Drug-induced immune-mediated uveitis: a real-world pharmacovigilance analysis using FAERS and JADER databases.

ABSTRACT:

Purpose

To analyse drug-associated immune-mediated uveitis (IMU) risk using large-scale pharmacovigilance data.

Methods

We conducted a retrospective pharmacovigilance study using data from the FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) databases, encompassing reports from Q1 2004 to Q4 2024. Disproportionality analysis identified drug-IMU associations using reporting odds ratios (ROR) and information component (IC). Time-to-onset (TTO) was also assessed.

Results

Disproportionality analysis identified 17 176 IMU cases in FAERS and 2580 in JADER. IMU prevalence was higher in females, with the 30-80 age group most affected. Antineoplastic and immunomodulating agents, sensory organ drugs and anti-infectives were the most

SUBMITTER: Xu S 

PROVIDER: S-EPMC12666161 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature