🇺🇸 Estrogel in United States

FDA authorised Estrogel on 9 February 2004 · 2,181 US adverse-event reports

Marketing authorisations

FDA — authorised 9 February 2004

  • Application: NDA021166
  • Marketing authorisation holder: ASCEND THERAPS US
  • Local brand name: ESTROGEL
  • Indication: GEL — TOPICAL
  • 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. Drug Ineffective — 389 reports (17.84%)
  2. Off Label Use — 299 reports (13.71%)
  3. Headache — 244 reports (11.19%)
  4. Fatigue — 241 reports (11.05%)
  5. Arthralgia — 207 reports (9.49%)
  6. Nausea — 192 reports (8.8%)
  7. Anxiety — 180 reports (8.25%)
  8. Bronchitis — 154 reports (7.06%)
  9. Insomnia — 139 reports (6.37%)
  10. Pain — 136 reports (6.24%)

Source database →

Estrogel in other countries

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

Other Other approved in United States

Frequently asked questions

Is Estrogel approved in United States?

Yes. FDA authorised it on 9 February 2004; FDA has authorised it.

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

ASCEND THERAPS US holds the US marketing authorisation.