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Febuxostat

Adenuric · ATC code M04AA03

Brand names: Adenuric, Feburo, Febuxostat +pharma, Febuxostat Genericon, Febuxostat Ratiopharm, Febuxostat Sandoz, Febuxodor, Febugut, Gustat

Key facts
Active substance
Febuxostat
Drug class
Antigout agent
ATC code
M04AA03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ADENURIC 80 mg film-coated tablets · ADENURIC 120 mg film-coated tablets
Marketing authorisation holder
Menarini International Operations Luxembourg S.A. (MIOL)
Information as of
2026-10-27

Key facts

Febuxostat (Adenuric) is a xanthine oxidase inhibitor that lowers uric acid in chronic hyperuricaemia with urate deposition and, at the 120 mg strength, prevents and treats hyperuricaemia during chemotherapy with tumour lysis risk.

What it is used for

  • Chronic hyperuricaemia where urate deposition has already occurred (tophus and/or gouty arthritis, present or past) in adults
  • Adenuric 120 mg: prevention and treatment of hyperuricaemia in adults undergoing chemotherapy for haematologic malignancies at intermediate to high risk of tumour lysis syndrome

Dosing

  • Gout: 80 mg once daily without regard to food; if serum uric acid is > 6 mg/dL after 2-4 weeks, 120 mg once daily may be considered
  • Gout: target uric acid below 6 mg/dL; flare prophylaxis of at least 6 months recommended
  • Tumour lysis syndrome: 120 mg once daily, started two days before cytotoxic therapy, for a minimum of 7 days
  • Mild hepatic impairment: 80 mg; no adjustment in mild or moderate renal impairment or in the elderly
  • Not studied in severe hepatic impairment; not fully evaluated in severe renal impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Pre-existing major cardiovascular disease: more fatal cardiovascular events observed in studies; cautious use and regular monitoring
  • Rare serious hypersensitivity reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, DRESS), mostly in the first month
  • Caution in patients with altered thyroid function
  • Contains lactose

Side effects

  • Most common: gout flares, liver function abnormalities, diarrhoea, nausea, headache, dizziness, rash, oedema
  • Mostly mild or moderate
  • Rare: serious hypersensitivity reactions and sudden cardiac death in post-marketing experience

Interactions

  • Mercaptopurine/azathioprine: concomitant use not recommended (myelotoxicity); if used, reduce dose to 20% or less
  • Theophylline: no increase in levels with 80 mg; no data for 120 mg
  • No data with other cytotoxic chemotherapy

Pregnancy and breastfeeding

  • Febuxostat should not be used during pregnancy or breastfeeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • FeburoG.L. Pharma Gmbh · 1 register entry
  • Febuxostat +pharma+pharma Arzneimittel Gmbh · 1 register entry
  • Febuxostat GenericonGenericon Pharma Gesellschaft M.B.H. · 1 register entry
  • Febuxostat RatiopharmTeva B.V · 1 register entry
  • Febuxostat SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • FebuxodorTad Pharma Gmbh · 1 register entry
  • Febuxostat1 A Pharma Gmbh, Ratiopharm Gmbh, Alembic Pharmaceuticals Europe Ltd, Heumann Pharma Gmbh & Co. Generica Kg, Vivanta Generics S.R.O., Zentiva Pharma Gmbh, Aristo Pharma Gmbh (Art 57), Indoco Remedies Czech S.R.O., Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh, Aliud Pharma Gmbh · 13 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AdenuricMENARİNİ İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries
  • FebugutBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • GustatGENVEON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 28 more European countries
Belgium
Feburik, Febuxostat Ab, Febuxostat Eg
Bulgaria
Адара, Друнилер, Фебуксогард, Фебуксостат Pil, Фебуцин, Феликса, Форур
Croatia
Abuxar, Febuksostat
Cyprus
Febuxostat Genepharm, Urichofeb
Czechia
Febuxostat Sandoz
Denmark
Febuxostat Accord, Febuxostat Teva
Estonia
Druniler, Febuxostat Alembic, Febuxostat Teva
Finland
Febuxostat Accord
France
Febuxostat Accord, Febuxostat Almus, Febuxostat Arrow, Febuxostat Biogaran, Febuxostat Cristers, Febuxostat Eg, Febuxostat Evolugen, Febuxostat Sandoz, Febuxostat Teva Sante, Febuxostat Zentiva Lab, Febuxostat Zydus France
Greece
Buxodem, Febuxostat Genepharm, Febuxostat Pharos, Uricaden®, Urichofeb
Hungary
Denofix, Doluric, Febuxostat Pharos, Febuxostat Sandoz, Febuxostat Stada, Forure, Urichofeb
Iceland
Adenuric, Febuxostat Krka, Febuxostat Viatris
Ireland
Febuxostat Clonmel, Febuxostat Rowa, Febuxostat Rowex
Italy
Alphabux, Arbux, Dymauric, Febuxen, Febuxostat Aurobindo, Febuxostat Doc Generici, Febuxostat Eg, Febuxostat Pensa, Febuxostat Sandoz, Febuxostat Tecnigen, Febuxostat Teva, Gauti, Gottart, Uriquid
Latvia
Denofix, Druniler, Febuxostat Teva
Liechtenstein
Adenuric, Febuxostat Viatris
Lithuania
Druniler, Febuxostat Teva
Luxembourg
Feburik, Febuxostat
Malta
Febuxostat Pharos
Netherlands
Feburik, Febuxostat Liconsa, Febuxostat Teva, Febuxostat Vivanta
Norway
Adenuric, Febuxostat Krka, Febuxostat Viatris
Poland
Denofix, Febuxostat Aurovitas, Forure
Portugal
Bluesar, Febuxostate Aristo, Febuxostate Bluepharma, Febuxostate Demo, Febuxostate Genepharm, Febuxostate Generis, Febuxostate Pentafarma, Febuxostate Tecnigen, Febuxostate Tolife, Urosat
Romania
Forure
Slovakia
Febuxostat Sandoz
Slovenia
Abuxar
Spain
Febuxostat Aurovitas, Febuxostat Cinfa, Febuxostat Cinfamed, Febuxostat Mabo, Febuxostat Normon, Febuxostat Pharma Combix, Febuxostat Sandoz, Febuxostat Stada, Febuxostat Tecnigen, Febuxostat Teva-Ratiopharm, Gotaric
Sweden
Feburo

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Adenuric – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/adenuric-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC M04AA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.