Objective To identify adverse drug event (ADE) signals associated with epcoritamab and glofitamab and compare their safety profiles in patients with diffuse large B-cell lymphoma.

Methods ADE reports related to epcoritamab and glofitamab were retrieved from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2023 to the third quarter of 2025. Signal detection was performed using the reporting odds ratio (ROR), proportional of reporting risk (PRR), Bayesian confidence propagation neural network (BCPNN) and multi-item gamma-Poisson shrinker (MGPS) methods. The safety profiles of the two drugs were evaluated by combining clinical priority and time-to-onset (TTO) analyses.

Results A total of 1,833 ADE reports involving epcoritamab and 967 involving glofitamab were included. At the system organ class level, positive signals for both drugs were detected only in immune system disorders. At the preferred term level, positive signals for epcoritamab were predominantly related to infections and gastrointestinal events, including a positive cytomegalovirus test (ROR=17.81), gastric perforation (ROR=16.43), and neutropenic infection (ROR=11.99). In contrast, signals for glofitamab spanned multiple organ systems and included neurologic and urinary events, such as ataxia (ROR=20.66) and urinary retention (ROR=15.77). Gastric perforation, ataxia, and urinary retention were potential ADE signals not listed in the current prescribing information. Cytokine release syndrome was a clinically high-priority ADE for both drugs. The median TTOs were 21 days for epcoritamab and 34 days for glofitamab.

Conclusion Epcoritamab and glofitamab share immune-related ADEs as a common safety concern; however, their ADE profiles and TTO distributions are not entirely consistent, which may be related to differences in antibody configuration and routes of administration. In clinical practice, risk management of cytomegalovirus-related and gastrointestinal events should be strengthened for epcoritamab, while the observation window for neurological, hematological, and urinary events associated with glofitamab should be appropriately extended.

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