🇺🇸 Carvedilol 12.5 MG in United States

36 US adverse-event reports

Marketing authorisation

FDA

  • Status: approved

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.

Most-reported reactions

  1. Death — 5 reports (13.89%)
  2. Diarrhoea — 4 reports (11.11%)
  3. Dyspnoea — 4 reports (11.11%)
  4. Fatigue — 4 reports (11.11%)
  5. Nausea — 4 reports (11.11%)
  6. Product Substitution Issue — 4 reports (11.11%)
  7. Somnolence — 4 reports (11.11%)
  8. Bradycardia — 3 reports (8.33%)
  9. Acute Kidney Injury — 2 reports (5.56%)
  10. Anaphylactic Reaction — 2 reports (5.56%)

Source database →

Carvedilol 12.5 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 Carvedilol 12.5 MG approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Carvedilol 12.5 MG in United States?

Beijing Friendship Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.