Real-world pharmacovigilance investigation of imipenem/cilastatin: signal detection using the FDA Adverse Event Reporting System (FAERS) database.

ABSTRACT:

Background

Although imipenem/cilastatin (IMI/CIL) has demonstrated favorable therapeutic efficacy against various infections, the incidence of potential adverse events (AEs) has escalated in parallel with its increased utilization and has been documented in clinical trials. However, a comprehensive understanding of real-world implications remains lacking.

Methods

By conducting a comprehensive search in the FDA Adverse Event Reporting System (FAERS) database, AE reports associated with IMI/CIL as the primary suspect (PS) were selected for analysis, spanning from the first quarter of 2004 to the fourth quarter of 2023. Utilizing disproportionality analysis techniques, potential signals of AE s were identified through reported odds ratio (ROR), proportional report ratio (PRR),

SUBMITTER: Jia P 

PROVIDER: S-EPMC11865190 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature