🇺🇸 Solifenacin + Mirabegron in United States

16 US adverse-event reports

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: 22 April 2025 – 22 April 2026
• Total reports: 16

Most-reported reactions

1. Atrial Fibrillation — 2 reports (12.5%)
2. Hypertension — 2 reports (12.5%)
3. Hypertensive Crisis — 2 reports (12.5%)
4. Hypotension — 2 reports (12.5%)
5. Overdose — 2 reports (12.5%)
6. Pneumonia — 2 reports (12.5%)
7. Abdominal Pain Upper — 1 report (6.25%)
8. Accidental Overdose — 1 report (6.25%)
9. Atrial Flutter — 1 report (6.25%)
10. Bradycardia — 1 report (6.25%)

Source database →

Frequently asked questions

Is Solifenacin + Mirabegron approved in United States?

Solifenacin + Mirabegron does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Solifenacin + Mirabegron in United States?

University of Aarhus is the originator. The local marketing authorisation holder may differ — check the official source linked above.