SIDE EFFECTS: See also Warning section. Upset stomach, nausea, vomiting, diarrhea, change in taste, decreased appetite, dry/cracked/thickened skin, watering eyes, swelling around eyes, numbness/tingling of arms/legs, or tiredness may occur. In some cases, drug therapy may be necessary to prevent or relieve nausea/vomiting/diarrhea. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly. This medication may cause patchy or complete hair loss and changes in hair/skin color. These effects are not harmful. However, talk to your doctor for more details since changes in skin color may also be a sign of a more serious condition. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: headache, rash/blisters on palms of hands/soles of feet, sores/pain on the tongue/mouth, easy bruising/bleeding, cold/heat intolerance, pain/redness/swelling of arms or legs, black/bloody stools, vomit that looks like coffee grounds, coughing up blood, slow wound healing, jaw pain, toe/joint pain, signs of low blood sugar (such as hunger, shakiness, fast heartbeat, sweating), symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), mental/mood changes (such as decreased alertness, irritability, nervousness), vision changes (such as decreased vision). This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication. Sunitinib sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, cloudy/pink/bloody urine, change in the amount of urine), muscle spasms/weakness. Get medical help right away if you have any very serious side effects, including: trouble breathing, chest/jaw/left arm pain, severe dizziness, fainting, fast/slow/irregular heartbeat, seizures. Sunitinib has rarely caused very serious (possibly fatal) skin reactions. Get medical help right away if you develop symptoms of serious skin reactions, including: rash, hot/peeling/blistering/painful skin, red/purple skin. This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat. 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking sunitinib, 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: bleeding problems, heart problems (such as heart attack), high blood pressure, liver problems, kidney disease, thyroid disease, diabetes. Sunitinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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 sunitinib, 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 sunitinib safely. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports. Wash your hands well to prevent the spread of infections. Some people taking sunitinib may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away. Before having surgery (including dental procedures), tell your doctor or dentist about this medication and all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above). Tell your doctor if you are pregnant or plan to become pregnant. Female patients should have a pregnancy test before starting this medication. You should not become pregnant while using sunitinib. Sunitinib may harm an unborn baby. Female patients should ask about reliable forms of birth control while using this medication and for 4 weeks after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 7 weeks after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 4 weeks after the last dose. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: bevacizumab, "blood thinners" (anticoagulants such as warfarin, heparins). Many drugs besides sunitinib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using sunitinib, report all medications you are currently using to your doctor or pharmacist. Other medications can affect the removal of sunitinib from your body, which may affect how sunitinib works. Examples include azole antifungals (such as ketoconazole, itraconazole), cimetidine, HIV protease inhibitors (such as ritonavir, saquinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin, rifabutin), St. John's wort, certain drugs used to treat seizures (such as phenytoin, phenobarbital), among others.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.