ethionamide brand name(s) trecator
everolimus adverse effects serious

- **Hematologic:** Decreased hemoglobin, Grade 4 (advanced renal cancer, 1% ; advanced pancreatic neuroendocrine tumor, 15%), Decreased lymphocyte count, Grade 4
(advanced renal cancer, 2% ; advanced pancreatic neuroendocrine tumor, 16%),
Hemorrhage (3%), Leukopenia (kidney transplant recipients, 3% ; subependymal giant cell astrocytoma, 54% ; advanced pancreatic neuroendocrine tumor, 43%), Thrombosis, Thrombotic microangiopathy, Thrombotic thrombocytopenic purpura
- **Immunologic:** Infectious disease (advanced renal cancer, 37% ; kidney transplant recipients, 62%)
- **Neurologic:** Seizure (29%)
- **Renal:** Hemolytic uremic syndrome, Renal failure (3%), Thrombosis of renal artery (1%
to less than 10%)
- **Respiratory:** Non-infectious pneumonia (14% to 17%), Pleural effusion (7%),
Pneumonia, Pulmonary embolism  
- **Cardiovascular:** Hypertension (kidney transplant recipients, 30% ; advanced renal cancer, 4%; subependymal giant cell astrocytoma, 4%), Peripheral edema (kidney transplant recipients, 45% ; advanced renal cancer, 25%; subependymal giant cell astrocytoma, 4%)
- **Dermatologic:** Infection of skin AND/OR subcutaneous tissue (18%), Rash (advanced renal cancer, 29%; subependymal giant cell astrocytoma, 18%; advanced pancreatic neuroendocrine tumor, 59%)
- **Endocrine metabolic:** Decreased phosphate level (37% to 40%), Dyslipidemia (15%),
Hyperlipidemia (21%), Increased glucose level, All grades (advanced pancreatic neuroendocrine tumor, 75%; advanced renal cell cancer, 57%; subependymal giant cell astrocytoma, 25%), Serum cholesterol raised (advanced renal cancer, 77%; subependymal giant cell astrocytoma, 68% ; advanced pancreatic neuroendocrine tumor, 66%), Serum triglycerides raised (advanced renal cell cancer, 73%; subependymal giant cell astrocytoma, 43% ; advanced pancreatic neuroendocrine tumor, 39%)
- **Gastrointestinal:** Constipation (kidney transplant recipients, 38% ; subependymal giant cell astrocytoma, 11%), Diarrhea (kidney transplant recipients, 19% ; advanced renal cancer, 30%; subependymal giant cell astrocytoma, 25%; advanced pancreatic neuroendocrine tumor, 50%), Loss of appetite (25% to 30%), Nausea (26% to 29%), Oropharyngeal mucositis, Stomatitis (kidney transplant recipients, 8% ; advanced renal cancer, 44%; advanced pancreatic neuroendocrine tumor, 70%; subependymal giant cell astrocytoma, 86%), Ulcer of mouth, Vomiting (advanced renal cancer, 20%;
subependymal giant cell astrocytoma, 21%; advanced pancreatic neuroendocrine tumor, 29% ; kidney transplant recipients, 15%)
- **Hematologic:** Anemia (kidney transplant recipients, 26% ; renal cell cancer, 50% or higher), Decreased hemoglobin, All grades (advanced renal cancer, 92%; subependymal giant cell astrocytoma, 39% ; advanced pancreatic neuroendocrine tumor, 86%), Decreased lymphocyte count, All grades (45% to 51%), Decreased platelet count, All grades (21% to 45%)
- **Hepatic:** ALT/SGPT level raised (advanced renal cell cancer, 21%; subependymal giant cell astrocytoma, 46%; advanced pancreatic neuroendocrine tumor, 48%), AST/SGOT
level raised (advanced renal cancer, 25%; advanced pancreatic neuroendocrine tumor, 56%; subependymal giant cell astrocytoma, 89%)
- **Immunologic:** Surgical wound finding (35%) - **Neurologic:** Asthenia (33%)
- **Otic:** Otitis media (36%) - **Renal:** Serum creatinine raised (advanced renal cancer, 50%; advanced pancreatic neuroendocrine tumor, 19%; subependymal giant cell astrocytoma, 11% ; kidney transplant recipients, 18%), Urinary tract infectious disease (advanced pancreatic neuroendocrine tumor, 16% ; kidney transplant recipients, 22%)
- **Respiratory:** Cough (advanced renal cancer, 30%; advanced pancreatic neuroendocrine tumor, 25%; subependymal giant cell astrocytoma, 21% ; kidney transplant recipients, 7%), Dyspnea (20% to 24%), Sinusitis (39%), Upper respiratory infection (kidney transplant recipients, 16% ; subependymal giant cell astrocytoma, 82%)
Other: Fatigue (advanced pancreatic neuroendocrine tumor, 45% advanced renal cancer, 31%;
subependymal giant cell astrocytoma, 7% kidney transplant recipients, 9%), Fever (advanced renal cancer, 20%; advanced pancreatic neuroendocrine tumor, 31%; subependymal giant cell astrocytoma, 32% ; kidney transplant recipients, 19%)
ethionamide brand name(s) trecator
famotidine brand name(s) fluxid pepcid

- **Dermatologic:** Stevens-Johnson syndrome (very rare), Toxic epidermal necrolysis (very rare)
- **Gastrointestinal:** Necrotizing enterocolitis in fetus OR newborn - **Immunologic:** Anaphylaxis (infrequent), Angioedema (infrequent) - **Neurologic:** Seizure (rare) - **Respiratory:** Interstitial pneumonia (infrequent), Nosocomial pneumonia  
- **Gastrointestinal:** Constipation (1.2% to 1.4%), Diarrhea (1.7%)
- **Neurologic:** Dizziness (1.3%), Headache (1.3% to 4.7%)  
- This drug may cause constipation, diarrhea, or dizziness.  
- Advise patient to take at bedtime.  
- Patient may take with antacids, if needed.  
- hypersensitivity to famotidine or any component - hypersensitivity to other H2-receptor antagonists, history Precautions
- neonates, very low birth weight (401 to 1,500 g); increased risk of developing necrotizing enterocolitis
- renal insufficiency, moderate or severe; risk of prolonged QT interval and CNS adverse effects; dose adjustment recommended
- symptomatic response does not rule out gastric malignancy  
| Common                                                                                                                                                                                         | Serious                                                                                                                                                                                                         |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Photosensitivity Weight loss Abdominal pain Constipation  Indigestion  Loss of appetite Nausea Taste sense altered Vomiting Purpuric disorder Adnormal gait Dizziness Headache Insomnia  Fever | Stevens-Johnson syndrome Agrnulocytosis  Aplastic anemia Bone marrow depression  Drug-induced eosinophilia  Leukopenia  Pancytopenia  Thrombocytopenia  Hepatic failure (acute) Anaphylactoid reaction  Seizure |
ethionamide brand name(s) trecator
felbamate

Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
This drug may cause weight loss, abdominal pain, constipation, dyspepsia, loss of appetite, nausea, altered sense of taste, vomiting, purpuric disorder, abnormal gait, dizziness, headache, or insomnia.  
Instruct patient to report signs/symptoms of pancytopenia, hepatic failure, or Stevens-Johnson syndrome (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering).  
Advise patient against sudden discontinuation of drug.  
Instruct patient to call healthcare provider for instructions if 2 or more doses are missed.  
| Common                                                                                                                     | Serious                                                                                        |
|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Peripheral edema (2% to 17.4%) Flushing (1.6%) Drug-induced gingival hyperplasia (<0.5%) Dizziness (4.4%) Headache (10.3%) | Angina (<0.5%) Hypotension (rare) Myocardial infarction (<0.5%) Tachyarrhythmia (0.4% to 2.5%) |
ethionamide brand name(s) trecator
felodipine

Patient should avoid activities requiring coordination until drug effects are realized, as drug may cause dizziness.  
Warn patient that hypotension may occur, especially with the first dose and dosage changes.  
This drug may cause peripheral edema, flushing, headache, myocardial infarction, or tachyarrhythmia.  
Inform patient that mild gingival hyperplasia may occur. Incidence and severity can be minimized with good dental hygiene.  
Patient should report exacerbation in angina. This may occur more frequently with initial dose, dose changes, or during drug withdrawal.  
Patient may take drug without food or with a light meal.  
Advise patient against sudden discontinuation of drug.  
Patient should avoid eating grapefruit or drinking grapefruit juice while taking this drug.  
Patient should not drink alcohol while taking this drug.
ethionamide brand name(s) trecator
fenoprofen

| Common                                                 | Serious                                                                                                                                                                                                                                                                                                                                       |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema Anemia Increased liver function test (up to 15%) | Hypertension Myocardial infarction (<2%) Thrombotic tendency observations  Scaling eczema Stevens-Johnson syndrome (<0.1%) Gastrointestinal perforation (<2%) Inflammatory disorder of digestive tract Hepatitis (<2%) Jaundice  Liver failure(<0.1%) Anajphylactoid reaction Cerebrovascular accident Acute renal failure Bronchospasm (<2%) |
|                                                       | This drug may cause edema.                                                                                                                                                                                                                                                                                                                    |  
Hypertension Myocardial infarction (<2%)  
Thrombotic tendency observations  
Scaling eczema Stevens-Johnson syndrome (<0.1%)  
Gastrointestinal perforation (<2%)  
Inflammatory disorder of digestive tract  
Hepatitis (<2%) Jaundice Liver failure(<0.1%)  
Anajphylactoid reaction Cerebrovascular accident  
Acute renal failure Bronchospasm (<2%)  
This drug may cause edema. Tell patient to report signs/symptoms of liver dysfunction or anemia. Patients with a history of cardiac disease or on long-term therapy may be at an increased risk  
for adverse cardiovascular thrombotic events. Advise patient to report signs/symptoms of myocardial infarction or stroke.  
Instruct patients to report signs/symptoms of serious gastrointestinal events such as bleeding,  
ulceration, or perforation of stomach or intestines. Elderly and debilitated patients may be at an increased risk for this adverse effect.  
Patient may take drug with meals or milk to lessen or prevent gastric upset.
ethionamide brand name(s) trecator
fexofenadine common rare

Nausea (1.6%)
Dyspepsia (1.3%) Headache (31.2%)
Drowsiness (1.3%)
Fatigue (1.3%) Dizziness Otitis media Dysmenorrhea (1.5%)
Decreased bilirubin Flu-like symptoms Upper respiratory infection Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
This drug may cause dyspepsia, dizziness, headache, somnolence, dysmenorrhea, or fatigue. Take drug with water. Do not take with fruit juices (grapefruit, orange, apple). Patient should avoid administration of aluminum- or magnesium-containing antacids within 30 min before or after taking drug.
ethionamide brand name(s) trecator
flucytosine brand name(s) ancobon adverse

- **Cardiovascular:** Cardiotoxicity
- **Hematologic:** Leukopenia, Myelosuppression, Thrombocytopenia
- **Renal:** Renal failure  
- **Gastrointestinal:** Abdominal pain, Diarrhea, Nausea, Vomiting - **Neurologic:** Confusion, Headache
- **Psychiatric:** Hallucinations  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause diarrhea, nausea, vomiting, confusion, headache, somnolence, or hallucinations.  
- Instruct patient to report signs/symptoms of infection or bleeding.  
- Patient may administer a few capsules at a time over 15 min to minimize nausea and vomiting.  
- hypersensitivity to flucytosine Precautions
- bone marrow depression
- renal impairment
fludarabine phosphate brand name(s) fludara
adverse effects serious

- **Hematologic:** Decreased hemoglobin (14% to 60%), Hemolytic anemia, Neutropenia
(37% to 59%), Pancytopenia, Thrombocytopenia (17% to 55%)
- **Neurologic:** Neurotoxicity, Progressive multifocal leukoencephalopathy - **Respiratory:** Pulmonary toxicity - **Other:** Graft versus host disease, Tumor lysis syndrome (0.33% to 1%)  
- **Gastrointestinal:** Loss of appetite (0% to 34%), Nausea (1% to 5%), Vomiting
- **Neurologic:** Asthenia (9% to 65%), Paresthesia (4% to 12%)
- **Respiratory:** Cough (6% to 44%)
- **Other:** Fatigue (10% to 38%), Fever (11% to 69%), Infectious disease (12% to 44% .),
Pain (5% to 22%), Shivering (11% to 19%)  
- Instruct patient to avoid driving and other activities requiring mental alertness or coordination until drug effects are realized, as drug causes fatigue, weakness, visual disturbances, confusion, agitation, and seizures (rare).  
- Advise patient to avoid live vaccines during therapy due to drug-induced immunosuppression.  
- Counsel patient to avoid pregnancy during and for at least 6 months after completion of therapy.  
- Drug may cause chills, loss of appetite, nausea, vomiting, diarrhea, cough, malaise, pneumonia, or fever.  
- Instruct patient to report signs/symptoms of myelosuppression, neurotoxicity, or infections.  
- Tell patient not to crush oral tablets and to avoid direct contact with skin and mucous membranes or inhalation.  
- Fludarabine (Intravenous route, Powder for Solution, Solution)
- Fludarabine (Oral route, Tablet)  
- hypersensitivity to fludarabine or to any product ingredient Precautions
- autoimmune hemolytic anemia (fatal) has occurred; monitor for hemolysis; discontinue if hemolysis occurs
- autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evan's syndrome, and acquired hemophilia has occurred; monitor for hemolysis (intravenous); discontinue if hemolysis occurs
- neurotoxicity, severe; dose-dependent , delay or discontinue treatment if neurotoxicity occurs
- concomitant pentostatin; use not recommended
- bone marrow suppression, severe (anemia, thrombocytopenia and neutropenia),
preexisting exacerbation or new onset; monitor blood counts before and during treatment
- infection (fatal), has occurred, monitor for signs and symptoms of infection - impaired performance; risk of compromising ability to drive or operate machinery
- pregnancy, avoid during treatment and for 6 months after cessation of treatment due to the potential for fetal harm (fertile male patients must take contraceptive measures)
- mild to moderate renal impairment, creatinine clearance 30 to 70 mL/min/1.73 m(2) or less; dose reduction and monitoring required
- severe renal impairment, creatinine clearance less than 30 mL/min/1.73 m(2); use not recommended (intravenous); dose reduction and monitoring required (oral)
- transfusion-associated graft-versus-host disease, has occurred after transfusion with non-irrradiated blood; recommend use of irradiated blood products
- tumor lysis syndrome (may present as flank pain and hematuria); increased risk in patients with chronic lymphocytic leukemia (CLL) with large tumor burdens
- vaccination with live vaccines, during and after treatment, should be avoided
- adverse event reporting; Antisoma 1-866-949-7420 or Food and drug Administration 1800-FDA-1088, or www.fda.gov/medwatch (oral)  
| Common                                                                                                                                                                                                                                                                                  | Serious                                                                                                                              |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Edema Bruising symptom Impaired would healing Petechiae Rash Urticaria Decreased body growth (children) Abnormal electrolytes Hypokalemia  Hyperglycemia  Abdominal distension Peptic ulcer disease Drug-induced myopath Muscle weakness Headache Vertigo Glycosuria  Irregular periods | Cardiomegaly Congestive heart failure Hypertension  Thrombophlebitis  Secondary hypocortisolism Raised intracranial pressure seizure |
|                                                                                                                                                                                                                                                                                        | Advise patient to avoid vaccines during therapy unless approved by healthcare professional.                                          |
fludarabine phosphate brand name(s) fludara
fludrocortisones

Advise patient to avoid vaccines during therapy unless approved by healthcare professional.  
Instruct patient to avoid exposure to chickenpox or measles. If exposure occurs, patient should notify healthcare professional.  
This drug may cause edema, bruising, impaired wound healing, petechiae, decreased body growth in children, abdominal distension, myopathy, muscle weakness, headache, vertigo, or irregular periods.  
Patient should report seizure activity or signs/symptoms of congestive heart failure. Advise patient against sudden discontinuation of drug.
fluoxetine hydrochloride brand name(s) prozac
adverse effects serious

- **Cardiovascular:** Prolonged QT interval - **Endocrine metabolic:** Hyponatremia - **Hematologic:** Bleeding (up to 1%) - **Neurologic:** Seizure - **Psychiatric:** Depression, worsening (rare), Mania (rare), Suicidal thoughts, Suicide
- **Other:** Serotonin syndrome  
- **Dermatologic:** Diaphoresis, Rash (7%)
- **Gastrointestinal:** Loss of appetite (3.5% to 15%), Nausea (20% to 30% .), Xerostomia
- **Neurologic:** Asthenia (9% to 21%), Dizziness (2% to 11%), Insomnia (9% to 26%),
Somnolence (13%), Tremor (12%)
- **Psychiatric:** Anxiety (3% to 9%), Feeling nervous (3% to 14%)
- **Respiratory:** Pharyngitis (6% to 10%), Rhinitis (16% to 23%)  
- Instruct patient to report use of a MAO inhibitor within the last 14 days prior to starting therapy. Notify patient that at least 5 weeks should be allowed between discontinuation of fluoxetine and initiation of MAO inhibitor therapy.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause anticholinergic effects, sweating, weight loss, dyspepsia, loss of appetite, nausea, asthenia, insomnia, tremor, abnormal ejaculation, or impotence.  
- Advise patient that symptomatic improvement may not be seen for a few weeks.  
- Instruct patient to report worsening depression, suicidal ideation, or unusual changes in behavior, especially at initiation of therapy or with dose changes. Children and adolescents are at higher risk for these effects during the first few months of therapy.  
- Advise patient to report abnormal bleeding.  
- Patient should report skin rash with or without systemic symptoms (fever, edema, pulmonary effects), as drug may cause serious cutaneous systemic illness.  
- Instruct diabetic patients to monitor for signs/symptoms of hyper- or hypoglycemia and report any changes in glycemic control.  
- Advise patient against sudden discontinuation of drug.  
- Advise patient not to use thioridazine with fluoxetine or within 5 weeks of discontinuation.  
Pimozide should not be used with fluoxetine.  
- Avoid NSAID or aspirin use during therapy.  
- Patient should not drink alcohol while taking this drug. - Instruct patients on a weekly dose to take a missed dose as soon as possible. Patient should then go back to regular schedule for the next week.  
- concomitant use of monoamine oxidase inhibitors (MAOIs), pimozide, or thioridazine - hypersensitivity to fluoxetine or any components of the product
- use of thioridazine or MAOIs within 5 weeks after fluoxetine discontinuation - use of fluoxetine within 14 days of MAOI discontinuation Precautions
- suicidal ideation and behavior or worsening depression; increased risk, particularly in children, adolescents, and young adults with major depressive and other psychiatric disorders during the first few months of therapy or following changes in dosage
- abrupt withdrawal; serious discontinuation symptoms have been reported; gradual reduction in dose recommended
- acute narrow angle glaucoma or increased intraocular pressure; mydriasis has been reported
- allergic reactions, including anaphylaxis, angioedema, and urticaria have been reported; in the case of rash, or other possibly allergic symptoms for which an alternative etiology cannot be identified, discontinue therapy
- bipolar disorder; increased risk of precipitation of a mixed/manic episode with antidepressant treatment only
- concomitant use of NSAIDs, aspirin, warfarin, or other drugs that affect coagulation; abnormal bleeding, particularly the gastrointestinal tract, may occur; monitoring recommended
- concomitant serotonergic drug use (serotonin precursors (tryptophan), SSRIs, serotoninnorepinephrine reuptake inhibitors); risk of serotonin syndrome, use is not recommended
- diabetes, history of; increased risk of hypoglycemia
- pulmonary events, including fibrosis, have been rarely reported - seizures, history of - serotonin syndrome and neuroleptic malignant syndrome-like reactions (serotonin syndrome in its most severe form), have been reported with fluoxetine therapy alone or in combination with other serotonergic drugs; monitoring recommended
- skin reactions, including serious cutaneous systemic illnesses (eg leukocytoclastic vasculitis, erythema multiforme, and lupus-like syndrome) with fatalities have been reported rarely; in the case of rash, or other possibly allergic symptoms for which an alternative etiology cannot be identified, discontinue therapy
- volume-depleted, elderly, or concurrent diuretic therapy; hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) has occurred with fluoxetine  
| Common                                                                               | Serious                                                                                                    |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Abdominal pain (3.7% to 4.9%) Diarrhea (3.3% to 7.9%) Nausea (2.5% to 3.2%) Headache | Pancreatitis (rare) Increased liver enzymes (1.1%) Disorder of muscle Rhabdomyolysis (rare) Tendon rupture |
|                                                                                     | This drug may cause abdominal pain, diarrhea, dyspepsia, nausea, or headache.                              |  
Pancreatitis (rare) Increased liver enzymes (1.1%)  
Disorder of muscle  
Rhabdomyolysis (rare)  
Tendon rupture  
This drug may cause abdominal pain, diarrhea, dyspepsia, nausea, or headache.  
Instruct patient to report signs/symptoms of renal failure or myopathy.  
Advise patients to administer capsule at least 2 h after taking a bile-acid resin (cholestyramine)  
if using concomitantly.  
Patient should not drink alcohol while taking this drug. Patient should avoid concomitant use of fibrates, niacin, cyclosporine, macrolides, or azole  
antifungals (eg, fluconazole, itraconazole), as combination may increase risk of myopathy.
fluoxetine hydrochloride brand name(s) prozac
fluvastatin common

- **Dermatologic:** Sweating (immediate-release, 7%; extended-release, 7%) - **Gastrointestinal:** Diarrhea (immediate-release, 11%; extended-release, 18%),
Indigestion (immediate-release, 10%; extended-release, 8%), Loss of appetite (immediate-release, 6%; extended-release, 13%), Nausea (immediate-release, 40%; extended-release, 34%), Xerostomia (immediate-release, 14%; extended-release, 10%)
- **Neurologic:** Asthenia (immediate-release, 14%; extended-release, 26%), Dizziness
(immediate-release, 11%; extended-release, 12%), Insomnia (immediate-release, 21%; extended-release, 35%), Somnolence (immediate-release, 22%; extended-release, 27%),
Tremor (immediate-release, 5%; extended-release, 6%)
- **Psychiatric:** Anxiety (immediate-release, 5%; extended-release, 6%), Feeling nervous
(immediate-release, 12%)
- **Reproductive:** Abnormal ejaculation (immediate-release, 8%; extended-release, 10%),
Orgasm incapacity (immediate-release, 2%; extended-release, 5%)  
- Instruct patient to report use of a MAO inhibitor within the last 14 days prior to initiation of drug therapy.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness or somnolence.  
- This drug may cause anticholinergic effects, weight loss, diarrhea, dyspepsia, nausea, vomiting, asthenia, headache, insomnia, agitation, anxiety, nervousness, or abnormal ejaculation.  
- Instruct patient to report worsening depression, suicidal ideation, or unusual changes in behavior, especially at initiation of therapy or with dose changes. Children and adolescents are at higher risk for these effects during the first few months of therapy.  
- Advise patient against sudden discontinuation of drug. - Advise patient there are multiple significant drug-drug interactions for this drug. Consult healthcare professional prior to new drug use (including over-the-counter and herbal drugs).  
- Patient should not drink alcohol while taking this drug.
fluoxetine hydrochloride brand name(s) prozac
fluvoxamine maleate brand name(s) luvox

- **Dermatologic:** Stevens-Johnson syndrome, Toxic epidermal necrolysis
- **Endocrine metabolic:** Hyponatremia
- **Hematologic:** Agranulocytosis, Bleeding, Abnormal - **Immunologic:** Anaphylaxis - **Neurologic:** Seizure (0.2%)
- **Psychiatric:** Depression, worsening, Suicidal thoughts, Suicide
- **Other:** Neuroleptic malignant syndrome, Serotonin syndrome  
- concomitant use with alosetron, pimozide, thioridazine, tizanidine , or ramelteon
- concomitant use of an MAOI or within 14 days (before or after) fluvoxamine therapy
fluoxetine hydrochloride brand name(s) prozac
precautions

- suicidal ideation and behavior or worsening depression has been reported, particularly in children, adolescents, and young adults during the first few months of therapy or following changes in dosage; monitoring recommended
- abnormal bleeding, including potentially life-threatening hemorrhages; has been reported - abrupt withdrawal; increased risk of serious discontinuation symptoms; monitoring and gradual dose reduction recommended
- bipolar disorder; increased risk of precipitation of a mixed/manic episode with antidepressant monotherapy; rule out disorder prior to initiating therapy
- concomitant use with alcohol should be avoided - concomitant use with serotonergic drugs (eg, SSRIs, serotonin-norepinephrine reuptake inhibitors), diazepam, or serotonin precursors (eg, tryptophan) is not recommended
- hepatic impairment; decreased fluvoxamine clearance; lower initial doses and monitoring recommended
- hyponatremia, primarily due to SIADH, has been reported, including serious cases
(serum sodium less than 110 mmol/L); increased risk in elderly, volume-depleted patients, or with concomitant use of diuretics; discontinue if symptomatic hyponatremia occurs
- mania, history of; risk of activation of mania/hypomania - seizure disorder, history of; seizures have been reported; avoid use in unstable epilepsy; monitoring recommended if controlled epilepsy
- serotonin syndrome has been reported, including cases that are life-threatening or that resemble neuroleptic malignant syndrome; monitoring recommended
- report suspected adverse reactions to the US Food and Drug Administration at 1-800-
FDA-1088 or www.fda.gov/Medwatch
fluoxetine hydrochloride brand name(s) prozac
folic acid brand name(s) folacin-800

- **Gastrointestinal:** Bad taste in mouth, Large doses, Loss of appetite, Nausea - **Neurologic:** Confusion
- **Psychiatric:** Irritability, Sleep pattern disturbance  
- his drug may cause loss of appetite, nausea, confusion, irritability, or sleep-pattern disturbance. Large doses of drug may cause bad taste in mouth.  
- Patient should not drink alcohol while taking this drug.  
- hypersensitivity to folic acid products
fluoxetine hydrochloride brand name(s) prozac
precautions

- folic acid doses above 0.1 mg/day may obscure pernicious anemia (hematologic remission while neurological manifestations progress)
- pernicious anemia and other megaloblastic anemias caused by vitamin B12 deficiency
furosemide brand name(s) lasix
adverse effects serious

- **Cardiovascular:** Orthostatic hypotension
- **Dermatologic:** Erythema multiforme, Erythroderma, Stevens-Johnson syndrome, Toxic epidermal necrolysis due to drug
- **Gastrointestinal:** Pancreatitis - **Hematologic:** Agranulocytosis, Aplastic anemia, Thrombocytopenia - **Immunologic:** Anaphylaxis  
- **Endocrine metabolic:** Hyperuricemia (40%), Hypomagnesemia
- **Gastrointestinal:** Loss of appetite
- **Renal:** Spasm of bladder  
- anuria
- history of hypersensitivity to furosemide Precautions
- diuresis, profound; may cause water and electrolyte depletion, dehydration, and blood volume reduction; monitoring recommended
- blood dyscrasias may occur; monitoring recommended
- blood glucose increases, alterations in glucose tolerance tests, or precipitation of diabetes have been reported
- concomitant use of aminoglycosides should be avoided - concomitant use of ethacrynic acid not recommended
- elderly patients; increased risk of dehydration
- electrolyte depletion, preexisting; should be corrected prior to treatment - electrolyte imbalance (eg, hyponatremia, hypochloremic alkalosis, hypokalemia, hypomagnesemia, hypocalcemia) may occur, especially in patients receiving higher doses and a restricted salt intake; monitoring recommended  
- Drug causes sun-sensitivity. Advise patient to use sunscreen and avoid tanning beds. - Patient should avoid activities requiring coordination until drug effects are realized, as drug may cause dizziness, vertigo, or blurred vision.  
- This drug may cause hyperglycemia, hyperuricemia, constipation, diarrhea, loss of appetite, nausea, vomiting, purpuric disorder, cramps, spasticity, asthenia, headache, paresthesia, or scaling eczema.  
- Instruct patient to report unusual bleeding/bruising or signs/symptoms of hypotension, infection, pancreatitis, or ototoxicity (tinnitus, hearing impairment).  
- Advise patient to report signs/symptoms of severe skin reactions (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering) or erythema multiforme.  
- Instruct patient to eat high-potassium foods during drug therapy, as directed by healthcare professional.  
- Patient should not drink alcohol while taking this drug
- hepatic cirrhosis and ascites, preexisting; may precipitate hepatic coma with sudden fluid or electrolyte alteration; monitoring recommended
- hepatic coma, preexisting; use not recommended until basic condition improved
- hepatic damage may occur; monitoring recommended allergy to sulfonamides; may also be allergic to furosemide
- hyperuricemia, asymptomatic or gout; may occur
- hypokalemia has been reported; especially with brisk diuresis, inadequate electrolyte intake, cirrhosis, or concomitant use with corticosteroids, ACTH, large amounts of licorice, or prolonged use of laxatives
- hypoproteinemia; reduced efficacy and increased risk of ototoxicity
- nephrocalcinosis/nephrolithiasis; increased risk in premature infants and children under 4 years without prematurity receiving chronic therapy
- ototoxicity (eg, tinnitus, reversible/irreversible hearing impairment, deafness) has been reported; especially with rapid injection (infusion rate not to exceed 4 mg/min in adults), severe renal impairment, higher than recommended doses, hypoproteinemia, or concomitant ototoxic drugs (eg, aminoglycosides, ethacrynic acid)
- patent ductus arteriosis, persistent; increased risk with administration to premature infants during first week of life
- radiocontrast nephropathy, high-risk; increased risk of renal deterioration - renal damage may occur; monitoring recommended - severe progressive renal disease, preexisting; discontinue use if increase in azotemia and oliguria occur
- sulfonamide allergy; increased risk of furosemide allergy
- systemic lupus erythematosus, preexisting; risk of exacerbation or activation - urinary retention, severe; increased risk of acute urinary retention particularly during initial stages of treatment; monitoring recommended  
- **Cardiovascular:** Peripheral edema (1.7% to 8.3%)
- **Gastrointestinal:** Nausea (greater than 1%), Vomiting (3.3%)
- **Immunologic:** Viral disease (10.9%)
- **Neurologic:** Ataxia (3.3% to 12.5%), Dizziness (adults, 10.9% to 28%; pediatrics, 2.5%),
Nystagmus (0.1% to 8.3%), Somnolence (4.5% to 21.4%)
- **Psychiatric:** Hostile behavior (1% to 7.6%) - **Other:** Fatigue (3.4% to 11%), Fever (greater than 1%)  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness and somnolence.  
- Drug may cause peripheral edema, myalgia, ataxia, nystagmus, tremor, or fatigue.  
- Advise patient to immediately report a rash or other signs/symptoms of hypersensitivity
(eg, fever, lymphadenopathy).  
- Instruct patient or caregiver to report new or worsening depression, suicidal ideation, or unusual changes in behavior.  
- Advise patient against sudden discontinuation of drug, as this may increase seizure frequency or precipitate status epilepticus.  
- Gralise(R) should be taken with the evening meal . - Counsel patient using an antacid containing aluminum hydroxide and magnesium hydroxide to wait 2 hours before taking gabapentin.  
- This drug is available in multiple brand names with varying properties by brand. Instruct patients to follow dosing instructions specific to each brand. Gralise(R) specifically is not interchangeable with other gabapentin products.  
- Patient should avoid alcohol and other CNS depressants while taking this drug.  
- hypersensitivity to gabapentin or any component of the product
furosemide brand name(s) lasix
precautions

