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

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The study analyzed adverse drug events associated with ipilimumab and nivolumab using the FDA Adverse Event Reporting System database.
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A total of 21,712,563 reports were included, with 4,600 for ipilimumab, 36,556 for nivolumab, and 10,862 for their combination therapy.
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Adverse reactions exhibited a bimodal onset pattern, with early outbreaks and long-term risks, particularly influenced by age.
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The drugs were strongly associated with colitis, adrenal insufficiency, malignant neoplasm progression, and death.
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Age and weight were identified as potential factors influencing the reporting of adverse reactions related to these therapies.

Frontiers In Endocrinology

by Ruming Liu, Yaoyu Xiang, Xidan Hu, Min Zhang, Lujie Wang, Tao Liu, Xi Wang, Bin Qian
June 18, 2026

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