🇺🇸 Restasis in United States

FDA authorised Restasis on 23 December 2002 · 24,300 US adverse-event reports

Marketing authorisations

FDA — authorised 23 December 2002

  • Application: NDA050790
  • 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. Eye Irritation — 6,116 reports (25.17%)
  2. Drug Ineffective — 3,558 reports (14.64%)
  3. Eye Pain — 2,988 reports (12.3%)
  4. Vision Blurred — 2,363 reports (9.72%)
  5. Ocular Hyperaemia — 1,963 reports (8.08%)
  6. Dry Eye — 1,772 reports (7.29%)
  7. Headache — 1,544 reports (6.35%)
  8. Off Label Use — 1,436 reports (5.91%)
  9. Fatigue — 1,354 reports (5.57%)
  10. Lacrimation Increased — 1,206 reports (4.96%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Restasis approved in United States?

Yes. FDA authorised it on 23 December 2002; FDA has authorised it.

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

ABBVIE holds the US marketing authorisation.