guaifenesin brand name(s) mucinex
pazopanib

Risks and side effects related to the pazopanib include **the following:** Likely:
- **Lack of enough red blood cells (anemia)**
- **Diarrhea**
- **Nausea or the urge to vomit**
- **Fatigue or tiredness** - **Increased blood level of a liver enzyme (ALT/SGPT)**
- **Increased blood level of a liver enzyme (AST/SGOT)**
- **Increased blood level of a liver pigment (bilirubin) often a sign of liver**
problems
- **Decreased number of a type of white blood cell (lymphocyte)**
- **Decreased number of a type of white blood cell (neutrophil/granulocyte)**
- **Decrease in the total number of white blood cells (leukocytes)** - **Increased blood sugar level**
- **Changes in hair color**
- High blood pressure Less Likely:
- **Belly pain** - **Constipation** - **Vomiting**
- **Test that shows a problem in blood clotting**
- Increased blood level of a liver or bone enzyme (alkaline phosphatase)
- **Increased blood level of creatinine (a substance normally eliminated by the**
kidneys into the urine)
- **Increased INR (measure of the ability of the blood to clot properly) which**
increases the risk of bleeding
- **Increased blood level of fat-digesting enzyme (lipase)**
- Decreased number of a type of blood cell that helps to clot blood **(platelet)**
- Increased blood level of a digestive **enzyme level (amylase)**
- **Loss of appetite**
- Dehydration (when your body does not have as much water and fluid as it should)
- **Increased blood level of potassium** - **Increased blood level of magnesium**
- **Increased blood level of sodium**
- **Decreased blood level of calcium**
- Decreased **blood sugar level**
- **Decreased blood level of potassium** - **Decreased blood level of magnesium**
- **Decreased blood level of sodium**
- **Decreased blood level of phosphate**
- **Joint pain**
- Back **pain** - **Dizziness (or sensation of lightheadedness, unsteadiness, or giddiness)** - **Taste changes**
- **Headache or head pain**
- More protein leaking into **the urine than usual, often a sign of kidney disease** - **Bleeding in some organ(s) of the respiratory tract**
- Hair **loss**
- **Skin rash with the presence of macules (flat discolored area) and papules**
(raised bump)
- Lightening of the skin Rare but Serious:
- **Decrease in heart's ability to pump blood during the "active" phase of the**
heartbeat (systole)
- Heart attack caused by a blockage or decreased blood supply to **the heart**
- Gastrointestinal fistula: Abnormal hole between an organ of the digestive tract and another organ **or tissue**
- **Bleeding in some organ(s) of the digestive tract** - Gastrointestinal perforation: A tear or hole in the stomach or gut that can lead to serious complications and may require surgery to repair
- **Abnormal electrical conduction within the heart that may result in sudden**
death
- Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss associated with MRI imaging findings (RPLS)
- Abnormal hole between part of the urinary system and another organ or tissue
- **Abnormal hole between a female reproductive organ and another organ**
- **Abnormal hole between the uterus (womb) and another organ**
- Abnormal hole between the vagina and another organ **or tissue**
- Swelling and redness of the skin on the palms of the hands and soles of the feet
- **Formation of a blood clot in a vein that breaks loose and is carried by the**
blood stream to plug another blood vessel
- Formation of a blood clot in an artery that breaks loose and is carried by the blood stream to plug another blood vessel
- **Bleeding into the tumor or organs which may be life threatening**
Reproductive risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. The effect of pazopanib on your ability to have children in the future is unknown. We will tell you if we learn any new information that may affect your health, welfare, or decision to stay in this study.  
| 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,  hyper/hypotension,  tachycardia, periorbital  edema, chills, fever,  dizziness, dyspnea,  bronchospasm, lip  edema, arthralgia,  myalgia, urticaria, mild  nausea/vomiting,  abdominal pain,  flatulence, somnolence,  lethargy, headache,  seizures (L),  hyperuricemia |
| Prompt: Within 2-3 weeks,  prior to                                    | Allergic reactions (total  likelihood of local, and or  systemic reaction  especially if previous  hypersensitivity reaction to  native asparaginase), pain  at injection site, weakness,  fatigue, diarrhea | Allergic reactions (total  likelihood of local, and or  systemic reaction if no  previous hypersensitivity  reaction to native  asparaginase), rash |                                                                                                                                                                                                                                                                                        |
| Hyperammonemia (L),  coagulation abnormalities  with prolonged PTT, PT | Hyperglycemia,  abnormal liver function  tests, pancreatitis (L),                                                                                                                                            | Hemorrhage (L), DIC,  thrombosis, anorexia,  weight loss, CNS                                                                                       |                                                                                                                                                                                                                                                                                        |
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| the next course                        | and bleeding times  (secondary to decreased  synthesis of fibrinogen,  AT-III & other clotting  factors) (L)                                                                                                                                                                                                                                                                                                                                                                                                 | increased serum   | ischemic attacks, edema,   |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------|
| lipase/amylase                         | azotemia and decreased  renal function, mild  leukopenia,  granulocytopenia,  thrombocytopenia,  pancytopenia, hemolytic  anemia, infections (sepsis  with/without septic  shock, subacute bacterial  endocarditis [SBE],  URI), CNS changes  including irritability,  depression, confusion,  EEG changes,  hallucinations, coma and  stupor, paresthesias,  hypertriglyceridemia,  hyperlipidemia,  Parkinson-like  syndrome with tremor  and increase in  muscular tone,  hyperbilirubinemia,  chest pain |                   |                            |
| Delayed: Any time later during therapy | Renal failure, urinary  frequency, hemorrhagic  cystitis, elevated  creatinine and BUN, fatty  liver deposits,  hepatomegaly, liver  failure                                                                                                                                                                                                                                                                                                                                                                 |                   |                            |
| Unknown  Frequency and Timing:         | Animal reproduction studies have not been conducted with pegaspargase. It is not  known whether pegaspargase can cause fetal harm when administered to a pregnant  woman or can affect reproduction capacity. However, fetal toxicities and teratogenic  effects of asparaginase have been noted in animals. It is unknown whether the drug  is excreted in breast milk.                                                                                                                                     |                   |                            |
| L)Toxicity may also occur later.       |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |                   |                            |
guaifenesin brand name(s) mucinex
pemetrexed

| Risks and side effects related to pemetrexed include:  Likely Less Likely   | Rare but Serious                                                                                                                                                                                                                                                           |              |                                                                              |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------|
| -                                                                           | Shortness of breath                                                                                                                                                                                                                                                        |              |                                                                              |
| -                                                                           | A feeling of extreme  tiredness not relieved  by sleep                                                                                                                                                                                                                     |              |                                                                              |
| -                                                                           | Fewer red blood cells  in the blood  o A low number of  red blood cells can  make you feel  tired and weak                                                                                                                                                                 |              |                                                                              |
| -                                                                           | Fever                                                                                                                                                                                                                                                                      |              |                                                                              |
| -                                                                           | Nausea and/or vomiting                                                                                                                                                                                                                                                     | -            | Chest pain, pain in the  abdomen (belly) or pain in  other parts of the body |
| -                                                                           | Fewer platelets in the blood  o A low number of  platelets causes you to  bruise and bleed more                                                                                                                                                                            |              |                                                                              |
| -                                                                           | Elevation in the blood of  certain enzymes or bilirubin  found in the liver which  could indicate liver irritation  or damage                                                                                                                                              | -            | Allergic reactions                                                           |
| -                                                                           | Inflammation of the pancreas  (an organ in the abdomen  which produces insulin and  certain digestive chemicals)  which may affect the function  of the pancreas and which  may cause pain in the  abdomen (belly) which can be  severe and may increase the  blood sugar. |              |                                                                              |
| -                                                                           | Damage to the lungs that can                                                                                                                                                                                                                                               |              |                                                                              |
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| lead to fluid in the lungs and  affect your ability to breath  and the levels of oxygen in  the blood.   |                                                                                                                                                                                             |              |          |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|----------|
| -                                                                                                        | Fever with a low white blood  cell count which could  indicate infection and may  require hospitalization and  treatment with antibiotics                                                   |              |          |
| -                                                                                                        | Severe kidney damage (which  may be permanent)                                                                                                                                              |              |          |
| -                                                                                                        | Severe liver damage (which  may be permanent)                                                                                                                                               |              |          |
| -                                                                                                        | Clotting of blood vessels  which can lead to pain and  swelling in the area of the  clot. Such clots may break  loose and cause damage or be  life-threatening depending on  where they go. |              |          |
| -                                                                                                        | Blockage of the intestines or  bleeding in the intestines                                                                                                                                   |              |          |
| -                                                                                                        | Inflammation of the part of the  intestines known as the colon  which can lead to infection,  blood in the stools and  abdominal (belly) pain                                               |              |          |
| -                                                                                                        | Heart attack                                                                                                                                                                                |              |          |
| -                                                                                                        | Swelling and tightening of the  throat (voice box) which can  cause difficulty with breathing                                                                                               |              |          |
| -                                                                                                        | Loss of appetite                                                                                                                                                                            |              |          |
| -                                                                                                        | Fewer white blood cells  in the blood which can  make it easier to get  infections                                                                                                          |              |          |
| -                                                                                                        | Infection                                                                                                                                                                                   |              |          |
| -                                                                                                        | Cough                                                                                                                                                                                       | -            | Headache |
| -                                                                                                        | Dizziness                                                                                                                                                                                   |              |          |
| -                                                                                                        | Inflammation and/or sores  in the mouth or throat  and/or the esophagus (the  tube that carries food from  the mouth to the stomach)  that may make swallowing  difficult and are painful   |              |          |
| -                                                                                                        | Inflammation of the lining  of the stomach                                                                                                                                                  |              |          |
| -                                                                                                        | A feeling of weakness                                                                                                                                                                       |              |          |
| -                                                                                                        | Aches and pains in the  muscles and joints                                                                                                                                                  |              |          |
| -                                                                                                        | Rashes with itching and  which may cause loss of  skin                                                                                                                                      |              |          |
| -                                                                                                        | Fluid build-up under the  skin                                                                                                                                                              |              |          |
| -                                                                                                        | Hair loss                                                                                                                                                                                   |              |          |
| -                                                                                                        | Constipation or diarrhea                                                                                                                                                                    |              |          |
| -                                                                                                        | Difficulty sleeping or  falling asleep                                                                                                                                                      |              |          |
| -                                                                                                        | Weight loss                                                                                                                                                                                 |              |          |
| -                                                                                                        | Things taste differently                                                                                                                                                                    |              |          |
| -                                                                                                        | Chills                                                                                                                                                                                      |              |          |
| -                                                                                                        | Hiccoughs                                                                                                                                                                                   |              |          |
| -                                                                                                        | Excessive sweating                                                                                                                                                                          |              |          |
| -                                                                                                        | Inflammation and clotting  of blood vessels which can  lead to pain and swelling in  the area of the clot; this  may occur where the IV is  placed.                                         |              |          |
| -                                                                                                        | Irritation to the skin if the  medication leaks from the  vein                                                                                                                              |              |          |
| -                                                                                                        | Irritation to the skin at the  site of the injection                                                                                                                                        |              |          |
| -                                                                                                        | Blurred vision, runny or  red eyes                                                                                                                                                          |              |          |
| -                                                                                                        | Reddening of the face or  skin with feelings of  warmth (flushing)                                                                                                                          |              |          |
| -                                                                                                        | Low or high blood pressure                                                                                                                                                                  |              |          |
| -                                                                                                        | Excessive loss of water  from the body  (dehydration)                                                                                                                                       |              |          |
| -                                                                                                        | Low or High levels of  certain salts in the body                                                                                                                                            |              |          |
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| like sodium, magnesium  and potassium   |                                                                                                                           |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| -                                       | Increase in heart rate                                                                                                    |
| -                                       | Acid or upset stomach  (heartburn)                                                                                        |
| -                                       | Too much gas produced in  the intestines                                                                                  |
| -                                       | Depression, anxiety or a  feeling of confusion                                                                            |
| -                                       | Feeling the urgency to urinate  or pain on urination                                                                      |
| -                                       | Increased levels of a chemical  (creatinine) in the blood which  could mean kidney irritation  or damage                  |
| -                                       | High levels of sugar in the  blood that may require  treatment                                                            |
| -                                       | A problem in nerve function  that may cause pain,  numbness, tingling, and  muscle weakness in various  parts of the body |
| -                                       | Inflammation or infection of  the skin which will require  treatment with antibiotics                                     |
| -                                       | Lung infection                                                                                                            |
| -                                       | Bladder or kidney infection                                                                                               |
| -                                       | Redness or burning at the sites  which have received radiation  in the past                                               |
guaifenesin brand name(s) mucinex
pentamidine

| Common ≥ 5%                                                                                                                                                                                                                     | Rare < 1%                                                                                     |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Rash Loss of appetite Nausea Increased liver function test Nephrotoxicity Bronchospasm Cough Dyspnea (Inhalation form only) Hypotension Injection site pain Hypoglycemia Leukopenia (<1% with Inhalation form) Thrombocytopenia | Cardiac dysrhythmia Skin necrosis Skin ulcer Tissue necrosis Acute pancreatitis Anemia (1.2%) |  
- This drug may cause nausea. Inhaled form may also cause bronchospasm, cough, and dyspnea.  
- Tell patient to report unusual bleeding/bruising or signs/symptoms of new or worsening infection (fever, chills, night sweats, fatigue, anorexia), nephrotoxicity, pancreatitis, or cardiac dysrhythmia.  
- This drug may cause severe hypoglycemia. Patient should be counseled on appropriate action to take during a hypoglycemic event.  
- Advise patients using inhaled form on proper nebulizer technique. - Patient should not mix other drugs with pentamidine in the nebulizer. Tell patient to avoid using nebulizer to give any other drugs.  
- Instruct patient to lie supine while receiving intravenous form. Patient should rise slowly after administration to avoid dizziness and other potentially severe hypotensive effects.  
- Patients using intravenous form should monitor IV insertion site closely during pentamidine infusion. Advise patient to immediately report signs/symptoms of extravasation, as drug is caustic.
guaifenesin brand name(s) mucinex
pentostatin brand name(s) nipent adverse

- **Dermatologic:** Rash (26% to 43%)
- **Endocrine metabolic:** Hyponatremia (less than 3%)
- **Hematologic:** Microangiopathic hemolytic anemia, Neutropenia, Thrombotic thrombocytopenic purpura
- **Immunologic:** Immune hypersensitivity reaction (2% to 11%) - **Neurologic:** Neurotoxicity (1% to 11%)
- **Renal:** Renal failure (less than 3%)  
- **Dermatologic:** Disorder of skin (4% to 17%), Pruritus (10% to 21%) - **Gastrointestinal:** Abdominal pain (4% to 16%), Diarrhea (15% to 17%), Loss of appetite
(13% to 16%), Nausea and vomiting (53%), Stomatitis (5% to 12%)
- **Hematologic:** Anemia (8% to 35%), Hemorrhage (3% to 10%), Leukopenia (22% to 60%), Thrombocytopenia (6% to 32%)
- **Hepatic:** Increased liver function test (2% to 19%) - **Immunologic:** Infectious disease (7% to 36%)
- **Musculoskeletal:** Myalgia (11% to 19%)
- **Neurologic:** Asthenia (10% to 12%), Headache (13% to 17%) - **Renal:** Disorder of the genitourinary system (15%) - **Respiratory:** Cough (17% to 20%), Disorder of lung (12%), Dyspnea (8% to 11%),
Rhinitis (10% to 11%), Upper respiratory infection (13% to 16%)
- **Other:** Fatigue (29% to 42%), Fever (42% to 46%), Pain (8% to 20%), Shivering (11% to 19%)  
- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression. - This drug may cause shivering, nausea, vomiting, myalgia, headache, cough, fatigue, or fever.  
- Patient should report signs/symptoms of hepatotoxicity, neurotoxicity, nephrotoxicity, or pulmonary toxicity. Patients receiving high dosages are at higher risk for these effects.  
- Advise patient to report angina, or signs/symptoms of cardiac dysrhythmia, heart failure or myelosuppression  
- hypersensitivity to pentostatin or any component of the product
guaifenesin brand name(s) mucinex
phentolamine mesylate brand name(s) oraverse

- **SeriousCardiovascular:** Cardiac dysrhythmia, Chest pain, Hypotension, Myocardial infarction
- **Neurologic:** CVA - cerebrovascular accident due to cerebral artery occlusion  
- **Dermatologic:** Injection site pain (4% to 6%)
- **Gastrointestinal:** Diarrhea (less than 3%)
- **Respiratory:** Nasal congestion (10%) - **Other:** Posttreatment pain (up to 10%)  
- This drug may cause nasal congestion, flushing, orthostatic hypotension, and arrhythmias.  
- Submucosal injection may cause pain at injection site.  
- Advise patient to report tachyarrhythmia or other signs/symptoms of cardiac dysfunction with parenteral forms.  
Precautions
- concomitant use with fludarabine phosphate is not recommended due to an increased risk of fatal pulmonary toxicity
- higher than recommended doses; may increase the risk of severe renal, liver, pulmonary, and CNS toxicity
- acute pulmonary edema and hypotension, some cases fatal, have been reported in bone marrow transplant patients who received pentostatin in combination with carmustine, etoposide, and high-dose cyclophosphamide (unapproved use)
- infection, active; use caution in patients with preexisting infection; withhold pentostatin if active infection develops during therapy
- nervous system toxicity may occur; withhold or discontinue therapy if nervous system toxicity occurs
- neutropenia, severe or worsening of, has occurred; monitoring recommended; temporarily withhold therapy for severe neutropenia
- rash, severe, has been reported; withhold therapy if severe rash occurs - renal impairment - renal toxicity (eg, elevated serum creatinine) has been reported; monitoring recommended; withhold therapy for elevated serum creatine
- angina
- coronary artery disease, other evidence suggestive of
- coronary insufficiency
- hypersensitivity to phentolamine or related compounds - myocardial infarction, history or recent
- specific contraindications have not been determined when used for soft-tissue anesthesia reversal in dental procedures (ORAVERSE(TM))
guaifenesin brand name(s) mucinex
precautions

- cardiovascular disease, history; increased risk of tachycardia and cardiac arrhythmias
(ORAVERSE(TM))
- cerebrovascular spasm and occlusion have been reported, usually in association with marked hypotensive episodes following parenteral administration
- myocardial infarction has been reported, usually in association with marked hypotensive episodes following parenteral administration  
| Common                                                                                                                                                                                                          | Serious                                                                                                                                                                                                                                                                                                                                                                        |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Swelling of the limbs Chloasma Hisutism Bloating Nausea Stomach cramps Vomiting Headache Migraine Depression Mood changes Breast tenderness, pain, and/or swelling Disorder of menstruation Withdrawal bleeding | Heart disease Hypertension Myocardial infarction Body fluid retention Breast cancer Hypercalcemia Gallbladder disorder Pancreatitis Deep venous thrombosis Venous thromboembolism Anaphylaxis Cerebrovascular accident Dementia Impaired cognition Thrombosis of retinal vein Malignat neoplasm of endometrium of corpus uteri Ocarian cancer Pulmonary embolism Breast cancer |  
Piperazine (Estropipate)
guaifenesin brand name(s) mucinex
piroxicam brand name(s) feldene adverse

- **Dermatologic:** Injection site reaction (34%)
- **Gastrointestinal:** Diarrhea (37%), Nausea (34%), Vomiting (10%)
- **Musculoskeletal:** Arthralgia (13%)
- **Neurologic:** Dizziness (11%), Headache (22%) - **Other:** Fatigue (27%)  
- Drug may cause splenic rupture. Advise patient to report left upper abdominal, scapular, or shoulder pain.  
- Drug may cause injection site reactions, headache, arthralgia, dizziness, vomiting, diarrhea, nausea, and fatigue.  
- Instruct patient to report signs and symptoms of systemic reaction (urticaria, periorbital swelling, dyspnea, hypoxia).  
- Instruct patient to report signs and symptoms of vasovagal reaction (orthostatic hypotension, syncope).  
- specific contraindications have not been determined
guaifenesin brand name(s) mucinex
precautions

- leukemia; may mobilize leukemic cells and contaminate the apheresis product; use not recommended
- peripheral blood neutrophil counts above 50,000/mcL; monitoring recommended - renal impairment, moderate and severe (CrCl 50 mL/min or less); dose reduction recommended
- thrombocytopenia has been reported
- women of childbearing potential; risk of fetal harm; avoid pregnancy using effective contraceptive measures
- report suspected adverse reactions to the Genzyme Corporation at 1-877-4MOZOBIL or to the US Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch  
| Common ≥ 2%                                                                                         | Rare <1%                                      |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Diarrhea (2%) Flatulence (1.2%) Heartburn (2%) Nausea (1.6%) Vomiting (1.6%) Rhabdomyolysis (11.8%) | Pancreatitis Hepatotoxicity Rupture of tendon |  
This drug should be discontinued 4 to 7 days before major surgery, as patient is at higher risk for occurrence of rhabdomyolysis.  
This drug may cause nausea, vomiting, diarrhea, abdominal pain, asthenia, headache, and flulike symptoms.  
Tell patient to report signs/symptoms of rhabdomyolysis (myalgias, dark urine, arthralgias, fatigue) or myopathy (unexplained muscle aches, tenderness, or weakness).  
Patient should take this drug at least 1 h before or 4 h after cholestyramine, colestipol or other bile-acid-binding resins.  
Patient should not drink large amounts of alcohol taking this drug.
guaifenesin brand name(s) mucinex
prazosin hydrochloride

| Common ≥ 1%                                                                                                                                                        | Rare <1%     |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Orthostatic hypotension (1-4%) Palpitation (5.3%) Syncope (1-4%) Nausea (4.9%) Asthenia (6.5%) Dizziness (10.3%) Headache (7.8%) Lethargy (6.9%) Somnolence (7.6%) | Pancreatitis |  
Tell patient to avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness and somnolence.  
Instruct patient to rise slowly from a sitting/lying position, as this drug may cause orthostatic hypotension.  
Patient may experience syncope or loss of consciousness, especially within 24 h of first dose.  
This drug may cause angina, palpitations, tachyarrhythmia, nausea, and asthenia.  
Advise patient against sudden discontinuation of drug, as this may cause rebound hypertension.  
Patient should not drink alcohol while taking this drug.  
| Common                                                                                                                                                                                                                                                                     | Serious                                                                                                                                                                                                                                                                            |              |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Body fluid retention Hypertension Acne Ecchymosis Skin superinfection Decreased body growth Hyperglycemia Abnormal lipids Gastrointestinal superinfection Muscle weakness Osteroporosis Headache Cararact Glaucoma Raised intraocular pressure Euphoria Psychotic disorder | Congestive heart failure Kaposi's sarcoma Diabetes mellitus with hyperosmolar coma Diabetic ketoacidosis Latrogenic Cushing's disease Secondary hypocortisolism Gastrointestinal perforation Pancreatitis Drug-induced myopathy Pseudotumor cerebri Seizure Pulmonary tuberculosis |              |
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guaifenesin brand name(s) mucinex
prednisolone

General superinfection  
| Common                                                                                                                                                                                                                                                                                                                         | Rare <1%                                                                                                                                                                                                                                                                                                                                     |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hypotension Orthostatic hypotension Diminished sweating Light sensitivity Constipation Xerostomia Akathisia Dizziness Drug-induced tardive dystonia Dystonia Extrapyramidal disease Parkinsonian Somnolence Tardive dyskinesia Blurred vision Epithelial keratopathy Eye/vision findings Retinitis pigmentosa Nasal congestion | Prolonged QT interval Torsades de pointes Obstipation Paralytic ileus Agranulocytosis Disorder of hematopoietic structure Leucopenia Thrombocytopenia Cholestatic jaundice syndrome Drug-induced lupus erythematosus, systemic Ineffective thermoregulation Heatstroke or hypothermia Neuroleptic malignant syndrome  Seizure Priapism Death |
guaifenesin brand name(s) mucinex
prochlorperazine

Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness and somnolence.  
Advise patient to rise slowly from a sitting/lying position, as drug may cause orthostatic hypotension.  
This drug may cause false readings on some types of pregnancy tests.  
Drug may impair heat regulation. Advise patient to use caution with activities leading to an increased core temperature, such as strenuous exercise, exposure to extreme heat, or dehydration.  
This drug may cause anticholinergic effects, eye dryness, extrapyramidal signs, and progressive loss of peripheral vision.  
Tell patient to report signs/symptoms of tardive dyskinesia (jerky muscle movements, tongue thrusting, facial grimacing/ticks, random movements of extremities) or neuroleptic malignant syndrome (sweating, fever, stupor, unstable blood pressure, muscular rigidity, autonomic dysfunction).  
Patients using intravenous form should maintain adequate hydration to prevent volume depletion and hypotensive effects. Parents or caretaker of pediatric patients should report recent illness or dehydration before next dose is given.  
Advise patient to avoid drinking alcohol or taking other central nervous system depressants during prochlorperazine therapy.  
Patient taking oral form should not take calcium- and magnesium-based antacids concomitantly with this drug.  
For patients taking multiple oral doses per day, instruct patient to take a missed dose if within 1 h of regular dosage time, otherwise skip the missed dose and continue with regular schedule.  
| Common                                               | Serious                                              |
|------------------------------------------------------|------------------------------------------------------|
| Rash Leukopenia Fever Skin rash Headache Sore throat | Hepatic Necrosis (<1%) Liver failure Nephritis (<1%) |  
Tell patient that symptomatic improvement may not be seen for a few weeks.  
Patient should immediately report, fever, skin rash, sore throat, or headache.  
Advise patient to report signs/symptoms of hepatic dysfunction, such as anorexia, pruritus, right upper quadrant pain, fatigue, weakness, abdominal pain that is vague, loss of appetite, itching, bruising, and yellowing of the eyes.  
Advise patient of importance of taking this drug regularly and at evenly spaced intervals as prescribed.  
If a dose is missed and it is almost time for the next dose, instruct patient to use two doses together and then return to the regular dosing schedule.  
Patient should contact healthcare professional if more than one dose is missed.  
|                                                                                                                                                                                   |                                    |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Common                                                                                                                                                                            | Serious                            |
| Diaphoresis Diarrhea Excessive salivation Increased peristalsis Nausea  Vomiting Stomach cramps Muscle cramps  Muscle fasciculation Asthenia Miosis Excessive bronchial secretion | Bradyarrhythmia Cholinergic crisis |  
Patient should avoid activities requiring visual clarity until drug effects are realized. This drug may cause diaphoresis, diarrhea, excessive salivation, nausea, vomiting, stomach cramps, muscle cramps/fasciculation, asthenia, or excessive bronchial secretions.  
Patient should report increasing muscle weakness, as this could be a sign of underdosage or cholinergic crisis (overdosage).  
Advise patient to also report signs/symptoms of bradyarrhythmia.  
Tell patient to take drug with food or milk to minimize gastric irritation.  
Patient should not drink alcohol while taking this drug.  
| Common                                                                                | Serious                                                                                   |
|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Headache Swelling of the limbs Abdominal pain Diarrhea Nausea Dizziness Sleeplessness | Stevens-Johnson syndrome Bone fracture (Osteoporosis-related) Hip fracture Rhabdomyolysis |
guaifenesin brand name(s) mucinex
rabeprazole sodium

This drug may cause edema, abdominal pain, diarrhea, nausea, dizziness, headache, and insomnia.  
Advise patients being treated for duodenal ulcer to take drug after the morning meal.
guaifenesin brand name(s) mucinex
raloxifene hydrochloride

| Common     | Serious                                                                                                  |
|------------|----------------------------------------------------------------------------------------------------------|
| Hot sweats | Deep venous thrombosis                                                                                   |
| Leg cramps | Venous thromboemoblism (1%) Verebrovascular accident Thrombosis of tetinal vein (<1%) Pulmonary embolism |  
Advise patient to avoid sitting for prolonged periods of time, as drug increases risk of venous thromboembolic disorders, especially during first 4 months of therapy.  
This drug may cause leg cramps and hot flashes (especially during the first 6 months of therapy).  
Instruct patient to report signs/symptoms of cerebrovascular accident, pulmonary embolism, and deep vein thrombosis.  
Patient should not use cholestyramine, colestipol, or an estrogen pill, patch, or injection while taking this drug.  
| Common                                                            | Serious                                                                                                         |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Hypotension Hyperkalemia Nausea Vomiting Dizziness Cough  fatigue | Intestinal angioedema Liver failure (starting with cholestatic jaundice)  (<1%) Angioedema (face, lips, throat) |  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness.  
- Advise patient to rise slowly from a sitting or lying position.  
- This drug may cause nausea, vomiting, persistent cough, and fatigue.  
- Tell patient to report signs/symptoms of angioedema (deep swelling around eyes and lips and sometimes hands and feet), intestinal angioedema (abdominal pain), unusual bleeding, or infection.  
- Instruct patient to maintain adequate hydration to prevent volume depletion and symptomatic hypotension.  
- Patient should avoid using potassium-containing supplements or salts while taking this drug.
guaifenesin brand name(s) mucinex
reserpine

| Common                                                    | Serious                                                                                                             |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Dizziness Lethargy Depression Nasal congestion Chest pain | Cardia dysrhythmia Gastrointestinal hemorrhage Thrombocytopenia (<1%) Vivid dreams Dream anxiety disorder Impotence |  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized.  
- This drug may cause dizziness, lethargy, nasal congestion, vivid dreams, dream anxiety disorder, or impotence.  
- Advise patient to report depression, chest pain, or signs/symptoms of gastrointestinal hemorrhage or cardiac dysrhythmia.  
- Tell patient to avoid abrupt discontinuation of drug. - Patient should not drink alcohol while taking this drug. - If a dose of reserpine is missed, advise patient to skip the missed dose and return to regular dosing schedule.  
| Common                                                                                                                                                         | Serious                                            |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Abnormal color Sweat Heartburn Loss of appetite Nausea Saliva discoloration Increased liver function test Tear discoloration Discolored urine Flu-like illness | Thrombocytopenia (high-dose therapy_ Hepatotoxcity |  
- This drug may decrease effectiveness of oral contraceptives with concurrent use.  
Recommend additional form of birth control.  
- Warn patient that drug may permanently discolor soft contact lenses. - Tell patient that drug causes red-orange discoloration of urine, feces, saliva, sweat, and tears.  
- This drug may cause flu-like symptoms, heartburn, or anorexia.  
- Advise patient to report signs/symptoms of hepatotoxicity or thrombocytopenia.  
- Patient should take drug in combination with other antibiotics exactly as prescribed, as resistance to this drug may occur rapidly.  
- Tell patient to take drug 1 h before or 2 h after a meal with a full glass of water.  
- Patient should not drink alcohol while taking this drug.  
| Common                                                                                                                                      | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |              |
|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Pruritus Nausea Vomiting Asthenia Dizziness Headache Fever (all grades, 53%; grades 3 & 4, 1%) Shivering (all grades, 33%; grades 3 & 4, 3% | Angina Cardia dysrhythmia Drug-induced pemphigus Lichenoid dermatitis Stevens-Johnson syndrome Toxic epidermal necrolysis Bowel obstruction Gastrointestinal perforation Anemia (all grades, 8%; grades 3 & 4, 3%) Aplastic anemia (transient) Cytopenia (grade 3 & 4, 48%) Hemolytic anemia Leukopenia (all grades 14%; grade 3 & 4, 4%) Lymphocytopenia (grade 3 & 4, 40%) Neurtropenia (all grades, 14%; grade 3 & 4, 6%) Thrombocytopenia (all grades, 12%; grade 3 &  4, 2 %) Relapsing type B viral hepatitis Complication of infusion (1st infusion, 77%;  subsequent infusions, 14-30%) |              |
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guaifenesin brand name(s) mucinex
rituximab

| Allergic reaction Progressive multifocal leukoencephalopathy Nephrooxicity Obliterative bronchiolitis Pneumonitis Infection (all grades 31%; grades 3 & $, 4%) Tumor lysis syndrome   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
guaifenesin brand name(s) mucinex
intravenous (solution)

- Fatal infusion reactions may occur within 24 hours of rituximab infusion; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue rituximab infusion for severe reactions. Acute renal failure requiring dialysis with instances of fatal outcome can occur in the setting of Tumor Lysis Syndrome following treatment in patients with non-Hodgkin's lymphoma. Severe and potentially fatal mucocutaneous reactions can occur. JC virus infection resulting in Progressive Multifocal Leukoencephalopathy (PML) and death can also occur.  
- Advise patient to avoid vaccines during therapy due to drug-induced immunosuppression.  
- Recommend women of childbearing potential use reliable contraception to avoid pregnancy during therapy and at least 12 months post-treatment.  
- This drug may cause nausea, vomiting, asthenia, dizziness, headache, or pruritus. - Tell patient to immediately report signs/symptoms of allergic reaction or severe mucocutaneous reaction such as dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering).  
- Patients with a history of hepatitis B should report signs/symptoms of an active infection, as drug may cause a relapse of hepatitis B.  
- Patient should also report signs/symptoms of myelosuppression, renal failure, hypotension, angina/cardiac dysrhythmia, or bronchiolitis/pneumonitis.
guaifenesin brand name(s) mucinex
romidepsin adverse effects serious

- **Cardiovascular:** Supraventricular arrhythmia (6%), Ventricular arrhythmia (4%),
Hypotension (7-23%)
- **Hematologic:** Anemia, Grades 3/4 (3% to 28%), Leukopenia, Grades 3/4 (Up to 45%),
Neutropenia, Grades 3/4 (4% to 47%), Thrombocytopenia, Grades 3/4 (up to 36%)
- **Immunologic:** Sepsis (5%) - **Other:** Tumor lysis syndrome (1% to 2%)  
- **Cardiovascular:** EKG ST segment changes (2% to 63%)
- **Dermatologic:** Pruritis (7-31%) - **Endocrine metabolic:** Weight decreased (10% to 15%); Hyperglycemia (2-51%);
Hypermagnesemia (up to 27%); Hyperuricemia (up to 33%), Hypoalbuminemia (3-48%),
Hypocalcemia (4-52%), Hypokalemia (6-20%), Hypomagnesemia (22-28%),
Hyponatremia (up to 20%), Hypophosphatemia (up to 27%),
- **Gastrointestinal:** Loss of appetite (23% to 54%), Nausea (56% to 86%), Vomiting (34%
to 52%), Constipation (12-40%), Diarrhea (20-36%), Altered taste sense (15-40%),
- **Hematologic:** Anemia, All grades (19% to 72%), Leukopenia, All grades (4% to 55%),
Neutropenia, All grades (11% to 66%), Thrombocytopenia, All grades (17% to 72%)
- **Hepatic:** ALT/SGPT raised (3-22%), AST/SGOT raised (3-28%), - **Immunologic:** Infectious disease (19% to 54%), Lymphocytopenia (4% to 57%)
- **Neurologic:** Asthenia, Headache (15% to 34%)
- **Respiratory:** Cough (18% to 21%), Dyspnea (13-21%),Pneumonia (5%)
- **Other:** Fatigue, Shivering (11% to 17%), Fever (20-47%)  
| Common               | Serious                                                                                                                                                                     |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Edema (4.8 to 14.7%) | Angina                                                                                                                                                                      |
| Weight gain          | Congestive heart failure Myocardial infarction Myocardial ischemia Cholestatic hepatitis Hepatotoxicity (<1%) Diabetic macular edema (<1%) Pleural effusion Pulmonary edema |  
- Premenopausal, anovulatory patients should use reliable contraception, as drug may stimulate ovulation.  
- This drug may cause edema and weight gain. - Advise patient to report signs/symptoms of congestive heart failure or pulmonary edema.  
- Tell patient that symptomatic improvement may not be seen for a few weeks and full effect of drug may not be realized until after 2 to 3 months of therapy.  
- Advise diabetic patients to monitor for signs/symptoms of hyper- or hypoglycemia and to report difficulties with glucose control, especially patients on concomitant hypoglycemic agents.  
| Common ≥ 2%                                                                                                                  | Rare < 2%                                                       |              |
|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------|
| Abdominal pain Constipation Nausea Arthralgia Myalgia Asthenia Headache Urinary tract infection Pharyngitis Flu-like illness | Abnormal liver enzymes Muscle disorders Rhabdomyolysis Backache |              |
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| Issued 12 June 2013                                                                                                          |                                                                 |              |  
Rupture of tendon tendinitis  
- This drug may cause headache and pharyngitis.  
- Patient should report signs/symptoms of myopathy or rhabdomyolysis (myalgias, dark urine, arthralgias, fatigue).  
- Patient should not use any aluminum- or magnesium-containing antacids for at least 2 h after taking this drug.  
- Advise patient to avoid using gemfibrozil while taking this drug.
guaifenesin brand name(s) mucinex
saha

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen. Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking SAHA. In some cases, side effects can be serious, long lasting, or may never go away. The combination of SAHA and 13-cis RA (for those children who will take both) may result in an unexpected toxicity. You should talk to your study doctor about any side effects that you have while taking part in the study. A child getting SAHA had blood clotting in his blood vessels, and this may be related to the SAHA. There have been reports of changes in blood clotting ability in patients who received both coumadin and SAHA. If you are receiving coumadin, you will be monitored carefully for signs related to increased risk of bleeding (such as easy bruising, bleeding from nose, gums etc.) In addition, the ability of your blood to clot will be watched more closely (at least monthly). Risks and side effects that adults who have been given SAHA had included those which are:
Likely  
- Low Blood Counts: decreased red blood cells (anemia), lower numbers of white blood cells (infection fighting cells) which may increase your risk of infection, decrease in the type of blood cells that act to help stop bleeding when you are cut.  
- feeling tired - weight loss
- decreased appetite
- diarrhea (watery bowel movements)
- nausea
- vomiting
- weak kidney function
- high levels of sugar in the blood
- bleeding of the upper digestive tract Less Likely:
Low Blood Counts: decreased number of a type of white blood cells, fever with dangerously low white blood cell count, infection that occurs when the white blood cell count is low.  
Heart-related: abnormal electrical conduction within the heart General: fever, chills, shivering, hair loss, infection, dehydration, dry mouth, swelling of the arms and legs, head pain Stomach/Intestine-related: constipation, heartburn, abnormal sense of taste, pain in the stomach Laboratory test-related: low levels of a blood protein called albumin, abnormal bone enzyme level, abnormal liver enzyme level, abnormal level of bilirubin in the blood (Bilirubin is a bile pigment found in the liver), low levels of potassium, sodium, phosphate, and calcium in the blood, increased blood magnesium level Nervous system-related: muscle spasms, muscle weakness, dizziness, condition of the nervous system that causes numbness, tingling, burning Breathing-related: cough, shortness of breath Vein-related: formation or presence of a blood clot inside a blood vessel, a blood test to check blood clotting ability Rare but Serious:
- Death of skin cells The following side effects have been experienced by adults treated on SAHA studies, but it is not certain yet if they are related to taking the drug SAHA
Heart-related: change in the regular beat of the heart, abnormally high or low blood pressure, changes in the heart rhythm which may affect blood flow, heart attack. General: sleeplessness, infection, sweating, pain throughout different parts of the body. Laboratory-test related: abnormalities in the balance of salts, proteins, sugars, and acids in the blood Muscle/Joint related: changes in the way you walk Nervous-system related: confusion Skin-related: hair loss, bruising, itching and rash, nail changes, tiny broken blood vessels under the skin.  
Stomach/Intestine related: difficulty swallowing, gas, inflammation, bleeding, acid from the stomach flowing back up which may cause damage to the throat tissues. Breathing related:, sinus congestion, coughing up of blood from the lungs indicating possible lung damage.  
Kidney-related: retaining urine in the body, inability to control bladder, blood in urine. Vein-related: changes to the way the blood clots, blood clot within a blood vessel.
guaifenesin brand name(s) mucinex
death

Patients receiving SAHA also experienced the following side effects and these may be related to the SAHA:
- a decrease in blood flowing to the brain which led to a stroke
- painful mouth sores
- decrease in memory function,
- bleeding of the respiratory tract
- kidney failure
- liver failure
- Loss of muscle coordination; awkward, uncoordinated walking; unsteadiness when walking  
| Common                                                                         | Serious                                                                                                    |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Constipation Stomach and bowel irritation Headache Upper respiratory infection | Liver toxicity (<1%) Compartment Syndrome of lower leg Muscle disorder Rhabdomyolysis (<1%) Tendon rupture |  
- This drug may cause constipation, gastrointestinal irritation, headache, and upper respiratory infection.  
- Patient should not drink alcohol while taking this drug. - Patient should not eat grapefruit or drink grapefruit juice while using this drug.  
| 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                                                              |                                                    |                                                                                                         |
| Headache (L), hypertension (L), nausea, immunosuppression  (L), diarrhea, constipation, | Chest pain, insomnia, dyspepsia, vomiting, dyspnea | Hypotension, asthma,  increased cough, flu like syndrome,  tachycardia, anorexia, sensitivity reactions |
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guaifenesin brand name(s) mucinex
sirolimus (rapamycin)

| fever                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |                                                                                                                                                                                             |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prompt: Within 2-3 weeks,  prior to next course                         | Gastritis, esophagitis,  flatulence, CNS abnormalities:  (Confusion (L),  somnolence (L), depression (L),  anxiety, anxiousness, paresthesias,  emotional lability,  hypo/ hypertonia, dizziness,  neuropathy, hypesthesia,  nervousness),  infections (bacterial, fungal,  viral sepsis, cellulitis, herpes simplex &  zoster, EBV, mycobacterial,  sinusitis, pharyngitis, abscess, pneumonia,  bronchitis, peritonitis), pleural  effusions, pleural edema, hypoxia  thrombosis, thrombophlebitis,  myalgia, delayed  wound healing, |                                                                                                                                                                                             |
| Delayed: Anytime later during  therapy, excluding the  above conditions | Tremor (L), renal dysfunction, elevated creatinine/BUN anemia, asthenia, pain (abdominal, back,  pain), hyperlipidemia, hypercholesteremia, hypertrigylceridema, hyperglycemia, peripheral edema,  weight gain, arthralgia                                                                                                                                                                                                                                                                                                              | Elevated LFT's, UTI, URI's, mild thrombocytopenia, leukopenia, hyper/hypokalemia  (L), hypophosphatemia,  rash, hives, pruritis, hyperuricemia,  delayed wound healing, hypomagnesaemia (L) |
| Acne                                                                    | Skin ulcer, hirsutism  (hypertrichosis) (L), gingival hyperplasia,  abnormal vision, ear pain, cataracts, otitis,  tinnitus, hemorrhage, ileus, chronic renal  dysfunction, renal tubular necrosis, post  transplant diabetes mellitus (L), CHF,  ascites, thrombocytopenic  purpura  (hemolyticuremic syndrome), arthrosis,  bone necrosis, osteoporosis                                                                                                                                                                               |                                                                                                                                                                                             |
| Late:                                                                   | Lymphoproliferative                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                             |
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Anytime after completion of therapy  
disorders, skin malignancies  
(L) Toxicity may also occur later.  
Unknown Frequency and Timing: Sirolimus was embryo/feto toxic in rats at dosages of 0.1 mg/kg and above (approximately 0.2 to 0.5 the clinical doses adjusted for body surface area). Embryo/feto toxicity was manifested as mortality and reduced fetal weights (with associated delays in skeletal ossification). Sirolimus is excreted in trace amounts in milk of lactating rats. It is not known whether sirolimus is excreted in human milk.
guaifenesin brand name(s) mucinex
sodium phenylbutyrate

| Common ≥4%                                                                                                                                    | Rare < 4%                                                                                                                                                                                                                                                                                                                                                                                                               |
|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lower limb swelling Skin rash Hypoalbuminemia Metabolic acidosis Alkalosis Hyperchloremia Anorexia Epigastric discomfort Abnormal menstration | Arrythmias Syncope Hyperuricemia Hypokalemia Hypothosphatemia Hypernatremia Weight gain Taste aversion Abdominal pain Nausea Vomiting Gastritis Peptic ulcer Retal bleeding Constipation Pancreatitis Aplastic anemia Anemia Leukopenia Leukocytosis Thrombocytopenia Thrombocytosis Headache Depression Fatigue Somnolence Lightheadedness Disorientation Memory impairment Renal tubular acidosis Offensive body odor |  
Risks and side effects related to Sorafenib include those which are:  
Likely:
- Hair loss
- Inflammation of the skin on the palms of the hands or soles of the feet
- Rash / flaking or shedding of outer layer of skin
- Fatigue or tiredness
- Loss of appetite
- Diarrhea - Nausea - Low levels of a blood protein called albumin - Low blood phosphate level
- Stomach ache
guaifenesin brand name(s) mucinex
less likely

Low blood counts: decrease in a red blood cell protein that carries oxygen in the body, decreased total number of white blood cells, decreased number of a type of white blood cell, decreased number of blood cells that help clot blood. Stomach / Intestine Related: bleeding in the digestive tract, constipation, painful inflammation and ulceration of the lining of the mouth and digestive tract, vomiting. Laboratory test-related: increased liver enzymes, abnormal liver or bone enzyme level, abnormal digestive enzyme level, high blood levels of a liver pigment indicative of abnormal liver function, low blood calcium level, high blood sugar, low blood sugar, abnormal level of fat-digesting enzyme, high blood potassium level, low blood potassium level, low blood sodium level.  
Breathing-related: shortness of breath, cough, fluid accumulation around the lungs (pleural effusion), voice changes (for example hoarseness, loss or change in voice), bleeding of the respiratory tract or lungs Skin-related: dry skin, itching.  
General: allergic reaction, dizziness, fever (with or without a dangerously low white blood cell count), weight loss, infection (with or without a low white blood cell count), pain throughout the body (such as back pain, chest pain, leg pain, headache, joint pain, muscle pain), difficulty sleeping or falling asleep.  
High blood pressure Bleeding in the reproductive organs or urinary system (such as the bladder or kidney) Swelling of the arms and legs Nerve damage causing numbness, tingling, or burning Kidney failure Formation or presence of a blood clot inside a blood vessel Rare but Serious: Heart-related: decreased blood supply to the heart, heart attack, decrease in the ability of the heart to pump blood. Nervous system-related: bleeding into the brain or spinal cord, Syndrome caused by high blood pressure characterized by headache, confusion, seizures, and vision loss associated with imaging findings.  
Stomach / Intestine-related: A hole somewhere in the intestinal tract from the esophagus to the anus. Reproductive Risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Abstinence is an acceptable method of birth control.  
| Common ≥ 3%                                                                                                                                                                                                                                                                                                            | Serious                                                                                                                                                                                                                                                                                                                                                                                                                 |              |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Rash (3-13%) Pruritus (3-4%) Abdominal pain (8%) Indigestion (13-33%)  Loss of appetite (33%) Nausea (19-33%)  Vomiting (8-33%)  Stomatitis (4%) Headache (9-33%)  Dizziness (4%) Oligozoospermia (reversible) (33%) Macrocytosis (9%) Fever (3-5%)  Discolored urine urticaria (3%) abnormal liver function test (4%) | Leukopenia (3.7%) Macrocytic anemia (<1%) Neutropenia (2%) Stevens-Johnson syndrome (<1%) Agranulocytosis (1%) Aplastic anemia (<1%)  Leukopenia (<3%) Hemolytic anemia (<3%)  Pure red cell aplasia (<1%) Thrombocytopenia (1%) Fulminant hepatic failure (<1%) Liver toxicity (<1%) Hypersensitivity reaction (<1%) Systemic lupus erythematosus (<1%) Central nervous system disorder (<1%) Myoneural disorder (<1%) |              |
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guaifenesin brand name(s) mucinex
sulfasalazine

| Hypogammaglobulinemia (10%)   | Kidney disease (<1%) Male infertility (<1%) Diffuse interstitial pulmonary fibrosis (<1%)   |
|-------------------------------|---------------------------------------------------------------------------------------------|  
- Inform patient that drug may cause urine/skin to turn yellow-orange color.  
- This drug may cause anorexia, nausea, vomiting, and headache. - Advise patient to report signs/symptoms of nephrotoxicity/hepatoxicity. - Patient should maintain adequate hydration during therapy to prevent renal stone formation.  
- Tell patients being treated for arthritis that symptomatic improvement may not be seen for 4 to 12 weeks.  
- Patient should take drug after meals.
guaifenesin brand name(s) mucinex
sulindac

| Risks and side effects related to Sulindac include those which are:                                                                                                                                                                                         | Rare but serious (see next                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |              |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Likely                                                                                                                                                                                                                                                      | Less Likely                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                | page)        |
| -                                                                                                                                                                                                                                                           | You may be                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |              |
| unaware of an infection  when the white count is  low (neutropenia) because  you may not develop a  fever while taking  Sulindac  - A decrease in the  ability of the platelets to  clot the blood which may  lead to bruising and to  bleeding more easily | - Acid or upset Stomach (heartburn) - Stomach or abdominal (belly) pain - Nausea and/or vomiting - Diarrhea or constipation - Headache - Drowsiness  - Fluid retention which could lead to weight  gain and puffiness  - Ringing in the ears or a decrease in the  ability to hear - Too much gas produced in the intestines - Cramping and discomfort in the intestines  - Dry mouth and/or a metallic or bitter taste in  the mouth - Itching and/or a rash - Sweating - Loss of appetite - Anxiety or depression - Sleepiness or inability to sleep (insomnia) - A feeling of weakness and/or tiredness - Numbness and tingling in the fingers and  toes - Fainting - Blurred vision - Inflammation and/or sores in the mouth that  may make swallowing difficult and are  painful (painful mouth sores) - Inflammation of the stomach - Increased tendency to sun burn |              |
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Rare but serious side effects of Sulindac
- Severe allergic reactions which can be life threatening or fatal with may include shortness of breath, low blood pressure, rapid heart rate, chills and fever, aches and pains in the muscles or joints, and abnormal laboratory values in blood tests
- 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.  
- Irritation of the small airways of your lungs that can make you cough and wheeze
- Inflammation of the part of the intestines known as the colon which can lead to infection, blood in the stools and abdominal (belly) pain
- Severe rashes which can affect the skin and mucous membranes and be life-threatening
•Bleeding due to irritation of the gastrointestinal tract and/or from erosion of the lining of the stomach
(an ulcer) which if untreated could rupture and may be fatal
- Inflammation or damage to the liver which can be severe and life-threatening and which may lead to an enlarged liver, a yellow appearing skin, and fluid collection in the abdomen which makes it look larger.  
- Inflammation of the pancreas (an organ in the abdomen which produces insulin and certain digestive chemicals) which may affect the function of the pancreas and which may cause pain in the abdomen (belly)which can be severe and may increase the blood sugar
- Severe damage to the kidney which may be irreversible and lead to kidney failure
- Drugs of this type called non-steroidal anti-inflammatory drugs (NSAIDS) have been associated with severe cardiovascular events such as heart attack, high blood pressure or stroke. This is more likely to occur in patients who are older, who have had coronary artery surgery or who have diseases that make them more susceptible to events of this type.  
- Seizures
•Changes in mood which may include severe depression, feelings of suicide, and feelings of aggressiveness
•Temporary inflammation of the brain which could lead to a stiff neck and severe headaches.  
- Damage to the heart muscle which may make you tired, weak, feel short of breath, and retain fluid
- Fewer white blood cells, red blood cells and platelets in the blood
-a low number of white blood cells can make it easier to get infections
-a low number of red blood cells can make you feel tired and weak
-a low number of platelets causes you to bruise and bleed more easily  
| Common                                                                                                                                                                                                                                                            | Serious                                                                                                                                                                                                                                                        |              |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Discoloration of skin, yellow (19-30%) Dry skin (18%) Rash (14-27%)  Hypothyroidism (3-36%)  Abdominal pain (22%) Constipation (16-20%)  Diarrhea (40-58%)  Increased serum lipase level (25-52%)  Indigestion (28%) Inflammatory disease of mucous membrane (29- | Porlonged QT interval (<0.1%) Severe hypothyroidism Gastrointestinal perforation (<1%) Pancreatitis (1%) Tumor hemorrhage (3%) Throbotic microangiopathy Liver failure (<1%) Posterior leukoencephalopathy syndrome,  reversible (<1%) Pulmonary embolism (1%) |              |
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Page 238
guaifenesin brand name(s) mucinex
sunitinib malate

| 43%) Loss of appetite (33-38%)  Nausea (49%) Mouth/tooth pain (6-10%)  Taste aversion (21-44%)  Vomiting (28%) Anemia (26-71%)  Bleeding (18-30%)  Leukopenia (78%) Lymphocytopenia (38-59%)  Neutropenic disorder (53-72%)  Abnormal liver function test Asthenia (22%) Increased uric acid level (41%) Hypertension (15-30%)  Left ventricular cardiac dysfunction (11-21%)  Thrombocytopenia (38-65%)   | Pulmonary hemorrhage Infection   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
|                                                                                                                                                                                                                                                                                                                                                                                                            |                                  |  
- This drug may cause yellow discoloration of skin, diarrhea, mucositis, anorexia, stomatitis, dyspepsia, nausea, vomiting, altered taste sense, hypertension, or asthenia.  
- Tell patient to report signs/symptoms of left ventricular dysfunction or congestive heart failure.  
- Patient should also report signs/symptoms of hemorrhagic events including pulmonary hemorrhage.  
- Patient should avoid eating grapefruit or drinking grapefruit juice while taking this drug.
guaifenesin brand name(s) mucinex
sunitinib

You may have side effects while on the study. Everyone taking part in the study will be watched carefully for any side effects. However, doctors don't know all the side effects that may happen.  
Side effects may be mild or very serious. Your health care team may give you medicines to help lessen side effects. Many side effects go away soon after you stop taking the Sunitinib. In some cases, side effects can be serious, long lasting, or may never go away. You should talk to your study doctor about any side effects that you have while taking part in the study. Possible Risks of Heart Damage: As of December 2007, two of 12 patients treated on this study developed a probable side effect involving their heart function, with both patients experiencing a decrease in how well their hearts were able to pump blood. These effects on the heart seemed to improve once sunitinib was stopped. In larger studies performed in adult patients with cancer, between 1 in 10 and 1 in 100 patients developed heart problems. In some cases the heart problems improved when treatment with sunitinib was stopped, but in other cases the problems did not improve when sunitinib was stopped. For children, we do not yet know how common this side effect actually is, and also do not know if it goes away completely once a patient stops taking sunitinib. However, you are only being offered to participate in this study because you have not previously been treated with medicines or radiation that could weaken the heart. All patients will have their heart function closely watched, and we will stop sunitinib if we find that it may be affecting your heart.  
Other risks and side effects related to Sunitinib include those which are:
Less Likely:
- Decrease in blood protein that carries oxygen
- Decrease in the total number of white blood cells
- Decrease number of a type of white blood cell
- Decrease number of blood cells that help blood to clot
- High blood pressure
- Fever
- Difficulty in sleeping or falling to sleep
- Chills
- Weight loss
- Change in hair color - Dry skin
- Hair loss
- Lightening of the skin
- Rash/flaking or shedding of outer layer of skin - Inflammation or blistering of the skin on the palms of the hands or soles of the feet
- Low thyroid function
- Constipation
- Dehydration - Feeling of fullness
- Dry mouth
- Excess passing of gas
- Irritation of the stomach lining
- Heartburn
- Nose bleed
- Swelling of the arms and/or legs
- Increased liver enzymes
- Low levels of a blood protein called albumin - Abnormal liver or bone enzyme level - Abnormal digestive enzyme level
- Increased liver pigment in blood indicative of abnormal liver function
- Increased blood level of a substance normally eliminated by the kidneys into the urine
- Abnormal level of fat-digesting enzyme - Decreased blood phosphate level
- Increased blood levels of uric acid (a waste material from food digestion)
guaifenesin brand name(s) mucinex
likely

- Fatigue
- Loss of appetite
- Diarrhea - Irritation or sores in the lining of the gastrointestinal tract
- Nausea
- Changes in taste
- Vomiting
- Stomach (belly) pain Less Likely (cont):
- Swelling of the nerve in the back of the eye responsible for vision
- Back pain
- Chest pain
- Leg pain - Headache - Joint pain - Muscle pain
- Mouth pain
- Cough
guaifenesin brand name(s) mucinex
rare but serious

- Abnormal electrical conduction within the heart
- Decrease in the ability of the heart to pump blood - Abnormal clotting of blood in small blood vessels - Swelling of a part of the eye
- Decrease in vision
Sunitinib may interact with other medications that you may be taking, including prescription medication, over-the-counter (non-prescription) medications, and herbal remedies or supplements. These interactions may increase your risk of having a bad reaction to sunitinib. Be sure to discuss all medications you are taking with your study doctor. Reproductive risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. It is important you understand that you need to use birth control while on this study. The long-term effects of sunitinib on fertility are unknown. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study. Pregnancy tests will be obtained in women interested in participating in this study.  
| Toxicity:                                     | 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  | Headache (L), hypertension (L),  nausea,vomiting,  anorexia,  immunosuppression  (L), diarrhea,  constipation, fever | Chest pain   | Anaphylaxis with the injection, allergic reaction, hypotension,  asthma, dyspnea, increased cough, flu  like syndrome, pleural effusion,  seizure (L), tachycardia, angina |
| Prompt:                                       | Tremor (L), ), renal                                                                                                 | Alopecia,    | Dyspepsia, dysphagia, gastritis,                                                                                                                                           |
| Within 2-3 weeks,                             | dysfunction (acute                                                                                                   | dizziness,   | esophagitis, flatulence, CNS                                                                                                                                               |
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| prior to the next                                                         | with decrease in                                                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| course                                                                    | GFR, impaired  urinary concentrating  ability, and sodium  retention), elevated  creatinine/BUN,  anemia, insomnia,  asthenia, pain  (abdominal, back,  pain), hyperglycemia, hypomagnesemia (L),  hyper/hypokalemia  (L),  hypophosphatemia,  paresthesia                         | abnormalities (confusion (L), somnolence (L), depression (L), anxiety, anxiousness, abnormal dreams, emotional labiality, hallucinations, psychosis, hypertonia, incoordination, neuropathy, nervousness encephalopathy), coagulation disorder, leukopenia (L), thrombocytopenia, polycythemia, anemia, leukocytosis, infections (bacterial, fungal, viral –sepsis, cellulites, fungal dermatitis, herpes simplex, sinusitis, pharyngitis,  abscess, pneumonia, bronchitis,  peritonitis), hyperbilirubinemia (L),  thrombosis, phlebitis, arthralgia,  myalgia, electrolyte abnormalities |
| Delayed: Any time later  during  therapy, excluding  the above conditions | elevated LFTs,  UTI, peripheral edema,  rash, pruritis, hyperlipidemia,  hypercholesteremia                                                                                                                                                                                        | Acne, exfoliative dermatitis, skin discoloration, photosensitivity reaction, skin ulcer, delayed wound healing, hirsutism (hypertrichosis)  (L), gingival hyperplasia, abnormal vision, amblyopia, ear pain, otitis, tinnitus,  GI hemorrhage, GI perforation, cholelithiasis, cholestatic jaundice, chronic renal dysfunction, renal failure, post-transplant diabetes mellitus (L), myocardial hypertrophy, elevated liver function tests, liver damage, ascites                                                                                                                         |
| Late: Any time after completion of treatment                              | Lymphoproliferative disorders, skin malignancies                                                                                                                                                                                                                                   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| Unknown  Frequency and Timing:                                            | Fetal toxic effects of tacrolimus have been noted in animals. Tacrolimus is  transported  across the placenta and its use during pregnancy has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus is excreted in human milk, nursing  should be avoided. |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
| (L) Toxicity may also occur later                                         |                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |
guaifenesin brand name(s) mucinex
tamoxifen

| breast cancer at standard doses] include those which are: Likely Less Likely   | Rare but serious      |              |                        |                               |                                |
|--------------------------------------------------------------------------------|-----------------------|--------------|------------------------|-------------------------------|--------------------------------|
| -                                                                              | Hot flashes           | -            | Nausea and/or vomiting | -                             | Severe rashes which can result |
| -                                                                              | Reddening of the face | -            | Bone pain              | in loss of skin and damage to |                                |
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| with feelings of warmth   |                                                                     |
|---------------------------|---------------------------------------------------------------------|
| -                         | Absence of menstrual  flow or changes in  menstrual flow  (periods) |
| -                         | Weight gain or loss                                                 |
| -                         | A decrease in the sexual  drive                                     |  
| mucous membranes and which  may be life-threatening   |                                                                                                                                                                                                            |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -                                                     | 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 life-threatening  depending on where they go.                |
| -                                                     | 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 |
| -                                                     | Damage to your eye which  could lead to a decrease in  vision                                                                                                                                              |
| -                                                     | Allergic reactions                                                                                                                                                                                         |
| -                                                     | A cyst (fluid filled sac) may  form on the ovaries which are  found in the abdomen (belly)  and may be associated with  pain                                                                               |
| -                                                     | An increased risk of cancer of  the lining of the uterus (womb)                                                                                                                                            |
| -                                                     | Fluid retention                                                                                                                                                                                            |
| -                                                     | Vaginal discharge, dryness or itching                                                                                                                                                                      |
| -                                                     | Fewer platelets in the blood  o a low number of platelets causes  you to bruise and bleed more  easily                                                                                                     |
| -                                                     | Cough                                                                                                                                                                                                      |
| -                                                     | Lightheadedness or dizziness                                                                                                                                                                               |
| -                                                     | Headache                                                                                                                                                                                                   |
| -                                                     | Skin changes or rashes                                                                                                                                                                                     |
| -                                                     | Thinning of the hair or partial loss of  hair                                                                                                                                                              |
| -                                                     | High levels of a certain salt in the  body calcium which may require  treatment                                                                                                                            |
| -                                                     | Elevation in the blood of certain  enzymes or bilirubin found in the  liver which could mean mild liver  damage                                                                                            |
| -                                                     | Increased levels of a chemical  (creatinine) in the blood which could  mean kidney damage                                                                                                                  |
| -                                                     | Increase in the level of thyroxin (T4)  which is hormone produced by the  thyroid                                                                                                                          |
| -                                                     | An increase in the levels of lipids  (fats) in your blood which if  prolonged could lead to heart  problems later in life                                                                                  |
| -                                                     | Changes on a test called an EKG that  measures the activity of your hear                                                                                                                                   |
guaifenesin brand name(s) mucinex
tarceva (osi-774)

| We know about the following side effects of OSI-774:  Common (happens in 21-100  patients out of 100)   | Rare                                                               |                                                                                                                                                                                                                                                                                                                                                                                     |
|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (happens in less than 5 patients out of  100)                                                           |                                                                    |                                                                                                                                                                                                                                                                                                                                                                                     |
| The timing of these  side effects (how  soon they happen  after taking OSI774) is not known.                                                                                                         | Occasional                                                         |                                                                                                                                                                                                                                                                                                                                                                                     |
| (happens in 5-20  patients out of 100)                                                                  |                                                                    |                                                                                                                                                                                                                                                                                                                                                                                     |
| Acne-like skin rash,  diarrhea, nausea,  vomiting, tiredness,  weariness, ill feeling                   | Dry skin, dry mouth,  decreased appetite,  mouth sores,  heartburn | Peeling of the skin, hives and itching,  elevation in liver function tests,  redness/inflammation of the  eye/damage to the cornea, dry eye,  inward growth of eyelashes, tearing,  kidney damage, headache,  inflammation of the lungs, lung tissue  changes and damage and scarring of  lung tissues, blurry vision, allergic  reaction, changes to taste, increase in  bilirubin |
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| Issued 12 June 2013                                                                                     |                                                                    |                                                                                                                                                                                                                                                                                                                                                                                     |
guaifenesin brand name(s) mucinex
allergic reactions may occur with

Also reported on OSI-774 trials but with the relationship to OSI-774 unknown: low levels of red blood cells, low levels of white blood cells, increased numbers of white blood cells in the blood, low number of platelets in the blood which may increase the risk of bleeding, poor blood supply to an area of bone causing bone death, blockage of the pulmonary artery (1 case), a clot blocking a vein, shaking chills, fever, hair loss, sore throat, burning or painful sensation in the tongue, inflammation and cracking of the skin of the lips, constipation, abdominal pain or cramping, sores in the stomach, too much gas produced in the intestines, difficulty swallowing, decreased blood flow to the intestines, inflammation of the pancreas, blood in the urine, nose bleed, dark, bloody bowel movement, blood in sputum or spit, bleeding in the intestines, elevated liver enzyme levels, inflammation of the lungs, urinary tract infection, infection with or without decrease in a type of white blood cell called a neutrophil, low levels of potassium and sodium in the blood, dryness in the nose, runny nose, depression, anxiety, sleeplessness, a skin sensation, such as burning, prickling, itching, or tingling, with no apparent cause, dizziness, blockage of the blood vessels of the brain (1 case), back pain, cough, difficulty breathing, too much protein in the urine, kidney failure, inflammation of the lining of the uterus, confusion, dehydration and increased levels of urea in the blood which is likely directly related to diarrhea, changes in blood clotting in patients also taking Coumadin, inflammation of the cornea causing watery painful eyes and blurred vision, inflammation of the eye, inflammation of the pancreas, the presence of air or gas in abnormal places in the body, and secondary skin infection from rash.  
If a person gets pregnant while receiving OSI-774, it could be dangerous for the baby. You should not become pregnant or father a baby while on this study. You should not nurse (breast feed) a baby while on this study. Ask about counseling and more information about preventing pregnancy. Women of child-bearing potential and males must agree to use an adequate form of birth control while on this protocol.
guaifenesin brand name(s) mucinex
temsirolimus

Risks and side effects related to temsirolimus include those which are:
guaifenesin brand name(s) mucinex
likely

- *Low Blood Counts:* low hemoglobin which means low red cell count (anemia),
low number of platelets which help the blood to clot.  
- Fatigue which is a feeling of extreme tiredness not relieved by sleep
- Rash including rash with peeling of the skin
- Loss of desire to eat or appetite
- Diarrhea - Inflammation or sores in the mouth, throat, or esophagus (the tube that leads from the mouth to the stomach) that may make swallowing difficult and are painful (painful mouth sores)
- Nausea
- Increase in a fat in the blood (cholesterol) which if continued for long periods of time could lead to heart or blood vessel problems
guaifenesin brand name(s) mucinex
less likely

