Drug Landscape ›
Mirabegron 25mg ›
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
Abdominal Pain — 1 report (10%) Anaphylactic Reaction — 1 report (10%) Angioedema — 1 report (10%) Atelectasis — 1 report (10%) Bladder Pain — 1 report (10%) Condition Aggravated — 1 report (10%) Decreased Appetite — 1 report (10%) Diarrhoea — 1 report (10%) Drug Hypersensitivity — 1 report (10%) Fall — 1 report (10%)
Source database →
Mirabegron 25mg 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 Mirabegron 25mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Mirabegron 25mg in United States?
Far Eastern Memorial Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.