FDA — authorised 18 September 1984
- Application: NDA018565
- Marketing authorisation holder: HIKMA
- Local brand name: DURAMORPH PF
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Epimorph in United States
FDA authorised Epimorph on 18 September 1984 · 12 US adverse-event reports
Marketing authorisations
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.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 12
Most-reported reactions
- Drug Ineffective — 4 reports (33.33%)
- Exposure During Pregnancy — 4 reports (33.33%)
- Procedural Hypotension — 2 reports (16.67%)
- Drug Effect Decreased — 1 report (8.33%)
- Dyspnoea — 1 report (8.33%)
Other Other approved in United States
Frequently asked questions
Is Epimorph approved in United States?
Yes. FDA authorised it on 18 September 1984; FDA has authorised it.
Who is the marketing authorisation holder for Epimorph in United States?
HIKMA holds the US marketing authorisation.