Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system.

Background: Our study utilized the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia.

Methods: The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS).

Result: Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a 'principal suspect(PS)' AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2-31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy.

Conclusion: Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.