Real‑world pharmacovigilance of rituximab‑associated adverse reactions in children and adolescents: Disproportionality signal detection and time‑to‑onset pattern characterization using the FAERS database

Several of these signals pertained to immune system – and infection‑related adverse events. Notably, the elevated signal magnitudes for certain signals were substantially confounded by indication bias, pre‑existing comorbidities, and reports associated with therapeutic failure. Stratified analyses revealed differences in the signal distribution of adverse‑event reports across age and sex subgroups.

Time‑to‑onset analysis of adverse‑event reports indicated that most events documented in these reports occurred within 30 d of therapy initiation, with a median of 7 d. This study characterizes the reported safety profile of rituximab in pediatric patients based on FAERS spontaneous reports. Our findings represent exploratory signal hypotheses only and can serve as a reference for subsequent relevant investigations.</p>