SIDE EFFECTS: See also Warning section. Nausea, vomiting, headache, tiredness, constipation, and diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. People using this medication may have serious side effects. 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. This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following serious symptoms: severe tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding (such as bloody/black stool, bloody/pink urine). Nilotinib 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, change in the amount of urine), muscle spasms/weakness. Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, toe/joint pain, swelling hands/ankles/feet, unusual/rapid weight gain, symptoms of high blood sugar (such as increased thirst/urination), signs of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine). Get medical help right away if you have any very serious side effects, including: fast/pounding/irregular heartbeat, severe dizziness, fainting, seizures, signs 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 bleeding in the brain (such as sudden severe headache, sudden vision changes, confusion, loss of consciousness), signs of blood circulation disease (such as numbness/pain in the legs, leg pain with physical activity, decrease in walking distance). 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 nilotinib, tell your doctor or pharmacist if you are allergic to it; or to lactose/galactose; 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, pancreatitis, heart disease (such as coronary artery disease, chest pain, heart attack), high blood pressure, high cholesterol, diabetes, stroke (including "mini-strokes" or transient ischemic attacks), blood circulation disease (peripheral arterial disease), blood vessel disease (hardening of the arteries/atherosclerosis), stomach surgery (such as gastrectomy). Nilotinib 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 nilotinib, 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 nilotinib safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Nilotinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details. Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). 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. This medication may affect a child's bone growth and development. Consult the doctor or pharmacist for more details. Children may be more sensitive to the side effects of this drug, especially liver disease. 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. You should not become pregnant while using nilotinib. Nilotinib may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 14 days after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 14 days after stopping treatment is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use. 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: antacids, H2 blockers (such as cimetidine/famotidine), proton pump inhibitors (such as omeprazole). Other medications can affect the removal of nilotinib from your body, which may affect how nilotinib works. Examples include azole antifungals (such as itraconazole, ketoconazole), HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as clarithromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others. Many drugs besides nilotinib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), 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.