Febuxostat

Pronunciation: feh-BUKS-oh-stat.

Generic name
febuxostat
Drug class
Xanthine oxidase inhibitor
Form
Tablet, 40 mg, 80 mg, or 120 mg depending on market
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Adenuric (5) · Full directory

What febuxostat is and how it works

Febuxostat is a prescription-only medicine that lowers uric acid levels by blocking the enzyme (xanthine oxidase) that produces it, used for long-term control of chronic gout. It carries an important cardiovascular safety warning and is generally reserved for people who cannot use allopurinol successfully. (1) (2)

Febuxostat is a long-term, preventive gout medicine -- it does not relieve a gout flare that is already happening. Take it exactly as your prescriber directs, and discuss your heart health history before starting.

Mechanism of action: how febuxostat works

Febuxostat is a non-purine selective inhibitor of xanthine oxidase, blocking conversion of hypoxanthine to xanthine and xanthine to uric acid, thereby lowering serum uric acid without the purine-analogue structure of allopurinol. (1)

What febuxostat is used for

Chronic gout (long-term uric acid control)

Used for long-term management of high uric acid (hyperuricaemia) in adults with gout who have not had an adequate response to a maximally adjusted dose of allopurinol, cannot tolerate allopurinol, or for whom allopurinol is not advisable. Not recommended for people with high uric acid but no symptoms of gout. (1) (4)

Tumour lysis syndrome prevention (120 mg strength, some markets)

In the UK, EU, and New Zealand, the 120 mg strength is also used to prevent and treat high uric acid in adults undergoing chemotherapy for blood cancers who are at intermediate-to-high risk of tumour lysis syndrome, with cardiac monitoring as clinically appropriate in that setting. (2) (6)

Before taking febuxostat

Do not take / not appropriate for

  • Do not take febuxostat if you have had a serious allergic reaction to it or any of its ingredients. (all countries) (2)
  • In the United States and Canada, febuxostat must not be taken together with azathioprine or mercaptopurine -- this combination is contraindicated because it can raise these medicines to dangerous levels. (United States, Canada) (1) (4)

Tell your clinician about

  • Any history of heart attack, stroke, unstable angina, or heart failure -- this affects whether febuxostat is an appropriate choice for you.
  • Any history of liver problems.
  • Whether you take azathioprine or mercaptopurine, or any other gout medicine (including allopurinol).
  • Any previous serious skin reaction to any medicine.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2)

How to take febuxostat

  • Take once daily, with or without food.
  • Febuxostat is a preventive, long-term treatment -- it will not relieve a gout attack that has already started.
  • Gout flares can become more frequent for a while after starting febuxostat, as urate deposits are mobilised; your prescriber may recommend an anti-inflammatory medicine or colchicine alongside it for the first several months to help prevent this.
  • If a gout flare happens while you are taking febuxostat, treatment is usually continued rather than stopped, with the flare managed alongside it -- your prescriber or care team will decide the right approach for you.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose. Contact your prescriber or pharmacist if you are unsure, since febuxostat is a preventive, not an emergency, medicine.

Overdose

Seek urgent medical advice if you or someone else has taken more febuxostat than prescribed. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Liver function test abnormalities.

What to notice: Liver function test abnormalities.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Nausea.

What to notice: Nausea.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Joint pain (arthralgia).

What to notice: Joint pain (arthralgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Rash.

What to notice: Rash.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Diarrhoea, headache, and shortness of breath (dyspnoea) have also been reported commonly.

What to notice: Diarrhoea, headache, and shortness of breath (dyspnoea) have also been reported commonly.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

Signs of a heart problem (chest pain, chest tightness, or a possible heart attack or stroke) — boxed_warning

Symptoms: Chest pain or pressure, pain spreading to the arm/jaw, sudden shortness of breath, sudden weakness or numbness on one side of the body, slurred speech, or sudden severe headache.

Action: Call emergency services immediately. Febuxostat carries a cardiovascular death warning versus allopurinol in people with existing heart or blood vessel disease -- your prescriber will have weighed this risk before starting treatment. (1) (4) (5)

Signs of a liver problem — high caution

Symptoms: Yellowing of the skin or eyes (jaundice), unusual tiredness, loss of appetite, dark urine, nausea, or pain in the upper right abdomen.

Action: Tell your prescriber promptly. Liver blood tests are checked before starting and periodically during treatment; fatal and non-fatal liver failure have been reported rarely. (1) (2)

Signs of a serious skin reaction — emergency

Symptoms: Widespread rash, blistering or peeling skin, mouth ulcers, fever, or swollen glands, especially in the first month of treatment.

Action: Seek emergency medical help immediately and mention febuxostat. A clinician will decide whether treatment needs to stop; febuxostat should not be restarted if a serious skin or hypersensitivity reaction has occurred. (2)

Interactions

  • Azathioprine or mercaptopurine: in the US and Canada this combination is contraindicated outright. In the UK, EU, and New Zealand it is 'not recommended,' and if it genuinely cannot be avoided, your prescriber will monitor you closely and reduce the azathioprine/mercaptopurine dose substantially to avoid blood-related toxicity. (1) (2) (6)
  • Theophylline: a formal US drug-interaction study found a large increase in a theophylline breakdown product's urinary excretion, so this combination is used with caution; a separate UK study of a single theophylline dose found no significant pharmacokinetic interaction. Tell your prescriber if you take theophylline. (1) (2)
  • Colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin, and desipramine did not require dose adjustment in clinical interaction studies. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Febuxostat is not recommended during pregnancy, as safety has not been established. (1) (2) (3) (4) (5) (6)

