When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to febuxostat, or if you are using azathioprine (Azasan®, Imuran®) or mercaptopurine (Purinethol®).

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• You may take this medicine with or without food. This medicine may also be taken with antacids.
• At first, when you start using this medicine you may have more gout attacks. Keep using this medicine even if this happens. Your doctor may give you other medicines (such as colchicine or pain medicines [NSAIDs]) to help prevent these gout attacks.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using theophylline (Theo-24®, Theo-Dur®, Uniphyl®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, have kidney disease, liver disease, a history of heart disease or stroke, or if you have secondary hyperuricemia from Lesch-Nyhan syndrome (rare, inherited enzyme problem), malignant disease (cancer), or you are an organ transplant recipient.
• This medicine may increase your risk of having serious heart and blood vessel problems such as heart attack or stroke. Check with your doctor right away if you start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Dry mouth, increased thirst, or muscle cramps.
• Fast, slow, or uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Joint or muscle pain.
• Lightheadedness or fainting.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Sudden and severe stomach pain, nausea, or vomiting.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Anxiety, depression, or trouble sleeping.
• Blurred vision.
• Constipation, heartburn, indigestion, loss of appetite, mild nausea, or stomach pain.
• Dizziness or drowsiness.
• Hair loss.
• Mild skin rash.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Warmth or redness in your face, neck, arms, or upper chest.
• Weight changes.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088