders 
               
               
                   Escherichia coli  Infection - see  E. coli  Infection 
               
               
                 Esophageal Candidiasis - see Thrush 
               
               
                 EVD (Ebola Virus Disease) 
               
               
                 EV-D68 - see Enterovirus D68 
               
               
                   Exserohilum rostratum  (Other Pathogenic Fungi) 
               
               
                 Extensively Drug-Resistant TB (XDR TB) 
               
               
                 Extreme Cold [Hypothermia] 
               
               
                 Extreme Heat [Hyperthermia] 
               
               
                 Falls from Elevation 
               
               
                 Falls, Older Adults 
               
               
                 Fasciitis, Necrotizing 
               
               
                   Fasciola  Infection [Fascioliasis] 
               
               
                 Fascioliasis - see  Fasciola  Infection 
               
               
                 Fasciolopsiasis - see  Fasciolopsis  Infection 
               
               
                   Fasciolopsis  Infection [Fasciolopsiasis] 
               
               
                 Fetal Alcohol Syndrome 
               
               
                 FETP - see Field Epidemiology Training Program 
               
               
                 FETP (Field Epidemiology Training Program) 
               
               
                 Fibromyalgia 
               
               
                 Fifth Disease [Parvovirus B19 Infection] 
               
               
                 Filariasis, Lymphatic 
               
               
                 Fireworks Injuries 
               
               
                 Flu 
               
               
                 Folliculitis 
               
               
                 Foodborne Illness 
               
               
                 Food-Related Diseases 
               
               
                 Fragile X Syndrome (FXS) 
               
               
                   Francisella tularensis  Infection - see Tularemia 
               
               
                 Fungal diseases [Mycotic diseases] 
               
               
                 Fungal Keratitis 
               
               
                 Fungal Meningitis 
               
               
                 Fungal Pneumonia - see Valley Fever 
               
               
                 FXS (Fragile X Syndrome) 
               
               
                 GAE (Granulomatous amebic encephalitis) 
               
               
                 GAS (Group A Strep Infection) 
               
               
                 Gastrointestinal Diseases from Animals [Zoonotic enteric diseases] 
               
               
                 GBS (Group B Strep Infection) 
               
               
                 GBS and Menactra Meningococcal Vaccine - see Guillain-Barré 
               
               
                 Syndrome and Menactra Meningococcal Vaccine 
               
               
                 GDDER (Global Disease Detection and Emergency Response) 
               
               
                 Genetics and Autism - see Autism and Genetics 
               
               
                 Genetics and Colorectal Cancer - see Colorectal Cancer and Genetics 
               
               
                 Genetics and Heart Disease - see Heart Disease and Genetics 
               
               
                 Genetics and Mental Health - see Mental Health and Genetics 
               
               
                 Genetics and Obesity - see Obesity and Genetics 
               
               
                 Genetics and Skin Cancer - see Skin Cancer and Genetics 
               
               
                 Genetics and Stroke - see Stroke and Genetics 
               
               
                 Genital Candidiasis (VVC) [Vulvovaginal Candidiasis] 
               
               
                 Genital Herpes [Herpes Simplex Virus Infection] 
               
               
                 Genital Warts - see Human Papillomavirus Infection 
               
               
                 German Measles (Rubella Virus) 
               
               
                   Giardia  Infection [Giardiasis] 
               
               
                 Giardiasis - see  Giardia  Infection 
               
               
                 Glanders [ Burkholderia mallei ] 
               
               
                   Gnathostoma  Infection - see Gnathostomiasis 
               
               
                 Gnathostomiasis [ Gnathostoma  Infection] 
               
               
                 Gonorrhea [ Neisseria gonorrhoeae  Infection] 
               
               
                 Gout 
               
               
                 Granulomatous amebic encephalitis (GAE) - see  Balamuthia  Infection 
               
               
                 Group A Strep Infection (GAS) [Group A Streptococcal Infection] 
               
               
                 Group A Streptococcal Infection - see Group A Strep Infection 
               
               
                 Group B Strep Infection (GBS) [Group B Streptococcal Infection] 
               
               
                 Group B Streptococcal Infection - see Group B Strep Infection 
               
               
                 Guillain-Barré Syndrome and Menactra Meningococcal Vaccine 
               
               
                 Guinea Worm Disease [Dracunculiasis] 
               
               
                 Gynecologic Cancers 
               
               
                 H1N1 Flu 
               
               
                 H3N2v influenza 
               
               
                 H5N1 - see Avian Influenza 
               
               
                   Haemophilus influenzae  Serotype b - see Hib Infection 
               
               
                   Haemophilus influenzae  Infection (including Hib Infection) 
               
               
                 Hand, Foot, and Mouth Disease (HFMD) 
               
               
                 Hansen&#39;s Disease 
               
               
                 Hantavirus Pulmonary Syndrome (HPS) 
               
               
                 Hazardous Drug Exposures in Healthcare 
               
               
                 Head Lice [ Pediculus humanus  capitis] 
               
               
                 Health Disparities in Cancer 
               
               
                 Health Disparities in HIV/AIDS, Viral Hepatitis, STDs, and TB 
               
               
                 Health Security - see Global Health Security 
               
               
                 Healthcare Associated Infections 
               
               
                 Healthy Pets, Healthy People - see Animal-Related Diseases 
               
               
                 Hearing Loss in Children 
               
               
                 Heart Disease [Cardiovascular Health] 
               
               
                 Heart Disease and Genetics 
               
               
                 Heat Stress 
               
               
                 Hemochromatosis 
               
               
                 Hemoglobinopathies 
               
               
                 Hemophilia 
               
               
                 Hemophilia Treatment Centers (HTC) 
               
               
                 Hemorrhagic Fevers, Viral - see Viral Hemorrhagic Fevers 
               
               
                 Hendra Virus Disease (HeV Infection) 
               
               
                 Hepatitis A Vaccination 
               
               
                 Hepatitis B Vaccination 
               
               
                 Hepatitis, Viral - see Viral Hepatitis 
               
               
                 Hereditary Bleeding Disorders - see Hemophilia 
               
               
                 Herpes B virus - see B virus Infection 
               
               
                 Herpes Simplex Virus Infection - see Genital Herpes 
               
               
                 Herpes Zoster - see Shingles 
               
               
                 Herpes Zoster Vaccination - see Shingles Vaccination 
               
               
                 Herpes, Genital - see Genital Herpes 
               
               
                 Herpesvirus B - see B virus Infection 
               
               
                 Herpesvirus simiae - see B virus Infection 
               
               
                 Heterophyes Infection [Heterophyiasis] 
               
               
                 Heterophyiasis - see Heterophyes Infection 
               
               
                 HeV Infection (Hendra Virus Disease) 
               
               
                 HFMD (Hand, Foot, and Mouth Disease) 
               
               
                 Hib Infection [ Haemophilus influenzae  Serotype b] 
               
               
                 Hib Vaccine ( Haemophilus influenzae  Serotype b Vaccination) 
               
               
                 High Blood Pressure 
               
               
                   Histoplasma capsulatum  Infection [Histoplasmosis] 
               
               
                 Histoplasmosis - see  Histoplasma capsulatum  Infection 
               
               
                 Histoplasmosis [ Histoplasma capsulatum  Infection] 
               
               
                 HIV/AIDS 
               
               
                 HIV/AIDS and STDs 
               
               
                 Hookworm, Human [ Ancylostoma duodenale  Infection, 
               
               
                   Necator americanus  Infection] see Human Hookworm 
               
               
                 Hookworm, Zoonotic - see Zoonotic Hookworm 
               
               
                 Horses, Infections from 
               
               
                 Hot Tub Rash [ Pseudomonas dermatitis  Infection] 
               
               
                 HPIV (Human Parainfluenza Viruses) 
               
               
                 HPS (Hantavirus Pulmonary Syndrome) 
               
               
                 HPV Infection (Human Papillomavirus Infection) 
               
               
                 HPV Vaccination (Human Papillomavirus Vaccination) 
               
               
                 HPV-Associated Cancers 
               
               
                 HTC (Hemophilia Treatment Centers) 
               
               
                 Human Ehrlichiosis - see Ehrlichiosis, Human 
               
               
                 Human Hookworm [ Ancylostoma duodenale  Infection, 
               
               
                   Necator americanus  Infection] 
               
               
                 Human Immunodeficiency Virus - see HIV/AIDS 
               
               
                 Human Papillomavirus Infection (HPV Infection) 
               
               
                 Human Papillomavirus Vaccination (HPV Vaccination) 
               
               
                 Human Parainfluenza Viruses (HPIV) 
               
               
                   Hymenolepis  Infection - see Dwarf Tapeworm 
               
               
                 Hypertension - see High Blood Pressure 
               
               
                 Hyperthermia - see Extreme Heat 
               
               
                 Hypothermia - see Extreme Cold 
               
               
                 IBD (Inflammatory Bowel Disease) 
               
               
                 IMMPaCt (International Micronutrient Malnutrition Prevention and 
               
               
                 Control Program) see Micronutrient Malnutrition 
               
               
                 Impetigo - see Group A Strep Infection 
               
               
                 including Hib Infection ( Haemophilus influenzae  Infection) 
               
               
                 Infectious Mononucleosis - see Epstein-Barr Virus Infection 
               
               
                 Infertility 
               
               
                 Inflammatory Bowel Disease (IBD) 
               
               
                 Influenza 
               
               
                 Influenza and Cancer - see Cancer and Flu 
               
               
                 Influenza in Pigs - see Swine Influenza 
               
               
                 Influenza Vaccination 
               
               
                 Influenza, Avian - see Avian Influenza 
               
               
                 Influenza, Pandemic - see Pandemic Flu 
               
               
                 Injury, Healthy Swimming and Recreational Water 
               
               
                 International Micronutrient Malnutrition Prevention &amp; Control 
               
               
                 Program (IMMPaCt) - see Micronutrient Malnutrition 
               
               
                 Intestinal Amebae Infection, Nonpathogenic - see Nonpathogenic 
               
               
                 (Harmless) Intestinal Protozoa 
               
               
                 Invasive Candidiasis 
               
               
                 Iron Deficiency - see Anemia 
               
               
                 Iron Overload [Hemochromatosis] - see Hemochromatosis 
               
               
                 Iron Storage Disease 
               
               
                   Isospora  Infection [Isosporiasis] - see  Cystoisospora  Infection 
               
               
                 Japanese Encephalitis (JE) 
               
               
                 Jaundice - see Newborn Jaundice 
               
               
                 JE (Japanese Encephalitis) 
               
               
                   K. pneumoniae  ( Klebsiella pneumoniae ) 
               
               
                 Kala-Azar - see  Leishmania  Infection 
               
               
                 Kawasaki Syndrome (KS) 
               
               
                 Keratitis, Fungal - see Fungal Keratitis 
               
               
                 Kernicterus - see Newborn Jaundice 
               
               
                 KFD (Kyasanur Forest disease) 
               
               
                 Kidney Disease (CKD) 
               
               
                   Klebsiella pneumoniae  ( K. pneumoniae ) 
               
               
                 KS (Kawasaki Syndrome) 
               
               
                 Kyasanur Forest disease (KFD) 
               
               
                 La Crosse Encephalitis (LAC) 
               
               
                 La Crosse Encephalitis virus (LACV) - see La Crosse Encephalitis 
               
               
                 LAC (La Crosse Encephalitis) 
               
               
                 LACV (La Crosse Encephalitis virus) 
               
               
                 Lassa Fever 
               
               
                 Latex Allergies 
               
               
                 LCM (Lymphocytic Choriomeningitis) 
               
               
                 Lead Poisoning 
               
               
                 Legionellosis - see Legionnaires&#39; Disease 
               
               
                 Legionnaires&#39; Disease [Legionellosis] 
               
               
                   Leishmania  Infection [Leishmaniasis] 
               
               
                 Leishmaniasis - see  Leishmania  Infection 
               
               
                 Leprosy - see Hansen&#39;s Disease 
               
               
                   Leptospira  Infection [Leptospirosis] 
               
               
                 Leptospirosis - see  Leptospira  Infection 
               
               
                 Lice 
               
               
                   Listeria  Infection [Listeriosis] 
               
               
                 Listeriosis - see  Listeria  Infection 
               
               
                 Liver Disease and Hepatitis - see Viral Hepatitis 
               
               
                   Loa loa  Infection - see Loiasis 
               
               
                 Lockjaw - see Tetanus Disease 
               
               
                 Lockjaw Vaccination - see Tetanus (Lockjaw) Vaccination 
               
               
                 Loiasis [ Loa loa  Infection] 
               
               
                 Lou Gehrig&#39;s Disease - see ALS 
               
               
                 LUHF (Lujo Hemorrhagic Fever) 
               
               
                 Lujo Hemorrhagic Fever (LUHF) 
               
               
                 Lung Cancer 
               
               
                 Lupus (SLE) [Systemic lupus erythematosus] 
               
               
                 Lyme Disease [ Borrelia burgdorferi  Infection] 
               
               
                 Lymphatic Filariasis 
               
               
                 Lymphedema - see Lymphatic Filariasis 
               
               
                 Lymphocytic Choriomeningitis (LCM) 
               
               
                 MAC ( Mycobacterium avium  Complex) 
               
               
                 Mad Cow Disease (BSE) - see Bovine Spongiform Encephalopathy 
               
               
                 Malaria 
               
               
                 Marburg Hemorrhagic Fever 
               
               
                 Marine Toxins 
               
               
                 MD (Muscular Dystrophy) 
               
               
                 MDR TB (Multidrug-Resistant TB) 
               
               
                 Measles 
               
               
                 Melioidosis [ Burkholderia pseudomallei  Infection] 
               
               
                 Meningitis 
               
               
                 Meningococcal Disease 
               
               
                 Meningococcal Vaccination 
               
               
                 Men&#39;s Health 
               
               
                 Mental Health 
               
               
                 Mental Health and Genetics 
               
               
                 Mental Retardation 
               
               
                 MERS-CoV (Middle East Respiratory Syndrome Coronavirus) 
               
               
                 Methicillin Resistant  Staphylococcus aureus  - see MRSA 
               
               
                 Micronutrient Malnutrition 
               
               
                   Microsporidia  Infection 
               
               
                 Middle East Respiratory Syndrome Coronavirus (MERS-CoV) 
               
               
                 MMR Vaccination 
               
               
                 
                   Molluscum Contagiosum 
                 
               
               
                 Monkey B virus - see B virus Infection 
               
               
                 Monkeypox 
               
               
                 Monkeypox Vaccination 
               
               
                 Mononucleosis, Infectious - see Epstein-Barr Virus Infection 
               
               
                 Motor Vehicle Injuries 
               
               
                 Mouse and Rat Control - see Rodents, Diseases from 
               
               
                 MRSA [Methicillin Resistant  Staphylococcus aureus ] 
               
               
                 Mucormycosis 
               
               
                 Mucus - see Cold, Common 
               
               
                 Multidrug-Resistant TB (MDR TB) 
               
               
                 Multiple organ dysfunction syndrome - see Sepsis 
               
               
                 Mumps 
               
               
                 Muscular Dystrophy (MD) 
               
               
                 Musculoskeletal Disorders - see Ergonomic and Musculoskeletal 
               
               
                 Disorders 
               
               
                   Mycobacterium abscessus  Infection 
               
               
                   Mycobacterium avium  Complex (MAC) 
               
               
                   Mycobacterium tuberculosis  Infection - see Tuberculosis 
               
               
                   Mycoplasma pneumoniae  Infection 
               
               
                 Mycotic diseases - see Fungal diseases 
               
               
                 Myelomeningocele - see Spina Bifida 
               
               
                 Myiasis 
               
               
                   Naegleria  Infection [Primary Amebic Meningoencephalitis (PAM)] 
               
               
                 Nairovirus Infection - see Crimean-Congo hemorrhagic fever 
               
               
                 National Amyotrophic Lateral Sclerosis (ALS) Registry - see ALS 
               
               
                 Necrotizing Fasciitis - see Group A Strep Infection 
               
               
                 Neglected Tropical Diseases (NTD) 
               
               
                   Neisseria gonorrhoeae  Infection - see Gonorrhea 
               
               
                 Neurocysticercosis - see Cysticercosis 
               
               
                 Newborn Hearing - see Hearing, Early Detection &amp; Intervention 
               
               
                 Newborn Jaundice [Kernicterus] 
               
               
                   Nocardia asteroides  Infection - see Nocardiosis 
               
               
                 Nocardiosis [ Nocardia asteroides  Infection] 
               
               
                 Nonpathogenic (Harmless) Intestinal Protozoa 
               
               
                 Non-Polio Enterovirus Infections 
               
               
                 Norovirus Infection 
               
               
                 Norwalk-like Viruses (NLV) - see Norovirus Infection 
               
               
                 NTD (Neglected Tropical Diseases) 
               
               
                 OA (Osteoarthritis) 
               
               
                 Obesity and Genetics 
               
               
                 Obesity and Overweight 
               
               
                 Obesity and Overweight, Childhood - see Childhood Overweight 
               
               
                 and Obesity 
               
               
                 Occupational Cancers 
               
               
                 Occupational Skin Conditions - see Skin Conditions, Occupational 
               
               
                 Occupational Stress - see Stress, Occupational 
               
               
                 OHF (Omsk hemorrhagic fever) 
               
               
                 Omsk hemorrhagic fever (OHF) 
               
               
                 Onchocerciasis - see River Blindness 
               
               
                   Opisthorchis  Infection 
               
               
                 Oral Cancer 
               
               
                 Orf Virus Infection - see Sore Mouth Infection 
               
               
                 Oropharyngeal Candidiasis - see Thrush 
               
               
                 Oroya fever - see Carrión&#39;s disease 
               
               
                 Osteoarthritis (OA) 
               
               
                 Osteoporosis - see Bone Health 
               
               
                 Otitis Media - see Ear Infection 
               
               
                 Outbreaks 
               
               
                 Ovarian and Breast Cancer and Family Health History - see Breast 
               
               
                 and Ovarian Cancer and Family Health History 
               
               
                 Ovarian Cancer 
               
               
                 PAD (Peripheral Arterial Disease) 
               
               
                 Pandemic Flu 
               
               
                 Paragonimiasis - see  Paragonimus  Infection 
               
               
                   Paragonimus  Infection [Paragonimiasis] 
               
               
                 Parainfluenza - see Human Parainfluenza Viruses 
               
               
                 Parasitic Diseases 
               
               
                 Parvovirus B19 Infection - see Fifth Disease 
               
               
                 PCP ( Pneumocystis  pneumonia) 
               
               
                 PCV (Pneumococcal Conjugate Vaccine) 
               
               
                 PE (Pulmonary Embolism) 
               
               
                 Pedestrian Injury 
               
               
                   Pediculus humanus  capitis - see Head Lice 
               
               
                   Pediculus humanus  corporis - see Body Lice 
               
               
                 Pelvic Inflammatory Disease (PID) 
               
               
                 Peripheral Arterial Disease (PAD) 
               
               
                 Peripheral Arterial Insufficiency - see Peripheral Arterial Disease 
               
               
                 Peripheral Arterial Occlusive Disease - see Peripheral Arterial Disease 
               
               
                 Peripheral Vascular Disease - see Peripheral Arterial Disease 
               
               
                 Pertussis (Whooping Cough) 
               
               
                 Pertussis (Whooping Cough) Vaccination 
               
               
                 Pet-Related Diseases - see Animal-Related Diseases 
               
               
                 Phthiriasis - see Pubic Lice 
               
               
                 PID (Pelvic Inflammatory Disease) 
               
               
                 Pigs, Influenza in - see Swine Influenza 
               
               
                 Pink Eye [Conjunctivitis] 
               
               
                 Pinworm Infection [ Enterobius vermicularis  Infection] 
               
               
                 Plague [ Yersinia pestis  Infection] 
               
               
                 Pneumococcal Conjugate Vaccine (PCV) 
               
               
                 Pneumococcal Disease 
               
               
                 Pneumococcal Polysaccharide Vaccine (PPV) 
               
               
                 Pneumoconioses, Coal Workers&#39; - see Black Lung 
               
               
                   Pneumocystis carinii  Pneumonia (PCP) Infection - see Pneumocystis 
               
               
                 pneumonia 
               
               
                   Pneumocystis jirovecii  pneumonia (previously  Pneumocystis carinii ) - 
               
               
                 see Pneumocystis pneumonia 
               
               
                   Pneumocystis  pneumonia (PCP) [ Pneumocystis jirovecii  pneumonia 
               
               
                 (previously  Pneumocystis carinii )] 
               
               
                 Pneumonia 
               
               
                 Polio Infection [Poliomyelitis Infection] 
               
               
                 Polio Vaccination [Poliomyelitis Vaccination] 
               
               
                 Poliomyelitis Infection - see Polio Infection 
               
               
                 Poliomyelitis Vaccination - see Polio Vaccination 
               
               
                 Pontiac Fever - see Legionnaires&#39; Disease 
               
               
                 Powassan (POW) virus 
               
               
                 Poxvirus Infections 
               
               
                 PPV (Pneumococcal Polysaccharide Vaccine) 
               
               
                 Primary Amebic Meningoencephalitis (PAM) - see  Naegleria  Infection 
               
               
                 Prion Diseases (TSEs) [Transmissible spongiform encephalopathies] 
               
               
                 Prostate Cancer 
               
               
                   Pseudomonas dermatitis  Infection - see Hot Tub Rash 
               
               
                 Psittacosis 
               
               
                 Psoriasis 
               
               
                 Pubic Lice [Phthiriasis] 
               
               
                 Pulmonary Embolism (PE) - see Deep Vein Thrombosis 
               
               
                 Pulmonary Hypertension 
               
               
                 Q Fever [ Coxiella burnetii  Infection] 
               
               
                 RA (Rheumatoid Arthritis) 
               
               
                 Rabies 
               
               
                 Raccoon Roundworm Infection [ Baylisascaris  Infection] 
               
               
                 Rat-Bite Fever (RBF) [ Streptobacillus moniliformis  Infection] 
               
               
                 RBF (Rat-Bite Fever) 
               
               
                 Recreational Water Illness (RWI) 
               
               
                 Reptiles, Infections from 
               
               
                 Respiratory Syncytial Virus Infection (RSV) 
               
               
                 Rheumatoid Arthritis (RA) 
               
               
                   Rickettsia rickettsii  Infection - see Rocky Mountain Spotted Fever 
               
               
                   Rickettsia , Spotted Fever Group - see Spotted Fever Group  Rickettsia   
               
               
                 Rickettsial Diseases 
               
               
                 Rift Valley Fever (RVF) 
               
               
                 Ringworm [Dermatophyte Infection] 
               
               
                 Ringworm [Dermatophytes] 
               
               
                 Ringworm in Animals 
               
               
                 River Blindness [Onchocerciasis] 
               
               
                 RMSF (Rocky Mountain Spotted Fever) 
               
               
                 Rocky Mountain Spotted Fever (RMSF) [ Rickettsia rickettsia   
               
               
                 Infection] 
               
               
                 Rodent Control - see Rodents, Diseases from 
               
               
                 Rodents - see Rat-Bite Fever 
               
               
                 Rodents, Diseases from 
               
               
                 Rotavirus Infection 
               
               
                 RSV (Respiratory Syncytial Virus Infection) 
               
               
                 Rubella (German Measles) Vaccination 
               
               
                 Rubeola - see Measles 
               
               
                 Runny Nose - see Cold, Common 
               
               
                 RVF (Rift Valley Fever) 
               
               
                 RWI (Recreational Water Illness) 
               
               
                   Salmonella typhi  Infection - see Typhoid Fever 
               
               
                   Salmonella  Infection [Salmonellosis] 
               
               
                 Salmonellosis - see  Salmonella  Infection 
               
               
                   Sappinia diploidea  and  Sappinia pedata  - see  Sappinia  Infection 
               
               
                   Sappinia  Infection [ Sappinia diploidea  and  Sappinia pedata ] 
               
               
                 SARS [Severe Acute Respiratory Syndrome] 
               
               
                 Scabies 
               
               
                 Scarlet Fever 
               
               
                   Schistosoma  Infection - see Schistosomiasis 
               
               
                 Schistosomiasis [ Schistosoma  Infection] 
               
               
                 Seasonal Flu 
               
               
                 Sepsis [Septicemia] 
               
               
                 Septic shock - see Sepsis 
               
               
                 Septicemia - see Sepsis 
               
               
                 Severe Acute Respiratory Syndrome - see SARS 
               
               
                 Sexually Transmitted Disease Surveillance Reports 
               
               
                 Sexually Transmitted Diseases (STDs) 
               
               
                 SFGR (Spotted Fever Group  Rickettsia ) 
               
               
                   Shigella  Infection [Shigellosis] 
               
               
                 Shigellosis - see  Shigella  Infection 
               
               
                 Shingles [Varicella Zoster Virus (VZV)] 
               
               
                 Shingles Vaccination 
               
               
                 Sickle Cell Disease 
               
               
                 SIDS (Sudden Infant Death Syndrome) 
               
               
                 Sinus Infection [Sinusitus] 
               
               
                 Sinusitus - see Sinus Infection 
               
               
                 Skin Cancer 
               
               
                 Skin Cancer and Genetics 
               
               
                 Skin Conditions, Occupational 
               
               
                 SLE (Lupus) 
               
               
                 Sleep and Sleep Disorders 
               
               
                 Sleeping Sickness [African Trypanosomiasis] 
               
               
                 Smallpox [Variola Major and Variola Minor] 
               
               
                 Smallpox Vaccination 
               
               
                 Smoking and Tobacco Use 
               
               
                 Sodium - see Salt 
               
               
                 Soil Transmitted Helminths 
               
               
                 Sore Mouth Infection [Orf Virus Infection] 
               
               
                 Sore Throat 
               
               
                 Southern Tick-Associated Rash Illness (STARI) 
               
               
                 Spina Bifida [Myelomeningocele] 
               
               
                   Spirillum minus  Infection - see Rat-Bite Fever 
               
               
                   Sporothrix schenckii  infection - see Sporotrichosis 
               
               
                 Sporotrichosis 
               
               
                 Sporotrichosis [ Sporothrix schenckii  infection] 
               
               
                 Spotted Fever Group  Rickettsia  (SFGR) 
               
               
                 Staph - see  Staphylococcus aureus  Infection 
               
               
                   Staphylococcus aureus  Infection 
               
               
                 STARI (Southern Tick-Associated Rash Illness) 
               
               
                 STDs (Sexually Transmitted Diseases) 
               
               
                 STDs and HIV/AIDS - see HIV/AIDS and STDs 
               
               
                 Strep Infection, Group A - see Group A Strep Infection 
               
               
                 Strep Infection, Group B - see Group B Strep Infection 
               
               
                 Strep Throat - see Sore Throat 
               
               
                   Streptobacillus moniliformis  Infection - see Rat-Bite Fever 
               
               
                   Streptococcus pneumoniae  Infection 
               
               
                 Stress, Occupational 
               
               
                 Stroke 
               
               
                 Stroke and Genetics 
               
               
                 Strongyloidiasis - see  Strongyloides  Infection [Strongyloidiasis] 
               
               
                 Strongyloidiasis - see Strongyloidiasis - see  Strongyloides  Infection 
               
               
                 Sudden Infant Death Syndrome (SIDS) 
               
               
                 surgical site infection (SSI) 
               
               
                 Surveillance Reports, Sexually Transmitted Disease - see Sexually 
               
               
                 Transmitted Disease Surveillance Reports 
               
               
                 Swimmer&#39;s Itch [Cercarial Dermatitis] 
               
               
                 Swimming-related Illness - see Recreational Water Illness 
               
               
                 Swine Influenza 
               
               
                 Symptom Relief for Upper Respiratory Infections 
               
               
                 Syphilis [ Treponema pallidum  Infection] 
               
               
                 Systemic lupus erythematosus - see Lupus 
               
               
                   Taenia  Infection - see Tapeworm Infection 
               
               
                 Tapeworm Infection [ Taenia  Infection] 
               
               
                 Tapeworm, Dog and Cat Flea [ Dipylidium  Infection] 
               
               
                 TB (Tuberculosis) 
               
               
                 TB (Tuberculosis) Vaccination 
               
               
                 TB and HIV Coinfection 
               
               
                 TBI (Traumatic Brain Injury) 
               
               
                 Testicular Cancer 
               
               
                 Tetanus (Lockjaw) Infection 
               
               
                 Tetanus (Lockjaw) Vaccination 
               
               
                 Tetanus Disease [ Clostridium tetani  Infection] 
               
               
                 Thalassemia - see Cooleys Anemia 
               
               
                 Thoracic Aortic Aneurysm - see Aortic Aneurysm 
               
               
                 Throat, Sore - see Sore Throat 
               
               
                 Throat, Strep - see Sore Throat 
               
               
                 Thrombophilia - see Clotting Disorders 
               
               
                 Thrombosis - see Clotting Disorders 
               
               
                 Thrush [Oropharyngeal Candidiasis] 
               
               
                 Tickborne Diseases - see Ticks 
               
               
                 Ticks 
               
               
                   Tinea  - see Ringworm 
               
               
                 Tobacco Use, Smoking and - see Smoking and Tobacco Use 
               
               
                 Tourette Syndrome (TS) 
               
               
                   Toxocara  Infection - see Toxocariasis 
               
               
                 Toxocariasis [ Toxocara  Infection] 
               
               
                   Toxoplasma  Infection - see Toxoplasmosis 
               
               
                 Toxoplasmosis [ Toxoplasma  Infection] 
               
               
                 Trachoma Infection 
               
               
                 Transmissible spongiform encephalopathies - see Prion Diseases 
               
               
                 Traumatic Brain Injury (TBI) 
               
               
                 Traumatic Occupational Injuries 
               
               
                 Trench fever [ Bartonella quintana  Infection] 
               
               
                   Treponema pallidum  Infection - see Syphilis 
               
               
                 Trichinellosis (Trichinosis) 
               
               
                   Trichomonas  Infection - see Trichomoniasis 
               
               
                 Trichomoniasis [ Trichomonas  Infection] 
               
               
                 Trichuriasis - see Whipworm Infection 
               
               
                 Trisomy 21 - see Down Syndrome 
               
               
                   Trypanosoma cruzi  Infection - see Chagas Disease 
               
               
                 Trypanosomiasis, African - see Sleeping Sickness 
               
               
                 TS (Tourette Syndrome) 
               
               
                 TSEs (Prion Diseases) 
               
               
                 Tuberculosis (TB) [ Mycobacterium tuberculosis  Infection] 
               
               
                 Tuberculosis (TB) Vaccination 
               
               
                 Tuberculosis and HIV Coinfection - see TB and HIV Coinfection 
               
               
                 Tuberculosis Skin Test - see TB Testing &amp; Diagnosis 
               
               
                 Tuberculosis Training - see TB Education and Training Network 
               
               
                 Tuberculosis Vaccine (BCG) 
               
               
                 Tularemia [ Francisella tularensis  Infection] 
               
               
                 Typhoid Fever [ Salmonella typhi  Infection] 
               
               
                 Typhoid Fever Vaccination 
               
               
                 Typhus Fevers 
               
               
                 Ulcerative Colitis - see Inflammatory Bowel Disease 
               
               
                 Undulant Fever - see  Brucella  Infection 
               
               
                 Unexplained Respiratory Disease Outbreaks (URDO) 
               
               
                 Upper Respiratory Infection Symptom Relief - see Symptom Relief 
               
               
                 for Upper Respiratory Infections 
               
               
                 URDO (Unexplained Respiratory Disease Outbreaks) 
               
               
                 Uterine Cancer 
               
               
                 Vaginal and Vulvar Cancers 
               
               
                 Vaginal Candidiasis - see Genital Candidiasis 
               
               
                 Valley Fever [Coccidioidomycosis] 
               
               
                 Vancomycin-Intermediate/Resistant  Staphylococcus aureus   
               
               
                 Infections [VISA/VRSA] 
               
               
                 Vancomycin-resistant Enterococci Infection (VRE) 
               
               
                 Variant Creutzfeldt-Jakob Disease (vCJD) 
               
               
                 Variant Viruses - see Influenza 
               
               
                 Varicella Disease - see Chickenpox 
               
               
                 Varicella Zoster Virus (VZV) - see Shingles 
               
               
                 Varicella-Zoster Virus Infection 
               
               
                 Variola Major and Variola Minor - see Smallpox 
               
               
                 vCJD (Variant Creutzfeldt-Jakob Disease) 
               
               
                 verruga peruana - see Carrión&#39;s disease 
               
               
                 VHF (Viral Hemorrhagic Fevers) 
               
               
                   Vibrio cholerae  Infection - see Cholera 
               
               
                   Vibrio  Illness [Vibriosis] 
               
               
                 Vibriosis - see  Vibrio  Illness 
               
               
                 Viral Hemorrhagic Fevers (VHF) 
               
               
                 Viral Hepatitis 
               
               
                 Viral Meningitis [Aseptic Meningitis] 
               
               
                 VISA/VRSA - see Vancomycin-Intermediate/Resistant 
               
               
                   Staphylococcus aureus  Infections 
               
               
                 Vision Impairment 
               
               
                 VRE (Vancomycin-resistant Enterococci Infection) 
               
               
                 Vulvovaginal Candidiasis - see Genital Candidiasis 
               
               
                 VVC (Genital Candidiasis) 
               
               
                 VZV (Varicella Zoster Virus) - see Shingles 
               
               
                 Water-Related Diseases 
               
               
                 Weight, Healthy - see Healthy Weight 
               
               
                 West Nile Virus Infection (WNV Infection) 
               
               
                 Whipworm Infection [Trichuriasis] 
               
               
                 Whitmore&#39;s Disease - see Melioidosis 
               
               
                 Whooping Cough - see Pertussis (Whooping Cough) 
               
               
                 Wildlife, Infections from 
               
               
                 WNV Infection (West Nile Virus Infection) 
               
               
                 Women&#39;s Bleeding Disorders 
               
               
                 XDR TB (Extensively Drug-Resistant TB) 
               
               
                 Xenotropic Murine Leukemia Virus-related Virus Infection - see 
               
               
                 XMRV Infection 
               
               
                 XMRV Infection [Xenotropic Murine Leukemia Virus-related 
               
               
                 Virus Infection] 
               
               
                 Yeast Infection - see Genital Candidiasis 
               
               
                 Yellow Fever 
               
               
                 Yellow Fever Vaccination 
               
               
                   Yersinia enterocolitica  Infection - see Yersiniosis 
               
               
                   Yersinia pestis  Infection - see Plague 
               
               
                 Yersiniosis [ Yersinia enterocolitica  Infection] 
               
               
                 Zoonotic Diseases from Animals - see Animal-Related Diseases 
               
               
                 Zoonotic enteric diseases - see Gastrointestinal Diseases from Animals 
               
               
                 Zoonotic Hookworm 
               
               
                 Zoster - see Shingles 
               
               
                 Zygomycosis - see Mucormycosis 
               
               
                   
               
            
           
         
       
     
     III. System and Method to Control the Delivery of Oral Medications 
     Various embodiments will be described hereinafter with reference to the accompanying drawings. These embodiments are illustrated and described by example only and are not intended to be limiting. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description discussion of several terms used herein follows. 
     The word “exemplary” is used herein to mean “serving as an example, instance, or illustration”. Any embodiment described herein as “exemplary” or “example” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term “embodiments of the invention” does not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. 
     Further, many embodiments are described in terms of sequences of actions to be performed by, for example, elements of a computing device. It will be recognized that various actions described herein can be performed by specific circuits (e.g., application specific integrated circuits (ASICs)), by program instructions being executed by one or more processors, or by a combination of both. Additionally, these sequences of actions described herein can be considered to be embodied entirely within any form of computer readable storage medium having stored therein a corresponding set of computer instructions that upon execution would cause an associated processor to perform the functionality described herein. Thus, the various aspects of the invention may be embodied in a number of different forms, all of which have been contemplated to be within the scope of the claimed subject matter. In addition, for each of the embodiments described herein, the corresponding form of any such embodiments may be described herein as, for example, “logic configured to” perform the described action. 
       FIG. 1  illustrates an exemplary embodiment of the present invention, an integrated drug dispensing and disease management system composed of a Drug Specific App  10  which contains a Drug Specific Dispensing Algorithm  15  resident on an Interface Device (Smart Phone, computer Tablet, portable or desktop computer, standalone drug dispenser, etc. with Internet communications capabilities)  20  used to control dispensing by a (single or multidrug) Drug Dispenser  30 ; an Integrated Support Center  40 ; a Patient  50 ; a Prescriber  60 ; and the Patient&#39;s Electronic Medical Record  70 . 
       FIG. 2  is an exemplary embodiment depicting a Drug Specific Dispensing App  80  which resides on an Interface Device  20  and controls drug dispensing. When the Patient  50  is prescribed a Drug, the Patient  50  is trained on the operation of the Drug Specific Dispensing App  80  and the related Drug Dispenser  30  using the Apps training interface. 
     In this embodiment of the invention, the Drug Specific App  80  is comprised of the following software modules: (i) Biometric Authentication  80   a , (ii) Prescription  80   b  module which can be programmed remotely by the Integrated Support Center  40 , (iii) Patient Reminder  80   c , (iv) Interface Device  80   d , (v) Patient Self-Assessment  80   e  module which is unique for each drug, (vi) Digital Capture (APIs)  80   f , (vii) the Drug Specific Dispensing Algorithm  80   g  which is unique for each drug, (viii) Dispensing Communication and Reporting  80   h , (ix) the Integrated Support Center  80   i , (x) the Patient Reporting  80   j , and (xi) the App and Dispensing Unit Operation Training Interface  80   k.    
     The following are exemplary descriptions of the  FIG. 2  embodiments of the invention: 
     Biometric Authentication module  80   a  encompasses the utilization of a biometric authentication screen and/or digital interface which allows the patient, upon authentication, to automatically move to the Patient Self-Assessment screens  100 ,  102 ,  104  if: (i) the authentication routine recognizes the Drug Dispenser&#39;s  30  serial number to be one that was registered to the Patient  50 , (ii) digitally Handshake with the Drug Specific App  10  and (iii) the Biometric Authentication  80   a  recognizes the Patient  50 . If the Biometric Authentication  80   a  does not recognize the Patient  50 , it asks the Patient  50  to try again. After a given number of tries, it alerts the patient to talk with the Integrated Support Center  40  and alerts the Integrated Support Center  40  of the failed attempts and lists the Patient  50  for a follow-up call if the drug has not been properly dispensed within a drug specific timeframe. If the App  50  does not recognize the Drug Dispenser  30 , the patient gets an alert screen explaining why it does not recognize the dispenser, this may include but is not limited to: (i) unable to locate the Drug Dispenser  30 , (ii) the Drug Dispenser  30  does not have the right serial number, etc. Simultaneously, if the App  10  senses that the Drug Dispenser does not have the right serial number, it will send a message to the Integrated Support Center  40  indicating the serial number of the recognized Drug Dispenser for follow-up action by the Integrated Support Center  40 . One alternative for the Integrated Support Center  40  is to lock the App screen to only give the Patient  50  the choice of calling the Integrated Support Center  40  to resolve his dispensing issue. 
     The Prescription module  80   b , which is unique to the drug, encompasses the ability of the Prescriber  60 , other authorized healthcare professionals, or the Integrated Support Center  40  to input the prescribing information into the Drug Specific App  10 . After loading the Drug Specific App  10  onto the Interface Device  20 , the person entering the prescription information begins by entering the drugs Brand and/or generic name, strength/dosage, NCD number, Batch Number, any pertinent required contact information in case of an overdose or emergency, and the drug&#39;s expiration date. This input can be done manually and/or via a barcode scan of the Individualized Drug Cassette  170 . The prescribing information defines the dosing strength and administration schedule (e.g, q.d., b.i.d., t.i.d., q.i.d., q.h.s., −X a day, −X per week, −X per month, q.4h, q.6h, q.o.d., a.c., p.c., prn, etc.). The prn dosing, and/or for example the patient self-analgesia dosing, can be designated to allow the Patient  50  to self-medicate using multiple smaller doses to a maximum cumulative dose over a specified period of time. Once the maximum does is dispensed, the Drug Dispenser is locked by the Drug Specific App  10  until the next dosing period begins and the patient enters the requisite information to enable the Drug Specific App  10  to signal the Drug Dispenser to dispense. 
     The Patient Reminder module  80   c  encompasses the ability of the Drug Specific App  10  to alert the Patient  50  using different methodologies including but not limited to: (i) initiating a phone call, (ii) buzzing the device, (iii) sending an email message, (iv) sending a text message, and/or (v) having the Integrated Support Center  40  call the Patient  50 , etc. 
     When the phone call is initiated, the Drug Specific App  10  is shown on the Smart Phone&#39;s screen. When the phone is turned on or unlocked, the screen automatically moves to the Biometric Authentication  90  screen. If the Drug Specific App  10  is clicked on a Smart Phone, it opens to the Biometric Authentications  90  screen. 
     The Interface Device module  80   d  encompasses many functions: (i) home for the Drug Specific App  10 , (ii) enables the Drug Specific App  10  to utilize the Interface Device features to facilitate the Drug Specific App&#39;s interface with the Patient  50 , (iii) uses the Interface Device&#39;s  20  Wi-Fi communications capability to interface with the Drug Dispenser  30  and its Internet communications capability to interface with the Integrated Support Center  40 , (iv) uses the phone to call the Integrated Support Center  40 , and utilizes the Interface Device&#39;s  20  memory to store the prescription, dispensing history, and the Patient Self-Assessment (see illustrative examples in  FIG. 4 ) and digital (see representative examples under  FIG. 5 ) physiological, psychological, lifestyle, currently taken medications, and environmental data. 
     The Patient  50  is, for example, able to utilize the Interface Device&#39;s  20  navigation capabilities to move between screens and to correct prior inputs before exiting by selecting the dispense or exit buttons. 
     Utilizes the Interface Device&#39;s  20  GPS device to capture the location when the medication is dispensed. 
     Patient Self-Assessment module  80   e  is specific for each drug based upon, for example, the drug&#39;s side effects, potential drug interactions, implications of under and/or overdosing, efficacy measures, dosing schedule, drug strength, single or multidrug regimen, effects of weight gain, aging, development of comorbidities, etc. Certain Patient Self-Assessment  100 ,  102 ,  104  screens will, for example, incorporate known self-assessment scales or will incorporate self-assessment screens specifically developed for the specific drug. The screens may also be those which are designed to capture Patient specific information required by regulatory agencies for the subsequent approval of the drug and/or for post marketing studies. 
     The Digital Capture (APIs) module  80   f  encompasses, as an exemplary, digital information that is integrated via the Drug Specific App  10  via Digital Capture from, as examples, a wearable monitoring device  110 , a digital scale  112 , a third-party monitoring App on a smart phone  114 , a hand held diagnostic device  116 , a lifestyle monitor  117 , a digitalized home diagnostic or self-diagnostic  118 , a swallowed tracking and/or diagnostic aid, a drug tracking chip, radio frequency identification device (RFID), or care giver or parent patient assessments and/or journal entries, etc. 
     The Drug Specific Dispensing Algorithm module  80   g  encompasses, as an example, the Product Expiration  122  date, Properly Stored  123  information (for example, temperature, moisture, etc.), one or more Patient Self-Assessment  125 ,  126  and/or one or more Digitally Captured  127  values, the Dispensing Algorithm  128 , the Dispense  129  command screen and interface with the Drug Dispenser  30 , and patient feedback and instruction screens  130 ,  132 ,  134 ,  136 ,  138 ,  140 ,  142 ,  144 ,  146 ,  148 ,  150 ,  152 , etc. 
     The Dispensing Communications and Reporting  80   h  module encompasses, for example, the interface between: (i) the Drug Specific App  10  and the Drug Dispenser  30  via the Interface Device  20 ; (ii) the interfaces between the Drug Specific App  10  and any proprietary or third-party digital devices, data aggregation devices, computer databases, diagnostic devices, and medication tracking devices, etc., for example, those digital devices listed under  FIG. 5 , e.g.,  110 ,  112 ,  114 ,  116 ,  117 ,  118 ; (iii) the interface between the Drug Specific App and the computer servers and the respective databases that store information captured by the Drug Specific App  10  and data and reports created by the Integrated Support Center  40  and accessed by the Drug Specific App  10 ; the interface between the Integrated Support Center  40  and the Drug Specific App  10  utilized to change the prescription on the Drug Specific App  10  as well as to update the App software as required, etc. 
     The Integrated Support Center  80   i  module encompasses, for example, (i) securely handshaking/connecting the Drug Specific App  10  to the Integrated Support Center  40 , (ii) sending to and receiving alerts from the Integrated Support Center  40 , (iii) enabling the Integrated Support Center  40  to lock or unlock the Drug Dispenser  30 , (iv) alert the Integrated Support Center  40  of unusual attempts to open the Drug Dispenser  30 , (v) the ability of the Integrated Support Center  40  to remotely update the Drug Specific App software, and (vi) enables the Drug Specific App  10  to access patient reports, charts, and graphs, (vii) enables the patient to require a refill prescription be sent to his/her pharmacy for refill, etc. 
     The Patient Reporting  80   j  module encompasses, as an example: (i) an ability by the Patient  50  to request certain reports, e.g., the last time the Patient  50  took the medication, prescription information details, drug details (brand and generics names, batch number, expiration date, doses remaining, reorder information, drug interactions, typical side effects, etc.; (ii) graphs and charts created by the Drug Specific App  10  based upon Interface Device  20  stored information; (iii) graphs, charts and/or reports downloaded from the Integrated Support Center&#39;s servers, etc. 
     The App and Dispensing Unit Operation Training Module  80   k  encompasses, as an example, (i) a hot link to a video library resident on the Integrated Support Center&#39;s servers, You Tube, and/or other consumer video services covering all aspects of utilizing the Drug Specific App  10 , using and troubleshooting the Drug Dispenser  30 , (ii) a step by step tutorial resident on the Interface Device  20 , (iii) a hot linked “help” button on each respective screen allowing the Patient  50  to bring up usage instructions for the respective screen without interrupting the sequence of entering the required prescription information or selecting a particular command, etc. 
       FIG. 3  The exemplary embodiment of the Biometric Authentication  90  interface encompasses a system that is compliant with the Health Insurance Portability and Accountability Act (HIPAA), which sets the standard for protecting sensitive patient data. This means that all the required physical, network, and process security measures are in place and followed and incorporated herein by reference. 
       FIG. 4  The exemplary embodiment of the Patient Self-Reporting Screens  100 ,  102 ,  104  encompass, for example, an abdominal pain self-reporting scale adapted from Wong Baker Faces  100 ; the stool consistency utilizes the Bristol Stool Scale, a well-accepted stool measure  102 ; and the current abdominal discomfort scale was developed by MMC International from the Defense and Veterans Pain Rating Scale  104 . These are examples of patient self-reporting screens that can be utilized in the embodiment as an input to the Drug Specific Dispensing Algorithm  15  to decide whether or not to dispense. The scales can be created, adapted, or integrated to capture the desired patient self-reported information. This can be, for example, for clinical trials, post marketing surveillance, and/or for incorporation into the Drug Specific Dispensing Algorithm  15 . 
       FIG. 5  The exemplary embodiment of the Digitally Captured information  110 ,  112 ,  114 ,  116 ,  117 ,  118  is illustrative for the types of digital information which can be collected and integrated into the Decision Tree/logic in the respective Drug Specific Dispensing Algorithms  15 . The availability of disease specific Apps and related disease or condition specific digitalized health information is rapidly emerging, making the examples in  FIG. 5  wanting not only for the disease information but for lifestyle, medications being taken, digital medication diagnostic and tracking devices, and environmental input, etc. 
       FIG. 6  The exemplary embodiment of a Drug Specific Dispensing Algorithm  120 ,  121 ,  122 ,  123 ,  124 ,  125 ,  126 ,  127 ,  128 ,  129 ,  130 ,  132 ,  134 ,  136 ,  138 ,  140 ,  142 ,  144 ,  146 ,  148 ,  150 ,  152  is illustrative of the Decision Tree, sequencing, and messaging that is utilized by each Drug Specific Dispensing Algorithm  15 . Biometric Authorization  120 ,  121 , Product Expiration  122 , and Properly Stored  123  are constant variables in the dispensing decision. The respective messages are either standard, as an example those related to locking the Drug Dispenser  130 ,  136 ,  142 ,  148  or Notify Call Center  132 ,  138 ,  144 ,  150 , or Product Expired  132 ,  134  or the drug was not Properly Stored  138 ,  140 , etc. Screens indicating why a drug is not “Allowed to Dispense” are specifically adapted to the drug and report the reasons why the drug was not dispensed  144 ,  146 . Each Drug Specific Dispensing Algorithm  15  is specifically developed to control the dispensing of a specific medication. 
       FIGS. 7A and 7B  present the exemplary embodiment illustration of the Patient  50  interaction to dispense, as example, alosetron, a 5HT3 antagonist for the treatment of diarrhea predominant irritable bowel syndrome (IBS-D). The process begins by the Drug Dispensing App  160  alerting the Patient  50  that it is time to take his/her medication. If it is on a smart phone, it also changes the screen to the Drug Dispenser App  160  graphic′ and when the Patient  50  unlocks the phone, the screen automatically changes to the Biometric Authentication screen  162 . Alternatively, the Patient  50  can click on the Drug Dispensing App  160  for alosetron, this is automatically followed by a Biometric Authentication screen  162 , upon authentication, the screen automatically moves to the Patient Self-Assessment screens  164 ,  166 ,  168 ,  170 . A click on a value of the self-assessment screen automatically moves the process to the next screen. If nothing is found to block dispensing by the alosetron Drug Specific Dispensing Algorithm  15 , then the Patient  15  sees the Dispense screen  172 . By clicking on Dispense, the patient is then able to go to the related Drug Dispenser  30  and click, for example, on top of the dispenser to dispense a single dose—after which the Drug Dispenser goes back to a locked position. If the Patient  50  wants to change a prior entry before dispensing, he/she can use the devices scroll back capabilities to return to the right screen and change the selection. If the alosetron Drug Specific Dispensing Algorithm  15  finds any reason not to allow dispensing, it selects from the appropriate drug specific screen to show why dispensing was rejected and to facilitate the Patient&#39;s ability to avail himself/herself of the proper medication support  176 ,  178 ,  180 . 
       FIGS. 8A-8D  are an exemplary embodiment of the alosetron Drug Specific App configured to capture all the Patient Self-Assessment information which is required by the FDA or EMA for the approval of a 5HT3 drug. The only difference to  FIGS. 7A and 7B  are the additional input screens  200 ,  202 ,  204 ,  208 ,  210 ,  212 ,  214  required by the regulatory agencies. The same Drug Specific Dispensing Algorithm  15 , decision tree, would be used for the clinical trial configuration as for the alosetron example in  FIGS. 7A and 7B . 
     The embodiment is applicable for, as an example, clinical trials, post-launch surveillance, for the FDA&#39;s Risk Evaluation and Mitigation Strategy (REMS) programs, and to control and ensure drugs are efficacious and safe as dispensed within the Drug Specific Dispensing Algorithm  15  as part of a prescribed drug regimen, etc. 
       FIG. 9  is an exemplary embodiment illustration of the Drug Dispenser  230 ,  232 ,  234  designed to be: (i) controlled by a Drug Specific App  10  resident on an Interface Device  20 , (ii) water proof, (iii) tamper resistant, (iv) withstand being dropped and/or banged, to be rugged, (v) operate and withstand hot and cold temperatures within defined temperature ranges, (vi) reusable, (vii) rechargeable, and (viii) small enough to be carried in a pants pocket or purse. The Drug Dispenser  230  automatically recognizes the drug based upon the Drug Specific Drug Cassette  240  docked into the device. The Drug Specific Drug Cassette  240  can only be docked or removed by a healthcare professional. The Drug Dispenser  230  remains locked from dispensing unless it receives an encrypted signal from the authorized Drug Specific App  10 . The Drug Dispenser  230  dispenses the drug with one click. 
     The Drug Dispenser  230  when interfaced through a digital handshake with the drug specific App transmits for example: (i) its serial number, (ii) the drug information on the Drug Specific Drug Cassette  240 , (iii) current and historic temperatures since the last dispense, (iv) humidity exposure since the last dispense, and (iv) the date and time the drug was last dispensed. 
       FIG. 10  is an exemplary embodiment illustration of the Drug Specific Drug Cassette  240  designed: (i) to use approved drug packaging materials, (ii) to dock into the Drug Dispenser  242 ,  244 , and (iii) as a blank cartridge which can accommodate a number of different pills, caplets, capsules, etc. within a specified size range. The blank Drug Specific Drug Cassette  240  is designed to be proprietary to the Drug Dispenser  230  and is marked, as part of the automated cassette fill operation, to allow the Drug Dispenser  230  to ascertain the: (i) name of the drug (brand and/or generic), (ii) drug&#39;s NDC number, (iii) drug batch number, (iv) drug&#39;s expiration date, etc. The cassette closure is designed to allow printing or any required regulatory information. 
       FIG. 11  presents exemplary embodiment of the Patient  50  specific charts  250 ,  252 ,  254  which illustrate the relationship between when the Patient  50  took their medication versus his/her self-assessment or digitally captured symptoms and/or diagnostic values. This clearly shows the relationship between the medication and symptoms. The charts or tables, which can be requested and viewed by the Patient  50  on the Interface Device  20  are designed to educate the patient and promote Patient  50  prescription compliance and persistence. 
     Prescribers  60  can utilize the information to ensure the medication is efficacious for the individual Patient  50 , to titrate dosing, and to personalize drug therapy (for personalized medicine). 
     The respective charts, graphs, reports, etc. may be generated by the Drug Specific App  10  and/or by the Integrated Support Centers  40  centralized analytics platform. 
       FIG. 12  is an exemplary embodiment illustration of Drug Dispensers designed to serve the needs of most Patients  50 . Approximately half of all Patients  50  take two medications and 20 percent take five or more. Consolidated Therapy App  270  automatically senses other Drug Specific Apps  10  that or on the Interface Device  20 . It consolidates from two to many Drug Specific Apps  10  into a single user interface for all drugs—eliminating duplicate logins, entries, and record keeping. It in turn digitally handshakes with the Multi-Drug Dispenser  280  and uses the individual Drug Specific Dispensing Algorithms to control dispensing of each individual medication. Furthermore, it coordinates the dispensing schedules to have as few dispensing times, within the respective prescriptions, as possible. Multi-Drug Dispenser eliminates concerns about which drugs have to be taken when. 
     Illustrations  282 ,  284 ,  286 , and  288  are exemplary of dispensing units containing from two drugs to five drugs. These units are standalone or can be docked into a Multi-Dispenser desktop unit. 
       FIG. 13  is an exemplary embodiment of the Drug Dispenser  292  and the Drug Specific App  294  interfaces with the: (i) centralized Servers, (ii) databases, and (iii) Analytics systems (the IT System  290 ), through the Interface Device  294   e , to ensure the Patient  304  is receiving the best care, tailored to the Patient (“personalized medicine”), for the prescribed Drug. 
     All the data collected by the Drug Specific App  294 , from the Drug Dispenser  292 , Digitally Captured Information  294   a ,  294   b ,  294   c , the Patient Self-Assessment screens  100 ,  102 ,  104  contained within the Drug Specific App  294 , and the respective output of the Drug Specific Dispensing Algorithm  15  are transmitted by the Drug Specific App  294  through the Interface Device  294   e  to the appropriate Patient database on the centralized Servers  290 . The data is utilized to update the respective patient screens used by the Disease Management Counselors in the Integrated Support Center. The data is also made available to the respective Drug Registries  306  and the related Electronic Medical Record  296 . Any information that requires a communication with the Patient  304  and/or the Prescriber  308  is handled either automatically by the patient management software or by the Integrated Support Center  302 . 
     The patient&#39;s information is continually analyzed by the analytical routines both individually for the patient as well as in comparison with treatment data from other like patients to ascertain if any changes in therapy may be warranted. This analytical capability is utilized by the Integrated Support Center  302  to assist Prescribers  308  when they are trying to develop a treatment plan for difficult patients. The Analytics  290  performed may include the patient&#39;s data, pooled patient information, as well as information from Electronic Medical Records  296 , clinical studies, and publications, etc. 
     As further example of the embodiment, the centralized Servers and Analytics  290  provide the following, as well as other, exemplary backbone support: 
     For the Drug Specific App  294 : (i) assigns the App to a specific Patient  304 , (ii) links the Drug Dispenser  292  to the Drug Specific App  294  which in turn limits the dispenser and App only to work with one another, (iii) stores the App codes on server, and (iv) enables and updates the Drug Specific App software via communication with the Interface Device  294   e , etc. 
     For the Drug Dispenser  292 : (i) stores all reported data in the designated databases on the Servers  290 , (ii) syncs the patient data on all the respective Interface Devices  294   e ; (iii) stores dispensing, dispensing attempts, lock, and malfunction data; (iv) transmits reports to patient via the Drug Specific App  294  on request; (v) enables lock or unlock transmission from the Integrated Support Center  302 ; changes the Drug prescription on the Drug Specific App  294  as imputed by the Disease Management Represented per the Prescribers  308  instructions, and (vi) stores the authorized medical professional identification code required for the professional to open the Drug Dispenser  292  in order to change or load the Drug Specific Drug Cassette  242 , etc. 
     For the Integrated Support Center  302 : (i) aggregate patient data, (ii) presents and updates data on patient specific Managed Care call center screens, (iii) provides the ability to change a Patient&#39;s  304  prescription, (iv) enables the remote locking and unlocking of individual Drug Dispensers  292  via their Drug Specific App, (v) enable drug specific transmissions to all Patients  304 , (vi) enables simultaneously locking all Drug Dispenser  292  for a specific Drug in the event of a Drug recall, and enables medical professionals to open, load, and close the Drug Dispenser  292 , etc. 
     For the Patient  304 : (i) prepares patient specific communications, (ii) creates personalized charts and reports, and (iii) generates “Payer Outcomes Reports”, etc. 
     For Registries  306 : (i) maintains the Registry  306 , Electronic Medical Record  296  and App databases and analytics. (ii) prepares Therapy efficacy reports, (iii) prepares best practices reports, and (iv) through the Integrated Support Center provides Patient  304  specific diagnosis and therapy assistance to Prescribers  308  as requested. 
     For the Prescriber  308 : (i) prepares and sends Patient  304  alerts, (ii) conducts meta-data analysis, prepares Patient specific reports and shares the results with the Prescriber  308 , (iii) provides the Prescriber  308 , through the Integrated Support Center  302 , assistance/guidance based upon Prescriber  308  requested database and analytics queries, and (iv) prepares best practices reports based upon patient and Electronic Medical Records  296  meta-data analysis, etc. 
     For Electronic Medical Records  296 : (i) interfaces with the Electronic Medical Record  296 , (ii) updates Patient  304  dispensing, compliance, and persistence information, (iii) updates any Integrated Support Center counseling notes, and (iv) extracts patient data, within HIPAA guidelines, for meta-data analysis, etc. 
       FIG. 14  is an exemplary embodiment illustration of how the Integrated Support Center  310  interfaces with the Drug Specific App  312 , the Patient  314 , the Prescriber  318 , and the Electronic Medical Record  316 . 
     The Integrated Support Center&#39;s  310  interactions with the Patient  314  can be instigated by a number of different scenarios and take on many different forms. Examples include but are not limited to: (i) receipt of a patient alert from the Patient&#39;s Drug Specific Drug App  312 ; (ii) Patient  314  calls; (iii) answering Patient  314  questions about the device, App, the drug, or their therapy; (iv) Patient  314  counseling within the support center&#39;s guidelines; (v) locking the individual patient&#39;s Drug Dispenser  30  based upon: (a) an Drug Specific App alert, (b) an Integrated Support Center Analytics alert, (c) a patient conversation, etc.; (vi) unlocking the individual patient&#39;s Drug Dispenser  30  based upon: (a) a conversation with the Patient  314 , (b) a conversation with the Prescriber  318 , etc. 
     In addition, as an example, the Integrated Support Center  310  provides: (i) “Compliance” and “Adherence” support; (ii) outbound patient telephone calls; (iii) patient monitoring; (iv) emails and/or calls the patient&#39;s physician to recommend therapy change, etc.; (v) patient disease management education; (vi) ensures patient has access to their drug; (vii) as required, works with payers to obtain coverage for high cost medications; (viii) looks for prescription financial assistance programs; (ix) patient education and reeducation; (x) patient follow-up, and (xi) Medical Affairs support. 
     The Integrated Support Center&#39;s  310  interactions with the Prescriber  318  can be instigated by a number of different scenarios and take on many different forms. Examples include but are not limited to: (i) locking or unlocking a specific patient&#39;s Drug Dispenser  30 ; (ii) changing the prescription; (iii) patient specific physician support using the Integrated Support Center&#39;s  310  Analytics  290  to ascertain patient specific treatment alternatives; (iv) assist with patient specific data analysis; (v) provide disease/condition specific information; and (vi) Medical Affairs support, etc. 
       FIG. 15  illustrates an exemplary embodiment of the design of a single drug Drug Dispenser  324 . The size of said dispenser  324  in the exemplary being 3.8 inches tall by 2.5 inches wide by 9/16 th  inches wide. The design incorporates a clam shell design  320 ,  330  with a pivot on one corner and a tamper resistant and waterproof seal on the opposite edge right before the corner. All design work meets the respective FDA 21 CFR 820 Quality System Regulation, design center ISO 13485:2003 certification and Risk Management process for design, ISO14971, requirements. The Drug Dispenser  320 ,  322 ,  324 ,  326 ,  328 ,  330  has been designed for manufacturing (on both PCB and plastics or sheet metal parts), assembly (PCBA and Box Build), and cost. The design incorporates failure modes and effects analysis (FMEA) to address all possible failures in design, manufacturing, assembly, interface with the Drug Specific App  10  or when used by a patient. It is designed for testing, continual design improvement, the environment, and reliability. 
       FIG. 16  is an exemplary embodiment illustration of the assembly and locking mechanism for the Drug Dispenser&#39;s  332  clamshell design. The interior of the top of the clamshell  334  incorporates hinges that marry with the hinges on the inside of the bottom clamshell interior  338 . These are locked together with a hinge pin  336  that is treaded through the holes in the respective hinges, much the same as the hinges are held together on most common entry doors. 
     The top 334 and bottom  348  clamshells are locked closed and together by use of a microactuator moved locking bar  342 . When the top of the clamshell is closed with the bottom clamshell, the locking bar is pulled down by the microactuator and the hook&#39;s male member docks into the the female orifice on the locking buttoms  344 . 
     The design incorporates integrated supports  354  to ensure the intergrity and durability of the design. They are also instrumental in addind strength, as required, for adding anchors for the respecitive Drug Dispenser  332  components. 
     The design eliminates the ability to open the Drug Dispenser without an authorized signal to cause the microactuator to unlock  342 . The Top Cap  340  is fitted to close the top of the Bottom Clamshell. The top of the Top Cap  340  covers the top of the Hinge Pin  336  and holds it in place. The Bottom Cap  350  covers the bottom of the Hinge Pin  336  and holds it in place. 
     The right interior to the Top Cap provides for a dock for the end of the Lock Bar  342  and allows it to move up and down, to lock or unlock, as required. The Bottom Cap  350  provides the seat that supports the Microacturator  342  that lock and unlocks the clamshell by moving the Lock Bar  342  up and down. 
     The Top  340  and Bottom  350  Caps are secured to the Bottom Clamshell Interior  348  by screws that securely marry each of the pieces together. The unit then forms a ridged platform for the Top Clamshell Interior  334  to dock with. When the Drug Dispenser  332  is closed, it forms a sturdy, tamper resistant housing for the Drug Specific Drug Cassette  240 . 
     In order to provide the requisite downward pressure to ensure the unit is both water and dust resistant and to contribute to its rugged design, the Drug Dispenser  332  has a Clasp Lock  346  designed to exert the desired level of pressure on the closing joints to secure design integrity. 
     In this embodiment, the Top Cap  338  incorporate the one click dispensing button. The Bottom Cap  352  houses the dispensing port. 
       FIG. 17  is an exemplary embodiment of the Drug Dispenser&#39;s  324  electronics and features schematic. The Drug Dispenser&#39;s  324  system is comprised of an Applications Processor  368  that contains the units Firmware, individual Drug Dispenser  324  serial number, and manages all functions. The main unit components are the: (i) communications connectivity  362  module, (ii) its data transfer capability  366 , (iii) the units sensors and/or applications  364  that allow the unit to authenticate the user, sense efforts to tamper/open the unit without authority, measure drug storage temperature and humidity, to time time stamp an action or event (clock function), and locate the unit via GPS; (iv) the display module  370 ; (v) the Power Management and recharge system  376 ; (vi) Memory management  374 ; (vii) Cassette Controller which rotates the Drug Specific Drug Cassette  240  which enables dispensing as well as the unit to read specific drug cassette information; (viii) the Dosage Dispenser system  372 ; and (ix) the various components designed to facilitate and protect the different system functions. 
       FIG. 18  is an exemplary embodiment of the placement of electronics and mechanical components on the outside and within the Drug Dispenser. The front of the Drug Dispenser  380  contains an On Off Button  382  which the user can depress if the Drug Dispenser  380  does not automatically come on when the Drug Specific App  10  handshakes with the Drug Dispenser  380 . When a handshake is effectuated or the On Off Button  382  are pushed, a blue led light comes on  384 . The light  384  turns to green if the unit is ready to dispense, yellow  384  if it is awaiting authority to dispense, and red  384  if the unit is locked and will not dispense. The display on  386  resides on the center of the face, Front View, of the Drug Dispenser  380 . 
     A number of components fit on the Top Clamshell Interior  388 ; these include: (i) the On Off Button  382  switch  390 , (ii) the LED status light  384  LED and electronics  394 ; (iii) the battery, power management, Wi-Fi, Bluetooth, GPS and antenna systems  392 ; (iv) the LED Screen  386  electronics and management system  396 ; and (v) the drug dispensing actuator arm and dispensing lock  398 . The Bottom Clamshell Interior  400  houses the: (vi) single click Dispensing Button  402 ; (vii) the Logic, Controls, Processor and Memory Board and its various components  404 ; (viii) Temperature and Humidity sensors  406 ; (iv) the Attempting Tampering Sensors  412 ; (x) the Cassette Rotation Motor and Controller (works like a CD-Rom rotator)  410 ; (xi) the Drug Cassette Reader  408 ; (xii) the Clamshell Lock microactuator controller  414 , and (xiii) the Dispensing Door Controller  416 . 
     IV. Examples 
     The embodiment of the invention can be utilized, for among other uses, 1) to improve the drug&#39;s safety profile by ensuring proper, personalized drug utilization (e.g., Dispensing), 2) as a diagnostic aid/tool, 3) to preclude drug related adverse events, 4) to decrease the chance of addiction, 5) to preclude overdosing, 6) to manage drug dependence withdrawal, 7) to manage oral patient controlled analgesia, 7) to preclude drug divergence, 8) to guard the medication against accidental ingestion by a child, and 9) to capture the information required and control drug dispensing during clinical trials. 
     A. Dispensing 
     Ensuring the proper utilization of antihypertensive medications serves as an example of how the embodiment can be used to ensure proper drug utilization. As patients get older, they have a tendency to gain weight and to develop comorbidities. These factors can interfere with how the medication is metabolized and alter the need or effectiveness of the drug over time. As a result, certain patients may become dizzy or faint as a result of a hypotensive event. If the patient is prescribed an antihypertensive, it is beneficial to prevent a potential hypotensive event, especially as it may lead to an untoward accident. 
     Under the current embodiment, the patient would be prescribed an antihypertensive dispensed using the Drug Specific App  10  controlled Drug Dispenser  30 . When the Patient  50  clicks on the Drug Specific App  10  to take his/her next dose, the Drug Specific Dispensing Algorithm  15  would automatically check to ensure the drug has not expired, and if it has not, then to see if it has been stored correctly, and if the Drug has been stored correctly, then, for example, it would handshake with designated devices to digitally capture blood pressure and heart rate information. Thereafter, it asks the Patient  50  at least one Patient Self-Assessment question. Examples include but are not limited to: (i) have you gotten dizzy since the last time you took your antihypertensive medication, (ii) do you have blurry vision, (iii) have you felt like fainting since you took your last antihypertensive, etc. If the patient answered yes to any of the Patient Self-Assessment questions, the Drug Specific Dispensing Algorithm  15  would check the trending of the Patient&#39;s  50  blood pressure and heart rate information since the last dose. If the indication would be that the Patient  50  may suffer a hypotensive event as defined by the Decision Tree, the Drug Specific Dispensing Algorithm  15  would lock the Drug Dispenser  30  and inform the Patient  50  that he/she should call the Integrated Support Center  40  or talk with their Prescriber  60  or a physician prior to being able to dispense the next dose, even if the dose is within prescribing parameters. After talking with the Patient  50 , the Disease Management representative at the Integrated Support Center  40  can decide within their operating constraints whether or not to unlock the Drug Dispenser  30  and allow the Patient  50  to dispense and take the prescribe antihypertensive. If not appropriate, the representative would send an email, text, and/or call the Prescriber  60  to advise him/her that an adjustment has to be made to the Patient&#39;s  50  hypertension treatment. The Drug Dispenser  30  can then be unlocked and allowed to dispense the medication if those are the Prescriber&#39;s  60  instructions or the prescription can be changed based upon the Prescriber&#39;s  60  instructions. 
     In the process, an accident and/or costlier intervention can be averted, the drug efficacy for the specific Patient  50  is assured, the patient&#39;s quality of care is personalized and improved, and the patient&#39;s quality of life is enhanced. 
     B. Diagnostic 
     The embodiment of the Invention can also be utilized to assist in diagnosis. As an example, there are many different types of pain and different types of headaches. Patients will generally begin by self-medicating with over the counter (OTC) analgesics such as aspirin. As the pain or discomfort increases, patients increase the number of tablets taken (i.e., the dosage), as well as the frequency of self-medication. At a certain point, they go to their doctor seeking adequate relief. 
     When the doctor talks with the Patient  50 , he/she may describe many different types of pain, making it difficult to diagnose. Pain has multiple causes, and people respond to it in multiple and individual ways. The pain that one person pushes their way through might be incapacitating to someone else. 
     Headaches represents an example. It is important to figure out what type of headache is causing the pain. If the doctor knows the type of headache, he/she can treat it correctly. However, as was highlighted by a  2004  study, 80% of people who had a recent history of self-described or doctor-diagnosed sinus headache, but no signs of sinus infection, actually met the criteria for migraine. The following discusses the different types of headaches:
         1) Tension headaches, the most common type of headache, can generally be adequately treated with over-the-counter treatments such as aspirin, ibuprofen, or acetaminophen (Tylenol). Experts believe these may be caused by the contraction of neck and scalp muscles (including in response to stress), and possibly changes in brain chemicals.   2) Cluster headaches, which affect more men than women, are recurring headaches that occur in groups or cycles. They appear suddenly and are characterized by severe, debilitating pain on one side of the head, and are often accompanied by a watery eye and nasal congestion or a runny nose on the same side of the face. During an attack, people often feel restless and unable to get comfortable; they are unlikely to lie down, as someone with a migraine might. The cause of cluster headaches is unknown, but there may be a genetic component. There is no cure, but medication can cut the frequency and duration.   3) Sinus headaches occur when a sinus becomes inflamed, often due to an infection. They can generally be diagnosed by symptoms or the presence of pus viewed through a fiber-optic scope. Headaches due to sinus infection can be treated with antibiotics, as well as antihistamines or decongestants.   4) Rebound headaches, ironically, can be caused by the overuse of painkillers for headaches. Culprits include over-the-counter medications like aspirin, acetaminophen (Tylenol), or ibuprofen (Motrin, Advil), as well as prescription drugs.   5) Migraine headaches can run in families and are diagnosed using certain criteria: (i) at least five previous episodes of headaches, (ii) last between 4-72 hours, (iii) at least two out of four headaches have one-sided pain, throbbing pain, moderate-to-severe pain, and pain that interferes with, is worsened by, or prohibits routine activity, and (iv) at least one of the following is associated with the pain: nausea and/or vomiting, or, if those are not present, then sensitivity to light and sound. A migraine may be foreshadowed by aura, such as visual distortions or hand numbness. (About 15 percent to 20 percent of people with migraines experience these.)   6) Mixed headache syndrome, also called transformed migraines, is a combination of migraine and tension headaches.   7) Acute headaches are headaches that occur suddenly and have symptoms that subside after a relatively short period of time.   8) Hormone headaches are often associated with women&#39;s changing hormone levels during menstruation, pregnancy, and menopause. Chemically induced hormone changes, such as with birth control pills, also trigger headaches in some women.   9) Chronic progressive headaches also called traction or inflammatory headaches, are chronic progressive headaches that get worse and happen more often over time. These are the least common type of headache, accounting for less than five percent of all headaches in adults and less than two percent of all headaches in kids. Chronic progressive headaches may be the result of an illness or disorder of the brain or skull.       

     Diagnosis requires a headache evaluation that includes: (i) headache history, (ii) description of the headaches, (iii) headache symptoms, (iv) characteristics, (v) a list of things that cause the headache, (vi) aggravate the headache, and (vii) things the patient has done to relieve a headache. The patient is also requested to keep a headache diary. 
     The proper treatment will depend on several factors, including the type and frequency of the headache and its cause. There are many migraine and headache medications and other treatments are available. The appropriate treatment often depends on the type of headache. 
     Headache pain may need to be managed with medications. Headache drugs used to treat headache pain can be grouped into three different categories: symptomatic relief (drugs used to treat the headache pain or accompanying symptoms of migraines like nausea), abortive therapy (drugs used to stop a migraine headache), and preventive therapy (drugs used to prevent a migraine). Botox injections represents another migraine and headache treatment. 
     The way the body responds to migraine and headache medications may change over time, so medications may need to be adjusted. 
     The embodiment of the Invention enables the aggregation of Patient  50  specific dispensing information and Patient Self-Assessment information specifically developed to assist in the diagnosis and management of headaches. 
     C. Management of Complex Drug Therapy 
     Cystic fibrosis (CF) serves as an example of how the system can be utilized to manage complex drug therapy. There is no cure for CF, but treatment can ease symptoms and reduce complications, physician office visits and hospitalizations. Close monitoring and early, aggressive intervention is recommended. 
     Managing CF is complex, so treatment is best if managed by a center that specializes in cystic fibrosis. The goals of treatment include: (i) preventing and controlling lung infections, (ii) loosening and removing mucus from the lungs, (iii) preventing and treating intestinal blockage, (iv) providing adequate nutrition, and (v) medications. 
     The patient must take multiple drugs, the schedule and combination which must be personalized for each patient. The medicines include those to help treat or prevent lung infections, reduce swelling and open up the airways, and thin mucus. If the patient has mutations in a gene called G551D, which occurs in about 5 percent of people who have CF, the doctor may prescribe the oral medicine ivacaftor (approved for people with CF who are 6 years of age and older). Adherence and persistence with each drug regimen is critical to avoid costly complications. The options include:
         a. antibiotics to treat and prevent lung infections (Most people with CF have ongoing, low-grade lung infections. Sometimes, these infections become so serious that the patient may need to be hospitalized. Antibiotics are the primary treatment.)   b. mucus-thinning drugs to help the patient cough up the mucus, which improves lung function.   c. bronchodilators to help keep the airways open by relaxing the muscles around the bronchial tubes, and   d. oral pancreatic enzymes to help your digestive tract absorb nutrients.       

