Objective:

To conduct a comprehensive pharmacovigilance analysis of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICIs) using FAERS data from 2011 to 2023.

Key Findings:

• 320,556 adverse event reports associated with eight ICIs were analyzed, involving 123,210 patients.
• Endocrine and hepatobiliary disorders showed the strongest adverse event signals at the SOC level.
• Cardiac and respiratory toxicities exhibited the highest mortality risks.
• Prominent signals at the SMQ level included noninfectious encephalitis and hypothyroidism.
• Leading signals at the PT level included immune-mediated lung disease, immune-mediated enterocolitis, immune-mediated hepatitis, myocarditis, hypophysitis, and adrenal insufficiency.

Interpretation:

This study provides a systematic overview of the clinical spectrum of irAEs linked to ICIs, emphasizing the importance of interdisciplinary collaboration in managing these adverse events.

Limitations:

• Potential reporting bias due to nonprofessional submissions.
• Data may not capture all adverse events due to underreporting.
• Variability in reporting quality within the FAERS data.

Conclusion:

The findings enhance understanding of ICI-related toxicities and support multidisciplinary approaches for their management.