The real-world safety profile of empagliflozin: a disproportionality analysis based on the FDA Adverse Event Reporting System (FAERS) database.

ABSTRACT:

Objective

This study aimed to investigate the entire adverse events (AEs) spectrum and to identify some new or rare AEs associated with empagliflozin based on the FAERS database.

Methods

A retrospective analysis was conducted on AE reports extracted from the FAERS, spanning from the first quarter of 2004 to that of 2023. Disproportionality analysis methods, including the ROR, PRR, BCPNN, and MGPS, were employed to quantify signals of AEs associated with empagliflozin. Additionally, demographic characteristics and time to onset were further elucidated.

Results

The results showed a total of 20,734 AE reports related to empagliflozin, identifying 322 significant preferred terms (PTs) covering 27 System Organ Classes (SOCs). Empagliflozin was significantly associated with

SUBMITTER: Hu H 

PROVIDER: S-EPMC11806693 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature