SIDE EFFECTS: Nausea, vomiting, stomach/abdominal pain, loss of appetite, cough, joint pain, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Diarrhea is a common side effect. Drink plenty of fluids as directed by your doctor to reduce your risk of losing too much body water. Your doctor may prescribe anti-diarrhea medication (such as loperamide) to control your symptoms. Tell your doctor right away if you develop severe or persistent diarrhea, signs of dehydration (such as extreme thirst, dizziness, decreased urination). 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 unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bleeding/bruising. Tell your doctor right away if you have any serious side effects, including: severe stomach/abdominal pain, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, signs of kidney problems (such as change in the amount of urine). Get medical help right away if you have any very serious side effects, including: chest pain, shortness of breath. 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. Bosutinib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash. 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 bosutinib, 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, kidney disease. This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also increase the risk of serious liver problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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). Wash your hands well to prevent the spread of infection. 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 is not recommended for use during pregnancy. It may harm an unborn baby. Women of childbearing age should use reliable form(s) of birth control during treatment and for at least 1 month after the end of treatment. Consult your doctor for more details. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. 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: drugs that reduce stomach acid (for example, antacids, H2 blockers such as famotidine/ranitidine, proton pump inhibitors such as omeprazole). Other medications can affect the removal of bosutinib from your body, which may affect how bosutinib works. Examples include azole antifungals (such as ketoconazole, itraconazole), boceprevir, macrolide antibiotics (such as clarithromycin), nefazodone, HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telaprevir, telithromycin, 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.