FDA
- Status: approved
🇺🇸 metformine in United States
3,523 US adverse-event reports
Marketing authorisation
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: 27 March 2025 – 27 March 2026
- Total reports: 3,523
Most-reported reactions
- Acute Kidney Injury — 965 reports (27.39%)
- Lactic Acidosis — 682 reports (19.36%)
- Diarrhoea — 332 reports (9.42%)
- Hyperkalaemia — 292 reports (8.29%)
- Vomiting — 284 reports (8.06%)
- Drug Interaction — 214 reports (6.07%)
- Nausea — 211 reports (5.99%)
- Metabolic Acidosis — 190 reports (5.39%)
- Fall — 185 reports (5.25%)
- Renal Failure — 168 reports (4.77%)
Other Other approved in United States
Frequently asked questions
Is metformine approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for metformine in United States?
Semnan University of Medical Sciences is the originator. The local marketing authorisation holder may differ — check the official source linked above.