- abrupt discontinuation; may increase seizure frequency or precipitate status epilepticus; discontinue gradually over a minimum of 1 week
- drug reaction with eosinophilia and systemic symptoms (DRESS)/multiorgan hypersensitivity, including fatal cases, has been reported; evaluate early signs/symptoms and discontinue Neurontin(R) if confirmed
- gabapentin products are not interchangeable; differing pharmacokinetic profiles affect dosing frequency
furosemide brand name(s) lasix
gabapentin brand name(s) neurontin adverse

- **Dermatologic:** Stevens-Johnson syndrome
- **Immunologic:** Drug hypersensitivity syndrome
- **Neurologic:** Drug-induced coma, Seizure (0.6%) - **Psychiatric:** Suicidal thoughts  
- pediatric patients (age 3 to 12 years); neuropsychiatric adverse events, including emotional lability, hostility, thought disorder, and hyperkinesia, have been reported with Neurontin(R)
- renal impairment or hemodialysis; dose adjustment of Neurontin(R) is necessary
- renal impairment; dose adjustment may be required in mild to moderate impairment; do not administer Gralise(R) in patients with severe renal impairment (CrCl 15 to 30 mL/min)
or on hemodialysis
- suicidality, worsening depression, and/or any unusual behavioral or mood changes (eg, anxiety, agitation, hostility, mania, and hypomania); monitoring recommended
- report suspected adverse reactions to the US Food and Drug Administration at 1-800-
FDA-1088 or www.fda.gov/medwatch  
| Common                                                                                                                                                                                                               | Serious                                                                                                                                                                                  |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ance (25% to 33%) Dry skin (13% to 26%) Pruritus (8% to 9%) Rash (43% to 54%) Weight loss (3% to 5%) Diarrhea (48% to 67%) Loss of appetite (7% to 10%) Nausea (13% to 18%) Vomiting (9% to 12%) Asthenia (4% to 6%) | Tumor hemorrhage Hepatotoxicity Eye disorder New onset eye pain Aberrant eyelash Corneal erosion/ulcer Interstitial lung disease Interstitial pneumonia Pneumonitis (1%) Alveolitis (1%) |  
Tumor hemorrhage Hepatotoxicity Eye disorder New onset eye pain  
Aberrant eyelash  
Corneal erosion/ulcer Interstitial lung disease  
Interstitial pneumonia  
Pneumonitis (1%)  
Alveolitis (1%)  
This drug may cause acne, dry skin, loss of appetite, nausea, vomiting, or asthenia.  
Instruct patient to report diarrhea, skin rash, or signs/symptoms of hepatotoxicity or ocular  
toxicity (new onset eye pain, aberrant eyelash, corneal erosion/ulcer).  
Patient should also report signs/symptoms of myelosuppression.  
Advise patient to report respiratory issues such as signs/symptoms of interstitial pneumonia,  
pneumonitis, or pulmonary fibrosis.  
If patient vomits after taking drug, instruct patient to contact healthcare professional for  
instructions.
furosemide brand name(s) lasix
gemcitabine

| Gemcitabine                                    | Common Happens to 21-100  children out of every  100                                                                                                                            | Occasional Happens to 5-20 children out  of every 100   | Rare Happens to <5 children out of  every 100   |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-------------------------------------------------|
| Immediate: Within 1-2  days of  receiving drug | Nausea, vomiting,  fever, pain at the  injection site, fluid build  up in tissues causing  swelling, flu-like  symptoms, rash (L),  mild diarrhea or  Unnatural drowsiness (L), | Decreased blood pressure; a                             |                                                 |
| difficulty breathing                           | group of side effects: fever,  decreased kidney function, low  hemoglobin and platelets -  which may result in death                                                            |                                                         |                                                 |
| Version 2.0 Final                              | Page 176 of 268                                                                                                                                                                 | Confidential                                            |                                                 |
| Issued 12 June 2013                            |                                                                                                                                                                                 |                                                         |                                                 |  
Page 177  
constipation  
Prompt: Within 2-3 weeks, prior to the next course  
Decrease in the number of red and white blood cells and platelets made in the bone marrow, decreased liver function, protein in the urine, blood in the urine  
Mouth sores, weakness (L) Kidney toxicity, confusion,  
seizure (L), coma (L), fluid buildup in the lungs, - unrelated to heart function, which occurs very rarely but may be fatal  
| constipation                                                                      |                                                   |                              |
|-----------------------------------------------------------------------------------|---------------------------------------------------|------------------------------|
| Prompt:                                                                           | Decrease in the number  Mouth sores, weakness (L) | Kidney toxicity, confusion,  |
| Within 2-3                                                                        | of red and white blood                            | seizure (L), coma (L), fluid |
| weeks, prior to  cells and platelets made                                         | buildup in the lungs, - unrelated                 |                              |
| the next course in the bone marrow,                                               | to heart function, which occurs                   |                              |
| decreased liver                                                                   | very rarely but may be fatal                      |                              |
| function, protein in the  urine, blood in the urine                               |                                                   |                              |
| Delayed: Any time later  during therapy,  excluding the  above  conditions        | Hair loss, numbness or  tingling, itching         |                              |
| Late: Any time after  completion of  treatment (L) Toxicity may also occur later. |                                                   |                              |
furosemide brand name(s) lasix
gentamicin sulfate brand name(s) gentak

- **Neurologic:** Neuromuscular blockade finding
- **Otic:** Ototoxicity - **Renal:** Nephrotoxicity
- **Respiratory:** Respiratory tract paralysis, Concomitant anesthesia, muscle relaxants  
- **None indicated**  
- Instruct patient to maintain adequate fluid intake and avoid dehydration during drug therapy, as this may increase risk for toxicity.  
- Instruct patient to report signs/symptoms of ototoxicity or nephrotoxicity. - Instruct patient on proper instillation technique for ophthalmic preparation.  
- hypersensitivity to gentamicin/aminoglycosides
furosemide brand name(s) lasix
precautions

- pre-existing renal, vestibular, or auditory impairment
- concomitant anesthesia or neuromuscular blockers; risk for neuromuscular blockade, respiratory paralysis
- concomitant neurotoxic, ototoxic, or nephrotoxic drugs, age (very young/very old), and dehydration; risk factor for toxicity
furosemide brand name(s) lasix
griseofulvin brand name(s) grifulvin gris-peg

- **Dermatologic:** Photosensitivity, Rash, Urticaria - **Gastrointestinal:** Diarrhea, Nausea, Vomiting
- **Neurologic:** Headache  
- Drug may cause sun-sensitivity. Advise patient to use sunscreen and avoid tanning beds.  
- Adverse effects to a fetus may be caused by either male or female patients receiving treatment with this drug. Emphasize the use of reliable contraception to patient. This applies during treatment and up to 1 month post therapy for women and 6 months post therapy for men.  
- This drug may cause rash, urticaria, diarrhea, nausea, vomiting, or headache.  
- hepatocellular failure
- hypersensitivity to griseofulvin
- porphyria - pregnancy Precautions
- alcohol use; griseofulvin may potentiate effects (eg, tachycardia, flush) - hepatotoxicity (jaundice and elevation in ALT, AST, and bilirubin), including serious and fatal cases, has been reported; monitoring recommended; discontinuation may be necessary
- lupus erythematosus or lupus-like syndromes have been reported
- penicillin allergy; potential for cross-sensitivity with penicillin
- photosensitivity may occur; avoid excessive exposure to sunlight - serious skin reactions (eg, Stevens-Johnson syndrome and toxic epidermal necrolysis)
and erythema, including serious and fatal cases, have been reported; discontinuation if severe skin reactions occur
guaifenesin brand name(s) mucinex
adverse effects serious

- **None indicated**
Common:
- **Gastrointestinal:** Nausea, Vomiting  
- This drug may cause nausea or vomiting.  
- Patient should take drug with a full glass of water and maintain adequate hydration during drug therapy.  
- Instruct patient that guaifenesin in combination with dextromethorphan should not be used in patients taking MAO inhibitors.  
- Advise patients with history of cardiac disorder, diabetes, peripheral vascular disease, prostatic hypertrophy, or glaucoma to avoid guaifenesin in combination with phenylpropanolamine.  
- hypersensitivity to guaifenesin products
guaifenesin brand name(s) mucinex
precautions

- cough accompanied by too much mucus - guaifenesin in combination with dextromethorphan should not be used in patients taking MAOI's
- guaifenesin in combination with phenylpropanolamine should be used with caution in patients with hypertension, cardiac disorders, diabetes or peripheral vascular disease, prostatic hypertrophy and glaucoma
- persistent or chronic cough such as that which occurs with smoking, asthma, chronic bronchitis, or emphysema
guaifenesin brand name(s) mucinex
guanethidine monosulfate brand name(s) intuniv

- **Cardiovascular:** Bradyarrhythmia (ADHD, 2% ; hypertension, 3% or less .), Hypotension
(ADHD, 3% to 7%), Syncope (ADHD, 1% ; hypertension, less than 1%)
- **Dermatologic:** Peeling of skin - **Neurologic:** Seizure  
- **Cardiovascular:** Orthostatic hypotension (ADHD, 1% ; hypertension, 15%)
- **Gastrointestinal:** Abdominal pain (ADHD, 10% to 11%), Constipation (ADHD, 2% to 3%;
hypertension, up to 15%), Xerostomia (ADHD, 2% to 4%; hypertension 5% to 54%)
- **Neurologic:** Dizziness (ADHD, 6% to 8% ; hypertension, 1% to 15%), Headache (ADHD,
21% to 24% ; hypertension, 1% to 13%), Insomnia (ADHD, 12% ; hypertension, 4%), Somnolence (ADHD, 18% to 38% ; hypertension, up to 39%)
- **Reproductive:** Impotence (hypertension, up to 7%) - **Other:** Fatigue (ADHD, 10% to 14% ; hypertension 2% to 10%)  
- hypersensitivity to guanfacine or to any component of the product Precautions
- abrupt withdrawal; risk of rebound hypertension - blood pressure decreases have been reported; monitoring recommended
- bradycardia, history; risk of decreased blood pressure and heart rate
- cardiovascular disease, history; risk of decreased blood pressure and heart rate
- concomitant use of alcohol; should be avoided
- concomitant use of other guanfacine-containing products (eg, Tenex(R)); do not use - dehydration or becoming overheated; risk of decreased blood pressure and heart rate
- heart block, history; risk of decreased blood pressure and heart rate
- heart rate decreases have been reported; monitoring recommended
- hypotension, history; risk of decreased blood pressure and heart rate - sedation and somnolence have been reported; consider potential for additive effects before coadministering centrally active depressants (eg, phenothiazine, barbiturates, or benzodiazepines)
- syncope has been reported; increased risk in patients with history or predisposition (eg, hypotension, orthostatic hypotension, bradycardia, or dehydration)
- report suspected adverse reactions to Shire US Inc. at 1-800-828-2088 or to the US Food and Drug Administration at 1-800-FDA-1088 or www.fda.gov/medwatch
guaifenesin brand name(s) mucinex
hydroxyurea brand name(s) droxia hydrea

- **Dermatologic:** Gangrenous disorder, Skin cancer, Skin ulcer
- **Hematologic:** Genetic mutation, Long-term use, Secondary leukemia, Long-term use  
- **Hematologic:** Myelosuppression  
- Adverse effects to a fetus may be caused by either male or female patients receiving treatment with this drug. Emphasize the use of reliable contraception to patient. This applies during treatment and up to 6 months post-therapy.  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness or somnolence.  
- Advise patient to use caution with activities leading to an increased core temperature to avoid dehydration, orthostatic hypotension, and syncope.  
- Drug may cause sedation, hypotension, dry mouth, headache, fatigue, constipation, or abdominal pain.  
- Advise patient against sudden discontinuation of drug, as this may cause rebound hypertension.  
- Patient should not drink alcohol or take CNS depressants with this drug. - Tell patient to contact healthcare professional for instructions if more than 2 successive doses are missed as titration may be necessary.  
- Instruct patient to avoid vaccines during therapy due to drug-induced immunosuppression.  
- Advise patient on the proper handling and disposal of chemotherapy drugs. - This drug may cause skin ulcers.  
- Counsel patient to report signs/symptoms of myelosuppression, especially in patients receiving radiotherapy or cancer chemotherapy.  
- Advise HIV-infected patients receiving concomitant didanosine and/or stavudine to report signs/symptoms of pancreatitis and hepatotoxicity.  
- hypersensitivity to hydroxyurea or any component of the product - significant bone marrow depression, such as leukopenia, thrombocytopenia or severe anemia (Hydrea(R))
Precautions
- causes macrocytosis which may mask development of folic acid deficiency (prophylactic folic acid recommended with Droxia(R) therapy)
- correct severe anemia prior to initiating hydroxyurea therapy - cutaneous vasculitic toxicities, including vasculitic ulcerations and gangrene; reported in patients with myeloproliferative disorders and receiving interferon therapy
- elderly patients; increased sensitivity to effects
- exacerbation of postirradiation erythema
- HIV-infected patients; hepatotoxicity, hepatic failure, pancreatitis, some fatal, and severe peripheral neuropathy have been reported; avoid combination of hydroxyurea, didanosine and stavudine
- hydroxyurea is mutagenic and clastogenic; secondary leukemias have occurred with long-term therapy for myeloproliferative disorders
- myelosuppression; especially in patients previously receiving radiotherapy or cancer chemotherapy
- renal impairment; initial dose reduction required
guaifenesin brand name(s) mucinex
ibuprofen

| Common                                                                                                                                                                                                                                                                                                                                                                                                                       | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                               |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hypotension (intravenous, up to 10%) Rash (oral, 3% to 9%) Hypernatremia (intravenous, up to 10%) Hypoalbuminemia (intravenous, 3% to 10%) Hypoproteinemia (intravenous, up to 13%) Serum lactate dehydrogenase level elevated  (intravenous, 3% to 10%) Flatulence (injection, 7% to 16%) Heartburn (oral, 3% to 9%) Nausea (oral, 3% to 9%; intravenous, 53% to  57%)  Vomiting (oral, 1% to 3%; intravenous, 15% to  22%) | Congestive heart failure (oral, less than 1%),  Hypertension (oral, less than 1%; intravenous, up  to 10%),  Myocardial infarction,  Thrombotic tendency observations Erythema multiforme (oral, less than 1%.),  Erythroderma,  Stevens-Johnson syndrome (oral, less than 1%),  Toxic epidermal necrolysis Gastrointestinal hemorrhage (oral, less than 1%),  Gastrointestinal perforation (oral, less than 1%),  Gastrointestinal ulcer,  Inflammatory disorder of digestive tract, |  
Page 181  
| Thrombocytosis (intravenous, 3% to 10%) Bacteremia (injection, 13%) Dizziness (oral, 3% to 9%; intravenous 4% to 6%)  Headache (oral, 1% to 3%; intravenous, 9% to  11%) Serum blood urea nitrogen raised (intravenous, up  to 10%)  Urinary retention (intravenous, 3% to 5%) Bacterial pneumonia (intravenous, 3% to 10%)   | Melena (oral, less than 1%),  Pancreatitis (oral, less than 1%) Agranulocytosis (oral, less than 1%),  Anemia (intravenous, 2% to 36%),  Aplastic anemia (oral, less than 1%),  Bleeding (intravenous, 4% to 10%),  Hemolytic anemia (oral, less than 1%),  Neutropenia (intravenous, 7% to 13%; oral, less  than 1%),  Thrombocytopenia (less than 1%),  Wound hemorrhage (intravenous, 1% to 3%) Fulminant hepatitis (rare),  Hepatic necrosis (rare),  Hepatitis (oral, less than 1%),  Hepatotoxicity (rare),  Jaundice (oral, less than 1%),  Liver failure (rare),  Vanishing bile duct syndrome Anaphylactoid reaction (oral, less than 1%),  Immune hypersensitivity reaction (oral, less than  1%) Aseptic meningitis (oral, less than 1%),  Cerebrovascular accident Amblyopia (oral, less than 1%) Hearing loss (oral, less than 1%) Depression (oral, less than 1%) Acute renal failure (oral, less than 1%),  Hematuria (oral, less than 1%),  Renal azotemia (oral, less than 1%) Reye's syndrome   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                                                                                                                                                                                                                                                                                              | Advise patient to avoid use of additional NSAIDs or aspirin during therapy, unless approved                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |  
Advise patient to avoid use of additional NSAIDs or aspirin during therapy, unless approved by doctor.  
Advise patient to avoid use in late pregnancy as drug may cause premature closure of ductus arteriosus.  
Drug may cause fluid retention, abdominal pain, constipation, diarrhea, dyspepsia, heartburn, nausea, vomiting, dizziness, headache and hemorrhage.  
Advise patient with previous cardiac history to report signs/symptoms of myocardial infarction or stroke, especially with long-term use.  
Instruct patient to report signs/symptoms of serious gastrointestinal events, such as bleeding, ulceration, or perforation. Elderly and debilitated patients may be at increased risk.  
Instruct patient to report signs/symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms).  
Patient should promptly report skin rash, blistering, or any symptoms of a serious skin reaction.  
Tell patient to take oral form with food or milk to minimize GI irritation.  
| Risks and side effects related to Gleevec (imatinib mesylate include): Common Happens to 21-100  children out of every  100 Occasional Happens to 5-20  children out of every  100   | Rare                                                                                                                                                                                                                                                                                                                                                                                                                |        |    |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----|
| Happens to <5 children out of every  100                                                                                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                     |        |    |
| Immediate: Within 1-2 days of  receiving drug                                                                                                                                        | Heartburn,  nausea/vomiting,  headache, fluid buildup  in the arms, legs, face,  or around the eyes (L),  weight gain Fever,), increase in liver  enzymes (SGOT,  SGPT, alkaline  phosphatase) and  bilirubin indicating  possible liver damage  (L),, abdominal  pain/cramping, muscle  and joint pain (L) Swelling of the brain, breakdown of  bone (L), inflammation of the lung  and/or damage to the lungs (L) |        |    |
| Prompt: Within 2-3 weeks,  prior to the next  course                                                                                                                                 | Dark, bloody bowel movements,  diarrhea, difficulty swallowing,  inflammation of the passage  between the throat and stomach,  pain during swallowing,widespread  red itching rash , bleeding, vomiting  blood                                                                                                                                                                                                      |        |    |
| Delayed: Any time later  during therapy,  excluding the above  condition                                                                                                             | Decrease in numbers  of red and white blood  cells and platelets  made in bone marrow  (L), fatigue Decreased                                                                                                                                                                                                                                                                                                       | number | of |
| bone marrow cells (L),  scaly and/or itchy rash,  rash, muscle pain and  cramping, loss of  appetite Skin color changes,  Liver Damage (L)* usually lighter patches                  |                                                                                                                                                                                                                                                                                                                                                                                                                     |        |    |
| Late: Any time after the  completion of  treatment (L) Side effect may also occur later * One patient with no known history of liver problems died on study due to liver failure.    |                                                                                                                                                                                                                                                                                                                                                                                                                     |        |    |
guaifenesin brand name(s) mucinex
imatinib

Late: Any time after the completion of treatment
(L) Side effect may also occur later
* One patient with no known history of liver problems died on study due to liver failure.  
This patient was also taking acetaminophen (Tylenol®), also known as paracetamol in European countries. It is recommended you adhere carefully to the instructions and warnings on the acetaminophen package label. Additionally, it is recommended that over-the-counter medications be carefully reviewed, as these may possibly contain combinations of drugs, including acetaminophen or paracetamol.  
Since there is an increased risk of bleeding when taking imatinib mesylate
(Gleevec), the blood anticoagulant warfarin sodium must not be taken. Your doctor will discuss alternatives with you. However, even when alternative anti clotting drugs are used it will be necessary to closely watch for bleeding and to maintain platelet counts at a safe level with transfusion if necessary. Bleeding may occur into a tumor or a space near the tumor and may be dangerous.  
| Indomethacin                                                                                                                                                                         |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common                                                                                                                                                                               | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Abdominal pain (1% to 3%), Constipation (1% to 3%),  Diarrhea (1% to 3%),  ndigestion (3% to 9%),  Nausea (3% to 9%) Dizziness,  Headache,  Somnolence  Tinnitus  Depression Fatigue | Cardiac dysrhythmia (less than 1%),  Chest pain (less than 1%),  Congestive heart failure (less than 1%),  Edema (less than 1%),  Hypertension (less than 1%),  Myocardial infarction Erythema multiforme (less than 1%),  Rash (less than 1%),  Scaling eczema,  Stevens-Johnson syndrome (less than 1%),  Toxic epidermal necrolysis (less than 1%) Hyponatremia,  Transitory neonatal hyperkalemia (3-9%) Gastrointestinal hemorrhage (less than 1%),  Gastrointestinal perforation (less than 1%),  Gastrointestinal ulcer (less than 1%),  Inflammatory disorder of digestive tract (less than  1%) Agranulocytosis (less than 1%),  Anemia (less than 1%),  Aplastic anemia,  Leukopenia (less than 1%),  Neutropenia,  Thrombocytopenic purpura (less than 1%) Hepatitis (less than 1%),  Jaundice (less than 1%),  Liver failure IAnaphylactoid reaction (less than 1%) Cerebrovascular accident,  Epilepsy,  Aggravation,  Parkinsonism,  Aggravation (less than 1%), Peripheral neuropathy (less than 1%),  Seizure (less than 1%) Blurred vision (less than 1%),  Corneal deposit (less than 1%),  Retinal disorder (less than 1%) Hearing loss (less than 1%) Psychic disease (less than 1%) |  
| Hematuria (less than 1%),  Interstitial nephritis (less than 1%), Nephrotic syndrome (less than 1%),  Newborn renal dysfunction (41%),  Renal failure (less than 1%) Asthma (less than 1%),  Bronchospasm (less than 1%),  Dyspnea (less than 1%),  Persistent pulmonary hypertension of the newborn  (<3%),  Pulmonary edema (less than 1%)   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
Patient should avoid activities requiring mental alertness until drug effects are realized, as drug may cause somnolence.  
This drug may cause abdominal pain, anal irritation, constipation, diarrhea, dyspepsia, nausea, tenesmus, vomiting, dizziness, headache, tinnitus, depression, scaling eczema, or fatigue.  
Instruct patient to report signs/symptoms of a serious cardiovascular thrombotic event, such as myocardial infarction or stroke. Patients with cardiovascular disease or on prolonged therapy may be at increased risk for this adverse effect.  
Advise patients to report signs/symptoms of a serious gastrointestinal adverse event, such as bleeding, ulceration, or perforation of the stomach or intestines. Elderly or debilitated patients may be at increased risk for this adverse effect.  
Patient should take the oral formulations with food, immediately after meals, or with antacids. Patient should not use other NSAIDs concomitantly without approval by healthcare professional.
guaifenesin brand name(s) mucinex
irinotecan hydrochloride brand name(s) camptosar

- **Cardiovascular:** Disorder of cardiovascular system
- **Gastrointestinal:** Diarrhea, Grade 3 and 4 (4.9% to 31%), Gastrointestinal perforation
- **Hematologic:** Anemia, Grade 3 and 4 (2.1% to 8.4%), Febrile neutropenia (adults, 2% to 7.1%; pediatrics, 8.8%), Hemorrhage (1% to 5%), Infectious disease, Neutropenic (1% to 2.2%), Leukopenia, Grade 3 and 4 (17.4% to 37.8%), Neutropenia, Grade 3 or 4 (adults, 26% to 53.8%; pediatrics, 31.8%), Thrombocytopenia, Grade 3 and 4 (up to 4%),
Thromboembolic disorder (5.4% to 11.7%)
- **Immunologic:** Hypersensitivity reaction
- **Respiratory:** Interstitial lung disease
guaifenesin brand name(s) mucinex
common - dermatologic alopecia (43.1%

- **Endocrine metabolic:** Weight decreased (30%) - **Gastrointestinal:** Abdominal pain (all grade, 17.2% to 67.7%; grade 3 and 4, 2.1% to 14%), Constipation (all grade, 30% to 43.9%; grade 3 and 4, 0.4% to 10%), Diarrhea, All grade (early-onset, 43% to 51%; late-onset, 72.4% to 88%), Loss of appetite (all grade, 34.2% to 55%; grade 3 and 4, 2.1% to 7.2%), Nausea (all grade, 66.9% to 86%; grade 3 and 4, 2.1% to 17%), Vomiting (all grade, 44.8% to 67%; grade 3 and 4, 3.5% to 14%)
- **Hematologic:** Anemia, All grade (60% to 97.2%), Drug-induced eosinophilia, Leukopenia, All grade (63% to 96.9%), Neutropenia, All grade (54% to 96.9%), Thrombocytopenia, All grade (32.6% to 96%)
- **Hepatic:** Increased bilirubin level (19.1% to 87.6%)
- **Neurologic:** Asthenia (all grade, 57.9% to 76%; grade 3 and 4, 9% to 19.5%), Dizziness
(15% to 23.1%)
- **Respiratory:** Cough (17% to 26.7%), Dyspnea (9.7% to 27.6%)
- **Other:** Fever (42.2% to 45%), Infectious disease (13.9% to 35.9%), Pain (all grade, 22.9% to 64.1%; grade 3 and 4, 2% to 19%), Poisoning by parasympathomimetic drug (28.3%)  
- Drug may cause dizziness or visual disturbances, especially within 24 h after infusion.  
Patient should avoid driving or other activities requiring clear vision until drug effects are realized.  
- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression. - This drug may cause alopecia, nausea, vomiting, or interstitial lung disease. - Instruct patient to report diarrhea that occurs during or shortly after infusion. Inform patient that diarrhea may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, or abdominal cramping.  
- Patient should also report diarrhea that occurs more than 24 h after drug infusion. Instruct patient to take anti-diarrheal medicine only as prescribed by healthcare professional.  
- Patient should contact healthcare professional if diarrhea cannot be controlled within 24 h, nausea/vomiting precludes patient from taking liquids, or patient has signs/symptoms of dehydration or infection.  
- hypersensitivity to irinotecan or any component of the product
guaifenesin brand name(s) mucinex
precautions

- diarrhea, early or late; may be life-threatening due to possible dehydration, electrolyte imbalance, and sepsis
- bilirubin levels, elevated serum (1 to 2 mg/dL); increased risk for first cycle, grade 3 or 4 neutropenia
- bone marrow failure, severe; potential for neutropenia, leucopenia, and anemia
- concomitant use with live vaccine; avoid use - elderly patients, greater than 65 years of age; increased risk of late diarrhea - hepatic insufficiency; deficient glucuronidation of bilirubin (Gilbert's syndrome), increased risk of myelosuppression
- hereditary fructose intolerance; Camptosar(R) contains sorbitol - homozygous for UGT1A1*28 allele ; increased risk of neutropenia; testing of the UGT1A1 6/6, 6/7 and 7/7 genotypes may be considered
- interstitial pulmonary disease (IPD)-like events, including fatalities, have been reported; hold therapy for any suspicious symptoms pending diagnostic evaluation
- Mayo Clinic regimen (5-fluorouracil/leucovorin) concomitant use; especially in patients receiving treatment with pelvic/abdominal radiation, elderly with comorbidities; may result in increased risk of neutropenic fever, hospitalization, thromboembolism, first-cycle treatment discontinuation, early death, toxicity, including toxic death
- myelosuppression, severe - neutropenia; may lead to sepsis and death; dose reduction may be necessary
guaifenesin brand name(s) mucinex
ixabepilone

| Ixabepilone has been tested in more than one thousand adults, and risks and side  effects related to Ixabepilone in adults include: Likely Less Likely Rare but Serious - A feeling of  weakness  and/or  tiredness - Loss of  appetite or  desire to eat  - Nausea, and/or  vomiting - Diarrhea - Inflammation  and/or sores in  the mouth that  may make  swallowing  difficult and  are painful  (painful mouth  sores) - Hair loss - Muscle and  joint pains - A problem in  nerve function  that may cause  pain,  numbness,  tingling, and  muscle  weakness in  various parts  of the body. - Allergic reactions - Fever caused by the medication  - Fewer white blood cells, red  blood cells and platelets in the  blood o a low number of white blood  cells can make it easier to  get infections o a low number of red blood  cells can make you feel tired  and weak o a low number of platelets  causes you to bruise and  bleed more easily - Constipation - A slower than normal heart rate - Chest pain which may be  caused by heart damage - Heart attack - An increased level of a protein  in the blood which is found in  heart muscle and when  elevated may indicate a heart  attack or heart damage that  could lead to a heart attack - A decrease in blood pressure  - Change in the ability of the  blood to clot if you are on a  drug called warfarin or  coumadin. You will need to be  closely followed if you are on  this medication. - Weight loss - Reddening of the face with  feelings of warmth - Dizziness or fainting - Difficulty sleeping or falling  asleep  - Damage to the skin if the  medication leaks from the vein  - Changes to your finger or  toenails - Itching - Redness and burning at sites  which have received radiation  in the past - Allergic reactions which  can be life threatening  with shortness of breath,  low blood pressure, rapid  heart rate, hives and  facial swelling - A condition in which fluid  and proteins leak out of  tiny blood vessels and  flow into surrounding  tissues, resulting in  dangerously low blood  pressure. Vascular or  capillary leak syndrome  may lead to multiple  organ failure such as  kidney, heart or liver  failure and shock - Fluid build-up in the  lungs that can make you  feel short of breath. - A stoppage (or blockage)  of the intestine which  may require treatment •Version 2.0 Final Page 187 of 268 Confidential Issued 12 June 2013   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|  
| -                 | Rash with peeling of the skin                                                                                                                                 |              |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| -                 | Severe rash with redness and  pain on the palms of the hand  and soles of the feet                                                                            |              |
| -                 | Excessive loss of water from  the body                                                                                                                        |              |
| -                 | Difficulty or discomfort on  swallowing                                                                                                                       |              |
| -                 | Inflammation and/or sores in  the throat and/or esophagus  (the tube between the mouth  and the stomach) that may  make swallowing difficult and  are painful |              |
| -                 | Upset stomach (heartburn)                                                                                                                                     |              |
| -                 | Things taste differently                                                                                                                                      |              |
| -                 | Erosion (ulceration) of the  lining of the intestines which  can result in pain and/or  bleeding                                                              |              |
| -                 | Bleeding from the intestines                                                                                                                                  |              |
| -                 | Damage to the liver which  could lead to liver failure                                                                                                        |              |
| -                 | Fever with a low white blood  cell count which could indicate  infection and may require  hospitalization and treatment  with antibiotics                     |              |
| -                 | Infections including those  caused by bacteria, virus, and  fungus                                                                                            |              |
| -                 | Fluid build -up in the tissues of  the head, neck, arms, legs,  body, abdomen (belly), body  and sex organs                                                   |              |
| -                 | Increased levels of a chemical  (creatinine) in the blood which  could mean kidney damage                                                                     |              |
| -                 | Unsteadiness when walking                                                                                                                                     |              |
| -                 | Inability to speak or difficulty  with speaking or putting words  together                                                                                    |              |
| -                 | Watery eyes (tearing)                                                                                                                                         |              |
| -                 | Abdominal (belly) pain                                                                                                                                        |              |
| -                 | Bone pain                                                                                                                                                     |              |
| -                 | Headache                                                                                                                                                      |              |
| -                 | Arm or leg pain                                                                                                                                               |              |
| -                 | Tumor pain                                                                                                                                                    |              |
| -                 | Muscle weakness                                                                                                                                               |              |
| -                 | Hiccoughs                                                                                                                                                     |              |
| -                 | Cough                                                                                                                                                         |              |
| -                 | Feeling short of breath or  shortness of breath                                                                                                               |              |
| -                 | Low levels of oxygen in the  blood which may make you feel  10/01/07                                                                                          |              |
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| short of breath   |                                                                                                                                                                         |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -                 | Inflammation of the lungs that  can lead to fluid in the lungs  and affect your ability to  breathe and the levels of  oxygen in your blood making  you short of breath |
| -                 | Difficulty emptying the bladder  which may be caused by nerve  damage                                                                                                   |
| -                 | Lowered amount of salt  (sodium) in the blood                                                                                                                           |  
The side effects that occurred in the adult patients may or may not occur in children entered on this study.  
| Common                                                                                                                           | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |
|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema Rash Abdominal pain,  Constipation,  Diarrhea,  Flatulence,  Indigestion,  Nausea Dizziness,  Headache, Insomnia  Tinnitus | Congestive heart failure (<1%),  Hypertension (<1%),  Myocardial infarction (<2%), Thrombotic tendency observations Scaling eczema, Stevens-Johnson syndrome (<0.1%) Gastrointestinal hemorrhage (<1%), Gastrointestinal perforation (<1%), Inflammatory disorder of digestive tract, Melena (<1%) Agranulocytosis (<1%), Anemia (<1%), Thrombocytopenia (<1%) Hepatitis (<1%), Increased liver function test (up to 15%), Jaundice (<1%), Liver failure (<0.1%) Anaphylactoid reaction (<1%), Immune hypersensitivity reaction Cerebrovascular accident Impaired renal function disorder (3-9%), Interstitial nephritis (<1%), Renal failure (<1%) Bronchospasm (<2%) |
|                                                                                                                                 | This drug may cause edema, abdominal pain, constipation, diarrhea, dyspepsia, flatulence,                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |  
This drug may cause edema, abdominal pain, constipation, diarrhea, dyspepsia, flatulence,  
nausea, dizziness, headache, insomnia, or tinnitus.  
Ketoprofen Patients with a history of cardiac disease or on a long-term treatment regimen are at an increased risk for adverse cardiovascular thrombotic events. Advise patient to report signs/symptoms of myocardial infarction or stroke.  
Instruct patients to report signs/symptoms of serious gastrointestinal events such as bleeding, ulceration, or perforation of stomach or intestines. Elderly and debilitated patients may be at an increased risk for this adverse effect.  
Patient may take with food, milk, or antacids to minimize gastrointestinal irritation. Advise patient to avoid use of additional NSAIDs without healthcare professional approval. Patient should not drink alcohol while taking this drug.  
| Common                                                                                                                                                                                                                                                                                                                                                                                                                         | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |              |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Edema,  Hypertension  Injection site pain,  Pruritus,  Rash,  Sweating Abdominal pain (13%),  Diarrhea (7%),  Indigestion (12%),  Nausea (12%) Anemia Dizziness,  Headache,  Somnolence  Burning sensation in eye, Transient,  ophthalmic ketorolac (20% to 40%, ophthalmic),  Corneal edema (1% and 10%, ophthalmic),   Eye irritation, Iritis (1% and 10%, ophthalmic),   Keratitis (1% and 10%, ophthalmic) Feeling nervous | Myocardial infarction,  Thrombotic tendency observations Body pale (<1%),  Erythema multiforme,  Erythroderma,  Stevens-Johnson syndrome,  Toxic epidermal necrolysis Gastrointestinal hemorrhage,  Gastrointestinal perforation,  Gastrointestinal ulcer,  Melena,  Pancreatitis (rare (incidence less than 0.1%)  HBleeding,  Blood coagulation disorder with prolonged  bleeding time,  Hematoma,  Postoperative hemorrhage Hepatitis,  Increased liver function test,  Jaundice, Liver failure Anaphylactoid reaction Aseptic meningitis,  Cerebrovascular accident Corneal epithelial degeneration,  Corneal erosion,  Corneal thinning,  Perforation of cornea Hearing loss Hematuria,  Hemolytic uremic syndrome,  Interstitial nephritis,  Nephrotic syndrome, |              |
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| Issued 12 June 2013                                                                                                                                                                                                                                                                                                                                                                                                            |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |              |
guaifenesin brand name(s) mucinex
ketorolac

Papillary necrosis, Proteinuria, Renal failure Asthma, Bronchospasm, Dyspnea, Pulmonary edema Angioedema This drug may cause edema, sweating, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, nausea, stomatitis, vomiting, anemia, dizziness, headache, or somnolence. The ophthalmic formulation may cause a burning sensation in the eye.  
Patients with a history of cardiac disease or on a long-term regimen are at an increased risk for adverse cardiovascular thrombotic events. Advise patient to report signs/symptoms of myocardial infarction or stroke.  
Instruct patients to report signs/symptoms of serious gastrointestinal events such as bleeding, ulceration, or perforation of stomach or intestines. Elderly and debilitated patients may be at an increased risk for this adverse effect.  
Advise patients using the ophthalmic formulation to remove contact lenses prior to instilling drug. Lenses may be reinserted 15 min following instillation.  
Advise patient to avoid use of additional NSAIDs without healthcare professional approval.  
Patients using the ophthalmic formulation should avoid concomitant use of topical steroids.  
| Common                                                                                                                                                      | Serious                                                                |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Abdominal pain (up to 5%),  Constipation (1% to 5%),  Diarrhea (up to 7.4%),  Nausea (1.3% to 3%) Vomiting  Taste sense altered Dyspepsia  Headache Fatigue | Fracture of bone, Osteoporosis-related,  Hip fracture,  Rhabdomyolysis |
guaifenesin brand name(s) mucinex
lansoprazole

This drug may cause abdominal pain, constipation, diarrhea, dyspepsia, loss of appetite, nausea, vomiting, altered taste, headache, or fatigue.  
Patient should take oral preparations before eating.
guaifenesin brand name(s) mucinex
lapatinib

| Common                                                                 | Serious                                                                                |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Hand-foot syndrome due to cytotoxic therapy  (53%),  Rash (28% to 31%) | Depression of left ventricular systolic function  (1.3% to 2%),  Prolonged QT interval |  
| Diarrhea (42% to 65%),  Indigestion (11%),  Nausea (13% to 44%),  Vomiting (26%) Anemia (56%),  Thrombocytopenia (18%) ALT (SGPT) level raised (37%), AST/SGOT level raised (49%),  Hyperbilirubinemia (45%) Backache (11%),  Pain in limb (12%) Insomnia (10%) Dyspnea (12%)   | Hepatotoxicity (less than 1%) Interstitial lung disease                   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
|                                                                                                                                                                                                                                                                                | Advise patient on the proper handling and disposal of chemotherapy drugs. |  
Advise patient on the proper handling and disposal of chemotherapy drugs.  
This drug may cause gastrointestinal (nausea and vomiting) and dermatological (palmarplantar erythrodysesthesia and rash) adverse events and fatigue.  
Instruct patient to report severe diarrhea and consult a healthcare professional prior to taking antidiarrheal medicine.  
Patient should report signs/symptoms of interstitial lung disease, pneumonitis, or decreased left ventricular ejection fraction (eg, dyspnea, palpitation, and/or fatigue).  
Advise patient to take this drug at least one hour before or one hour after a meal. In contrast, capecitabine should be taken with food or within 30 minutes after food.  
Patient should not eat grapefruit or drink grapefruit juice while taking this drug.
guaifenesin brand name(s) mucinex
leflunomide

| Common                                     | Serious                                                                                                                                                                                                                                                                                                                                         |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Alopecia (10%),  Rash (10%) Diarrhea (17%) | Hypertension (9% to 10%; new-onset, 1% to 2%) Stevens-Johnson syndrome (rare),  Toxic epidermal necrolysis (rare) Agranulocytosis (rare),  Pancytopenia (rare) Hepatic necrosis (rare),  Hepatotoxicity (rare),  Increased liver enzymes,  Liver failure (rare) Anaphylaxis,  Opportunistic infection,  Sepsis Interstitial lung disease (rare) |  
Adverse effects to a fetus may be caused by either male or female patients receiving treatment with this drug. Emphasize the use of reliable contraception to patient. If pregnancy is desired or suspected in females, or males wishing to father a child, a drug elimination procedure may be employed in order to rapidly remove leflunomide from the body. Consult healthcare professional.  
Advise patient to avoid vaccines during therapy without healthcare professional approval.  
This drug may cause rash, alopecia, diarrhea, or hypertension.  
Instruct patient to report signs/symptoms of hepatotoxicity, especially if using concomitant methotrexate.  
Advise patient to report signs/symptoms of a severe skin reaction such as Stevens-Johnson syndrome (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering) or toxic epidermal necrolysis (widespread peeling/blistering of skin).  
Tell patients with a history of or active hematological abnormalities to monitor for and report signs/symptoms of pancytopenia.
guaifenesin brand name(s) mucinex
lenalidomide (cc-5013) we know about

