Post-marketing safety analysis of blonanserin: a retrospective pharmacovigilance study using the Japanese adverse drug event report database (2008-2024).
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Blonanserin, an atypical antipsychotic approved in Japan for the treatment of schizophrenia, exhibits a unique receptor affinity profile and a reportedly favorable safety profile; however, comprehensive large-scale real-world data on its adverse drug events (ADEs) remain limited. We conducted a retrospective pharmacovigilance study using the Japanese Adverse Drug Event Report (JADER) database from 2008 to 2024, focusing on ADEs where blonanserin was identified as the primary suspect drug. Safety signals were detected via disproportionality analyses employing both frequentist and Bayesian approaches and prioritized according to clinical relevance. Temporal characteristics were assessed by time-to-onset analysis, and multivariate logistic regression was used to identify risk factors for poor clinical outcomes. Analysis of 1203 patient cases revealed a female predominance (51.12 %), with nearly half of patients (48.79 %) aged 20-49 years. Sixty-three preferred term signals spanning 16 system organ classes were identified, including well-established adverse effects such as neuroleptic malignant syndrome, as well as novel signals absent from product labeling, such as oculogyric crisis and hypertriglyceridemia. Most ADEs occurred within 30 days of treatment initiation. Tardive dyskinesia, dystonia, extrapyramidal disorder, and pulmonary embolism were independent predictors of poor clinical outcomes (area under the curve = 0.75). Sensitivity analyses confirmed the robustness of these findings. This large-scale real-world pharmacovigilance analysis delineates the ADE profile of blonanserin, highlighting the predominance of early-onset adverse events and uncovering new potential risks. These results contribute valuable safety information to clinical practice and underscore the need for further prospective studies to validate and expand upon these observations.