🇺🇸 Nuvaring in United States

FDA authorised Nuvaring on 3 October 2001 · 16,685 US adverse-event reports

Marketing authorisations

FDA — authorised 3 October 2001

  • Application: NDA021187
  • Marketing authorisation holder: ORGANON USA ORGANON
  • Status: supplemented

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. Pulmonary Embolism — 3,990 reports (23.91%)
  2. Deep Vein Thrombosis — 2,674 reports (16.03%)
  3. Inappropriate Schedule Of Drug Administration — 2,232 reports (13.38%)
  4. Device Expulsion — 1,353 reports (8.11%)
  5. No Adverse Event — 1,189 reports (7.13%)
  6. Headache — 1,140 reports (6.83%)
  7. Metrorrhagia — 1,134 reports (6.8%)
  8. Incorrect Drug Administration Duration — 1,018 reports (6.1%)
  9. Nausea — 1,006 reports (6.03%)
  10. Unintended Pregnancy — 949 reports (5.69%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Nuvaring approved in United States?

Yes. FDA authorised it on 3 October 2001; FDA has authorised it.

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

ORGANON USA ORGANON holds the US marketing authorisation.