Ipilimumab and nivolumab for cancer treatment - a pharmacovigilance study based on the FDA adverse event reporting system database

Sep 22, 2026

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Cancer treatment with ipilimumab and nivolumab continues to expand, while safety concerns require ongoing signal monitoring. This study analyzed adverse drug event (ADE) signals and factors associated with reporting in FAERS for all cancers from Q1 2004 to Q4 2024. It examined report characteristics, cumulative ADE onset trends across age groups, and safety signals using disproportionality analysis. Results identified significant signals and age/weight-associated reporting factors, with adverse reaction onset showing a bimodal “early outbreak + persistent risk” pattern, emphasizing the need for heightened clinical vigilance and routine endocrinological monitoring.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages12

Reading Time30 min

AccessFree to download

Introduction

Background and epidemiology

Immunotherapy and study rationale

Data sources and methods

Results and key safety signals

Discussion, implications, and conclusions

TYPE Original Research PUBLISHED 18 June 2026 DOI 10.3389/fendo.2026.1786504 OPEN ACCESS EDITED BY Ippazio Cosimo Antonazzo, University of Milan-Bicocca, Italy REVIEWED BY Lukasz Chlewicki, Dechra Veterinary Products, United States Shanshan Xu, Capital Medical University, China *CORRESPONDENCE Xidan Hu [yunduan702914@126.com](yunduan702914@126.com)[ ](yunduan702914@126.com)Min Zhang [zhangmin800424@163.com](zhangmin800424@163.com) †These authors have contributed equally to this work and share ﬁrst authorship RECEIVED 13 January 2026 REVISED 30 April 2026 ACCEPTED 25 May 2026 PUBLISHED 18 June 2026 CITATION Liu R, Xiang Y, Hu X, Zhang M, Wang L, Liu T, Wang X and Qian B (2026) Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database. Front. Endocrinol. 17:1786504 . doi: 10.3389/fendo.2026.1786504 COPYRIGHT © 2026 Liu, Xiang, Hu, Zhang, Wang, Liu, Wang and Qian. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database Ruming Liu 1†, Yaoyu Xiang 2†, Xidan Hu 1*, Min Zhang 1*, Lujie Wang 1, Tao Liu 3, Xi Wang 1 and Bin Qian 1 1 Department of Clinical Pharmacy, The First Afﬁliated Hospital of Kunming Medical University, Kunming, Yunnan, China, 2 Department of Sports Medicine, The First Afﬁliated Hospital of Kunming Medical University, Kunming, Yunnan, China, 3Organ Transplantation Center, The First Afﬁliated Hospital of Kunming Medical University, Kunming, Yunnan, China Background: Cancer remains one of the leading is associated with of death globally. This study analyzed adverse drug event (ADE) signals and potential factors associated with reporting in ipilimumab and nivolumab-treated cancer data from the Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database. Methods: This study collected ADEs associated with ipilimumab, nivolumab, and their combination therapy for all cancers from the ﬁrst quarter of 2004 to the fourth quarter of 2024 through the FAERS database. It investigated the basic information of all adverse reaction reports, analyzed the cumulative trends of ADE onset time across different age groups, and mined safety signals signiﬁcantly associated with the three drug groups via disproportionality analysis. Additionally, the study explored potential factors associated with reporting of these adverse reactions. Results: A total of 21,712,563 reports were included in this study as research subjects, among which there were 4,600, 36,556, and 10,862 adverse reaction reports for ipilimumab, nivolumab, and ipilimumab/nivolumab, respectively. Separate analysis of these three groups of drugs showed that the onset time of adverse reactions mostly exhibited a bimodal pattern characterized by “early concentrated outbreak + long-term persistent risk”, which was related to age. These three groups of drugs showed a stronger associated with colitis, adrenal insufﬁciency, malignant neoplasm progression, death, and intentional product use issues. Age and weight were identiﬁed as potential factors associated with reporting of adverse reactions related to these three groups of drugs. Conclusion: Based on the FAERS database, this study identiﬁes signiﬁcant pharmacovigilance signals and potential reporting-associated factors for ipilimumab, nivolumab, and their combination. Importantly, these ﬁndings represent hypothesis-generating signal detections rather than deﬁnit

FAQs

Which data source and time period were used to study safety signals for ipilimumab and nivolumab?

The analysis used the FDA Adverse Event Reporting System (FAERS) database, covering all cancers from the first quarter of 2004 through the fourth quarter of 2024.

How did the study analyze adverse event onset timing across age groups?

It investigated cumulative trends of ADE onset time across different age groups, finding a bimodal pattern characterized by “early concentrated outbreak + long-term persistent risk,” related to age.

What safety categories and drug-related reactions showed stronger associations?

The study reported stronger associations with colitis, adrenal insufficiency, malignant neoplasm progression, death, and intentional product use issues across the three drug groups.

Sep 22, 2026

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