- Allergic reactions - Runny nose
- *Low Blood Counts:* low number of white blood cells which help fight infection.  
- An increase or decrease in blood pressure
- A change in the amount of a protein that helps your blood to clot
- Fever (high body temperature)
- Difficulty sleeping or falling asleep
- Chills and shaking chills - Weight loss
- Dry Skin
- Nail changes
- Itching of the skin
- Rash and acne (pimples) - Hives
- Wound complication
- Low levels of testosterone, a hormone found in the body
- Diabetes, a condition which causes an inability to tolerate glucose (sugar) in the body
- Constipation
- Feeling bloated, tightness or pain in the belly
- Mouth sores
- Taste alteration where things taste differently
- Vomiting
- Fever with a low white blood cell count which could indicate infection and may require hospitalization and treatment with antibiotics
- Risk of bleeding
- Risk of infection - Fluid build-up in the arms, legs, head or neck.  
- Acidosis that is metabolic (through your body's system) or respiratory (in the lungs).  
- Abnormal amounts of liver enzymes
- Low amounts of calcium
- High levels of glucose (sugar) in the blood which may require treatment
- An increase in the levels of lipids (fats) in your blood which if prolonged could lead to heart problems later in life
- Low levels of certain salts in your body (such as potassium and phosphate)
- Increase of triglycerides in the blood which could lead to heart problems later in life
- Depression
- Somnolence which is a feeling of sleepiness, an inability to stay awake or aware
- Pain (such as belly, back, chest, head, joint, or muscle pain)
- Cough
- Shortness of breath
- Nose or sinus reactions - Inflammation of the lungs that can lead to fluid in the lungs and affect your ability to breath and the levels of oxygen in your blood making you short of breath
- Erectile dysfunction
- Decreased libido, which means a decrease in sexual desire - Flu type symptoms with fever, tiredness, aches and pains  
Rare but serious
- Holes or tears in the gastrointestinal tract (including the stomach, intestine and colon).  
- Severe kidney damage (which may be permanent)
- Clotting of blood vessels which can lead to pain and swelling in the area of the clot. Such clots may break loose and cause damage or be life-threatening depending on where they go.
Reproductive risks: You should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breastfeed a baby while on this study. These precautions should be in place for the whole duration of the study therapy and for at least 3 months after the last dose of temsirolimus due to the long half lives of these drugs. It is important you understand that you need to use birth control while on this study. Check with your study doctor about what kind of birth control methods to use and how long to use them. Some methods might not be approved for use in this study.  
| Risks and side effects related to temozolomide include those which are: Likely Less Likely   | Rare but can be Serious                                                                                                                                                                                                                                                                 |    |             |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|-------------|
| -                                                                                            | Fewer red and white blood  cells and platelets in the  blood  o a low number of red  blood cells can make  you feel tired and weak o a low number of white  blood cells can make it  easier to get infections o a low number of  platelets causes you to  bruise and bleed more  easily |    |             |
| -                                                                                            | Nausea                                                                                                                                                                                                                                                                                  |    |             |
| -                                                                                            | Vomiting                                                                                                                                                                                                                                                                                |    |             |
| -                                                                                            | Constipation                                                                                                                                                                                                                                                                            |    |             |
| -                                                                                            | Loss of appetite                                                                                                                                                                                                                                                                        | -  | Diarrhea    |
| -                                                                                            | Headache                                                                                                                                                                                                                                                                                |    |             |
| -                                                                                            | Tiredness                                                                                                                                                                                                                                                                               |    |             |
| -                                                                                            | Difficulty swallowing                                                                                                                                                                                                                                                                   |    |             |
| -                                                                                            | Dizziness                                                                                                                                                                                                                                                                               |    |             |
| -                                                                                            | Anxiety or depression                                                                                                                                                                                                                                                                   |    |             |
| -                                                                                            | Difficulty sleeping                                                                                                                                                                                                                                                                     |    |             |
| -                                                                                            | Rash                                                                                                                                                                                                                                                                                    |    |             |
| -                                                                                            | Itching                                                                                                                                                                                                                                                                                 |    |             |
| -                                                                                            | Increased need to urinate                                                                                                                                                                                                                                                               |    |             |
| -                                                                                            | Urinary Tract Infections                                                                                                                                                                                                                                                                |    |             |
| -                                                                                            | Mouth sores                                                                                                                                                                                                                                                                             |    |             |
| -                                                                                            | Fluid Build up in legs and  arms                                                                                                                                                                                                                                                        |    |             |
| -                                                                                            | Hair loss                                                                                                                                                                                                                                                                               |    |             |
| -                                                                                            | Elevation in the blood of  certain enzymes found in  the liver                                                                                                                                                                                                                          |    |             |
| -                                                                                            | Visual disturbances that  may cause double vision                                                                                                                                                                                                                                       |    |             |
| -                                                                                            | Forgetfulness or confusion                                                                                                                                                                                                                                                              |    |             |
| -                                                                                            | Aches and pains in muscles  and joints                                                                                                                                                                                                                                                  |    |             |
| -                                                                                            | Pain in the abdomen                                                                                                                                                                                                                                                                     | -  | Convulsions |
| -                                                                                            | Severe allergic reaction  which can be life  threatening with  shortness of breath, low  blood pressure, rapid  heart rate, chills and  fever                                                                                                                                           |    |             |
| -                                                                                            | Low numbers of white  blood cells called  lymphocytes that may  last a long time and  make it easier to get  infections which may be  life-threatening                                                                                                                                  |    |             |
| -                                                                                            | Partial paralysis or  weakness of one side of  the body                                                                                                                                                                                                                                 |    |             |
| -                                                                                            | Blood clots which may  be life-threatening                                                                                                                                                                                                                                              |    |             |
| -                                                                                            | A new cancer or  leukemia resulting from  this treatment                                                                                                                                                                                                                                |    |             |
| (L) Toxicity may also occur later.                                                           |                                                                                                                                                                                                                                                                                         |    |             |  
| Common                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    | Serious                                                                                                                          |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Swelling of the limbs (4.2% to 56.9%) Rash (30.4%) Hypocalcemia (71.6%)  Hypokalemia (22.5%) Hyponatremia (43.1%) Hypothyroidism (20%) Increased appetite (21.6%) Weight loss (22.5%) Constipation (54.9%) Nausea (28.4%) Leukopenia (35.3%) Confusion (28.4%) Somnolence (37.5%) Tremor (4.2% to 25.5%) Neutropenia (31.4%) Thrombosis (22.5%) Peripheral neuropathy (21.6% to 53.9%) Increased liver function test (24.5%) Increased serum bilirubin (13.7%) Joint pain (12.7%) Bone pain (30.4%) Muscle pain (16.7%) Muscle weakness (40.2%) Headache (12.5% to 19.6%) Sleeplessness (22.5%) Dizziness/lightheadedness (4.2% to 19.6%) Anxiety (25.5%) Fatigue (79.4%) | Stevens-Johnson syndrome Toxic epidermal necrolysis Teratogenesis Pulmonary embolism Seizure (rare) Loss of menstruation (<0.1%) |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |                                                                                                                                  |
guaifenesin brand name(s) mucinex
oral (capsule)

- Thalidomide can cause severe birth defects or death to an unborn baby if taken during pregnancy. Women of childbearing potential should have a pregnancy test before starting therapy, then weekly for first month, and monthly thereafter. Effective contraception must be used for at least 4 weeks before beginning thalidomide therapy, during thalidomide therapy, and for 4 weeks following discontinuation of thalidomide therapy. Males must always use a latex condom during any sexual contact with women of childbearing potential. Only prescribers and pharmacists registered with the S.T.E.P.S.(R) distribution program can prescribe and dispense thalidomide. The use of thalidomide in multiple myeloma results in an increased risk of venous thromboembolic events, such as deep vein thrombosis and pulmonary embolus.  
- This drug may decrease effectiveness of oral contraceptives with concurrent use. Instruct patient to use 2 forms of reliable contraception to avoid pregnancy during therapy and at least 4 weeks before and after therapy.  
- Male patients must use a latex condom during intercourse during any sexual contact with women of childbearing potential, even if patient has had a vasectomy.  
- Tell patient to avoid activities requiring mental alertness until drug effects are realized, as this drug may cause dizziness and somnolence.  
- Patient should rise slowly from a sitting/lying down position. - This drug may cause edema, constipation, nausea, confusional state, and tremors. - Advise patient to immediately report signs/symptoms of Stevens-Johnson syndrome/toxic epidermal necrolysis (flu-like symptoms, spreading red rash, or skin/mucous membrane blistering), thromboembolism (shortness of breath, chest pain, or arm/leg swelling), or pregnancy.  
- Patient should also report signs/symptoms of infection, bleeding, or peripheral neuropathy (numbness, tingling, pain, or burning in hands/feet).  
- Advise patient to closely follow healthcare professional's instructions regarding frequency of taking pregnancy test.  
- Tell patient to take drug at bedtime at least 1 h after evening meal.  
- Patient should not drink alcohol while taking drug.  
| Common                                                               | Serious                                                                                       |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Nausea  Vomiting Headache Insomnia Tremor Irritability  Restlessness | Attial fibrillation Trachyarrhythmia Stevens-Johnson syndrome Intracranial hemorrhage Seizure |  
- Advise patient that this drug is not indicated for acute asthma attacks or other respiratory flare-ups.  
- This drug may cause nausea, headache, insomnia, tremors, and restlessness. - Patient should immediately report signs/symptoms of theophylline toxicity (vomiting, arrhythmia, seizures).  
- Advise patient to report signs/symptoms of infection or any changes in ongoing health, as healthcare professional may need to make dose adjustments.  
- Serious toxicity is not necessarily preceded by mild/moderate side effects. Inform patient that regular blood work is important to ensure therapeutic drug level.  
- Instruct patient to take drug the same way every dose. Patient should choose to take drug always with food or always without food, as this influences drug level.  
- Counsel patient to avoid abruptly discontinuing or changing dosage without supervision by healthcare professional.  
- Patient should inform provider of significant changes in diet (such as "low carb" diet, increased caffeine) and smoking habits (start/stop smoking tobacco or marijuana, increased exposure to second-hand smoke).  
- 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).  
Thioguanine  
| Common                                      | Serious                                                                                                                                                                        |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Loss of appetite Nausea Stomatitis Vomiting | Hyperuricemia Gastrointestinal necrosis (with combination  regimens) Perforation of intestine Myelosuppression Hepatotoxicity Jaundice  Abnormal liver function test Infection |  
- Patient should avoid vaccines during therapy due to drug-induced immunosuppression.  
- Advise patient on the proper handling and disposal of chemotherapy drugs.  
- This drug may cause anorexia, nausea, stomatitis, and vomiting. - Advise patient to immediately report signs/symptoms of bleeding (unexplained bruising, black tarry stools, hematuria, purpura) or infection.  
- Instruct to report signs/symptoms of gastrointestinal toxicity or hepatotoxicity (jaundice, right upper quadrant pain, weight gain, ascites).  
- Encourage patient to maintain adequate hydration to prevent hyperuricemia.  
- Patient should not drink alcohol while taking this drug.  
| 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    | Anorexia,  nausea,  vomiting,  diarrhea, malaise                                                                                                | Urticaria, rash, hyperuricemia                                            |
| Prompt: Within 2-3 weeks,  prior to next course | Myelosuppression                                                                                                                                | Toxic hepatitis (L), increased  SGOT (AST)/SGPT (ALT),  ataxia, mucositis |
| Delayed: Anytime later during therapy           | Hepatic fibrosis(L), sinusoidal  obstruction syndrome (SOS,  formerly VOD) (L),  hyperbilirubinemia                                             |                                                                           |
| Unknown  Frequency and Timing:                  | Fetal toxicities and teratogenic effects of thioguanine have been noted in  animals. It is unknown whether the drug is excreted in breast milk. |                                                                           |
| -                                               | (L) Toxicity may also occur later.                                                                                                              |                                                                           |
guaifenesin brand name(s) mucinex
thioguanine toxicity

