Assessment the real-world safety of intravitreal dexamethasone implant (Ozurdex): novel insights from a comprehensive pharmacovigilance analysis utilizing the FAERS database.

ABSTRACT:

Objective

The intravitreal dexamethasone implant (Dex) is widely used for various ocular conditions, including diabetic macular edema (DME), retinal vein occlusion (RVO), and non-infectious uveitis. Despite its efficacy, concerns remain regarding its safety profile. This study aims to analyze the adverse events (AEs) associated with Dex reported in the FDA Adverse Event Reporting System (FAERS) database from 2010 to 2024.

Methods

Data were extracted from FAERS, focusing on cases where Dex was the primary suspect drug. The dataset was processed to eliminate duplicates and incomplete entries. Disproportionality analysis, including Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR), was used to detect safety signals. AEs were categorized by system organ class (SO

SUBMITTER: Zhao CF 

PROVIDER: S-EPMC11809023 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature