Safety profile of faricimab: a multi-source pharmacovigilance analysis using FAERS and JADER.

ABSTRACT:

Background

Faricimab is a bispecific antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), offering a novel therapeutic approach for ocular diseases. However, its long-term safety profile remains under evaluation. This study analyzes its adverse events (AEs) using the U.S. FDA Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER).

Methods

AEs from FAERS (2004-2024) and JADER (2004-2024) were analyzed using disproportionality algorithms. Subgroup analyses assessed differences by age and sex. AE onset time was also assessed.

Results

Several newly identified adverse events (AEs) were observed, including macular ischemia, keratic precipitates, and optic nerve injury, with strong safety signals detected

SUBMITTER: Liu C 

PROVIDER: S-EPMC11994024 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature