🇺🇸 Estradiol+Drospirenone in United States

FDA authorised Estradiol+Drospirenone on 28 September 2005 · 25 US adverse-event reports

Marketing authorisation

FDA — authorised 28 September 2005

  • Application: NDA021355
  • Marketing authorisation holder: BAYER HLTHCARE
  • Local brand name: ANGELIQ
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Eosinophilia — 4 reports (16%)
  2. Drug Interaction — 3 reports (12%)
  3. Pericardial Effusion — 3 reports (12%)
  4. Pericarditis — 3 reports (12%)
  5. Drug Level Increased — 2 reports (8%)
  6. Fatigue — 2 reports (8%)
  7. Headache — 2 reports (8%)
  8. Nausea — 2 reports (8%)
  9. Toxicity To Various Agents — 2 reports (8%)
  10. Vomiting — 2 reports (8%)

Source database →

Other Contraception / Gynecology approved in United States

Frequently asked questions

Is Estradiol+Drospirenone approved in United States?

Yes. FDA authorised it on 28 September 2005.

Who is the marketing authorisation holder for Estradiol+Drospirenone in United States?

BAYER HLTHCARE holds the US marketing authorisation.