Research Article: A systemic pharmacovigilance assessment of ophthalmic atropine: signal detection and clinical prioritization from the FAERS database
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, IC 025 =?6.62, ROR 025 =?101.90) was the most frequent and strongest ADR signal detected. Other high-intensity ADR signals were choroiditis (IC 025 =?6.05, ROR 025 =?69.26), intraocular pressure increased (IC 025 =?5.77, ROR 025 =?56.93), visual acuity reduced (IC 025 =?5.46, ROR 025 =?45.74), mydriasis (IC 025 =?5.36, ROR 025 =?43.34), and uveitis (IC 025 =?5.36, ROR 025 =?42.93). Additionally, eye pain ( n =?64, IC 025 =?4.99, ROR 025 =?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.
Introduction:
Atropine, a non-selective muscarinic antagonist, has been used in ophthalmology for decades ( 1 ). Its ocular effects support a range of clinical applications, including routine fundus examinations, uveitis management, amblyopia therapy. In recent years, low-concentration atropine has gained widespread use for myopia control in children, particularly in East Asia ( 2 , 3 ). Although topical atropine is generally considered safer than systemic administration, it is not free from adverse effects. Ocular adverse…
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