🇺🇸 Xalatan in United States

FDA authorised Xalatan on 5 June 1996 · 8,218 US adverse-event reports

Marketing authorisations

FDA — authorised 5 June 1996

  • Application: NDA020597
  • Marketing authorisation holder: UPJOHN
  • 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. Cataract — 1,090 reports (13.26%)
  2. Intraocular Pressure Increased — 1,086 reports (13.21%)
  3. Drug Ineffective — 1,060 reports (12.9%)
  4. Eye Irritation — 897 reports (10.92%)
  5. Glaucoma — 821 reports (9.99%)
  6. Dyspnoea — 687 reports (8.36%)
  7. Fatigue — 655 reports (7.97%)
  8. Headache — 654 reports (7.96%)
  9. Fall — 641 reports (7.8%)
  10. Eye Pain — 627 reports (7.63%)

Source database →

Xalatan in other countries

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

Other Cardiovascular approved in United States

Frequently asked questions

Is Xalatan approved in United States?

Yes. FDA authorised it on 5 June 1996; FDA has authorised it.

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

UPJOHN holds the US marketing authorisation.