# A systemic pharmacovigilance assessment of ophthalmic atropine: signal detection and clinical prioritization from the FAERS database

## TL;DR

This study identifies safety concerns with ophthalmic atropine using a U.S. adverse event database, highlighting risks like eye infections and vision issues.

## Contribution

A novel pharmacovigilance analysis of ophthalmic atropine using FAERS data to detect and prioritize ADR signals.

## Key findings

- Endophthalmitis was the most frequent and strongest ADR signal associated with ophthalmic atropine.
- Most detected ADR signals were categorized as weak clinical priority, with only 18.07% classified as moderate.

## Abstract

To comprehensively and systematically explore adverse drug reactions (ADRs) associated with ophthalmic atropine, providing evidence-based safety references for clinical medication practices.

Signal detection for ophthalmic atropine-associated ADRs was conducted using the Information Component (IC) and Reporting Odds Ratio (ROR) methods, analyzing data from the inception of the FDA Adverse Event Reporting System (FAERS) database through the second quarter of 2025.

The FAERS database contained 425 reports of ophthalmic atropine-associated ADRs, with 83 positive signals detected. These signals primarily involved eye disorders, nervous system disorders, injury, poisoning and procedural complications, and infections and infestations. Endophthalmitis (n = 74, IC025 = 6.62, ROR025 = 101.90) was the most frequent and strongest ADR signal detected. Other high-intensity ADR signals were choroiditis (IC025 = 6.05, ROR025 = 69.26), intraocular pressure increased (IC025 = 5.77, ROR025 = 56.93), visual acuity reduced (IC025 = 5.46, ROR025 = 45.74), mydriasis (IC025 = 5.36, ROR025 = 43.34), and uveitis (IC025 = 5.36, ROR025 = 42.93). Additionally, eye pain (n = 64, IC025 = 4.99, ROR025 = 32.90) represented another frequently reported ADR after endophthalmitis. Of the preferred terms, 81.93% were assigned a grade of weak clinical priority, with the remainder (18.07%) falling into the moderate category.

Ophthalmic atropine demonstrates potential ADR burdens in ocular systems, necessitating heightened clinical vigilance and prompt risk mitigation strategies to ensure medication safety. It should be noted that these findings represent safety signals from a spontaneous reporting database, not incidence estimates or proof of causality.