The main side effects that were seen in adults taking this drug were low blood counts, itchiness, and rash. All the bad effects, both common and uncommon, that have been seen so far in people getting this drug are listed below. Some of these problems might not have been related to the drug.  
Risks and side effects related to CC-5013 include:  
Low blood counts: low number of red blood cells, increased or decreased levels of white blood cells which help fight infection, low number of platelets which help the blood to clot, breakdown of red blood cells.  
Heart-related: abnormal heart rhythm, unusually fast or slow heartbeat, changes in your heart tracing (EKG), chest pain, high or low blood pressure, blockage of blood vessels decreasing the blood supply to the heart. A 15 year old girl getting CC-5013 had chest pain and a heart attack. This might have been related to the CC-5013. She recovered, but people can die from heart attacks.  
CC-5013 can cause blood clots in veins. These clots could break off and block veins or arteries in other parts of the body, such as the heart or lungs. Blood clots may be more likely in patients who are getting certain medicines like corticosteroids (prednisone, dexamethasone), interferon, erythropoietin (a medicine to make the red blood cells increase) or chemotherapy. Patients who smoke or who do not move around very much may also be more likely to have blood clots. If you have pain or swelling in an arm or leg, or feel chest pain or have trouble breathing, you should call your doctor right away.  
You might need to come to the hospital for more tests.  
Eye-related: dry eyes, blurred vision, visual flashing, disease of the retina.  
Stomach/Intestine-related: bloated feeling, constipation (bowel movements that are difficult and less often than usual), diarrhea (watery bowel movements), dry mouth, difficulty swallowing, nausea (feeling as though you need to vomit), vomiting, stomach pain, pain in the gums, inflammation, dehydration, loss of appetite, excessive gas in the stomach, heartburn/indigestion, tearing of the colon, blockage in the intestine, gallbladder stones; irritation of the pancreas, the organ in the body that makes insulin.  
General: allergic reaction, sleepiness, fatigue, trouble sleeping, fever, weight loss, headache, general body pain; sweating, rigors/chills, infection, inflammation and swelling in the nose and sinus due to allergy and including sneezing, nasal stuffiness, and postnasal drip.  
Laboratory test-related: abnormal liver or kidney function, abnormalities in the balance of salts in the blood (magnesium, calcium, potassium, sodium), high blood sugar, low testosterone (a male hormone), abnormal thyroid function, high cholesterol.  
Muscle/ Joint-related: joint, muscle, or bone pain; back pain, muscle weakness, partial paralysis usually with loss of feeling on half of the body, arthritis, excessive buildup of fluids in the arms and legs.  
Nervous system-related: difficulty speaking or writing, difficulty understanding spoken or written words; feeling dizzy, confusion, change in the sense of taste; , fainting spells, ringing in the ears, shaking, disease of the brain, blockage of blood vessels decreasing the blood supply to the brain, changes in your mental, motor, and sensory abilities, inflammation of the spinal cord, hallucinations/delusions, seizures, bleeding which may be life-threatening.  
Mood-related: depression, anxiety, agitation.  
Kidney-related: bleeding, problems with urination, disease of the kidney, kidney failure.  
Breathing-related: problems with your sinuses, cough, difficulty breathing, fluid build-up in the chest, bleeding which may be life-threatening, lung collapse Skin-related: dry skin, severe itching, rash, hives, hair loss all over the body, pimples, a skin disease characterized by rash and bumps. You may be more sensitive than usual to severe sunburn and should use sunblock or cover your skin if outside in the sun.  
Vein-related: a disorder in which blood clots form throughout the body, problems with blood clotting.  
Tumor Lysis Syndrome: very rapid death of cancer cells releases chemicals which may lead to reduced kidney function. Accumulation of these chemicals may harm muscle or nerve function.  
Reproductive Risks: If a person gets pregnant while receiving CC-5013, it could be dangerous for the baby. CC-5013 is related to thalidomide. If pregnant women take thalidomide, their babies can be born with no arms or legs. We do not know if CC-5013 causes similar birth defects, but you should be sure not to get pregnant or father a baby while on this study. A pregnancy test will be done before each course of therapy for girls and women of childbearing age on this study. If at any time you think you might be pregnant, tell the study staff right away. You must not nurse (breast feed) a baby while on this study. You must NEVER donate blood or ova while on this study. CC-5013 does not cause abortion of the fetus and should never be used as a form of birth control. Men must NOT be sperm or blood donors while taking CC-5013.  
| Common                                                | Serious   |
|-------------------------------------------------------|-----------|
| Abdominal pain Constipation  Diarrhea Nausea Headache |           |  
ADVERSE EFFECTS: Diarrhea is the most common reported adverse effect. Hyperkalemia, peripheral neuropathy, myopathy, myalgias, acute renal failure, rhabdomyolysis, elevated liver enzymes, hepatitis, behavioral changes, CNS depression also reported. One patient developed compartment syndrome resulting in a four-compartment fasciotomy from statin-induced myositis.  
| Dermatomyositis Hepatotoxicity Drug-induced myopathy Myalgia  Rhabdomyolysis  Rupture of Tendon   |
|---------------------------------------------------------------------------------------------------|  
- This drug may cause abdominal pain, constipation, diarrhea, nausea, or headache.  
- Instruct patient to report myalgias or signs/symptoms of myopathy or renal failure.  
- Patient should take tablets with evening meal and extended-release tablets at bedtime.  
- Advise patient there are multiple significant drug-drug interactions for this drug. Consult healthcare professional prior to new drug use (including over-the-counter and herbal drugs).  
- Patient should not drink large amounts of grapefruit juice (greater than 1 quart/day) while taking this drug.  
- Instruct patient to avoid alcohol during drug therapy.
guaifenesin brand name(s) mucinex
megestrol acetate brand name(s) megace

- **Endocrine metabolic:** Adrenal insufficiency
- **Hematologic:** Anemia, Deep venous thrombosis, Thrombophlebitis
- **Respiratory:** Pulmonary embolism Common:
- **Cardiovascular:** Hypertension - **Dermatologic:** Rash, Sweating symptom
- **Endocrine metabolic:** Hot sweats, Weight gain
- **Gastrointestinal:** Diarrhea, Flatulence, Indigestion, Nausea, Vomiting - **Neurologic:** Insomnia - **Psychiatric:** Mood swings - **Reproductive:** Impotence  
- This drug may cause sweating, hot flashes, weight gain, diarrhea, dyspepsia, flatulence, nausea, vomiting, insomnia, mood swings, impotence, anemia, deep venous thrombosis, thrombophlebitis, or pulmonary embolism.  
- Instruct patient to report signs/symptoms of adrenal insufficiency, as drug may suppress the hypothalamic-pituitary-adrenal axis.  
- Inform patient that drug may need to be taken for at least 2 months before effectiveness can be determined.  
- history of hypersensitivity to megestrol acetate or any component of the formulation - known or suspected pregnancy Precautions
- diabetes
- history of thromboembolic disease - megestrol acetate is not intended for prophylactic use to avoid weight loss
- possibility of adrenal insufficiency in patients receiving or being withdrawn from chronic megestrol acetate therapy
- use of megestrol in other types of neoplastic disease is not recommended  
| Risks and side effects related to mercaptopurine include those which are: Likely Less Likely                                                                                                                                                                                                           | Rare But Serious                                                                                                                                                                     |                  |                                                                      |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------|
| - Fewer white blood  cells, red blood cells  and platelets in the  blood  - A low number  of red blood cells  can make you feel  tired and weak - A low number  of white blood  cells can make it  easier to get  infections  - A low number  of platelets cause  you to bruise and  bleed more easily | -                                                                                                                                                                                    | Loss of appetite |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Nausea and/or vomiting                                                                                                                                                               |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Diarrhea                                                                                                                                                                             |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Inflammation an/or sores in the mouth which  may look like thrush                                                                                                                    |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Red itchy rash and/or hives which may even  occur a few weeks after treatment stops                                                                                                  |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Darkening of the skin (L)                                                                                                                                                            |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Elevation in the blood of certain enzymes or  bilirubin found in the liver which may mean  liver irritation or damage                                                                |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Hair loss                                                                                                                                                                            |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | High levels of uric acid in the blood which  could damage the kidneys                                                                                                                |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | A feeling of extreme tiredness or weakness  or not feeling well                                                                                                                      |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Absence or decrease in the number of sperm  which may decrease the ability to have  children                                                                                         | -                | Inflammation of the  pancreas which can cause  severe abdominal pain |
| -                                                                                                                                                                                                                                                                                                      | Inflammation or scarring  of the lungs which could  lead to chest pain or  discomfort and shortness  of breath                                                                       |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | Damage to the liver which  can lead to inflammation  and or scarring which  could lead to a yellow  appearing skin, and fluid  collection in the stomach  which makes it look larger |                  |                                                                      |
| -                                                                                                                                                                                                                                                                                                      | A new cancer or leukemia  resulting from this  treatment                                                                                                                             |                  |                                                                      |
guaifenesin brand name(s) mucinex
mercaptopurine mesalamine brand name(s) apriso

Serious:
- **Cardiovascular:** Pericarditis (rare) - **Gastrointestinal:** Pancreatitis (less than 1%), Rectal hemorrhage (less than 3%) - **Hematologic:** Agranulocytosis (rare), Aplastic anemia (rare), Leukopenia (rare),
Neutropenia (rare), Pancytopenia (rare), Thrombocytopenia (rare)
- **Hepatic:** Cholestatic hepatitis (less than 3%), Hepatotoxicity (rare), Liver failure
- **Immunologic:** Hypersensitivity reaction
- **Renal:** Renal impairment
- **Other:** Drug intolerance, Syndrome Common:
- **Gastrointestinal:** Abdominal pain (2.2% to 2.3%), Diarrhea (up to 8%), Flatulence (up to 4%), Nausea (up to 4%), Ulcerative colitis (2.3% to 5.8%), Upper abdominal pain (1.2%
to 5%)
- **Hepatic:** Liver function tests abnormal (2.3%)
- **Neurologic:** Headache (2.9% to 11%)
- **Respiratory:** Nasopharyngitis (1.4% to 4%)  
- Instruct patient to stop drug and report signs/symptoms of acute intolerance syndrome
(cramping, acute abdominal pain, bloody diarrhea, fever, headache, or rash).  
- Warn patient with phenylketonuria that Apriso(TM) extended-release capsules contain aspartame.  
- Advise patient with sulfite sensitivity that Rowasa(R) enema contains metabisulfite.  
- Drug may cause abdominal pain, constipation, diarrhea, nausea, vomiting, arthralgia, asthenia, dizziness, or headaches.  
- Oral formulations may cause blood dyscrasias, especially in the elderly (65 years and older).  
- Advise patient to report signs/symptoms of renal failure (eg, nausea, vomiting, reduced urine output, drowsiness, headache, or back pain).  
- For rectal formulations, advise patient on proper administration technique and timing (use at bedtime) for maximum retention of drug.  
- Advise patient to avoid antacids with Apriso(TM) extended-release capsules.  
- hypersensitivity to mesalamine, other salicylates (including aspirin), or to any component
guaifenesin brand name(s) mucinex
precautions

- acute intolerance syndrome, similar to exacerbation of inflammatory bowel disease or colitis, has been reported; discontinue treatment if this occurs
- cardiac hypersensitivity reactions (myocarditis or pericarditis) have been reported; use cautiously in conditions predisposing patient to myocarditis or pericarditis (Lialda(R), rectal suspension, and enema)
- concomitant use with antacids should be avoided (extended-release capsules
(Apriso(TM))
- concurrent oral products which contain or release mesalamine; increased risk of renal abnormalities (rectal suppositories and enema)
- elderly (65 years and older); greater risk of blood dyscrasias; monitoring recommended
(extended-release capsules and delayed-release tablets)
- inflammatory bowel disease; exacerbation of symptoms including melena and hematochezia may occur (enema)
- liver disease; hepatic failure has been reported (extended-release capsules and delayedrelease tablets)
- pancolitis has been reported (rectal suppositories and enema) - phenylketonuria; contains aspartame (extended-release capsule)
- pyloric stenosis; possibility of prolonged gastric retention of mesalamine (delayed-release tablets)
- renal dysfunction or history of renal disease; increased risk of renal toxicity; monitoring recommended
- renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and rarely renal failure have been reported; increased risk in those with renal disease; monitoring recommended
- sulfasalazine hypersensitivity, history; possibility of similar hypersensitivity reaction
- sulfite hypersensitivity; contains metabisulfite (enema)
- report suspected adverse reactions to the US Food and Drug Administration at 1-800-
FDA-1088 or www.fda.gov/medwatch  
| Common                                                                          | Serious                                                                                                                       |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Cobalamin deficiency Diarrhea Flatulence Indigestion  Nausea Vomitting Asthenia | Lactic acidosis (generally associated with  underlying conditions such as renal  insufficiency, hepatic disease, sepsis, etc) |  
- Drug may cause diarrhea, dyspepsia, flatulence, nausea, vomiting, hyper- or hypoglycemia, or asthenia.  
- Instruct patient to report signs/symptoms of lactic acidosis (nausea, vomiting, abdominal pain, tachypnea). Elderly patients (80 years and older) are at increased risk.  
- Patient should take tablets with meals and extended-release tablets with the evening meal. - Tell patient to maintain adequate hydration to prevent renal dysfunction. - Tell patients to notify healthcare provider of metformin use before having radiologic studies using IV dye.  
- Patient should not drink alcohol while taking this drug.  
| Common                                                                                         | Serious                                                                                                                                      |              |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Skin rash Uriticaria Nausesa Vomiting Epigastric distress Arthralgia Paresthesia Loss of taste | Agranulocytosis Aplastic anemia Hepatotoxicity Drug fever Lupus-like syndrome Insulin autoimmune syndrome Periartheritis Hypoprothrombinemia |              |
| Version 2.0 Final                                                                              | Page 198 of 268                                                                                                                              | Confidential |
| Issued 12 June 2013                                                                            |                                                                                                                                              |              |  
| Abnormal loss of hair Myalgia  Headache Pruritus Drowsiness Neuritis Edema Vertigo Skin pigmentation Jaundice  Sialadenopathy  Lymphadenopathy   | Nephritis (very rarely)   |
|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Advise patient to report signs/symptoms of hepatotoxicity, aplastic anemia, or infection (fever,                                                 |                           |  
Advise patient to report signs/symptoms of hepatotoxicity, aplastic anemia, or infection (fever, headache, malaise, skin eruptions, sore throat).  
Methotrexate Risks and side effects related to methotrexate (when given by mouth or vein) include those which are:  
| Likely                                                                                    | Less Likely                                                                                                                                                                                                                                                                           | Rare But Serious   |                                                                                                                               |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------------------------------------------------------------------------------------------------------------------|
| - High levels of liver  enzymes in the  blood which may  mean liver irritation  or damage | -                                                                                                                                                                                                                                                                                     | Nausea             |                                                                                                                               |
| -                                                                                         | Vomiting                                                                                                                                                                                                                                                                              |                    |                                                                                                                               |
| -                                                                                         | Loss of appetite                                                                                                                                                                                                                                                                      |                    |                                                                                                                               |
| -                                                                                         | Diarrhea                                                                                                                                                                                                                                                                              |                    |                                                                                                                               |
| -                                                                                         | Chills and/or fever                                                                                                                                                                                                                                                                   |                    |                                                                                                                               |
| -                                                                                         | Inflammation and/or sores in the  mouth, gums, throat and/or  esophagus                                                                                                                                                                                                               |                    |                                                                                                                               |
| -                                                                                         | Inflammation of the intestines  which may cause bleeding                                                                                                                                                                                                                              |                    |                                                                                                                               |
| -                                                                                         | Sensitivity to sunlight and  increased risk of sunburn                                                                                                                                                                                                                                |                    |                                                                                                                               |
| -                                                                                         | Fewer white blood cells, red  blood cells and platelets in the  blood.  - A low number of red blood  cells can make you feel tired  and weak. - A low number of white  blood cells can make it easier  to get infections. - A low number of platelets  causes you to bruise and bleed |                    |                                                                                                                               |
| -                                                                                         | Learning disability                                                                                                                                                                                                                                                                   |                    |                                                                                                                               |
| -                                                                                         | Dizziness                                                                                                                                                                                                                                                                             |                    |                                                                                                                               |
| -                                                                                         | Sense of not feeling well or  tiredness                                                                                                                                                                                                                                               |                    |                                                                                                                               |
| -                                                                                         | Drowsiness                                                                                                                                                                                                                                                                            |                    |                                                                                                                               |
| -                                                                                         | Blurred vision                                                                                                                                                                                                                                                                        |                    |                                                                                                                               |
| -                                                                                         | Rashes with itching and hives                                                                                                                                                                                                                                                         |                    |                                                                                                                               |
| -                                                                                         | Hair loss, inflammation of the                                                                                                                                                                                                                                                        | -                  | Severe allergic reaction which can be  life threatening with shortness of  breath, low blood pressure and a rapid  heart rate |
| -                                                                                         | The rapid death of large numbers of  tumor cells which can cause the  potassium and phosphate salts and the  uric acid in the blood to rise quickly  and this could lead to a life-threatening  irregular heart beat or damage to the  kidneys.                                       |                    |                                                                                                                               |
| -                                                                                         | Severe rashes which can cause loss of  skin or damage to mucous membranes  or which can cause peeling, redness  and pain on the palms of the hands and  soles of the feet                                                                                                             |                    |                                                                                                                               |
| -                                                                                         | Damage, inflammation and/or scarring  of lung tissue which may make you  short of breath and cough                                                                                                                                                                                    |                    |                                                                                                                               |
| -                                                                                         | Seizures                                                                                                                                                                                                                                                                              |                    |                                                                                                                               |
| -                                                                                         | Temporary damage to the brain such  that you may experience headaches,  drowsiness, difficulty speaking or  forming words, blurred vision or  temporary blindness, and decreased  reflexes                                                                                            |                    |                                                                                                                               |
| -                                                                                         | Temporary loss of function or feeling  in the lower part of the body (partial  paralysis)                                                                                                                                                                                             |                    |                                                                                                                               |
| -                                                                                         | Severe damage to brain tissue which  over time could lead to difficulty  carrying out normal daily tasks or                                                                                                                                                                           |                    |                                                                                                                               |
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| hair follicles   |                                                                                  |                       |
|------------------|----------------------------------------------------------------------------------|-----------------------|
| -                | Acne                                                                             |                       |
| -                | Tearing and inflammation of the  eyes                                            |                       |
| -                | Darkening of the fingernails                                                     | could lead to a coma. |
| -                | Inflammation and scarring of the liver                                           |                       |
| -                | Damage to the bone which could lead  to arthritis pain and weakness of the  bone |                       |
| -                | Inflammation of the heart                                                        |                       |
| -                | Fluid buildup around the heart                                                   |                       |
| -                | Damage to the kidney                                                             |                       |
guaifenesin brand name(s) mucinex
methyl ccnu

