A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases
Abstract 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 dr...
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2025-01-01
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| Online Access: | https://doi.org/10.1186/s12888-025-06493-0 |
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| author | Siyu Lou Zhiwei Cui Yingyong Ou Junyou Chen Linmei Zhou Ruizhen Zhao Chengyu Zhu Li Wang Zhu Wu Fan Zou |
| author_facet | Siyu Lou Zhiwei Cui Yingyong Ou Junyou Chen Linmei Zhou Ruizhen Zhao Chengyu Zhu Li Wang Zhu Wu Fan Zou |
| author_sort | Siyu Lou |
| collection | DOAJ |
| description | Abstract 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 schizophrenia, which was consistent with drug label. Noteworthy, unexpected signals not listed in the drug label were also identified, such as psychosexual disorders, prolactin-producing pituitary tumors, suicide attempt, and sudden death. The median onset time for all ADEs was 40 days. Furthermore, gender-based difference in risk signals was detected. Females are more likely to experience elevated blood prolactin and weight increase, whereas males are more prone to sexual dysfunction. Among the 1,065 ADE reports from the JADER database, we identified 51 positive signals, 35 of which overlapped with those found in FAERS, including schizophrenia, hyperprolactinemia, and erectile dysfunction. Conclusion The study findings from two independent databases serve as crucial references for ensuring the safe of paliperidone palmitate. Additionally, the gender-specific monitoring references provided can enhance clinical surveillance efforts and facilitate more effective risk identification. |
| format | Article |
| id | doaj-art-194b801ced9740da921d2abca7fae272 |
| institution | Kabale University |
| issn | 1471-244X |
| language | English |
| publishDate | 2025-01-01 |
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| series | BMC Psychiatry |
| spelling | doaj-art-194b801ced9740da921d2abca7fae2722025-01-26T12:46:46ZengBMCBMC Psychiatry1471-244X2025-01-0125112010.1186/s12888-025-06493-0A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databasesSiyu Lou0Zhiwei Cui1Yingyong Ou2Junyou Chen3Linmei Zhou4Ruizhen Zhao5Chengyu Zhu6Li Wang7Zhu Wu8Fan Zou9Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Obstetrics and Gynecology, The First Affiliated Hospital of Xi’an Jiaotong UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityDepartment of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical UniversityAbstract 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 schizophrenia, which was consistent with drug label. Noteworthy, unexpected signals not listed in the drug label were also identified, such as psychosexual disorders, prolactin-producing pituitary tumors, suicide attempt, and sudden death. The median onset time for all ADEs was 40 days. Furthermore, gender-based difference in risk signals was detected. Females are more likely to experience elevated blood prolactin and weight increase, whereas males are more prone to sexual dysfunction. Among the 1,065 ADE reports from the JADER database, we identified 51 positive signals, 35 of which overlapped with those found in FAERS, including schizophrenia, hyperprolactinemia, and erectile dysfunction. Conclusion The study findings from two independent databases serve as crucial references for ensuring the safe of paliperidone palmitate. Additionally, the gender-specific monitoring references provided can enhance clinical surveillance efforts and facilitate more effective risk identification.https://doi.org/10.1186/s12888-025-06493-0Paliperidone palmitateFAERSJADERAdverse drug eventsDisproportionality analysisReal-world analysis |
| spellingShingle | Siyu Lou Zhiwei Cui Yingyong Ou Junyou Chen Linmei Zhou Ruizhen Zhao Chengyu Zhu Li Wang Zhu Wu Fan Zou A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases BMC Psychiatry Paliperidone palmitate FAERS JADER Adverse drug events Disproportionality analysis Real-world analysis |
| title | A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases |
| title_full | A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases |
| title_fullStr | A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases |
| title_full_unstemmed | A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases |
| title_short | A multidimensional assessment of adverse events associated with paliperidone palmitate: a real-world pharmacovigilance study using the FAERS and JADER databases |
| title_sort | multidimensional assessment of adverse events associated with paliperidone palmitate a real world pharmacovigilance study using the faers and jader databases |
| topic | Paliperidone palmitate FAERS JADER Adverse drug events Disproportionality analysis Real-world analysis |
| url | https://doi.org/10.1186/s12888-025-06493-0 |
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