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Biliary disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system (FAERS) database

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Immune checkpoint inhibitors (ICIs) are linked to severe biliary disorders (BDs). Using FAERS data (Q1 2015-Q1 2025), we identified 4,405 BD cases via standardized MedDRA queries (144 preferred terms). ICIs were significantly associated with BDs (overall ROR 3... ...