SIDE EFFECTS: Nausea may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly. 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. Febuxostat may rarely cause serious (possibly fatal) liver disease. It may also cause an increase in liver enzymes. Your doctor will order blood tests to measure these enzymes. Keep all medical/lab appointments. Tell your doctor right away if you develop symptoms of liver disease, including nausea that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin. Tell your doctor right away if you have any serious side effects, including: pink/bloody urine, painful urination. A small number of people who took this medication had heart-related problems or stroke. However, it is not known if this medication caused these problems. Get medical help right away if you have any of these very serious side effects, including: weakness on one side of the body, sudden vision changes, confusion, chest/jaw/left arm pain, unusual sweating, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain). Febuxostat may cause a rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash. 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: fever, swollen lymph nodes, 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 febuxostat, 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: cancer, heart disease, liver disease, kidney disease, organ transplant, stroke. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if febuxostat passes into breast milk. 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: azathioprine, mercaptopurine.

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.