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Febuxostat

Warning

Febuxostat may rarely cause very serious side effects including heart attack, stroke, or possibly fatal heart-related problems. Before taking this medication, tell your doctor if you have heart disease, chest pain (angina), or have had a heart attack or stroke in the past since these conditions may increase your risk. Discuss the risks and benefits of this medication and treatment options with your doctor. Get medical help right away if you have any of these very serious side effects: chest/jaw/left arm pain, unusual sweating, shortness of breath, fast/irregular heartbeat, dizziness, fainting, weakness on one side of the body, sudden vision changes, confusion, trouble speaking, sudden severe headache.

Precautions

See also Warning section.

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 (such as heart attack, chest pain/angina), stroke, liver disease, kidney disease, organ transplant.

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 breastfeeding.

Side Effects

See also Warning section.

Nausea may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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. 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.

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.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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