Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis.

ABSTRACT:

Objective

The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods

Adverse event (AE) reports in the FAERS database from January 2021 to December 2023 were extracted to perform the disproportionality analysis by calculating the reporting OR. The clinical characteristics and onset times of AEs were investigated. The differences across ages and regions in belimumab-related AEs were also explored.

Results

A total of 4 974 201 AE reports were retrieved from the FAERS database, among which 9782 reports were related to belimumab. 485 positive safety signals related to belimumab were identified. In addition to the labelled AEs, such

SUBMITTER: Li H 

PROVIDER: S-EPMC11751785 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature