🇺🇸 Prednisolone Acetate Ophthalmic in United States

69 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.

• Window: 20 April 2025 – 20 April 2026
• Total reports: 69

Most-reported reactions

1. Treatment Failure — 33 reports (47.83%)
2. Headache — 7 reports (10.14%)
3. Drug Ineffective — 5 reports (7.25%)
4. Nausea — 5 reports (7.25%)
5. Fatigue — 4 reports (5.8%)
6. Eye Irritation — 3 reports (4.35%)
7. Eye Pain — 3 reports (4.35%)
8. Feeling Abnormal — 3 reports (4.35%)
9. Keratitis Bacterial — 3 reports (4.35%)
10. Vision Blurred — 3 reports (4.35%)

Source database →

Frequently asked questions

Is Prednisolone Acetate Ophthalmic approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Prednisolone Acetate Ophthalmic in United States?

EyePoint Pharmaceuticals, Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.