🇺🇸 Estrofem in United States

75 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. Death — 13 reports (17.33%)
  2. Off Label Use — 10 reports (13.33%)
  3. Exposure During Pregnancy — 9 reports (12%)
  4. Dyspnoea — 8 reports (10.67%)
  5. Abortion Spontaneous — 7 reports (9.33%)
  6. Pulmonary Embolism — 7 reports (9.33%)
  7. Spinal Operation — 6 reports (8%)
  8. Cardiac Failure — 5 reports (6.67%)
  9. Depression — 5 reports (6.67%)
  10. Drug Interaction — 5 reports (6.67%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Estrofem approved in United States?

Yes. FDA has authorised it.

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

Assaf-Harofeh Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.