🇺🇸 Estradiol valerate / dienogest in United States

FDA authorised Estradiol valerate / dienogest on 6 May 2010 · 101 US adverse-event reports

Marketing authorisation

FDA — authorised 6 May 2010

  • Application: NDA022252
  • Marketing authorisation holder: BAYER HLTHCARE
  • 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. Pregnancy On Oral Contraceptive — 19 reports (18.81%)
  2. Headache — 13 reports (12.87%)
  3. Metrorrhagia — 13 reports (12.87%)
  4. Amenorrhoea — 10 reports (9.9%)
  5. Abortion Spontaneous — 9 reports (8.91%)
  6. Hypersensitivity — 8 reports (7.92%)
  7. Vaginal Haemorrhage — 8 reports (7.92%)
  8. Asthenia — 7 reports (6.93%)
  9. Pruritus — 7 reports (6.93%)
  10. Vomiting — 7 reports (6.93%)

Source database →

Other Contraception / Gynecology approved in United States

Frequently asked questions

Is Estradiol valerate / dienogest approved in United States?

Yes. FDA authorised it on 6 May 2010.

Who is the marketing authorisation holder for Estradiol valerate / dienogest in United States?

BAYER HLTHCARE holds the US marketing authorisation.