Hepatobiliary Adverse Events Associated with Pembrolizumab: A Pharmacovigilance Study from the FDA Adverse Event Reporting System (FAERS) Database
Abstract
:1. Introduction
2. Methods
3. Results
3.1. Hepatic Adverse Events
3.2. Biliary Adverse Events
4. Discussion
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Adverse Event | ROR (95% CI) | Number of Events |
---|---|---|
Hepatic Adverse Events | ||
Abnormal Liver Function | 9.347 (95% CI: 8.609, 10.148) | 594 |
Immune-Mediated Hepatitis | 346.716 (95% CI: 303.568, 395.997) | 485 |
ALT Increased | 3 (95% CI: 2.685, 3.351) | 319 |
AST Increased | 3.256 (95% CI: 2.901, 3.654) | 294 |
Hepatotoxicity | 6.436 (95% CI: 5.72, 7.242) | 284 |
Hepatic Cytolysis | 15.721 (95% CI: 13.854, 17.84) | 255 |
Drug-Induced Liver Injury | 3.316 (95% CI: 2.858, 3.847) | 177 |
Hepatic Failure | 2.368 (95% CI: 2.001, 2.803) | 137 |
Transaminitis | 2.822 (95% CI: 2.346, 3.394) | 114 |
Hepatocellular Injury | 2.663 (95% CI: 2.065, 3.434) | 60 |
Mixed Liver Injury | 9.919 (95% CI: 7.264, 13.546) | 41 |
Acute Hepatitis | 2.414 (95% CI: 1.664, 3.502) | 28 |
Cholestatic Hepatitis | 2.819 (95% CI: 1.929, 4.119) | 27 |
Fulminant Hepatitis | 3.681 (95% CI: 2.341, 5.788) | 19 |
Liver Abscess | 3.535 (95% CI: 2.248, 5.558) | 19 |
Cholestatic Liver Injury | 4.933 (95% CI: 3.095, 7.862) | 18 |
Hepatitis Viral | 7.342 (95% CI: 4.139, 13.024) | 12 |
Total | 2883 | |
Biliary Adverse Events | ||
Cholangitis | 19.597 (95% CI: 16.852, 22.791) | 181 |
Cholecystitis | 7.002 (95% CI: 5.944, 8.25) | 147 |
Hyperbilirubinemia | 2.366 (95% CI: 1.969, 2.843) | 115 |
Cholestasis | 3.335 (95% CI: 2.735, 4.067) | 99 |
Sclerosing Cholangitis | 24.735 (95% CI: 19.888, 30.763) | 88 |
GGT Increased | 2.094 (95% CI: 1.668, 2.629) | 75 |
Acute Cholecystitis | 5.39 (95% CI: 4.117, 7.056) | 54 |
Immune-Mediated Cholangitis | 199.335 (95% CI: 136.623, 290.833) | 46 |
Gallbladder Enlargement | 13.82 (95% CI: 8.719, 21.906) | 19 |
Biliary Obstruction | 7.452 (95% CI: 4.296, 12.927) | 13 |
Acute Cholangitis | 9.891 (95% CI: 5.421, 18.046) | 11 |
Biliary Tract Disorder | 4.235 (95% CI: 2.335, 7.682) | 11 |
ALP Increased | 6.966 (95% CI: 3.719, 13.047) | 10 |
Bile Duct Stenosis | 5.465 (95% CI: 2.922, 10.218) | 10 |
Total | 879 |
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Frey, C. Hepatobiliary Adverse Events Associated with Pembrolizumab: A Pharmacovigilance Study from the FDA Adverse Event Reporting System (FAERS) Database. Pharmacoepidemiology 2025, 4, 1. https://doi.org/10.3390/pharma4010001
Frey C. Hepatobiliary Adverse Events Associated with Pembrolizumab: A Pharmacovigilance Study from the FDA Adverse Event Reporting System (FAERS) Database. Pharmacoepidemiology. 2025; 4(1):1. https://doi.org/10.3390/pharma4010001
Chicago/Turabian StyleFrey, Connor. 2025. "Hepatobiliary Adverse Events Associated with Pembrolizumab: A Pharmacovigilance Study from the FDA Adverse Event Reporting System (FAERS) Database" Pharmacoepidemiology 4, no. 1: 1. https://doi.org/10.3390/pharma4010001
APA StyleFrey, C. (2025). Hepatobiliary Adverse Events Associated with Pembrolizumab: A Pharmacovigilance Study from the FDA Adverse Event Reporting System (FAERS) Database. Pharmacoepidemiology, 4(1), 1. https://doi.org/10.3390/pharma4010001