A Real-world Pharmacovigilance Study Of FDA Adverse Event Reporting System (FAERS) Events For Gender Of Voriconazole Drugs

Abstract

Purpose

To detect the gender variations in adverse events (AEs) of voriconazole, promote personalised medicine.

Methods

A normalized dataset from Q1 2004 to Q4 2022 from the US Food and Drug Administrationʼs Adverse Event Reporting System (FAERS) was analyses. The reporting odds ratio (ROR), proportional reporting ratio (PRR), and P value were used to examine data from the FAERS database to detect risk signals and quantify the presence and extent of gender variations in voriconazole adverse events.

Results

A total of 7670 cases (female/male (2785/4885)) of adverse reactions to voriconazole were analysed, and drug interaction (ROR 1.30 (1.10,1.54)), death and sudden death (ROR 1.31 (1.06,1.61)), actinic keratosis (ROR 1.98 (1.10,3.57)) were found to be significantly more frequent in male patients than in female patients.

Conclusion

We found that gender was a determinant in voriconazole-related AEs using FAERS. Our results require future validation due to the inherent limits of this open data source, but they also identify potential contributing elements for a customised side effect profiling.

Keywords

voriconazole - gender differences - real-world study - FAERS - adverse events

Publication History

Received: 01 January 2025

Accepted: 31 March 2025

Article published online:
28 April 2025

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