febuxostat

What is the most important information I should know about febuxostat?

You should not use this medication if you are allergic to febuxostat, or if you are also being treated with azathioprine (Azasan, Imuran), mercaptopurine (Purinethol), or theophylline (Elixophyllin, TheoCap, Theochron, Uniphyl).

Before taking febuxostat, tell your doctor if you have kidney disease, liver disease, heart disease, cancer, Lesch-Nyhan syndrome, a history of heart attack or stroke, or if you have ever received an organ transplant.

You may have an increase in gout symptom flares when you first start taking febuxostat. For best results, keep taking the medication as directed. Your doctor may prescribe other gout medications for you to use during the first 6 months of treatment with febuxostat.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

What is febuxostat?

Febuxostat reduces the production of uric acid in your body. Uric acid buildup can lead to gout or kidney stones.

Febuxostat is used to treat gout.

Febuxostat may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking febuxostat?

You should not use this medication if you are allergic to febuxostat, or if you are being treated with any of the following medications:

• azathioprine (Azasan, Imuran);
• mercaptopurine (Purinethol); or
• theophylline (Elixophyllin, TheoCap, Theochron, Uniphyl).

To make sure you can safely take febuxostat, tell your doctor if you have any of these other conditions:

• kidney disease;
• liver disease;
• heart disease;
• a history of heart attack or stroke;
• cancer;
• Lesch-Nyhan syndrome; or
• if you have ever received an organ transplant (kidney, liver, lung, heart).

FDA pregnancy category C. It is not known whether febuxostat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether febuxostat passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take febuxostat?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

You may have an increase in gout symptom flares when you first start taking febuxostat. For best results, keep taking the medication as directed. Your doctor may prescribe other gout medications for you to use during the first 6 months of treatment with febuxostat.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking febuxostat?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of febuxostat?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• nausea;
• joint pain, swelling, or stiffness;
• mild skin rash; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect febuxostat?

There may be other drugs that can interact with febuxostat. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about febuxostat.

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