Abstract Background Lumateperone, a novel atypical antipsychotic, has emerged as an illuminating hope for patients with schizophrenia and bipolar disorder. While prior studies have employed spontaneous reporting databases and identified over 100 novel adverse events associated with lumateperone, the differences in these adverse events across subgroups remain unclear. Objective This study provides a comprehensive evaluation of the adverse event profile of lumateperone using the Food and Drug Administration Adverse Event Reporting System database, focusing on the potential differences in reporting adverse events across subgroups. Methods Based on the results of clinical characteristics and signal detection, the potential differences in reporting lumateperone-associated adverse events across specific subgroups regarding report year, reporter type, sex, age, outcome, indication, and concomitant drug were analyzed using the ROR algorithm and Fisher’s exact test with Bonferroni correction. The observed differences were further validated using sensitivity analyses, stratified analyses, and comparative analyses. Results This study identified 1762 reports and 5074 adverse events associated with lumateperone. Notably, females had a higher frequency of reporting nervous system disorders. Tardive dyskinesia was more frequently resulted in serious consequences. Moreover, bipolar disorder patients more frequently reported nervous system disorders, while schizophrenia patients more frequently reported psychiatric disorders. Conclusions This study underscores the need for future confirmatory studies into the potential sex, outcome and indication differences in adverse events associated with lumateperone. The findings should be considered preliminary and require further validation.
Jiang et al. (Wed,) studied this question.