Febuxostat reduces the production of uric acid in your body. A build-up of uric acid can cause gout symptoms.

Febuxostat is used to keep uric acid levels from getting to high in people with gout.

Febuxostat is for use only in people who cannot take another medicine called allopurinol, or when allopurinol has stopped working.

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

Taking febuxostat may increase your risk of serious or fatal heart problems. Seek medical attention if you have chest pain, trouble breathing, fast heartbeats, sudden severe headache, numbness or weakness on one side of your body, or problems with vision or speech.

You should not use febuxostat if you also use azathioprine or mercaptopurine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take febuxostat with or without food. Febuxostat may be taken with an antacid if needed.

You may have an increase in gout symptoms (flares) when you first start taking febuxostat. Your doctor may prescribe other medications for you to use during the first 6 months of treatment with febuxostat.

You should not stop using febuxostat suddenly. Stopping suddenly may make your condition worse.

For best results, keep using your medications as directed. Call your doctor if your symptoms do not improve after 6 months, or if they get worse.

You will need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Gout:

Initial dose: 40 mg orally once a day
-If serum uric acid level is greater than 6 mg/dL after 2 weeks, increase the dose to 80 mg orally once a day
Maintenance dose: 40 to 80 mg orally once a day
Maximum dose: 80 mg/day

Comments:
-Use of this drug should occur after an acute gout flare subsides.
-Gout flares may occur due to increased urate mobilization from tissue deposits, especially during initiation; gout flare prophylaxis with a NSAID or colchicine is recommended and may be beneficial for up to 6 months.
-Uric acid levels may be checked as soon as 2 weeks after beginning this drug.

Use: For the chronic management of hyperuricemia in patients with gout who have an inadequate experience to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

You should not use febuxostat if you are allergic to it, or if you also use:

• azathioprine; or

• mercaptopurine.

Taking febuxostat may increase your risk of serious or fatal heart problems. Talk with your doctor about the risks and benefits of febuxostat.

Tell your doctor if you have ever had:

• heart problems;

• a heart attack or stroke;

• liver or kidney disease;

• cancer;

• Lesch-Nyhan syndrome; or

• an organ transplant (kidney, liver, lung, heart).

Tell your doctor if you are pregnant or breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light, and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Febuxostat may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, fast heartbeats, shortness of breath;

• liver problems--stomach pain (upper right side), unusual tiredness, dark urine, jaundice (yellowing of the skin or eyes); or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects of febuxostat may include:

• gout flares, joint pain;

• nausea;

• mild rash; or

• liver problems.

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.

Tell your doctor about all your other medicines, especially:

• theophylline.

This list is not complete. Other drugs may affect febuxostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to febuxostat.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.