Post-market safety profile of cefiderocol: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS).

ABSTRACT:

Background

Cefiderocol is a new drug class, which is approved to treat Gram-negative bacteria infection. Its approval for marketing has provided clinicians with additional options for treating antimicrobial resistant gram-negative infections. The aim of our study was to assess the safety profiles of cefiderocol in real-world through data mining of the United States Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

We included adverse event (AE) reports regarding cefiderocol submitted to the FAERS from 2019 quarter 4 (2019Q4) to 2024 quarter 3 (2024Q3). Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MG

SUBMITTER: Lin H 

PROVIDER: S-EPMC11899456 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature