🇺🇸 ethinyl estradiol/etonogestrel vaginal ring in United States

FDA authorised ethinyl estradiol/etonogestrel vaginal ring on 3 October 2001 · 12 US adverse-event reports

Marketing authorisation

FDA — authorised 3 October 2001

  • Application: NDA021187
  • Marketing authorisation holder: ORGANON USA ORGANON
  • Local brand name: NUVARING
  • Indication: RING — VAGINAL
  • Status: approved

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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. Nausea — 2 reports (16.67%)
  2. Product Substitution Issue — 2 reports (16.67%)
  3. Abdominal Pain — 1 report (8.33%)
  4. Decreased Appetite — 1 report (8.33%)
  5. Depression — 1 report (8.33%)
  6. Diarrhoea — 1 report (8.33%)
  7. Drug Ineffective — 1 report (8.33%)
  8. Fungal Infection — 1 report (8.33%)
  9. Headache — 1 report (8.33%)
  10. Impaired Work Ability — 1 report (8.33%)

Source database →

Other Contraception / Reproductive Health approved in United States

Frequently asked questions

Is ethinyl estradiol/etonogestrel vaginal ring approved in United States?

Yes. FDA authorised it on 3 October 2001.

Who is the marketing authorisation holder for ethinyl estradiol/etonogestrel vaginal ring in United States?

ORGANON USA ORGANON holds the US marketing authorisation.