     The embodiment of the Invention enables the complex management of the CF Patient  50  via the utilization of the Multi-Drug Dispenser  280 . The Consolidated Therapy App  270  consolidates from two to as many Drug Specific Apps  10  as are resident on the Interface Device  20  into a single user interface for all drugs—eliminating duplicate logins, entries, and record keeping. It in turn digitally handshakes with the Multi-Drug Dispenser  280  and uses the individual Drug Specific Dispensing Algorithms  15  to control dispensing of each individual medication. Furthermore, it coordinates the dispensing schedules to have as few dispensing times, within the respective prescriptions, as possible. Multi-Drug Dispenser  280  eliminates concerns about which drugs have to be taken when. It can also be programmed to provide alerts for the patient to take his/her related injectable and/or inhaled medications. In this way, the Dispensing System simplifies CF drug management, encourages prescription compliance and persistence, avoids complications, and thereby reduces the total cost of treating a CF patient by decreasing the number of physician interventions and hospitalizations. 
     D. Opioids 
     Opioid medications (examples include: codeine, fentanyl and analogs, hydrocodone, hydromorphone, methadone, oxycodone, Oxymorphone, etc.) are effective in controlling pain. However, physicians are reluctant to prescribe them due to their overdose, abuse, addiction and divergence potential and related REMS programs. Some patients are also reluctant to take them due to their addiction potential. The embodiment provides control and real time monitoring and thereby address each of these shortcomings. 
     Overdosing is addressed by the inability of the patient to dispense a dose more frequently than allowed by the prescription. This is handled by the Drug Specific Dispensing Algorithm  15  which controls dispensing by the Drug Dispenser  30 . 
     Abuse is addressed by the design of the tamper resistant Drug Dispenser  230 . The Drug Specific Drug Cassette  240  can only be docked with the Drug Dispenser  244  by an authorized medical professional. Any attempt by an unauthorized person to open the Drug Dispenser  244  triggers a signal to the Drug Specific App  10  which automatically locks the Drug Dispenser  244  and alerts the Integrated Support Center  40 . The Integrated Support Center  40  then calls the Patient  50  to ascertain why they are trying to open the Drug Dispenser  30 . At this point, the Integrated Support Center  40  works with the Patient  50  to address any dispensing related issues and unlocks the Drug Dispenser  30  or, if attempted abuse is suspected, contacts the Prescriber  60  to alert them of the conversation with the Patient  50  and asks the Prescriber  60  whether or not the Drug Dispenser  30  should remain locked or if it should be unlocked. If authorized, the Integrated Support Center  40  updates the Electronic Medical Record  70  related to the calls to the Patient  50  and the Prescriber  60 . 
     The potential for addiction is mitigated by: (i) the patient&#39;s inability to dose more frequently than the prescribed medication schedule, (ii) by tracking attempted earlier than prescribed dosing events, (iii) by capturing any attempts to open the Drug Dispenser  30 , and (iv) through the use of patient self-assessment  100 ,  102 ,  104  and/or digitally captured relevant information, trended over time, to ascertain the effectiveness of the drug on the specific patient. The centralized drug specific patient and population focused analytics programs  290  are designed to take a myriad of patient specific actions and inputs into account in order to identify potential movement of the Patient  50  toward addiction. When potential addiction is identified, the analytics software  290  is programmed to alert the Integrated Support Center  40  so they may alert the Prescriber  60  and update the patient&#39;s Electronic Medical Record  70 . 
     Divergence is precluded by a number of combined features: (i) the serial number of the Drug Specific Drug Cassette  240  and the drug&#39;s batch number are digitally married to the Drug Dispenser  244 , (ii) the serial number of the Drug Dispenser  230  is linked to the Patient&#39;s Drug Specific App  10 , (iii) the use of the Drug Specific App is restricted to a specific Patient  50 , and (iv) the Drug Specific App  10  requires a biometric login  90  to access the Drug Specific App  10  in order to instruct the Drug Dispenser  230  to dispense the drug. The unit further supplies additional control of the drug being taken can be tracked with RFID tracking which would allow the Drug Specific App  10  to track the drug until it is ingested by the patient. The time interval between the time the drug is dispensed and the time it is ingested, over time, provides an indication of compliance or abuse. When coupled with mega-data analytics conducted by the Integrated Support Center, the probability of accurately identifying potential abusers is significantly increased. 
     The system is designed to comply with the respective REMS program and to virtually eliminate required data capture and automate patient specific tracking and dispensing report preparation. The Integrated Support Center  40  will also support the Prescriber  60  by preparing the required REMS reports encompassing all his/her patients. 
     The system also allows for the redefinition of Prescription Drug Monitoring Programs by closing the loop between pharmacies and healthcare providers and the patient by controlling and tracking use on an individual patient basis. 
     Attributes of the system enable oral patient controlled analgesia. Studies have shown that patients that have the ability to self-medicate as warranted, e.g., PRN with set prescription parameters, tend to use less medication, further mitigating potential side effects. 
     The system may also be utilized to predict, for example, opioid related constipation and to alert the patient to take a laxative at the appropriate time. If the system&#39;s multi-drug dispenser is utilized, the program can dispense the laxative as well as the opioid and/or other medication as prescribed. 
     E. Addiction and Withdrawal 
     Addiction is a global crisis with an estimated 2.4 million opioid-dependent people in United States, 1.3 million in Europe and twenty million in the rest of the world. Opioid overdose is the second leading cause of accidental death in the US. Overdoses claimed 16,000 lives in the United States alone in 2012. 
     If other kinds of addiction are added, 4.5% of disease and injury around the globe can be attributed to alcohol, and these numbers are most likely underreported. The true population that suffers from opioid, prescription drug, and alcohol addiction is estimated to be much greater. 
     Addiction can either be treated with buprenorphine and/or naloxone (examples of brand names include Butrans, Suboxone, Zubsolv). In cases of physical dependent, withdrawal must be managed through the gradual decrease of doses of the dependent drug (e.g., barbiturates, benzodiazepines, methamphetamines, narcotics, opioids, methadone, etc.). 
     Appropriate precautions must be taken to minimize risk of misuse, abuse, or diversion, appropriate protection from theft, and unintended pediatric exposure; much the same as with the opioids. In addition, appropriate clinical monitoring as to the patient&#39;s level of stability is essential. The embodiment of the system provides control and real time monitoring and thereby address each of these shortcomings. 
     Overdosing is addressed by the inability of the patient to dispense a dose more frequently than allowed by the prescription. This is handled by the Drug Specific Dispensing Algorithm  15  which controls dispensing by the Drug Dispenser  30 . The controls are in place even for the Drug Specific App  10  and Drug Dispenser  30  enabled oral PRN dosing regimen. 
     Abuse is addressed by the design of the tamper resistant Drug Dispenser  230 . The Drug Specific Drug Cassette  240  can only be docked with the Drug Dispenser  244  by an authorized medical professional. Any attempt by an unauthorized person to open the Drug Dispenser  244  triggers a signal to the Drug Specific App  10  which automatically locks the Drug Dispenser  244  and alerts the Integrated Support Center  40 . The Integrated Support Center  40  then calls the Patient  50  to ascertain why they are trying to open the Drug Dispenser  30 . At this point, the Integrated Support Center  40  works with the Patient  50  to address any dispensing related issues and unlocks the Drug Dispenser  30  or, if attempted abuse is suspected, contacts the Prescriber  60  to alert them of the conversation with the Patient  50  and asks the Prescriber  60  whether or not the Drug Dispenser  30  should remain locked or if it should be unlocked. If authorized, the Integrated Support Center  40  updates the Electronic Medical Record  70  related to the calls to the Patient  50  and the Prescriber  60 . 
     The potential for addiction is mitigated by: (i) the patient&#39;s inability to dose more frequently than the prescribed medication schedule, (ii) by tracking attempted earlier than prescribed dosing events, (iii) by capturing any attempts to open the Drug Dispenser  30 , and (iv) through the use of patient self-assessment  100 ,  102 ,  104  and/or digitally captured relevant information, trended over time, to ascertain the effectiveness of the drug on the specific patient. The centralized drug specific patient and population focused analytics programs  290  are designed to take a myriad of patient specific actions and inputs into account in order to identify potential movement of the Patient  50  toward addiction. When potential addiction is identified, the analytics software  290  is programmed to alert the Integrated Support Center  40  so they may alert the Prescriber  60  and update the patient&#39;s Electronic Medical Record  70 . 
     Divergence is precluded by a number of combined features: (i) the serial number of the Drug Specific Drug Cassette  240  and the drug&#39;s batch number are digitally married to the Drug Dispenser  244 , (ii) the serial number of the Drug Dispenser  230  is linked to the Patient&#39;s Drug Specific App  10 , (iii) the use of the Drug Specific App is restricted to a specific Patient  50 , and (iv) the Drug Specific App  10  requires a biometric login  90  to access the Drug Specific App  10  in order to instruct the Drug Dispenser  230  to dispense the drug. 
     The system is designed to comply with the respective REMS program and to virtually eliminate required data capture and automate patient specific tracking and dispensing report preparation. The Integrated Support Center  40  will also support the Prescriber  60  by preparing the required REMS reports encompassing all his/her patients. 
     F. Clinical Trial 
     The system is designed to capture, store, analyze, and act upon drug specific patient reported self-assessment (AKA self-reported outcomes, patient-reported outcomes, PROs, etc.) and digitally captured physiological, psychological, lifestyle, other drugs currently being taken, and environmental information along with the drug&#39;s prescription and drug dispensing history in order for the Drug Specific App  10  to decide if the drug should or should not be dispensed. Dispensing can be precluded by the Drug Specific App  15  if the required dispensing criteria are not met, even if without the self assessment and digitally captured data, the prescription would normally allow dispensing. 
     Most of the time, clinical outcomes are held as the ultimate outcome in a clinical trial because they often provide more objective interpretation, increased reliability and greater simplicity of interpretation. However, certain disease conditions require consideration of subjective outcomes. As a result, regulatory agencies, such as the FDA, are combining patient reported outcomes (PROs) and clinical outcomes in their approval decisions. Examples include the: (i) FDA&#39;s “Guidance for Industry, Irritable Bowel Syndrome—Clinical Evaluation of Drugs for Treatment”, dated May 2012 and (ii) the European Medicines Agency (EMA) “Guideline on the evaluation of medicinal products for the treatment of irritable bowel syndrome” dated April 2015. They utilize a combination of PROs and patient self-assessment reporting to measure primary and secondary endpoints required for regulatory approval of any 5HT3 drugs for irritable bowel syndrome (IBS). 
     Interest in developing and applying patient-reported outcomes (PROs) across the drug development and postmarket spectrum is growing—among sponsors, clinicians, payers, regulators and patients. A growing number of clinical trials now are going beyond conventional randomized control measurements to collect self-reported outcomes from patients—focusing on improving patients&#39; involvement by including their perspectives throughout the drug development process. An analysis of sponsor-funded interventional studies listed on CenterWatch&#39;s Clinical Trials Listing Service found between 2005 and 2007, only 6.1% of total study procedures involved some type of subjective outcome assessment. That grew to 11.8% in the 2008 to 2010 timeframe and, most recently, between 2011 and 2013, increased to 16.3% of total study procedures. PROs can capture a range of information, from symptom changes and level of functioning, to health-related qualify of life and treatment satisfaction and adherence. 
     Although their value is widely recognized, PRO use often is inconsistent and underutilized in understanding how patients feel in relation to their diseases, such as cancer, cardiovascular disease, diabetes, etc. Generally, regulatory agencies do not require sponsors to consider PROs in clinical trials and, until recently, did not do much to encourage their use. However, signs point to that sentiment is changing. Janet Woodcock, M.D., director of the FDA&#39;s Center for Drug Evaluation &amp; Research (CDER) stated: “We understand that people with chronic diseases are experts in that disease, as far as the symptoms and the impact on quality of life, and what might be acceptable tradeoffs on risk and uncertainty. The challenge for the FDA is incorporating that knowledge in a way that accurately informs regulatory decisions.” She asked, “how can we meaningfully collect that knowledge in a rigorous manner, given there&#39;s a spectrum of opinions and a spectrum of disease burden in any given disease?” PRO measurements often are used to evaluate products that treat chronic, disabling conditions, for which the goal of treatment is focused on alleviating the frequency, severity or duration of disease symptoms. 
     PROs generally are used as primary endpoints in clinical trials in indications such as migraines and irritable bowel syndrome, in which specific symptoms play a major role in treatment. PROs also are important in the final product labeling manufacturers are allowed to use to promote their products, and to clinicians seeking information to support their prescribing choices. Now, trials for psychiatric and age-related illnesses, among others, are including PROs as part of the protocol design. 
     Pain studies initially used PROs as a primary outcome in a clinical trial because attempts to obtain an objective measure of pain through a dolorimeter, a spring-loaded instrument with a gauge for measuring sensitivity to, or levels of, pain, or through a galvanic skin response lacked validity compared to simple pain scales. Other disease examples where PROs are preferable include neurology, depression, anxiety, and irritable bowel syndrome (IBS) which may utilize co-primary and/or key secondary PROs. 
     Keeping trial participants involved also is the hallmark of the publication and promotion of the FDA&#39;s PRO guidance at the end of 2009. In 2011, the FDA took the next step, seeking multiple ways to give the patient a clear voice in clinical research by ensuring all measurements and outcomes reflect what is happening with the patient through instruments or tools, along with PROs. Increasingly, we are seeing patients in clinical trials demanding to know what is going on and they want to be given a greater voice. 
     Generally, larger clinical sites can handle adding PROs more easily, while smaller sites, especially in more remote locations, can find it more challenging. Collecting data directly from the patient can provide stronger information. As an example, patients can be hesitant to report outcomes if they have been asked to take a medication a certain way and have not done so. 
     Furthermore, collecting data through specific data streams provides, in some cases, better quality. Patients will contact the independent group, such as the clinical trial CRO or in the embodiment, the Integrated Support Center  40  and not necessarily go back to their physicians for technical issues and concerns. 
     While using PROs is becoming critical in many clinical trials to prove safety and effectiveness to gain FDA approval, the next step for biopharmaceutical companies and payers will be to combine PROs with other observational studies to create real world evidence (RWE). RWE is becoming essential for sound medical coverage, payment and reimbursement decisions, according to the International Society for Pharmaeconomics Outcomes Research Real-World Data Task Force. RWE can be used with randomized clinical trials to design more efficient trials and understand a drug&#39;s benefit-risk profile, as well as to gain understanding of the market for launch planning, according to the task force. RWE shows how a drug is accepted from patients who have experience using it. It reveals how a drug is utilized in different geographies and can be used to help frame policy or regulatory decisions. It is a highly credible source of information. 
     The embodiment provides:” (i) the requisite data capture, (ii) patient involvement, (iii) dispensing control, (iv) avoidance of certain drug related side effects, (v) real time reminders for the patient to take the medication, (vi) intervention alerts if the patient fails to take their medication within a predefined time interval, (vii) dispensing tracking (date and time), (viii) real time monitoring, and (ix) reporting. It addresses the shortcomings of current systems to capture and compile real time, patient and drug specific data to facilitate ongoing clinical trial data aggregation, analysis, and reporting while minimizing the number of calls to the clinical trial physician. 
     Under the current embodiment, the patient would be prescribed the medication to be dispensed per a defined prescription using the Drug Specific App  10  controlled Drug Dispenser  30 . When the Patient  50  clicks on the Drug Specific App  10  to take his/her next dose, the Drug Specific Dispensing Algorithm  15  automatically handshakes with the Drug Dispenser  30 , handshakes with defined digital devices (e.g., blood pressure, heart rate, etc.)  FIG. 5  and downloads the latest data to the Interface Device&#39;s  20  Drug Specific App  10  data base, checks to ensure the drug has not expired, and if it has not, then to see if it has been stored correctly. If the Drug has been stored correctly, then, for example, it automatically moves to the next screen and asks the Patient  50  to answer the specific questions. In this example, the Patient  50  would answer the PRO and data capture screens  194  to  214  required by the FDA and EMA to get approval for a 5HT3 drug to treat IBS-D. The ability to capture the requisite PRO primary and secondary end point data and the related compliance and persistence data are illustrated in  FIG. 8 . These screens can be configured to capture and aggregate drug specific information. 
     The Drug Specific Dispensing Algorithm  15  then utilizes its decision tree  FIG. 6  to check the prescription instructions and when the drug was last dispensed to ascertain if the drug can be dispensed. It then either generates a screen stating that the dose will not be authorized for a specific period of time  222  or proceeds to ascertain if the designated digital and self-assessment reported values allow the medication to be dispensed. If yes, then the screen shows a green dispense  216 . If the Drug Specific Dispensing Algorithm  15  indicates that the patient should not receive the medication, even if it is within the prescription guidelines, then it will either generate, for example, a screen stating that the dose is not warranted at the specific time and provide the Patient  50  the ability to click on dial to call the Integrated Support Center  40  or if a problem is ascertained, it will either show a specifically designed screen or a screen that the Integrated Support Center should be called  224 . The type and sequence of screens is dictated by the drug&#39;s clinical trial data capture requirements. The algorithm can contain routines that only ask for specific information if certain predefined criteria are met. 
     Every non-fruitful event to dispense the medication is tracked. At a certain point the Drug Specific Dispensing Algorithm&#39;s  15  logic will send a message for the Integrated Support Center  40  to call the Patient  50 . 
     The embodiment allows for better prescription compliance, an improved drug safety profile, increased prescription persistence, uniform data capture, facilitates data analysis, decreases required interventions by the clinical trial physician(s), decreases the cost of the trial, and provides real time data capture and analysis. 
     G. Intermittent Chronic Conditions 
     There are a number of chronic conditions that come and go and do not always require treatment. Examples include IBS, pain, allergies, arthritis, certain heart conditions, anxiety, depression, intermittent claudication, etc. The Drug Specific App  10  is capable of being programmed to control PRN dosing in various configurations and schedules. This allows for real time data capture which is useful in in diagnosis, patient management, and dispensing control. 
     H. Revitalization of Select Drugs that Previously Failed to Get Regulatory Approval 
     There are a myriad of drugs that failed to get regulatory approval due to dosing-related side effects. Examples include certain 5HT 3  antagonists used to treat diarrhea predominant irritable bowel syndrome (IBS-D). Some physicians hypothesize that there is a relationship between dosing (both strength and frequency) and constipation. In turn, that constipation has a relationship with Ischemic colitis. 
     Patients prefer to use PRN dosing. They can take the medication when symptoms arise and continue taking it until they resolve themselves. Lostronex® (alosetron), a 5HT 3 , approved only in the United States which requires a complex REMS program, serves an example of how the Embodiment can transform drugs that failed to get approval with similar profiles into approvable agents. To lower the risk of constipation, Lostronex® should be started at a dosage of 0.5 mg twice a day. Patients who become constipated at this dosage should stop taking Lostronex® until the constipation resolves. They may be restarted at 0.5 mg once a day. If constipation recurs at the lower dose, Lostronex® should be discontinued immediately. 
     Patients well controlled on 0.5 mg once or twice a day may be maintained on this regimen. If after 4 weeks the dosage is well tolerated but does not adequately control IBS symptoms, then the dosage can be increased to up to 1 mg twice a day. Lostronex® should be discontinued in patients who have not had adequate control of IBS symptoms after 4 weeks of treatment with 1 mg twice a day. 
     Cilansetron, a more potent 5HT3 antagonist for the treatment of IBS-D failed to get FDA and European regulatory approval because of the concerns related to potential constipation that could potentially lead to ischemic colitis. The utilization of the system designed to identify and block dispensing  FIG. 4  if potential constipation is suspected would address this concern. If we use the Lotronex® example, the system could also change the dosing to allow PRN dosing using, for example, 0.5 mg for up to four times per day. This would control the maximum dosing to 2 mg per day. The system would ensure compliance with the prescription and would protect against potential constipation.