🇺🇸 Estrogen patch in United States

FDA authorised Estrogen patch on 10 September 1986 · 159 US adverse-event reports

Marketing authorisations

FDA — authorised 10 September 1986

  • Application: NDA019081
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: ESTRADERM
  • Indication: SYSTEM — TRANSDERMAL
  • Status: approved

Read official source →

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. Headache — 25 reports (15.72%)
  2. Fatigue — 21 reports (13.21%)
  3. Nausea — 19 reports (11.95%)
  4. Drug Ineffective — 16 reports (10.06%)
  5. Insomnia — 16 reports (10.06%)
  6. Feeling Abnormal — 14 reports (8.81%)
  7. Anxiety — 13 reports (8.18%)
  8. Dizziness — 13 reports (8.18%)
  9. Dyspnoea — 11 reports (6.92%)
  10. Off Label Use — 11 reports (6.92%)

Source database →

Estrogen patch 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 Estrogen patch approved in United States?

Yes. FDA authorised it on 10 September 1986; FDA has authorised it.

Who is the marketing authorisation holder for Estrogen patch in United States?

NOVARTIS holds the US marketing authorisation.