Immunotherapy-induced cholestasis in cancer: insights from the two real-world pharmacovigilance databases of FAERS and VigiBase

ICI-treated patients exhibit a higher cholestasis risk compared to conventional chemotherapy. Long-term liver function monitoring is crucial for patient safety. ICI-related cholestasis may result from immune-mediated bile duct injury or metabolic disorders, potentially influenced by baseline liver function. This comprehensive article provides crucial evidence for the risk assessment and management of ICI-related cholestasis, thereby contributing to safe medication use and enhanced patient care in clinical practice.