🇺🇸 Epleronone in United States

20 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. Abdominal Pain Upper — 2 reports (10%)
  2. Bronchitis — 2 reports (10%)
  3. Cardiac Failure Congestive — 2 reports (10%)
  4. Cardiomegaly — 2 reports (10%)
  5. Cardiomyopathy — 2 reports (10%)
  6. Cholecystitis — 2 reports (10%)
  7. Dyspnoea — 2 reports (10%)
  8. Hypertension — 2 reports (10%)
  9. Influenza Like Illness — 2 reports (10%)
  10. Insomnia — 2 reports (10%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Epleronone approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Epleronone in United States?

Vanderbilt University Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.