🇺🇸 Fortesta in United States

FDA authorised Fortesta on 29 December 2010 · 2,029 US adverse-event reports

Marketing authorisations

FDA — authorised 29 December 2010

  • Application: NDA021463
  • Marketing authorisation holder: ENDO OPERATIONS
  • Local brand name: FORTESTA
  • Indication: GEL, METERED — 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. Cerebrovascular Accident — 274 reports (13.5%)
  2. Deep Vein Thrombosis — 267 reports (13.16%)
  3. Pulmonary Embolism — 267 reports (13.16%)
  4. Myocardial Infarction — 242 reports (11.93%)
  5. Pain — 208 reports (10.25%)
  6. Thrombosis — 176 reports (8.67%)
  7. Cardiovascular Disorder — 165 reports (8.13%)
  8. Anxiety — 153 reports (7.54%)
  9. Cardiac Failure Congestive — 139 reports (6.85%)
  10. Death — 138 reports (6.8%)

Source database →

Fortesta 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 Fortesta approved in United States?

Yes. FDA authorised it on 29 December 2010; FDA has authorised it.

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

ENDO OPERATIONS holds the US marketing authorisation.