🇺🇸 Acular LS in United States

FDA authorised Acular LS on 30 May 2003 · 59 US adverse-event reports

Marketing authorisation

FDA — authorised 30 May 2003

  • Application: NDA021528
  • Marketing authorisation holder: ABBVIE
  • Status: supplemented

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 — 7 reports (11.86%)
  2. Dyspnoea — 7 reports (11.86%)
  3. Off Label Use — 7 reports (11.86%)
  4. Ulcerative Keratitis — 7 reports (11.86%)
  5. Eye Inflammation — 6 reports (10.17%)
  6. Eye Irritation — 6 reports (10.17%)
  7. Pain — 6 reports (10.17%)
  8. Pneumonia — 5 reports (8.47%)
  9. Cataract — 4 reports (6.78%)
  10. Diverticulum — 4 reports (6.78%)

Source database →

Other Ophthalmology approved in United States

Frequently asked questions

Is Acular LS approved in United States?

Yes. FDA authorised it on 30 May 2003.

Who is the marketing authorisation holder for Acular LS in United States?

ABBVIE holds the US marketing authorisation.