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Overview: Febuxostat is used to lower uric acid levels in people with gout. It works by reducing the amount of uric acid the body makes, which helps prevent future gout flares. When you first start taking febuxostat, you may have more gout flares for a short time before they become less common. Other common side effects include nausea, rash, and changes in liver test results. Febuxostat may increase the risk of heart-related death in some people, so it is usually used only when another medicine called allopurinol did not work well or is not a safe option.

Uses

What is febuxostat used for?

Febuxostat is commonly used for gout, which is a form of arthritis caused by too much uric acid in your blood and joints. Febuxostat may be used when another medicine for gout, allopurinol, cannot be safely used or has not worked well enough.

Febuxostat may also be used for other conditions as determined by your health care provider.

How does febuxostat work (mechanism of action)?

Febuxostat works by reducing how much uric acid is made in your body. If uric acid levels get too high, crystals can form in your joints and cause inflammation and pain (gout flares). By reducing the levels of uric acid, febuxostat helps prevent gout flares.

How is febuxostat supplied (dosage forms)?

Brands and other names

  • Uloric 

Dosage forms and strengths

  • 40 mg, 80 mg oral tablets

How should I store febuxostat?

Febuxostat should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep tightly closed. Protect from light.

Side Effects

What are the most common side effects of febuxostat?

The most common side effects of febuxostat are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Liver damage (see below)
  • Nausea
  • Joint pain
  • Rash (see below)

There may be other side effects of febuxostat that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of febuxostat?

While less common, the most serious side effects of febuxostat are described below, along with what to do if they happen.

Heart-Related Death. Febuxostat may increase your risk of heart-related death compared to another medicine for gout, allopurinol. This risk was seen in people with heart disease. Get emergency help if you have any of the following symptoms.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden and severe headache
  • Numbness or weakness on one side of your body
  • Slurring of speech
  • Sudden blurry vision

Gout Flares. Febuxostat may increase your gout flares before making your symptoms better. It may take several months to reduce uric acid levels enough to control your gout flares. It is very important to follow your health care provider’s recommendations, which may include taking medicine for pain and inflammation while taking febuxostat, and drinking enough fluids.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking febuxostat. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Febuxostat can cause severe skin reactions called Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) that can lead to death if not treated. If you get a rash, stop febuxostat and call your health care provider right away. Get emergency help right away if you have any of the following symptoms of SJS or TEN.

  • Skin that looks burned and peels off
  • Flat rash or blisters on your skin, mouth, nose, or genitals
  • Red, painful, watery eyes

Severe Allergic Reactions. Febuxostat may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking febuxostat and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (jaundice)

Warnings & Precautions

Who should not use febuxostat?

Allergies to Ingredients. People who are allergic to any of the following should not take febuxostat.

  • Febuxostat
  • Uloric
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific febuxostat products they stock.

Drug Interactions. Febuxostat should not be taken while you are using certain other medicines. Before taking febuxostat, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

What should I know about febuxostat before using it?

Do not take febuxostat unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share febuxostat with other people, even if they have the same condition as you. It may harm them.

Keep febuxostat out of the reach of children.

If you are being treated for gout, your symptoms may get worse before getting better while taking febuxostat. Talk to your health care provider about managing gout flares while taking febuxostat.

What should I tell my health care provider before using febuxostat?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if febuxostat is right for you.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems, including heart disease or a prior heart attack
  • Stroke
  • Liver problems
  • Kidney problems
  • Cancer
  • Organ transplant

 

Pregnancy. It is not known if or how febuxostat could affect pregnancy or harm a fetus. Tell your health care provider if you are or plan to become pregnant. 

Breastfeeding. It is not known if febuxostat passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should take febuxostat while breastfeeding.

Interactions

Does febuxostat interact with foods or drinks?

There are no known interactions between febuxostat and foods or drinks.

It is unknown if drinking alcohol will affect febuxostat.

Does febuxostat interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking febuxostat.

  • Mercaptopurine or azathioprine, which are used to suppress your immune system in treating certain diseases
  • Theophylline, which is used to treat certain breathing conditions

This may not be a complete list of medicines that can interact with febuxostat. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much febuxostat?

If you or someone else has used too much febuxostat, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of febuxostat?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.