🇺🇸 Femarelle in United States

10 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. Alopecia — 1 report (10%)
  2. Female Orgasmic Disorder — 1 report (10%)
  3. Gingival Bleeding — 1 report (10%)
  4. Libido Decreased — 1 report (10%)
  5. Malaise — 1 report (10%)
  6. Meningitis — 1 report (10%)
  7. Myalgia — 1 report (10%)
  8. Pain — 1 report (10%)
  9. Postmenopausal Haemorrhage — 1 report (10%)
  10. Pulse Abnormal — 1 report (10%)

Source database →

Femarelle 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 Femarelle approved in United States?

Yes. FDA has authorised it.

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

Hadassah Medical Organization is the originator. The local marketing authorisation holder may differ — check the official source linked above.