Generic Name: Febuxostat (feb-UX-oh-stat)Brand Name: Uloric

Febuxostat is used for:

Treating high levels of uric acid in the blood in patients with gout.

Febuxostat is a xanthine oxidase inhibitor. It works by blocking an enzyme in the body (xanthine oxidase), which lowers levels of uric acid in the blood. This helps to prevent gout flare-ups.

Do NOT use Febuxostat if:

  • you are allergic to any ingredient in Febuxostat
  • you are taking azathioprine, mercaptopurine, or theophylline
  • you have malignant disease or Lesch-Nyhan syndrome

Contact your doctor or health care provider right away if any of these apply to you.

Before using Febuxostat :

Some medical conditions may interact with Febuxostat . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver or kidney problems
  • if you have a history of heart problems (eg, heart attack) or stroke
  • if you have secondary hyperuricemia or if you have received an organ transplant

Some MEDICINES MAY INTERACT with Febuxostat . Tell your health care provider if you are taking any other medicines, especially any of the following

  • Azathioprine, mercaptopurine, and theophylline because the risk of their side effects may be increased by Febuxostat

This may not be a complete list of all interactions that may occur. Ask your health care provider if Febuxostat may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Febuxostat :

Use Febuxostat as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Febuxostat . Talk to your pharmacist if you have questions about this information.
  • Take Febuxostat by mouth with or without food.
  • If you miss a dose of Febuxostat , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Febuxostat .

Important safety information:

  • Febuxostat may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Febuxostat with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Some patients may experience a gout flare-up when they start taking Febuxostat . Your doctor may prescribe a nonsteroidal anti-inflammatory drug (NSAID) or colchicine to take to help control or prevent a gout flare-up. Do not stop taking this medication if you experience a gout flare-up without talking to your doctor. Talk with your doctor if you have any questions or concerns.
  • Lab tests, including uric acid levels and kidney, liver, and heart function, may be performed while you use Febuxostat . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Febuxostat with caution in the ELDERLY; they may be more sensitive to its effects.
  • Febuxostat should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Febuxostat while you are pregnant. It is not known if Febuxostat is found in breast milk. If you are or will be breast-feeding while you use Febuxostat , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Febuxostat :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Joint pain; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain or discomfort; dark urine; fast, slow, or irregular heartbeat; pale stools; signs of high or low blood pressure (eg, headache, dizziness, tiredness, weakness); one sided weakness; shortness of breath; slurred speech; stomach pain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Febuxostat :

Store Febuxostat at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Febuxostat out of the reach of children and away from pets.

General information:

  • If you have any questions about Febuxostat , please talk with your doctor, pharmacist, or other health care provider.
  • Febuxostat is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Febuxostat . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

  • Febuxostat Professional Patient Advice (Wolters Kluwer)
  • Uloric Prescribing Information (FDA)
  • Uloric Consumer Overview