| as listed below Common                                                                     | Serious                                                                                                                                                                                                                                                                                                   |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nausea Vomiting Burning at injection site Suffusion of the conjunctiva Chest pain Headache | Pulmonary infiltrates (late effect) Pulmonary fibrosis (late effect) Delayed myelosuppression Delayed leucopenia Delayed thrombocytopenia Anemia Neutropenia  Hepatic toxicity Renal damage Nephrotoxicity  Decreased kidney size Renal failure Allergic reaction Neuroretinitis Hypotention  tachycardia |
guaifenesin brand name(s) mucinex
minocycline risks and discomforts

If you agree to enroll in this study, there may be some risks to your health and well-being.  
Known side effects associated with minocycline use are: sensitivity to sunlight (frequent; greater than 20%); dizziness; constipation; nausea; vomiting; and loss of appetite (occasional; 2 to 20%). To avoid sunlight sensitivity, you can use sunscreen, wear clothing with long sleeves and long pants, and try to stay out of direct sun as much as possible. In rare cases (less than 2%), staining of the outer layer of teeth, kidney disease, anemia (low iron and red blood cells which may cause tiredness and shortness of breath), and liver disease have been reported.  
Rare instances of inflammation of the esophagus (or food pipe) and ulcers in the esophagus have also been reported with minocycline. To reduce the risk of irritation of the esophagus, your study medication, if taken by mouth, should be taken with a full glass of water (8 ounces). If you experience pain when swallowing, you must report this to your study doctor immediately. The study medication can be taken with or without food.  
Other side effects of minocycline include rash, hives, headache, joint pain, and allergic reactions
(rare; 1-3%).  
Serious allergic reactions that can be life-threatening may occur with minocycline use. You should be very careful when driving or using machinery until you know how the study drug(s) will affect you. This is because the study medication(s) may cause drowsiness, dizziness, lack of coordination, or slow your reaction time.  
There may be other risks which are not known at this time and which we cannot predict. Minocycline may not be as effective if taken with any antacids, calcium supplements, iron products, and laxatives containing magnesium. None of these medications may be taken within 2 hours before or after taking Minocycline.  
In addition, minocycline may interfere with the effectiveness of oral contraceptives. Therefore, for female subjects of childbearing potential, the addition of a barrier method of contraception
(condom or diaphragm) will be required during the study. Minocycline may be dangerous to an unborn child (fetus or embryo). If, at any time during the study, you suspect that you are pregnant, you must immediately notify your study doctor.  
| Rare Happens to < 5  children out of every  100                                    |                                                                                                      |                                                                    |                                                                                                                                                                                                                                                              |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Immediate: Within 1-2 days of  receiving drug                                      | Common Happens to 21-100  children out of every  100                                                 | Occasional Happens to 5-20  children out of every  100             | Anaphylaxis,  angioedema, cardiac arrhythmias1  (bradycardia),  seizures,  extravasation  reactions rare but if  occur can lead to:  (erythema, swelling,  pain, burning and/or  blue  discoloration of the  skin  and rarely tissue  necrosis), tumor lysis |
| Prompt: Within 2-3 weeks,  prior to the next course                                | Nausea, vomiting,  diarrhea, fever,  anorexia, green blue  discoloration of the  urine and/or sclera | Abdominal pain, back  pain, headache,  phlebitis, constipation     |                                                                                                                                                                                                                                                              |
| Myelosuppression (L), mucositis /stomatitis, immunosuppression,  alopecia, fatigue | Transient elevation of  LFTs, pruritis with  desquamation of the  skin due to  progressive dryness   | Rash, conjunctivitis,  (GI) hemorrhage,  interstitial  pneumonitis |                                                                                                                                                                                                                                                              |
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| Delayed: Any time later during therapy                                                                | Amenorrhea, menstrual disorders, temporary reduction in sperm  count                                                                                                                                                                                                                         | Cardiotoxicity  (decreased LVEF)2 (L)   | CHF, hepatotoxicity   |
|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------|
| Late: Any time after  completion of treatment                                                         | Secondary  malignancy                                                                                                                                                                                                                                                                        |                                         |                       |
| Unknown  Frequency and Timing:                                                                        | Fetal toxicities and teratogenic effects of mitoxantrone have been noted  in animals. Toxicities include: low birth weight and prematurity. Mitoxantrone is  excreted in human milk and significant concentrations (18 ng/mL) have been  reported for 28 days after the last administration. |                                         |                       |
| 1 Rarely clinically significant. 2 Risk increases with chest radiation and prior anthracycline dosage |                                                                                                                                                                                                                                                                                              |                                         |                       |  
Nabumetone  
| Common                                                                                                                                                     | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema Pruritus Skin Rash Abdominal pain Constipation  Diarrhea Flatulence Indigestion  Nausea Occult blood in stools Dizziness Headache Insomnia  tinnitus | Hypertension Myocardial infarction (<2%) Thrombotic tendency observation  Erythema multiforme (rare) Scaling eczema Stevens-Johnson syndrome Toxic epidermal necrolysis (<0.1%) Gastrointestinal hemorrhage (<1%) Gastrointestinal perforation (<1%) Inflammatory disorder of digestive tract Melena (<1%) Anemia Thrombocytopenia (<1%) Hepatitis Increased liver function test (up to 15%) Jaundice  Liver failure (rare) Immune Hypersensitivitiy reaction (<1%) Cerebrovascular accident Albuminuria (<1%) Interstitial nephritis (rare) Renal azotemia (<1%) Renal failure (rare) Bronchospasm (<2%) |  
- Advise patient to immediately report signs/symptoms of Stevens-Johnson syndrome (flulike symptoms, spreading red rash, or skin/mucous membrane blistering).  
- Patients with a cardiac history or on a long-term regimen are at an increased risk for adverse cardiovascular thrombotic events. Advise patient to report signs/symptoms of myocardial infarction or stroke.  
- Instruct patients to report signs/symptoms of serious gastrointestinal events such as bleeding, ulceration, or perforation of stomach or intestines. Tell patient drug is best taken with food or milk.  
- Patient should not drink alcohol while taking this drug. - Advise patient to avoid concomitant use of oral corticosteroids, as this may increase the risk for serious gastrointestinal effects.  
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Nabumetone is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG)
surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.  
| Common (>3 %)                                                                                                                                            | Serious (1-3%)                                                                                                                                    | Rare (<1%)                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema Pruritus Skin Rash Abdominal Pain Constipation  Diarrhea Heartburn Indigestion  Nausea Stomatitis Dizziness Headache Somnolence  Tinnitus  Dyspnea | Lightheadedness Vertigo Scaling eczema Inflammatory disorder of digestive  tract Anemia Thrombotic tendency observations Increased liver function | Congestive Heart Failure Myocardial Infarction Pulmonary Edema Vasculitis Steven-Johnson syndrome Toxic epidermal necrolysis Gastrointestinal hemorrhage Gastrointestinal perforation Pancreatitis Agranulocytosis  Granulocytopenic disorder Thrombocytopenia  Hepatitis Jaundice  Liver failure Anaphylactoid reaction Aspectic meningitis Cerebrovascular accident Seizure Interstitial nephritis Nephrotic syndrome Papillary necrosis Renal failure Serum creatinine raised |  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness or somnolence.  
- This drug may cause edema, abdominal pain, constipation, diarrhea, dyspepsia, heartburn, nausea, stomatitis, anemia, headache, tinnitus, dyspnea, scaling eczema, or liver failure.  
- Patients with a cardiac history or on a long-term regimen are at an increased risk for adverse cardiovascular thrombotic events. Advise patient to report signs/symptoms of myocardial infarction or stroke.  
- Instruct patients to report signs/symptoms of serious gastrointestinal events such as bleeding, ulceration, or perforation of stomach or intestines. Elderly and debilitated patients may be at an increased risk for this adverse effect.  
- Tell patient drug is best taken with food or milk.  
- Patient should not drink alcohol while taking this drug.  
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Naproxen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
guaifenesin brand name(s) mucinex
vinorelbine tartrate brand name(s) navelbine

- **Cardiovascular:** Non-ST segment elevation myocardial infarction, acute
- **Gastrointestinal:** Bowel obstruction, Constipation, Pancreatitis, Paralytic ileus, Perforation of intestine
- **Hematologic:** Granulocytopenic disorder (Severe), Significantly greater in combination with cisplatin, Myelosuppression, Significantly greater in combination with cisplatin
- **Hepatic:** AST/SGOT level raised (frequent)
- **Respiratory:** Acute respiratory distress syndrome, Bronchospasm, Interstitial lung disease
- **Other:** Sepsis  
- **Dermatologic:** Alopecia (grades 1 and 2, up to 35%; grades 3 and 4, 4% to 12%),
Injection site reaction
- **Gastrointestinal:** Diarrhea, Nausea, Vomiting - **Neurologic:** Asthenia, Neuromyopathy  
- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression. - This drug may cause alopecia, tissue necrosis, diarrhea, nausea, vomiting, constipation, asthenia, and neuromyopathy.  
- Drug may also cause significant adverse effects including bowel obstruction, pancreatitis, paralytic ileus, and perforation of intestine.  
- Instruct patient to report signs/symptoms of myelosuppression.  
- Advise patient to report signs/symptoms of respiratory adverse effects such as acute respiratory distress syndrome, bronchospasm, and dyspnea.  
- granulocytopenia, granulocyte counts less than 1,000 cells/mm(3); withhold administration
- intrathecal administration; can be fatal Precautions
- extravasation causing local tissue necrosis and/or thrombophlebitis can occur
- granulocytopenia, granulocyte counts from 1,000 to 1,499 cells/mm(3); dose adjustments according to complete blood counts with differentials obtained on the day of treatment
- compromised bone marrow reserve
- concomitant mitomycin, cisplatin, CYP3A inhibitors
- concomitant or sequential treatment with paclitaxel
- prior history or pre-existing neuropathy
- prior radiation therapy- radiation recall - severe hepatic injury or impairment - use proper procedures for handling and disposal of chemotherapy  
| Adverse Events Common ≥ 1%                                                                                                                                              | Rare < 1%                                                                                           |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Exfoliative Dermatitis Dry Skin Cutaneous pruritus Alopecia Maculopapular rashes Leukopenia Thrombocytopenia Conjunctivitis Corneal opacity Keratitis Light sensitivity | Diarrhea Abdominal pin Gastroenteritis Gastrointestinal hemorrhage  Liver failure Neoplasm of liver |  
- Patient should report development of a rash or signs/symptoms of leukopenia, thrombocytopenia, or hepatic failure.  
- Advise patient to report ocular symptoms (photophobia, eye pain, burning, redness, or swelling).  
- Patient should take drug on an empty stomach at least 1 h before a meal. - Instruct patient on any dietary tyrosine restrictions. Foods high in tyrosine include dairy products, meat, fish, eggs, pumpkin or sesame seeds, almonds, avocados, and soy.  
| Omeprazole                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                                                                         |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common ≥ 1%                                                                                                                                                                                                                                                    | Rare < 1%                                                                                                                                                                                                                                                               |
| Abdominal pain (2.4% to 5.4%), Diarrhea (3%  to 3.7%) Diarrhea (3% to 3.7%) Constipation (1.1% to 1.5%) Flatulence (2.7%) Nausea (2.2% to 4%) Vomiting (1.5% to 3.2%)  Headache (2.9% to 6.9%) Back pain (1.1%) Asthenia (1.2%) Dizziness (1.5%)  Cough (1.1%) | Pancreatitis Hepatotoxicity Bone fracture Joint pain Muscle cramps Osteroporosis-related bone fracture Hip fracture Rhabdomyolysis Myalgia Myositis Leg pain Throat pain Interstital nephrisis Visual disturbances Ringing in the ear Urinary Tract infection Epistaxis |  
- This drug may cause constipation, diarrhea, nausea, and headache. - Tell patients on long-term therapy to report signs/symptoms of atrophic gastritis.  
- Advise patient to take drug before a meal.
guaifenesin brand name(s) mucinex
orlistat

| Common ≥ 5%                                                                                          | Rare < 1%            |
|------------------------------------------------------------------------------------------------------|----------------------|
| Abdominal discomfort Abdominal pain Defecation urgency Increased frequency of defecation Steatorrhea | Cholelithiasis (2.9) |  
- This drug may cause abdominal discomfort or pain, urgency or increased frequency of defecation, and steatorrhea.  
- If using concurrently with orlistat, patient should take multivitamins or cyclosporine at least 2 h before or 2 h after an orlistat dose.  
- Advise patient to take this drug during or up to 1 h after meals containing fat. Patient should omit dose if a meal is missed or contains no fat.  
- Instruct patient to take a missed dose as soon as possible up to 1 h after meal. If missed dose is more than 1 h overdue, skip the missed dose.  
Risks and side effects related to oxaliplatin include those which are:
guaifenesin brand name(s) mucinex
likely

