ArticleFrontiers in medicine2026
Systematic analysis of echinocandin-associated adverse reactions using the FAERS database: identification of unique DRESS and resistance signals.
Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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6 authors.
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Abstract
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.
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