Breastfeeding

Febuxostat is not recommended while breastfeeding, as safety has not been established. (1) (2) (3) (4) (5) (6)

Children

Not established as safe and effective in children under 18; not recommended in this age group. (1) (2) (3) (4) (5) (6)

Elderly

No clinically significant differences in safety or effectiveness were seen in older adults compared with younger adults in clinical studies; the cardiovascular warning is especially relevant for older patients, who more often have existing heart disease. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Use with caution; has not been extensively studied in severe hepatic impairment. (1) (2) (3) (4) (5) (6)

Renal_impairment

No dose adjustment needed for mild-to-moderate kidney impairment; in the US, severe renal impairment limits dosing to 40 mg once daily and febuxostat has not been studied in very severe or dialysis-dependent kidney failure. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Baseline liver function tests
  • Cardiovascular history review (heart attack, stroke, unstable angina, heart failure)
  • Baseline serum uric acid

During treatment

  • Serum uric acid checks to guide dose (target usually under 6 mg/dL / 357 micromol/L).
  • Periodic liver function tests.
  • Ongoing awareness of cardiovascular symptoms, given the cardiovascular death signal versus allopurinol.
(1) (2)

Storage

Store at room temperature around 25C (77F); brief excursions between 15-30C are permitted. Protect from light. Keep out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and UK SmPC; verify against the current full label before prescribing.

United States

Indication: Chronic hyperuricaemia in gout, second-line after allopurinol

Dose summary: Start 40 mg once daily; increase to 80 mg if serum uric acid >=6 mg/dL after 2 weeks. Severe renal impairment: limit to 40 mg daily.

Renal context: Severe renal impairment: 40 mg once daily maximum; not studied in dialysis. (1)

United Kingdom / European Union

Indication: Chronic hyperuricaemia in gout; 120 mg also for TLS prevention in chemotherapy

Dose summary: Start 80 mg once daily; increase to 120 mg once daily if serum uric acid remains >6 mg/dL (357 micromol/L) after 2-4 weeks.

Renal context: No adjustment needed for mild-moderate renal impairment per SmPC. (2)

Mechanism of action

Hepatic guidance

Fatal and non-fatal hepatic failure reported; obtain baseline LFTs and monitor periodically; use caution in hepatic impairment.

Overdose note

Limited overdose experience; manage supportively with monitoring. (1)

Frequently asked questions

Is febuxostat available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, febuxostat is approved in all of these regions -- as Uloric in the US and Canada, and as Adenuric in the UK, EU, Australia, and New Zealand. (1) (2) (3) (4) (5) (6)

Why does febuxostat have a warning about the heart?

A large clinical trial (CARES) comparing febuxostat with allopurinol in people who already had heart or blood vessel disease found a higher rate of cardiovascular death in the febuxostat group. Because of this, febuxostat is generally reserved for people who have not done well on allopurinol, and your prescriber will consider your heart health history before starting it. (1) (2)

Is febuxostat the same as allopurinol?

No. Both lower uric acid by blocking the same enzyme (xanthine oxidase), but they are chemically different medicines, and febuxostat is generally used only when allopurinol has not worked well enough or could not be tolerated. (1)

What is the mechanism of action of febuxostat?

Febuxostat is a non-purine selective inhibitor of xanthine oxidase, blocking conversion of hypoxanthine to xanthine and xanthine to uric acid, thereby lowering serum uric acid without the purine-analogue structure of allopurinol. (1)

What is the generic name of Febuxostat?

The generic name is febuxostat. (1)

What class of drug is febuxostat?

Febuxostat is classed as: Xanthine oxidase inhibitor. (1)

References

  1. ULORIC (febuxostat) tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information · United States · accessed 2026-07-29 · source 1
  2. Adenuric 80 mg film-coated tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- A. Menarini Farmaceutica Internazionale SRL · United Kingdom · accessed 2026-07-29 · source 2
  3. Adenuric European Public Assessment Report (EPAR)European Medicines Agency (EMA) · European Union · accessed 2026-07-29 · source 3
  4. ULORIC (febuxostat 80 mg tablets) Product MonographHealth Canada product monograph, Takeda Canada Inc. · Canada · accessed 2026-07-29 · source 4
  5. ADENURIC febuxostat 80 mg tablets -- ARTG entry and safety alertTherapeutic Goods Administration (TGA), Australia · Australia · accessed 2026-07-29 · source 5
  6. Adenuric (febuxostat 80 mg, 120 mg film-coated tablets) New Zealand Data SheetMedsafe (New Zealand regulator) New Zealand Data Sheet · New Zealand · accessed 2026-07-29 · source 6

Brand names by country

Single-ingredient febuxostat names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • ULORIC80 mg, 40 mg · takeda pharmaceuticals america, inc.

United Kingdom

  • Adenuric (2)MHRA licensed emc smpc confirmed · 80 mg, 120 mg · A. Menarini Farmaceutica Internazionale SRL

Canada

  • ULORIC

Australia

  • Adenuric (5)TGA ARTG registered boxed warning strengthened confirmed · 80 mg · A. Menarini Australia Pty Ltd

New Zealand

  • Adenuric (6)Medsafe approved confirmed · 80 mg, 120 mg · not specified in fetched source
View brands in additional countries.

European Union

Adenuric (3)

This page provides general reference information about febuxostat and is not a substitute for advice from the prescriber managing your treatment. All dosing and treatment decisions should be made with your prescriber.

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