Teclistamab-associated adverse events: a disproportionality analysis of the FDA adverse event reporting system

Teclistamab, a B-cell maturation antigen (BCMA) × CD3 bispecific antibody, is effective in relapsed/refractory multiple myeloma, but its real-world post-marketing safety profile remains incompletely characterized.

To evaluate adverse event (AE) signals, temporal patterns, and clinical priorities associated with teclistamab using the FDA Adverse Event Reporting System (FAERS).

We retrospectively analyzed FAERS reports from 2022 to 2025 using four disproportionality methods: reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. Time-to-onset, Weibull, Kaplan-Meier, and semi-quantitative clinical prioritization analyses were also performed.

Among 2,631 reports, 85.2% involved serious outcomes and 21.7% fatal outcomes. The most frequently reported system organ class was infections and infestations. Seventy significant preferred-term signals were identified, including 52 previously documented and 18 novel signals. Cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, infection, pneumonia, pyrexia, and neutropenia were most frequently reported. Sepsis was the sole high-priority signal, with fatal outcomes in 58.57% of sepsis-related reports. Immune-related and neurological events occurred earlier, whereas infectious complications tended to occur later. Safety profiles were generally consistent across sex and age groups, although septic shock was less frequently reported in females.

The safety profile broadly aligned with clinical trial data, but novel signals and sepsis-related fatality highlighted clinically important risks.

These findings support targeted risk mitigation and continued monitoring, particularly for severe infections and immune-related toxicities.