Clinical Report: Pharmacovigilance Analysis of Ipilimumab and Nivolumab

Overview

This study analyzes adverse drug event signals associated with ipilimumab and nivolumab using the FDA Adverse Event Reporting System (FAERS) database. It identifies significant adverse reactions and potential factors influencing reporting.

Background

Cancer remains a leading cause of death worldwide, with nearly 20 million new cases diagnosed in 2022. Immunotherapy, particularly with agents like ipilimumab and nivolumab, has become a cornerstone of cancer treatment, yet these therapies are associated with significant immune-related adverse events (irAEs).

Data Highlights

Key Findings

• The onset time of adverse reactions exhibited a bimodal pattern across age groups.
• Common adverse reactions included colitis, adrenal insufficiency, malignant neoplasm progression, and death.
• Age and weight were identified as potential factors associated with reporting adverse reactions.
• The study included a total of 21,712,563 reports from the FAERS database.
• Findings represent hypothesis-generating signals rather than definitive causal risk estimations.

Clinical Implications

Healthcare professionals should maintain vigilance for immune-related adverse events in patients treated with ipilimumab and nivolumab.

Conclusion

This pharmacovigilance analysis highlights the importance of monitoring adverse events associated with ipilimumab and nivolumab.

Related Resources & Content

1. Frontiers in Immunology, 2026 -- Severe renal and pancreatic toxicities associated with ipilimumab and nivolumab combination therapy in non-small cell lung cancer: a pharmacovigilance analysis of the FDA adverse event reporting system
2. Frontiers in Immunology, 2026 -- Sex-specific reporting patterns and onset timing of immune-related adverse events associated with nivolumab and pembrolizumab: a dual-database pharmacovigilance analysis
3. The ASCO Post, 2021 -- Adverse Events in Patients With Melanoma Treated With Ipilimumab: Results of a Toxicity Monitoring Program
4. Frontiers in Immunology, 2026 -- Comprehensive safety analysis of the clinical spectrum of adverse events associated with immune checkpoint inhibitors based on FAERS
5. FDA -- FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer
6. New England Journal of Medicine -- Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma
7. PMC -- Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on FAERS database
8. FDA approves nivolumab with ipilimumab for unresectable or metastatic MSI-H or dMMR colorectal cancer | FDA
9. Final, 10-Year Outcomes with Nivolumab plus Ipilimumab in Advanced Melanoma | New England Journal of Medicine
10. Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on FAERS database - PMC