- Numbness or tingling sensation of mouth, throat, arms, legs, fingers and toes which may become worse with cold temperatures and which may affect the ability to perform tasks that require fine muscle coordination
- Nausea and vomiting
- Stomach cramps or pain
- Diarrhea or constipation Less Likely
- Headache
- Runny nose
- Feeling of "heartburn"
- Change in taste - Dehydration (fluid loss) - Dizziness and/or loss of coordination
- Feeling of extreme tiredness not relieved by rest or sleep
- Reddening and cracking of the skin on the hand palms and soles of the feet, associated with pain and possibly infection
- Sudden reddening of face and neck
- Rash - Difficulty sleeping
- Loss of appetite or desire to eat
- Allergic reaction that may be life threatening - Shaking chills
- Blood in the urine
- Painful or difficulty urinating
- Inflammation of the vein through which the drug was given
- Fewer white blood cells, red blood cells and platelets in the blood* o A low number of white blood cells can make it easier to get infections o A low number of red blood cells can make you feel tired and weak o A low number of platelets causes you to bruise and bleed more easily
- Nose bleed
- Loss of weight - Soreness or ulcers inside the mouth and throat - Hair loss - Swelling of the hands, arms, feet and legs
- Joint pain
- Lung infections
- Sore throat
- Fever
- Increased levels of creatinine in the blood which could mean kidney damage - Lower levels of a salt (potassium) which is measured in the blood
- Too much acid in the blood
- Hiccups
- Too much gas produced in the intestines
- Difficulty swallowing
- Mild increases in liver enzymes without symptoms and usually returning to normal
- Increase in blood pressure
- Inflammation of the ear - Inflammation of the small bowel which may cause pain and discomfort
- A feeling of depression
- Cough
- Bone Pain - Inability to urinate
- Damage to the surface of the eye which might lead to pain and tearing
- Restless movements that are not under your control (involuntary)
Rare but some of these can be serious
- Shortness of breath
- Sudden, temporary feeling of difficulty in swallowing or breathing which can occur during or shortly after the infusion and may be caused by swallowing a cold drink
- Infections - Irregular or rapid heart beat
- Rare but serious damage to the liver which can lead to an enlarged liver and spleen, bleeding from the veins in the esophagus, a yellow appearing skin, and fluid collection in the abdomen which makes your abdomen look larger
- Tissue irritation or damage which may be severe if drug leaks from the injection site - this may cause pain, redness and swelling
- Severe allergic reaction which can be life threatening with shortness of breath, low blood pressure and a rapid heart rate
- Blood clots
- Blurred vision or blind spots in vision
- Damage to lung tissue
- Damage to kidney which may be permanent
- Loss of some hearing - A bleeding disorder that can cause bleeding from many areas of the body including the nose, the rectum and the urine
- A blockage of the intestine that may require treatment - Inflammation of the pancreas which can cause severe abdominal pain  
| Common ≥ 1%                                                                       | Rare < 1%                                                                                                                                               |              |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| %) Rash Abdominal pain Constipation Diarrhea Indigestion Nausea Vomittin Tinnitus | Edema Hypertension Palpitations Thrombotic tendency observations Erythema multiforme Scaling eczema Stevens-Johnson Syndrome Toxic epidermal necrolysis |              |
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| Issued 12 June 2013                                                               |                                                                                                                                                         |              |
guaifenesin brand name(s) mucinex
oxaprozin

| Dysuria Increased frequency of urination Myocardial infaraction   | Cerebrovascular accident Gastrointestingal hemorrhage Gastrointestinal perforation Inflammatory disorder of digestive tract Pancreatitis Agranulocytosis Anemia Leucopenia Thrombocytopenia Hepatitis Increased liver function test Jaundice Liver failure Anaphylactoid reaction Amblyopia Hearing loss Acute renal failure Hematuria Interstitial nephritis Bronchospasm  Serum sickness due to drug   |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                          |  
- This drug may cause abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting, tinnitus, dysuria, photosensitivity, increased urinary frequency, or bronchospasm.  
- Advise patient to report signs/symptoms of serious cardiovascular thrombotic events, myocardial infarction, and stroke.  
- Patient should also report signs/symptoms of bleeding, ulceration, or perforation of the stomach or intestines. Elderly and debilitated patients are at higher risk while taking this drug.  
- Tell patient to avoid concurrent use of other NSAIDs unless approved by healthcare professional.
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxaprozin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG)
surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
guaifenesin brand name(s) mucinex
paclitaxel

Risks and side effects related to Paclitaxel include those which are:  
| Likely              | Less Likely                                     | Rare but serious   |                                                                         |
|---------------------|-------------------------------------------------|--------------------|-------------------------------------------------------------------------|
| -                   | Nausea                                          |                    |                                                                         |
| -                   | Reddening of the face or  skin with feelings of | -                  | Vomiting                                                                |
| -                   | Diarrhea                                        |                    |                                                                         |
| -                   | Shortness of breath                             | -                  | Severe allergic reaction  which can be life  threatening with shortness |
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| warmth              |                                                                                                                                                                                                                                          |                                                                                  |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| -                   | Temporary changes on a  test called an EKG that  measures the activity of  your heart                                                                                                                                                    |                                                                                  |
| -                   | A feeling of weakness  and/or tiredness                                                                                                                                                                                                  |                                                                                  |
| -                   | Aches and pains in the  muscles or joints                                                                                                                                                                                                |                                                                                  |
| -                   | Loss of appetite                                                                                                                                                                                                                         |                                                                                  |
| -                   | Temporary hair loss                                                                                                                                                                                                                      |                                                                                  |
| -                   | Fewer white blood cells  and red blood cells in the  blood o a low number of white  blood cells can make  it easier to get  infections o a low number of red  blood cells can make  you feel tired and  weak                             |                                                                                  |
| -                   | A problem in nerve  function that may cause  pain, numbness, tingling,  and muscle weakness in  various parts of the body                                                                                                                |                                                                                  |
| -                   | Inflammation and/or sores  in the mouth (and/or throat  and /or esophagus, the  tube that leads from the  mouth to the stomach) that  may make swallowing  difficult and are painful  (painful mouth sores)                              |                                                                                  |
| -                   | Elevation in the blood of  certain enzymes or  chemicals found in the  liver which might indicate  liver irritation or damage                                                                                                            | of breath, low blood  pressure, rapid heart rate,  chest pain, chills and  fever |
| -                   | Severe allergic reaction  which can be life  threatening with rapid  build-up of fluid under the  skin, in the lining of the  intestine and possibly in  the throat or swelling of  the tongue which could  make it difficult to breath. |                                                                                  |
| -                   | Clotting of blood vessels  which can lead to pain  and swelling in the area of  the clot. Such clots make  break loose and cause  damage or be lifethreatening depending on  where they go.                                                                                                                                                                                                                                          |                                                                                  |
| -                   | Abnormal heart rate  which may be lifethreatening                                                                                                                                                                                                                                          |                                                                                  |
| -                   | Heart attack                                                                                                                                                                                                                             |                                                                                  |
| -                   | Bleeding which can occur  in the head, stools, the  nose, urine and other parts  of the body                                                                                                                                             |                                                                                  |
| -                   | Seizures                                                                                                                                                                                                                                 |                                                                                  |
| -                   | Severe damage to the  brain which may lead to  difficulty carrying out  normal daily tasks and to  coma                                                                                                                                  |                                                                                  |
| -                   | A stoppage (or blockage)  of the intestine which may  require treatment                                                                                                                                                                  |                                                                                  |
| -                   | Severe rashes which can  result in loss of skin and  damage to mucous  membranes and which  may be life-threatening                                                                                                                      |                                                                                  |
| -                   | Damage to the heart  muscle which may make  you tired, weak, feel short  of breath, and retain fluid                                                                                                                                     |                                                                                  |
| -                   | Inflammation, infection or  scarring of the lungs that  can lead to fluid in the  lungs and affect your                                                                                                                                  |                                                                                  |
| -                   | Fluid retention and buildup in the tissues usually of  the lower legs leading to an  increase in weight                                                                                                                                                                                                                                          |                                                                                  |
| -                   | Cough                                                                                                                                                                                                                                    |                                                                                  |
| -                   | Rash with itching or hives                                                                                                                                                                                                               |                                                                                  |
| -                   | Low or high blood pressure                                                                                                                                                                                                               |                                                                                  |
| -                   | Fainting                                                                                                                                                                                                                                 |                                                                                  |
| -                   | Infections including those  caused by bacteria, virus,  and fungus                                                                                                                                                                       |                                                                                  |
| -                   | Elevation in the blood of  bilirubin (a substance that  comes from the liver  breaking down waste  products) found in the  liver                                                                                                         |                                                                                  |
| -                   | found in the liver                                                                                                                                                                                                                       |                                                                                  |
| -                   | Fewer platelets in the blood  o a low number of  platelets causes you to  bruise and bleed more  easily                                                                                                                                  |                                                                                  |
| -                   | Back or chest pain                                                                                                                                                                                                                       |                                                                                  |
| -                   | Pain, redness,  inflammation and skin  damage in the vein through  which the drug was given                                                                                                                                              |                                                                                  |
| -                   | Fever with a low white  blood cell count which  could indicate infection  and may require  hospitalization and  treatment with antibiotics                                                                                               |                                                                                  |
| -                   | Unsteadiness when  walking                                                                                                                                                                                                               |                                                                                  |
| -                   | Inflammation, pain and  reddening of the eye with  watery eyes                                                                                                                                                                           |                                                                                  |
| -                   | Inflammation of the nerves  to the eye which could lead  to blurred vision or other  vision changes                                                                                                                                      |                                                                                  |
| -                   | Damage to the ear causing  hearing loss, which maybe  temporary or permanent,  balance problems  (dizziness) and ringing in  the ears                                                                                                    |                                                                                  |
| -                   | The finger or toe nails may  darken in color                                                                                                                                                                                             |                                                                                  |
| Version 2.0 Final   | Page 210 of 268                                                                                                                                                                                                                          | Confidential                                                                     |
| Issued 12 June 2013 |                                                                                                                                                                                                                                          |                                                                                  |  
| -   | Chills                                                                                                                                                                                        | ability to breathe and the  levels of oxygen in your  blood making you short of  breath   |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| -   | Damage to the liver which  can lead to inflammation  and/or scarring which  could lead to a yellow  appearing skin, and fluid  collection in the abdomen  (belly) which makes it  look larger |                                                                                           |
guaifenesin brand name(s) mucinex
pamidronate disodium brand name(s) aredia

- **Musculoskeletal:** Arthralgia (13.6%), Aseptic necrosis of bone of jaw, Bone pain (at least 10% to 15%), Myalgia (26%)
- **Neurologic:** Seizure (2%)
- **Renal:** Focal segmental glomerulosclerosis  
- **Dermatologic:** Injection site reaction
- **Endocrine metabolic:** Hypocalcemia (12%), Hypokalemia (18%), Hypomagnesemia
(12%), Hypophosphatemia (18%)
- **Gastrointestinal:** Loss of appetite, Nausea, Vomiting
- **Hematologic:** Anemia (42.5%)
- **Renal:** Urinary tract infectious disease (18.5%)
- **Other:** Fever  
- This drug may cause anorexia, nausea, vomiting, or fever.  
- Advise patient to report incapacitating or severe bone, joint, and/or muscle pain . - Patient should report signs/symptoms of renal impairment or anemia. - Tell patients with concomitant risk factors for osteonecrosis of the jaw to report signs/symptoms of this condition (gum loss, numbness, or pain, swelling, infection of jaw/gums). Risk factors for osteonecrosis of the jaw include cancer, chemotherapy, corticosteroids, or poor oral hygiene.  
- hypersensitivity to pamidronate or other bisphosphonates
guaifenesin brand name(s) mucinex
precautions

- anemia, leukopenia, or thrombocytopenia, preexisting; monitoring recommended
- focal segmental glomerulosclerosis (including the collapsing variant); has been reported, especially when treating multiple myeloma and breast cancer
- metabolic abnormalities (eg, calcium, phospate, magnesium, potassium levels) may occur; monitoring recommended
- musculoskeletal pain, severe; has been reported within days, months, or years following therapy initiation; consider discontinuing bisphosphonates if symptoms occur
- osteonecrosis of the jaw has been reported; risk factors include: cancer (advanced breast cancer, multiple myeloma), chemotherapy, corticosteroids, local infections, and dental status (dental extraction, periodontal disease, local trauma including poor fitting dentures); a dental examination with appropriate preventive dentistry should be considered prior to bisphosphonate treatment; invasive dental procedures should be avoided during bisphosphonate treatment
- renal function deterioration, progression to renal failure, and dialysis have been reported following initial or single doses; patients with multiple myeloma also receiving thalidomide may be at increased risk; single doses should not exceed 90 mg; monitoring recommended; withhold therapy for renal deterioration in patients with bone metastases
- renal impairment, preexisting; increased risk of renal adverse events; monitoring recommended; treatment of bone metastases in severe impairment is not recommended
- thyroid surgery, history of; may predispose to hypoparathyroidism and increase risk of hypocalcemia