🇺🇸 Estradiol vaginal cream in United States

FDA authorised Estradiol vaginal cream on 15 July 2021 · 425 US adverse-event reports

Marketing authorisation

FDA — authorised 15 July 2021

• Application: ANDA212313
• Marketing authorisation holder: PRASCO
• Status: supplemented

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.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 425

Most-reported reactions

1. Off Label Use — 83 reports (19.53%)
2. Product Quality Issue — 72 reports (16.94%)
3. Wrong Technique In Product Usage Process — 45 reports (10.59%)
4. Vulvovaginal Burning Sensation — 42 reports (9.88%)
5. Application Site Pain — 41 reports (9.65%)
6. Drug Ineffective — 41 reports (9.65%)
7. Incorrect Dose Administered — 35 reports (8.24%)
8. Device Issue — 23 reports (5.41%)
9. Vulvovaginal Discomfort — 22 reports (5.18%)
10. Urinary Tract Infection — 21 reports (4.94%)

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Frequently asked questions

Is Estradiol vaginal cream approved in United States?

Yes. FDA authorised it on 15 July 2021.

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

PRASCO holds the US marketing authorisation.