Disseminated intravascular coagulation (DIC) associated with immune checkpoint inhibitor therapy: a real-world study of the FDA adverse event reporting system

While immune checkpoint inhibitor (ICI)-related adverse effects have gained increasing attention, disseminated intravascular coagulation (DIC) remains understudied. This retrospective study analyzed the FAERS database from 2011 to 2025 using disproportionality analyses to investigate the association between ICIs and immune-mediated DIC. A total of 501 DIC reports associated with ICIs were identified, with male predominance and death as the most frequent serious outcome (276 cases). Anti-CTLA-4 agents, particularly Ipilimumab, exhibited the strongest signal association with DIC. The median time to onset was 23.5 days. Reporting frequency of DIC associated with anti-PD-1/PD-L1 drugs decreased over time, while remaining constant for anti-CTLA-4 agents. This pharmacovigilance analysis identifies a significant signal for DIC following ICI therapy, providing clinicians with critical insights into this potential adverse event and underscoring the need for optimized management to mitigate fatal outcomes.