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Febuxostat

Also known as: Adenuric · Febuxostat Viatris (previously Febuxostat Mylan) · Febuxostat Krka · ULORIC

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In short

In the European Union, the 80 mg and 120 mg strengths of febuxostat are indicated for the treatment of chronic hyperuricaemia in adults where urate deposition has already occurred, including a history or presence of tophus and/or gouty arthritis. The 120 mg strength is also indicated in the European Union for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome. In the United States, febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have had an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom allopurinol treatment is not advisable. The limitations of use in the United States specify that febuxostat is not for the treatment of asymptomatic hyperuricemia, and the medicine is listed by the cited source as having an approved use for gout.

From: Source: European Medicines Agency (EMA), Adenuric — EPAR, 26/02/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
73689 febuxostat
EMA
EMEA/H/C/000777, EMEA/H/C/004374, EMEA/H/C/004773

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Adenuric

80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults.

Source: European Medicines Agency (EMA), Adenuric — EPAR, 26/02/2026. © European Medicines Agency.

Document date: 26/02/2026 · Official document →

FDA (USA) FEBUXOSTAT

1 INDICATIONS AND USAGE Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablet is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260310 · Official document →

Related terms in the cited sources

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External resources

Questions

What is Febuxostat approved for in the European Union?

80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults. (Source: European Medicines Agency (EMA), Adenuric — EPAR, 26/02/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Adenuric — EPAR, 26/02/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →