Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database.

ABSTRACT:

Objective

This study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.

Methods

Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. We analyzed reports where sevoflurane was the primary suspect in individuals aged 0-18, employing disproportionality analysis to detect adverse events associated with sevoflurane. We also compared the adverse events related to sevoflurane between pediatric and adult populations.

Results

The FAERS database yielded 21,838,627 adverse event reports for children, with 474 involving sevoflurane as the primary suspect. Descriptive analysis revealed a majority of reports from male patients, pr

SUBMITTER: Yang C 

PROVIDER: S-EPMC11847804 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature