A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases

作者：Siyu Lou, Zhiwei Cui, Yingyong Ou, Junyou Chen, Linmei Zhou, Ruizhen Zhao, Chengyu Zhu, Li Wang, Zhu Wu, Fan Zou · 发表于：BMC Psychiatry · 年份：2025 · DOI：10.1186/s12888-025-06493-0 · 被引用次数：9 · 研究领域：Pharmacovigilance and Adverse Drug Reactions、Schizophrenia research and treatment、Pharmaceutical Practices and Patient Outcomes

OBJECTIVE: Paliperidone palmitate is a second-generation antipsychotic that has undergone extensive investigation in clinical trials. However, real-world studies assessing its safety in large populations are lacking. As such, this study aimed to comprehensively evaluate real-world adverse drug events (ADEs) linked to paliperidone palmitate by employing data mining techniques on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. METHODS: The study retrieved ADE reports from the FAERS database covering the period from 2009 through the third quarter of 2024, and from the JADER database covering the period from 2013 through the second quarter of 2024. Utilizing disproportionality analyses such as the reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item Poisson shrinkage (MGPS), significant associations between ADEs and paliperidone palmitate were evaluated. RESULTS: A total of 27,672 ADE reports related to paliperidone palmitate were identified in FAERS, with 285 significantly disproportionate preferred terms (PTs) identified by all four algorithms. Paliperidone palmitate-associated ADEs encompassed 27 System Organ Classes (SOCs). The top three PTs with the highest reported cases were off-label use, drug ineffective, and hospitalization. Common ADEs included increased blood prolactin, galactorrhea, and ...