Analysis of adverse events induced by fluconazole based on FAERS database.

Abstract

Background: Fluconazole, a widely used antifungal agent, has been associated with various adverse events (AEs). This study aimed to analyze the safety profiles of fluconazole using the FDA Adverse Event Reporting System (FAERS) database to provide insights for its safe use.

Research design and methods: Fluconazole-related AEs from 2004 to 2024Q2 were extracted from the FAERS database. The Reporting Odds Ratio (ROR) method was employed to detect and analyze safety signals. Additionally, the impact of COVID-19 on fluconazole safety was also examined.

Results: A total of 7,720 AEs were identified, with 40.3% being serious. The most common AEs involved skin, gastrointestinal, and administration site reactions. High doses of fluconazole were linked to increased teratogenic risks. Weekly dosing regimens and doses below 200 mg/day were associated with fewer severe AEs. During the COVID-19 pandemic, there was a notable rise in reports of drug inefficacy and hepatic/renal damage. Additionally, 45 new adverse reactions were identified.

Conclusions: The study highlights the importance of monitoring liver, kidney, and cardiovascular functions during fluconazole use, especially in high-risk populations. The findings underscore the need for careful dosing and consideration of drug interactions, particularly during the COVID-19 pandemic, to ensure safe and effective use of fluconazole.