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

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

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

Taking Uloric 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 Uloric if you also use azathioprine or mercaptopurine.

Before taking Uloric, tell your doctor if you have kidney disease, liver disease, diabetes, 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 Uloric. 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.

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

Take Uloric exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

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

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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

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 non-steroidal anti-inflammatory 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: Chronic management of symptomatic hyperuricemia in patients with gout

You should not use Uloric if you are allergic to febuxostat, 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 this medicine.

To make sure Uloric is safe for you, 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).

It is not known whether febuxostat will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using Uloric. Ask your doctor about any risk.

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.

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

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 to Uloric (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. This reaction may occur several weeks after you began using Uloric.

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 Uloric side effects may include:

• gout flares, joint pain;

• nausea;

• mild rash; or

• abnormal liver function tests.

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 current medicines and any you start or stop using, especially:

• theophylline.

This list is not complete. Other drugs may interact with febuxostat, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.