FDA — authorised 28 October 1994
- Application: NDA020323
- Marketing authorisation holder: SANDOZ
- Local brand name: VIVELLE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
🇺🇸 Estradiol patch in United States
FDA authorised Estradiol patch on 28 October 1994 · 80 US adverse-event reports
Marketing authorisations
FDA — authorised 16 August 2000
- Application: NDA021167
- Marketing authorisation holder: NOVARTIS
- Local brand name: VIVELLE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- 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.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 80
Most-reported reactions
- Headache — 12 reports (15%)
- Product Substitution Issue — 10 reports (12.5%)
- Rash — 9 reports (11.25%)
- Dizziness — 8 reports (10%)
- Nausea — 8 reports (10%)
- Dyspnoea — 7 reports (8.75%)
- Feeling Abnormal — 7 reports (8.75%)
- Pain — 7 reports (8.75%)
- Malaise — 6 reports (7.5%)
- Off Label Use — 6 reports (7.5%)
Other Endocrinology / Women's Health approved in United States
Frequently asked questions
Is Estradiol patch approved in United States?
Yes. FDA authorised it on 28 October 1994; FDA authorised it on 16 August 2000.
Who is the marketing authorisation holder for Estradiol patch in United States?
SANDOZ holds the US marketing authorisation.