Febuxostat, Oral Tablet

1. Febuxostat oral tablet is available as a brand-name drug. It’s not available as a generic drug. Brand name: Uloric.
2. Febuxostat comes only as a tablet you take by mouth.
3. Febuxostat oral tablet is used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout. It’s used for people who are unable to take allopurinol, or who have tried allopurinol and it was not effective enough for them.

• Gout flare-ups warning: You may have more gout flare-ups when you start taking febuxostat. You should continue taking this drug even if gout flare-ups occur. Your doctor may give you nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine to prevent flare-ups when you start febuxostat. The NSAIDs or colchicine may help prevent flare-ups for up to 6 months.
• Liver injury warning: Your doctor may do blood tests to check your liver function before you start this drug. This drug can also cause inaccurate liver function test results. This effect may make it difficult for your doctor to tell how this drug is affecting your liver. If you develop liver damage while taking this drug, your doctor may stop your treatment with this drug.
• Heart attack warning: Febuxostat may cause heart problems that can lead to heart attack. Symptoms of a heart attack can include:
  • chest pain or discomfort
  • upper body discomfort
  • shortness of breath
  • cold sweats
  • nausea
  • vomiting
  • sudden and unexplainable dizziness
  • extreme tiredness

If you experience these symptoms, call 911 or your local emergency services or go to the nearest emergency room.

• Stroke warning: Febuxostat may cause problems in the blood vessels that go to your brain. This can lead to stroke. The symptoms of a stroke can include:
  • sudden numbness or weakness in your face, arms, or legs
  • sudden confusion
  • trouble speaking or understanding speech
  • trouble seeing out of one or both of your eyes
  • sudden trouble walking, dizziness, or loss of balance or coordination
  • sudden and unexplainable severe headache

If you experience these symptoms, call 911 or your local emergency services or go to the nearest emergency room.

• Serious skin reactions warning: Febuxostat may cause life-threatening allergic reactions. These are called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These reactions may cause severe damage to your skin or internal organs. If you’ve had a previous serious skin reaction to a gout drug called allopurinol, tell your doctor before starting febuxostat. Call your doctor right away if you have any of these symptoms while taking febuxostat:
  • skin rash
  • hives
  • sores in your mouth
  • blistering or peeling of your skin
• Multi-organ hypersensitivity warning: Febuxostat can cause another severe allergic reaction. This is called drug reaction with eosinophilia and systemic symptoms (DRESS). This reaction can be fatal. If you’ve had a previous serious allergic reaction to the gout drug allopurinol, tell your doctor before starting febuxostat. Symptoms may include:
  • skin rash
  • fever
  • swollen lymph nodes
  • organ damage, including liver failure
  • jaundice (yellowing of your skin or the whites of your eyes)
  • swelling in the upper right part of your abdomen
  • change in how much you urinate

Febuxostat is a prescription drug. It comes only as a tablet you take by mouth.

Febuxostat oral tablet is available as the brand-name drug Uloric. It’s not available as a generic drug.

Febuxostat oral tablet may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it’s used

Febuxostat oral tablet is used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout. It helps decrease your symptoms of gout. Symptoms of gout include pain, swelling, redness, heat, soreness, and stiffness in certain joints.

How it works

Febuxostat belongs to a class of drugs called xanthine oxidase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Febuxostat decreases uric acid levels by blocking xanthine oxidase. Xanthine oxidase is an enzyme that helps your body make uric acid from the substance xanthine. High levels of uric acid in your blood can cause gout.

Febuxostat oral tablet doesn’t typically cause drowsiness. However, it can cause other side effects.

More common side effects

The more common side effects of febuxostat can include:

• nausea
• joint pain
• rash
• inaccurate liver function test results
• gout flare-ups

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 or your local emergency services if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Liver injury. Symptoms can include:
  • tiredness
  • lack of appetite
  • unexplained weight loss
  • discomfort in the upper right part of your abdomen
  • dark urine
  • jaundice (yellowing of your skin or the whites of your eyes)
• Heart attack. Symptoms can include:
  • chest pain
  • shortness of breath
  • discomfort in your upper body
  • cold sweats
  • nausea
  • vomiting
  • sudden and unexplainable dizziness
  • extreme tiredness
• Stroke. Symptoms can include:
  • weakness or numbness in one part or side of your body
  • slurred speech
  • sudden confusion
  • trouble seeing in one or both of your eyes
  • sudden trouble walking, dizziness, or loss of balance or coordination
  • sudden and unexplainable severe headache

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Febuxostat oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with febuxostat are listed below.

Drugs you should not use with febuxostat

Do not take these drugs with febuxostat. Doing so can cause dangerous effects in your body. Examples of these drugs include:

• Azathioprine, a drug used for rheumatoid arthritis and kidney transplants
• Mercaptopurine, a drug used for leukemia and some autoimmune diseases

Interactions that can increase your risk of side effects

Taking febuxostat with certain drugs raises your risk of side effects from those drugs. Examples of these drugs include:

• Theophylline. Febuxostat can change how theophylline, a respiratory disease drug, breaks down. Your doctor may monitor the level of theophylline in your blood to make sure it’s not too high.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Febuxostat may cause a severe allergic reaction. Symptoms can include:

• trouble breathing
• swelling of your throat or tongue

If you develop these symptoms, call 911 or your local emergency services or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Warnings for people with certain health conditions

For people with cardiovascular disease: If you have a history of cardiovascular disease, you should only use febuxostat to treat your gout in two situations. The first is if you’re not able to take the gout drug allopurinol. The second is if you’ve tried allopurinol and it was not effective enough for you. Taking febuxostat places you at a much greater risk of cardiovascular death than taking allopurinol.

For people with other causes of high uric acid levels: If you have high uric acid levels associated with cancer or cancer treatments or with Lesch-Nyhan syndrome, this drug may not be a good option for you. Levels of a substance called xanthine could build up in your urine and cause stones in your urinary tract.

For people with liver disease: This drug has not been studied in people with severe liver disease. If you have severe liver disease, talk to your doctor about whether this drug is right for you. This drug may also cause liver function test results that aren’t accurate. This may make it difficult for your doctor to tell how this drug is affecting your liver. If you develop liver damage while taking this drug and a cause can’t be determined, your doctor may stop your use of this drug.

For people with severe kidney disease: If you have severe kidney disease, talk to your doctor about whether this drug is right for you. You may need a lower dose of febuxostat.

Warnings for other groups

For pregnant women: Research is limited regarding the use of this drug in pregnant women. Talk to your doctor if you’re pregnant or planning to become pregnant.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: Febuxostat may pass into breast milk and cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You and your doctor will decide whether breastfeeding is safe.

For children: This medication has not been studied in children. It should not be used in children younger than 18 years.

All possible dosages and drug forms may not be included here. Your dosage will depend on:

• how severe your condition is
• other medical conditions you have
• how your body reacts to the drug

Drug form and strengths

Brand: Uloric

• Form: oral tablet
• Strengths: 40 mg, 80 mg

Dosage for high levels of uric acid from gout

Adult dosage (ages 18 years and older)

• Typical starting dosage: 40 mg per day.
• Dosage increases: Your doctor may increase your dosage to 80 mg after 2 weeks if your uric acid level does not fall below 6 mg/dL.
• Maximum dosage: 80 mg per day.

Child dosage (ages 0–17 years)

Febuxostat has not been studied in children. It should not be used in children younger than 18 years.

Special dosage warnings

For people with severe kidney disease: Your maximum dosage should be 40 mg once per day.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Febuxostat oral tablet is used for long-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: Your uric acid levels will likely remain high and continue to cause gout symptoms.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 911 or your local emergency services or go to the nearest emergency room right away.

What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: Your uric acid levels should decrease after about 2 weeks of taking febuxostat. Over time, your levels of uric acid should stay lower than 6 mg/dL. Your symptoms of gout should also go away.

Keep these considerations in mind if your doctor prescribes febuxostat for you.

General

• You can take febuxostat with or without food.
• Take this drug at the time(s) recommended by your doctor.
• You can cut or crush the tablet.

Storage

• Store febuxostat at room temperature between 59°F and 86°F (15°C and 30°C).
• Store this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor should monitor certain health issues while you take this drug. This can help make sure you stay safe during your treatment. These issues include your:

• Uric acid levels. Your doctor may check your levels of uric acid two weeks after starting febuxostat. Your goal is a uric acid level in your blood that is less than 6 mg/dL.

Your diet

Uric acid results from a breakdown of substances called purines. These substances may be in some of the foods you eat. Some foods that contain purines include liver, dried beans and peas, and anchovies.

Your doctor or dietitian may tell you to limit the amount of these foods that you eat. You should also drink plenty of water. Both of these things can help make febuxostat work better for you.

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Hidden costs

You may need blood tests done to monitor your treatment while you take this drug. The cost of these tests will depend on your insurance coverage.

Prior authorization

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.