Ipilimumab and nivolumab for cancer treatment: a pharmacovigilance study based on the FDA adverse event reporting system database
By
Ruming Liu
Yaoyu Xiang
Xidan Hu
Min Zhang
Lujie Wang
Tao Liu
Xi Wang
Bin Qian
June 18, 2026
Clinical Scorecard: Pharmacovigilance Analysis of Ipilimumab and Nivolumab in Cancer Therapy Using the FDA Adverse Event Reporting System Database
At a Glance
Category Detail
Condition Key Mechanisms Ipilimumab promotes anti-tumor T-cell responses; Nivolumab restores anti-neoplastic T-cell function. Target Population Care Setting
Key Highlights
Analysis of 21,712,563 reports from FAERS database. Identified adverse reactions include colitis, adrenal insufficiency, and malignant neoplasm progression. Adverse reaction onset shows a bimodal pattern related to age. Age and weight are potential factors associated with reporting adverse reactions. Guideline-Based Recommendations
Diagnosis
Monitor for immune-related adverse events (irAEs) in patients receiving ipilimumab and nivolumab. Management
Implement routine endocrinological monitoring for patients on combination therapy. Monitoring & Follow-up
Heightened clinical vigilance is necessary for early detection of adverse reactions. Risks
Significant immune-related toxicities associated with combination therapy. Patient & Prescribing Data
Patients treated with ipilimumab, nivolumab, or their combination for cancer.
Combination therapy shows enhanced therapeutic efficacy but is associated with a broader spectrum of adverse events.
Clinical Best Practices
Conduct thorough patient assessments prior to initiating immunotherapy. Educate patients on potential adverse reactions and the importance of reporting them. Related Resources & Content
