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Updated: Jan 14, 2026

Bile Duct Ligation in Mice: Induction of Inflammatory Liver Injury and Fibrosis by Obstructive Cholestasis
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Biliary disorders associated with immune checkpoint inhibitors: a pharmacovigilance analysis of the FDA adverse event

Shiju Wei1, Zhenyu Zhang1, Xuhua Song2

  • 1The Second Clinical Medical College, Henan University of Chinese Medicine, Zhengzhou, People's Republic of China.

Journal of Chemotherapy (Florence, Italy)
|January 13, 2026
PubMed

Insights

Immune checkpoint inhibitors (ICIs) significantly increase the risk of severe biliary disorders. Early monitoring is crucial, especially for high-risk patients receiving ICI therapy.

Area of Science:

  • Oncology
  • Immunology
  • Gastroenterology

Background:

  • Immune checkpoint inhibitors (ICIs) are widely used cancer therapies.
  • Severe biliary disorders (BDs) have been anecdotally linked to ICI use.

Purpose of the Study:

  • To quantify the association between ICI use and BDs.
  • To identify specific ICI types and patient factors associated with increased BD risk.

Main Methods:

  • Analysis of the FAERS database from Q1 2015 to Q1 2025.
  • Standardized MedDRA queries identified 4,405 BD cases.
  • Reported Odds Ratios (ROR) were calculated to assess risk.

Main Results:

  • ICIs showed a significant overall association with BDs (ROR 3.37).
  • Anti-PD-1/PD-L1 monotherapy and combination therapies presented higher risks, with extreme RORs for bile duct necrosis and immune-mediated cholangitis.
  • 19.9% of BD cases were fatal, with earlier onset in fatal cases.

Conclusions:

  • ICI therapy is strongly associated with severe biliary injury.
  • Risk stratification and early biliary monitoring are essential for patients on ICIs, particularly those with specific risk factors.

Keywords:
FAERSImmune-related adverse eventsbiliary disordersimmune checkpoint inhibitorspharmacovigilance

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