Systematic analysis of echinocandin-associated adverse reactions using the FAERS database: identification of unique DRESS and resistance signals.

AIM: This pharmacovigilance study analyzed echinocandin-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) database to identify agent-specific safety signals and inform clinical decision-making.

METHODS

AE reports were extracted from FAERS covering Q1 2004 to Q4 2025. Four disproportionality algorithms-reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC025), and empirical Bayesian geometric mean (EBGM05)-were applied. Positive signals were defined when all four methods yielded positive results.

RESULTS

A total of 5,298 cases with echinocandins as the primary suspect drug were included. Caspofungin showed unique association with DRESS syndrome (ROR = 16.62, IC025 = 3.21). Exceptionally strong resistance signals were detected for caspofungin ("pathogen resistance": ROR = 68.83; "drug resistance": ROR = 22.32) and micafungin ("bronchopulmonary aspergillosis": ROR = 71.99; "Candida infection": ROR = 23.93). Hepatobiliary signals included cholestasis (ROR = 24.97) and alkaline phosphatase increase (ROR = 19.10) for caspofungin, with similar signals observed for micafungin and anidulafungin.

CONCLUSION

This pharmacovigilance study identified two clinically significant signals: DRESS as a unique safety concern for caspofungin, and striking resistance signals for caspofungin and micafungin. These findings emphasize the need for vigilant monitoring during echinocandin therapy and reinforce antifungal stewardship.