Peripheral nervous system safety signals of antibody–drug conjugates: cross-database reproducibility and labeling gaps identified using FAERS, JADER, and CVARD

ObjectiveTo characterize the spectrum, strength, and cross-database reproducibility of peripheral nervous system (PNS) safety signals associated with antibody–drug conjugates (ADCs), and to examine discrepancies between post-marketing pharmacovigilance signals and current regulatory labeling.MethodsA multi-database pharmacovigilance study was conducted using spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS; Q1-2025Q3), the Japanese Adverse Drug Event Report (J