🇺🇸 FreshKote in United States

71 US adverse-event reports

Marketing authorisation

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 — 12 reports (16.9%)
  2. Eye Pain — 10 reports (14.08%)
  3. Vision Blurred — 10 reports (14.08%)
  4. Drug Ineffective — 7 reports (9.86%)
  5. Dizziness — 6 reports (8.45%)
  6. Eye Discharge — 6 reports (8.45%)
  7. Headache — 6 reports (8.45%)
  8. Fatigue — 5 reports (7.04%)
  9. Ocular Hyperaemia — 5 reports (7.04%)
  10. Expired Product Administered — 4 reports (5.63%)

Source database →

FreshKote in other countries

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

Frequently asked questions

Is FreshKote approved in United States?

Yes. FDA has authorised it.

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

Innovative Medical is the originator. The local marketing authorisation holder may differ — check the official source linked above.