🇺🇸 Ilevro in United States

FDA authorised Ilevro on 16 October 2012 · 894 US adverse-event reports

Marketing authorisations

FDA — authorised 16 October 2012

  • Application: NDA203491
  • Marketing authorisation holder: HARROW EYE
  • 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 Pain — 367 reports (41.05%)
  2. Vision Blurred — 105 reports (11.74%)
  3. Drug Ineffective — 98 reports (10.96%)
  4. Eye Irritation — 62 reports (6.94%)
  5. Product Quality Issue — 57 reports (6.38%)
  6. Liquid Product Physical Issue — 52 reports (5.82%)
  7. Off Label Use — 40 reports (4.47%)
  8. Fatigue — 39 reports (4.36%)
  9. Incorrect Dose Administered — 38 reports (4.25%)
  10. Chronic Kidney Disease — 36 reports (4.03%)

Source database →

Ilevro 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 Ilevro approved in United States?

Yes. FDA authorised it on 16 October 2012; FDA has authorised it.

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

HARROW EYE holds the US marketing authorisation.