🇺🇸 Alphagan in United States

FDA authorised Alphagan on 16 March 2001 · 3,815 US adverse-event reports

Marketing authorisations

FDA — authorised 16 March 2001

  • Application: NDA021262
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

FDA — authorised 19 August 2005

  • Application: NDA021770
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

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 — 512 reports (13.42%)
  2. Ocular Hyperaemia — 467 reports (12.24%)
  3. Eye Irritation — 446 reports (11.69%)
  4. Intraocular Pressure Increased — 394 reports (10.33%)
  5. Fatigue — 377 reports (9.88%)
  6. Eye Pain — 368 reports (9.65%)
  7. Vision Blurred — 359 reports (9.41%)
  8. Dyspnoea — 307 reports (8.05%)
  9. Dizziness — 302 reports (7.92%)
  10. Off Label Use — 283 reports (7.42%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Alphagan approved in United States?

Yes. FDA authorised it on 16 March 2001; FDA authorised it on 19 August 2005; FDA has authorised it.

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

ABBVIE holds the US marketing authorisation.