| Common                                                                                                                                                                                                                                                                                                                                                | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hypotension Orthostatic hypotension Diminished sweating Light sensitivity (rare) constipation Xerostomia Akathisia Dizziness Drug-induced tardive dystonia Systonia Extrapyramidal disease Parkinsonian Somnolence Tardive dyskinesia Blurred vision Epithelial keratopathy Eye/vision change Retinitis pigmentosa Urinary retention Nasal congestion | Porlonged QT interval (rare) Sudden cardiac death  Torsades de pointes (rare) Obstipation (rare) Paralytic ileus (rare) Agranulocytosis (rare) Disorder of hematopoietic structure (rare) Leukopenia (rare) Thrombocytopenia (rare) Cholestatic jaundice syndrome (rare) Drug-induced lupus erythematosus (rare) Systemic (rare) Ineffective thermoregulation,  heatstroke/hypothermia (rare) Neuroleptic malignant syndrome (rare) Seizure (rare) Priapism (rare) Death |  
- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness or somnolence.  
- Instruct patient to rise slowly from a sitting/supine position, as drug may cause orthostatic hypotension.  
- This drug may cause hypotension, anticholinergic effects, akathisia, dystonia, epithelial keratopathy, retinitis pigmentosa, or nasal congestion.  
- Tell patient to report signs/symptoms of arrhythmia or tardive dyskinesia (jerky muscle movements, tongue thrusting, facial grimacing/ticks, random movements of extremities).  
- 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 avoid drinking alcohol while taking this drug.
guaifenesin brand name(s) mucinex
thiotepa

Risks and side effects related to the Thiotepa are listed below:  
| Likely              | Less Likely                                 | Rare but serious   |                                                                                                                |
|---------------------|---------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------|
| -                   | Nausea                                      |                    |                                                                                                                |
| -                   | Vomiting                                    |                    |                                                                                                                |
| -                   | Loss of appetite                            |                    |                                                                                                                |
| -                   | A feeling of extreme tiredness or  weakness |                    |                                                                                                                |
| -                   | Fewer white blood cells, red blood cells    | -                  | Pain at the injection site                                                                                     |
| -                   | Dizziness                                   |                    |                                                                                                                |
| -                   | Headache                                    |                    |                                                                                                                |
| -                   | Blurred vision                              |                    |                                                                                                                |
| -                   | Hives, skin rash                            |                    |                                                                                                                |
| -                   | Wheezing                                    | -                  | Severe allergic  reaction which can  be life threatening  with shortness of  breath, low blood  pressure and a |
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| 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   |                                                                                                                                   |                  |                   |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------|-------------------|
| -                                                                                                                                                                                                                                         | Absence or decrease in the number of  sperm which may be temporary or  permanent which may decrease the  ability to have children |                  |                   |
| -                                                                                                                                                                                                                                         | Absence or decrease in monthly periods  and could affect your ability to become  pregnant                                         | -                | Sudden high fever |
| -                                                                                                                                                                                                                                         | Pain in the abdomen                                                                                                               |                  |                   |
| -                                                                                                                                                                                                                                         | Difficulty emptying the bladder                                                                                                   |                  |                   |
| -                                                                                                                                                                                                                                         | Feeling the urgency to urinate or pain  on urination                                                                              |                  |                   |
| -                                                                                                                                                                                                                                         | Hair loss                                                                                                                         |                  |                   |
| -                                                                                                                                                                                                                                         | Inflammation and reddening of the  eye                                                                                            |                  |                   |
| -                                                                                                                                                                                                                                         | Inflammation of the skin where the  drug comes into contact with the skin                                                         | rapid heart rate |                   |
| -                                                                                                                                                                                                                                         | Swelling and  tightening of the  throat which can  cause difficulty  with breathing                                               |                  |                   |
| -                                                                                                                                                                                                                                         | A new cancer or  leukemia resulting  from this treatment                                                                          |                  |                   |
| With High Doses used before marrow  transplants:  - inappropriate behavior  - confusion - drowsiness - Elevation in the blood of certain  enzymes and/or bilirubin found in the  liver - Bronze discoloration or darkening of  the skin   |                                                                                                                                   |                  |                   |
| With High Doses used before marrow  transplants:  - Inflammation and/or sores in the  mouth, throat and/or esophagus (the  passage between the throat and  stomach)                                                                       |                                                                                                                                   |                  |                   |
guaifenesin brand name(s) mucinex
tolbutamide

| Common                                                                 | Serious                                                                                            |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Cutaneous hypersensitivity Hypoglycemia Hyperglycemia Heartburn Nausea | Death (cardiovascular, reported in  University group diabetes program) Severe hypoglycemia (0.35%) |  
- This drug may cause heartburn or nausea. - Drug may cause hypo- or hyperglycemia. Instruct patient to monitor for and report problems with glycemic control.  
- Tell patient to report stress due to infection, fever, trauma, or surgery, as dosing adjustments may need to be made.  
- Advise patient to avoid drinking alcohol while taking this drug.  
| Common                                                                                  | Serious                                                                                                                           |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Constipation Diarrhea Loss of appetite Nausea Xerostomia Dream disorder  Sleep disorder | Orthostatic hypotension Hyperpyrexia Fulminant hepatic failure (rare) Rhabdomyolysis Confusion Dyskinesia Dystonia Hallucinations |
guaifenesin brand name(s) mucinex
tolcapone

- Patient should avoid activities requiring mental alertness or coordination until drug effects are realized, as drug may cause dizziness and drowsiness.  
- Advise patient to rise slowly from a lying/sitting position, as this drug may cause orthostatic hypotension.  
- This drug may cause diarrhea, loss of appetite, nausea, anticholinergic effects, dystonia, dyskinesia, and hyperpyrexia (very high fever).  
- Drug may also cause hallucinations and dream/sleep disorders. - Advise patient to report signs/symptoms of acute renal failure or hepatic dysfunction
(persistent nausea, fatigue, dark urine, pruritus, right upper quadrant tenderness, jaundice, clay-colored stools).  
- May take with food to minimize gastric irritation.  
- Advise patient against sudden discontinuation of drug.  
| Common                                                                                                                                   | Serious                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          |
|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Swelling of the limbs Weight gain Weight loss Abdominal pain Diarrhea Flatulence Indigestion Nausea Vomiting Asthenia Dizziness Headache | Congestive heart failure (<1%) Hypertension (3-9%) Myocardial infarction (<2%) Thrombotic tendency observations Erythema multiforme (<1%) Scaling eczema Stevens-Johnson syndrome Toxic epidermal necrolysis (<1%) Gastrointestinal hemorrhage (<1%) Gastrointestinal perforation  Digestive tract inflammation Agranuloscytosis (<1%) Anemia (<3%) Neutropenia (<1%) Thrombocyutopenia (<1%) Hepatitis (<1%) Increased liver function test (increased up  to15%) Jaundice (<1%) Liver failure (<0.1%) Allergic reaction (<1%) Cerebrovascular accident Acute kidney failure (<1%) Hematuria (<1%) Proteinuria (<1%) Brochospasm |  
- Elderly and debilitated patients may be at higher risk for serious gastrointestinal adverse effects while taking this drug.  
- This drug may cause edema, weight gain or loss, abdominal pain, diarrhea, dyspepsia, flatulence, nausea, vomiting, asthenia, dizziness, and headache.  
- Advise patient to report signs/symptoms of thrombotic events, myocardial infarction, or stroke.  
- Instruct patient to report signs/symptoms of gastrointestinal bleeding or ulceration.  
| Common                                                                                                                                                                                                    | Serious                                                                                                                                                                                                     |              |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Diarrhea (5-11%) Loss of appetite (4-24%)  Nausea (6-14%)  Altered sense of taste (3-15%)  Weight loss (6-21%)  Confusion (3-14%)  Language disorder (6-10%)  Dizziness (8-32%)  Nervous feelings (7-14%) | Erythema mutiforme Stevens-Johnson syndrome Toxic epidermal necrolysis Increased body temperature Hperammonemia (with or without  encephalopathy) Hypohidrosis Metabolic acidosis (7% to 67%) Liver failure |              |
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guaifenesin brand name(s) mucinex
topiramate

| Headache Impaired psychomotor performance (3-21%)  Memory impairment (5-14%)  Paresthesia (2-51%)  Reduced concentration span (4-14%)  Somnolence (9-29%)  Speech and language disorder Abnormal vision (2% to 13%) Diplopia (1% to 10%) Nystagmus (10% to 11%) Fatigue (14% to 30%)   | Glaucoma Myopia Depression (3% to 13%) Mood disorder (2% to 11%) Suicidal thoughts Nephrolithiasis (1% to 3%)   |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|  
- Patient should avoid activities requiring mental alertness and coordination until drug effects are realized, as drug may cause dizziness, somnolence, and motor retardation.  
- Drug may impair heat regulation, especially in pediatric patients. Advise patient to use caution with activities leading to an increased core temperature, such as strenuous exercise, exposure to extreme heat, or dehydration.  
- Drug may decrease effectiveness of estrogen-containing oral contraceptives with concurrent use. Recommend additional form of birth control with oral contraceptives.  
- Drug may cause nausea, diplopia, nervousness, dysmenorrhea, breast pain, and fatigue. - Drug may cause asthenia, ataxia, confusion, speech and language problems, memory impairment, nystagmus, paresthesias, tremors, and inability to concentrate.  
- Advise patient to report signs/symptoms of acute myopia associated with angle-closure glaucoma (sudden decreased visual acuity, ocular pain).  
- Advise patient against sudden discontinuation of drug, as this may cause increased seizure activity.  
- Patient should avoid concomitant use of valproic acid. Hyperammonemia with encephalopathy is possible.  
| Common     | Occasional                                                                                                                                                          | Rare                                |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Immediate: | Nausea, vomiting, diarrhea (L),  mouth sores (L), flu-like  symptoms (L), headache,  rashes (L), increased liver  enzymes in the blood Stomach pain, shaking chills |                                     |
| Within 2-3 | Decrease in the number of red                                                                                                                                       |                                     |
| wks:       | and white blood cells and  platelets made in the bone  marrow, hair loss                                                                                            |                                     |
| Delayed:   | Loss of strength or energy                                                                                                                                          | Tiny amounts of blood in the  urine |
| Late: -    |                                                                                                                                                                     |                                     |