Febuxostat, Oral

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KEY POINTS

• This medicine is taken by mouth to lower blood uric acid levels in adults with gout. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: xanthine oxidase inhibitor; antigout

Generic and brand names: febuxostat, oral; Uloric

What is this medicine used for?

This medicine is taken by mouth to lower blood uric acid levels in adults with gout.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• An organ transplant
• Cancer
• Heart disease
• Kidney or liver disease

You should not take this medicine if you are also taking azathioprine (Azasan, Imuran) or mercaptopurine (Purinethol).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

Take the medicine with a full glass of water. You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. You may also take antacids to lessen stomach upset.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Your healthcare provider should check you regularly to see how this medicine affects you. You may need to have blood tests. Keep all appointments.

This medicine may cause gout flares when you first start taking it. Your healthcare provider may prescribe other gout medicines during your first few months of treatment with this medicine. Talk with your provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Follow the diet program your healthcare provider recommends. Certain food or drinks may cause gout attacks. Talk with your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Chest pain; unexplained swelling; shortness of breath; yellowing of the eyes or skin; dark urine; light-colored bowel movements; severe stomach pain, nausea, or vomiting; unexplained loss of appetite; unusual tiredness or weakness; slow, fast, or irregular heartbeat; unusual bruising or bleeding; trouble urinating or changes in urination; severe dizziness or fainting; hearing problems; unexplained fever, sore throat, or cough; unusual mood or behavior changes; severe skin redness, peeling, or blisters.

Other: Mild nausea or stomach pain, mild dizziness, joint pain, blurred vision, constipation.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Also, using these medicines together might cause harmful side effects. Talk to your healthcare provider if you are taking any of these medicines:

• Azathioprine (Azasan, Imuran)
• Didanosine (Videx)
• Mercaptopurine (Purinethol)
• Pegloticase (Krystexxa)
• Theophylline

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.