🇺🇸 Estradiol vaginal ring in United States

FDA authorised Estradiol vaginal ring on 29 June 2023 · 120 US adverse-event reports

Marketing authorisations

FDA — authorised 29 June 2023

  • Application: ANDA211157
  • Marketing authorisation holder: XIROMED
  • Status: approved

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 — 39 reports (32.5%)
  2. Deep Vein Thrombosis — 17 reports (14.17%)
  3. Product Substitution Issue — 13 reports (10.83%)
  4. Headache — 11 reports (9.17%)
  5. Depression — 10 reports (8.33%)
  6. Anxiety — 8 reports (6.67%)
  7. Nausea — 6 reports (5%)
  8. Off Label Use — 6 reports (5%)
  9. Back Pain — 5 reports (4.17%)
  10. Cerebrovascular Accident — 5 reports (4.17%)

Source database →

Estradiol vaginal ring in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Estradiol vaginal ring approved in United States?

Yes. FDA authorised it on 29 June 2023; FDA has authorised it.

Who is the marketing authorisation holder for Estradiol vaginal ring in United States?

XIROMED holds the US marketing authorisation.