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Votrient

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Votrient

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Votrient Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache, loss of appetite, weight loss, altered sense of taste, numbness/tingling/redness in hands/feet, or feeling tired/weak may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects.

Many people have more frequent/loose stools or diarrhea while taking this medication. Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor immediately if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, fainting).

If diarrhea persists or becomes a problem, your doctor may lower the dose or have you temporarily stop this medication. Do not stop or change the dose of this medicine without talking with your doctor. Tell your doctor immediately if you develop: persistent/severe diarrhea, abdominal or stomach pain/cramping, blood in your stool.

This medication may cause high blood pressure. Your doctor will check your blood pressure regularly while you are taking this medication and may start you on a medication to lower your blood pressure.

Temporary hair loss and/or change in hair or skin color may occur. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects and require a dosage reduction or drug discontinuation. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, unusual tiredness), signs of infection (such as fever, chills, persistent sore throat), wounds that do not heal, signs of congestive heart failure (such as swelling of the ankles/feet, trouble breathing, unusual tiredness), change in the amount of urine, unusual tiredness.

This drug can cause serious (rarely fatal) bleeding. Tell your doctor immediately if you have any signs of unusual bleeding such as: bloody/black stools, easy bleeding/bruising (such as nose bleed or bloody/pinkish urine), vomit that looks like coffee grounds, severe stomach/abdominal pain, coughing up blood.

Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), signs of a blood clot in the arms/legs/lungs (such as pain/redness/swelling in the arm/leg/calf/groin, coughing up blood, chest pain, trouble breathing), signs of a certain brain condition (such as headache, seizure, confusion, decreased alertness, vision changes, blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Votrient (pazopanib tablets) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: Before taking pazopanib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, chest pain/heart attack, high blood pressure, stroke, bleeding/clotting problem, intestinal or stomach problems (such as ulcer, fistula, pancreatitis), underactive thyroid.

Pazopanib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using pazopanib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using pazopanib safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Pazopanib may slow wound healing or cause healing wounds to reopen.

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Pazopanib is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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