FDA — authorised 20 October 1988
- Application: NDA050567
- Marketing authorisation holder: ALLERGAN
- Local brand name: POLYTRIM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 polytrim in United States
FDA authorised polytrim on 20 October 1988 · 178 US adverse-event reports
Marketing authorisations
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: 28 March 2025 – 28 March 2026
- Total reports: 178
Most-reported reactions
- Eye Pain — 28 reports (15.73%)
- Off Label Use — 25 reports (14.04%)
- Fatigue — 20 reports (11.24%)
- Pain — 17 reports (9.55%)
- Diarrhoea — 16 reports (8.99%)
- Drug Ineffective — 16 reports (8.99%)
- Vision Blurred — 16 reports (8.99%)
- Condition Aggravated — 14 reports (7.87%)
- Nausea — 14 reports (7.87%)
- Anxiety — 12 reports (6.74%)
Other Other approved in United States
Frequently asked questions
Is polytrim approved in United States?
Yes. FDA authorised it on 20 October 1988; FDA has authorised it.
Who is the marketing authorisation holder for polytrim in United States?
ALLERGAN holds the US marketing authorisation.