Febuxostat
Preparations Inhibiting Uric Acid Production
Sold as Adenuric
- Drug class
- Preparations Inhibiting Uric Acid Production
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 59
- FDA reports (12 mo)
- 979
Overview
Febuxostat is an active pharmaceutical ingredient in the Preparations Inhibiting Uric Acid Production group (M04AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 43 | May 29, 2026 |
| US United States | FDA | 7 | November 14, 2025 |
| CA Canada | Health Canada | 6 | May 4, 2026 |
| EU European Union | EMA | 3 | May 7, 2026 |
GBUnited Kingdom· MHRA
43 products
Uses
ELSTABYA 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). ELSTABYA 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).
ELSTABYA is indicated in adults.
How to take
USUnited States· FDA
7 products
Uses
1 INDICATIONS AND USAGE Febuxostat 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.
Limitations of Use :
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat 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 )
CACanada· Health Canada
6 products
Uses
AND CLINICAL USE ................................................................................ 3 CONTRAINDICATIONS ..................................................................................................... 3 WARNINGS AND PRECAUTIONS ....................................................................................
4 ADVERSE REACTIONS...................................................................................................... 7 DRUG INTERACTIONS ....................................................................................................
11 DOSAGE AND ADMINISTRATION ................................................................................ 13 OVERDOSAGE .................................................................................................................
14 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 14 STORAGE AND STABILITY ............................................................................................ 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................
EUEuropean Union· EMA
3 products
Uses
Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated in adults.
How to take
Drug interactions
Known interactions involving Febuxostat. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL494450065 · revised November 28, 2025
- [2]FDA DailyMed · 04f80eb2-8171-4e… · revised May 8, 2024 [PDF]
- [3]Health Canada (DPD) · 02549425 · revised May 26, 2025
- [4]European Medicines Agency · EMEA/H/C/004374 · revised May 7, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.