Association between immune-mediated cystitis and PD-1, PD-L1, CTLA-4, and LAG-3 immune checkpoint inhibitors: A pharmacovigilance study from the FAERS database.

BACKGROUND: Immune checkpoint inhibitors (ICIs) have transformed oncology but predispose patients to immune-related adverse events. Immune-mediated cystitis represents a rare yet clinically significant urological complication requiring enhanced surveillance. This studies characterizes the pharmacovigilance profile of immune-mediated cystitis across ICI classes using real-world post-market surveillance data. PATIENTS AND METHODS: = 1) inhibitors. RESULTS: = 15). PD-L1 inhibitors showed minimal signals with isolated cases. CONCLUSION: Immune-mediated cystitis demonstrates strongest association with PD-1 and CTLA-4 inhibitors, warranting enhanced clinical surveillance, prompt recognition, and evidence-based management protocols.