🇺🇸 Atropine Sulfate Ophthalmic Solution in United States

16 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 Pain — 3 reports (18.75%)
  2. Death — 2 reports (12.5%)
  3. Eye Irritation — 2 reports (12.5%)
  4. Heart Rate Increased — 2 reports (12.5%)
  5. Vision Blurred — 2 reports (12.5%)
  6. Abdominal Pain — 1 report (6.25%)
  7. Abdominal Pain Upper — 1 report (6.25%)
  8. Accidental Overdose — 1 report (6.25%)
  9. Chills — 1 report (6.25%)
  10. Coma — 1 report (6.25%)

Source database →

Atropine Sulfate Ophthalmic Solution 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 Atropine Sulfate Ophthalmic Solution approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Atropine Sulfate Ophthalmic Solution in United States?

Biomedical Advanced Research and Development Authority is the originator. The local marketing authorisation holder may differ — check the official source linked above.