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Febuxostat (Uloric): Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
80 mg, 40 mg
Brand names:
Drug class:
Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Febuxostat

What are febuxostat tablets?

Febuxostat tablet is a prescription medicine called a xanthine oxidase (XO) inhibitor used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you.

Febuxostat tablets are not for use in people who do not have symptoms of high blood uric acid levels.

It is not known if febuxostat tablets are safe and effective in children.

Who should not take febuxostat tablets?

Do not take febuxostat tablets if you:

  • take azathioprine (Azasan, Imuran)
  • take mercaptopurine (Purinethol, Purixan)

What should I tell my doctor before taking febuxostat tablets?

Before taking febuxostat tablets tell your doctor about all of your medical conditions, including if you:

  • have taken allopurinol and what happened to you while you were taking it.
  • have a history of heart disease or stroke.
  • have liver or kidney problems.

  • are pregnant or plan to become pregnant. It is not known if febuxostat tablets will harm your unborn baby. Talk with your doctor if you are pregnant or plan to become pregnant.

  • are breastfeeding or plan to breastfeed. It is not known if febuxostat passes into your breast milk. You and your doctor should decide if you should take febuxostat tablets while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Febuxostat tablets may affect the way other medicines work, and other medicines may affect how febuxostat tablets work.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take febuxostat tablets?

  • Take febuxostat tablets exactly as your doctor tells you to take it.

  • Febuxostat tablets can be taken with or without food.

  • Febuxostat tablets can be taken with antacids.
  • Your gout may get worse (flare) when you start taking febuxostat tablets. Do not stop taking febuxostat tablets because you have a flare.

Your doctor may do certain tests while you take febuxostat tablets.

What are the possible side effects of febuxostat tablets?

Febuxostat tablets may cause serious side effects, including:

  • Heart problems.See " What is the most important information I should know about febuxostat tablets?" .
  • Gout Flares.Gout flares can happen when you start taking febuxostat tablets. Your doctor may give you other medicines to help prevent your gout flares.
  • Liver problems.Liver problems can happen in people who take febuxostat tablets. Your doctor may do blood tests to check how well your liver is working before and during your treatment with febuxostat tablets. Tell your doctor if you get any of the following signs or symptoms of liver problems:
  • fatigue
  • loss of appetite for several days or longer
  • pain, aching, or tenderness on the right side of your stomach-area
  • dark or "tea-colored" urine
  • your skin or the white part of your eyes turns yellow (jaundice)
  • Severe skin and allergic reactions.Serious skin and allergic reactions that may affect different parts of the body such as your liver, kidneys, heart or lungs, can happen in people who take febuxostat tablets. Call your doctor right away or get emergency medical help if you have any of the following symptoms:
  • rash
  • red and painful skin
  • severe skin blisters
  • peeling skin
  • sores around the lips, eyes or mouth
  • swollen face, lips, mouth, tongue or throat
  • flu-like symptoms

The most common side effects of febuxostat tablets include:

  • abnormal liver function tests
  • nausea
  • joint pain
  • rash

These are not all of the possible side effects of febuxostat tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store febuxostat tablets?

  • Store febuxostat tablets at room temperature.
  • Keep febuxostat tablets out of the light.

Keep febuxostat tablets and all medicines out of the reach of children.

General information about the safe and effective use of febuxostat tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use febuxostat tablets for a condition for which it was not prescribed. Do not give febuxostat tablets to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your doctor or pharmacist for information about febuxostat tablets that is written for health professionals.

What are the ingredients in febuxostat tablets?

Active ingredient: febuxostat

Inactive ingredients:croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and Opadry II, white, the ingredients of Opadry II are polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

Trademarks are the property of their respective owners.

Distributed by:

HEC Pharm USA Inc.

Plainsboro, NJ 08536

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

No. 1, Northern Industry Road,

Northern Industry Park of Song Shan Lake,

DongGuan, GuangDong, 523808,China

For more information, contact HEC Pharm USA Inc. at 1-800-610-5709.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 213069 · View the label on DailyMed

Revision date stated in the text: March 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Febuxostat

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Xanthine Oxidase Inhibitor
Active ingredient Febuxostat
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SUNSHINE
FDA approval ANDA 213069Abbreviated New Drug Application (ANDA) – generic drug Approved June 2, 2020
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Uloric with the same TE code
Manufacturers 18 labelers list this drug on DailyMed
Packages (NDC)
Package
80 mg – 30 in 1 bottle NDC 72303-0856-1
40 mg – 30 in 1 bottle NDC 72303-0855-1

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.