FDA
- Status: approved
🇺🇸 Glibenclamide 5 mg in United States
3 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: 20 April 2025 – 20 April 2026
- Total reports: 3
Most-reported reactions
- Atrioventricular Block Complete — 1 report (33.33%)
- Drug Interaction — 1 report (33.33%)
- Gastric Ulcer Haemorrhage — 1 report (33.33%)
Glibenclamide 5 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 Glibenclamide 5 mg approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Glibenclamide 5 mg in United States?
University of Campinas, Brazil is the originator. The local marketing authorisation holder may differ — check the official source linked above.