Table 1_A systemic pharmacovigilance assessment of ophthalmic atropine: signal detection and clinical prioritization from the FAERS database.docx

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