🇺🇸 Methergine in United States

FDA authorised Methergine on 19 November 1946 · 362 US adverse-event reports

Marketing authorisations

FDA — authorised 19 November 1946

  • Application: NDA006035
  • Marketing authorisation holder: EDISON THERAPS LLC
  • Local brand name: METHERGINE
  • Indication: TABLET — ORAL
  • Status: approved

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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. Wrong Drug Administered — 62 reports (17.13%)
  2. Drug Exposure During Pregnancy — 51 reports (14.09%)
  3. Vomiting — 40 reports (11.05%)
  4. Abdominal Pain — 35 reports (9.67%)
  5. Headache — 35 reports (9.67%)
  6. Nausea — 31 reports (8.56%)
  7. Drug Ineffective — 30 reports (8.29%)
  8. Dyspnoea — 27 reports (7.46%)
  9. Haemorrhage — 27 reports (7.46%)
  10. Dizziness — 24 reports (6.63%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Methergine approved in United States?

Yes. FDA authorised it on 19 November 1946; FDA has authorised it.

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

EDISON THERAPS LLC holds the US marketing authorisation.