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Cancer Immunotherapies Linked to Increased Risk of Liver Cholestasis

Alexey Kryvenko, medical expert
Last reviewed: 03.08.2025

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01 August 2025, 09:15

A global study shows that cutting-edge cancer immunotherapies, despite their life-saving effectiveness, carry a hidden risk: they can cause cholestasis, a serious liver condition in which bile flow is blocked. After analyzing 634 patient reports from global drug safety databases (FAERS and VigiBase), scientists found that patients on immunotherapy have a significantly higher risk of developing cholestasis compared with chemotherapy recipients. Those under 65 face a greater risk, and women develop symptoms weeks earlier than men (median 1.17 vs. 1.90 months).

Anti-PD-1 drugs (eg, pembrolizumab) and combination regimens carried the greatest risk. In mouse models, the anti-CTLA-4/anti-PD-L1 combination caused severe bile duct damage. Molecular analysis linked this condition to abnormal bile acid metabolism and inflammatory pathways.

“This is not about abandoning immunotherapies — they save lives. But we need to aggressively monitor liver function, especially in the first month in women and young patients. Early detection of cholestasis prevents irreversible damage,” said Peng Luo, PhD, senior author of the study at Southern Medical University.

Surprisingly, cholestasis often developed without classic symptoms of hepatitis, suggesting that standard liver function tests alone may not be enough. The team calls for bile acid testing to be added to the standard monitoring kit.

The study was published in the International Journal of Surgery.