Drug Landscape ›
Febuxostat 40 mg ›
Regulatory · United States
Marketing authorisation
FDA
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Window: 20 April 2025 – 20 April 2026
Total reports: 10
Most-reported reactions
Apnoea — 1 report (10%) Cardiac Arrest — 1 report (10%) Cardio-Respiratory Arrest — 1 report (10%) Diarrhoea — 1 report (10%) Hypersensitivity — 1 report (10%) Myopathy — 1 report (10%) Nausea — 1 report (10%) Pruritus Generalised — 1 report (10%) Rash Papular — 1 report (10%) Rash Pruritic — 1 report (10%)
Source database →
Febuxostat 40 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Febuxostat 40 mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Febuxostat 40 mg in United States?
Ardea Biosciences, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.