🇺🇸 Isosorbid mononitrate in United States

90 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. Dyspnoea — 15 reports (16.67%)
  2. Dizziness — 10 reports (11.11%)
  3. Drug Ineffective — 10 reports (11.11%)
  4. Hypotension — 10 reports (11.11%)
  5. Asthenia — 8 reports (8.89%)
  6. Death — 8 reports (8.89%)
  7. Fatigue — 8 reports (8.89%)
  8. Cough — 7 reports (7.78%)
  9. Diarrhoea — 7 reports (7.78%)
  10. Fall — 7 reports (7.78%)

Source database →

Isosorbid mononitrate 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 Isosorbid mononitrate approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Isosorbid mononitrate in United States?

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