🇺🇸 Prometrium in United States

FDA authorised Prometrium on 14 May 1998 · 3,014 US adverse-event reports

Marketing authorisations

FDA — authorised 14 May 1998

  • Application: NDA019781
  • Marketing authorisation holder: ACERTIS PHARMS
  • Status: supplemented

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. Headache — 429 reports (14.23%)
  2. Fatigue — 409 reports (13.57%)
  3. Pain — 337 reports (11.18%)
  4. Off Label Use — 293 reports (9.72%)
  5. Breast Cancer — 288 reports (9.56%)
  6. Drug Ineffective — 287 reports (9.52%)
  7. Back Pain — 270 reports (8.96%)
  8. Constipation — 248 reports (8.23%)
  9. Nausea — 231 reports (7.66%)
  10. Rheumatoid Arthritis — 222 reports (7.37%)

Source database →

Prometrium in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Prometrium approved in United States?

Yes. FDA authorised it on 14 May 1998; FDA has authorised it.

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

ACERTIS PHARMS holds the US marketing authorisation.