IMPORTANT SAFETY INFORMATION FOR ULORIC (febuxostat)

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WARNING: CARDIOVASCULAR DEATH

ULORIC may cause serious side effects, including heart-related deaths.

Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: chest pain; shortness of breath or trouble breathing; dizziness, fainting, or feeling lightheaded; rapid or irregular heartbeat; numbness or weakness in one side of your body; slurring of speech; or sudden blurry vision or sudden severe headache.

Do not take ULORIC if you are taking azathioprine or mercaptopurine.

ULORIC may cause serious side effects, including:

Gout Flares. Gout flares can happen when you start taking ULORIC. Your doctor may give you other medicines to help prevent your gout flares.

Liver Problems. Liver problems can happen in people who take ULORIC. Your doctor may do blood tests to check how well your liver is working before and during your treatment with ULORIC. Tell your doctor if you get any of the following signs or symptoms of liver problems: fatigue; loss of appetite for several days or longer; pain, aching, or tenderness on the right side of your stomach-area; dark or “tea-colored” urine; or your skin or the white part of your eyes turns yellow (jaundice).

Severe Skin and Allergic Reactions. Serious skin and allergic reactions that may affect different parts of the body such as your liver, kidneys, heart or lungs, can happen in people who take ULORIC. Call your doctor right away or get emergency medical help if you have any of the following symptoms: rash; red and painful skin; severe skin blisters; peeling skin; sores around the lips, eyes or mouth; swollen face, lips, mouth, tongue or throat; or flu-like symptoms.

The most common side effects of ULORIC include abnormal liver function tests, nausea, joint pain, and rash. These are not all of the possible side effects of ULORIC.

USE OF ULORIC

ULORIC is a prescription medicine used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you. ULORIC is not for use in people who do not have symptoms of high blood uric acid levels.

Individual results may vary.

Please see the complete Prescribing Information, including Medication Guide, for ULORIC and talk to your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.