The Real-World Safety Profile of Haloperidol: A Comprehensive Pharmacovigilance Analysis Using the Large-Scale FAERS Database.
- 1Ganzhou Cancer Hospital, Ganzhou, Jiangxi, China.
- 2Department of Basic Medical Science, Chongqing Three Gorges Medical College, Chongqing, China.
- 3The Sixth People's Hospital of Chongqing, The First Affiliated Hospital of Chongqing Medical and Pharmaceutical College, Chongqing, China.
Abstract
Objective
Haloperidol is a widely prescribed antipsychotic, but its long-term safety profile across broad populations remains insufficiently researched. Using the large-scale FDA Adverse Event Reporting System (FAERS) database, this study sought to comprehensively characterize the real-world adverse event profile of haloperidol and identify potential safety signals.Methods
Adverse event reports from FAERS spanning Q1 2004 through Q1 2026, with haloperidol listed as the primary suspect drug, were analyzed. Disproportionality analyses employing four complementary algorithms (ROR, PRR, BCPNN, and MGPS) were conducted. Time-to-onset and Weibull distribution analyses were also performed.Results
A total of 9916 reports associated with haloperidol were analyzed, covering 27 System Organ Classes (SOC). The primary SOCs were nervous system disorders, psychiatric disorders, and cardiac disorders. At the preferred terms (PT) level, extrapyramidal disorder, weight increased, neuroleptic malignant syndrome, tremor, and dystonia were the most frequently reported adverse events. Cardiovascular-related adverse events (e.g., electrocardiogram QT prolonged, tachycardia, cardiac arrest, and torsade de pointes) were confirmed. Significantly, we identified signals for some under-recognized adverse events, including suicide-related behaviors (intentional self-injury, suicide attempt, suicidal ideation) and embolism venous. Most adverse events occurred within the first 30 days of treatment (72.03%), and the Weibull distribution indicated an early failure pattern, suggesting that the risk of adverse events gradually decreased over time.Conclusions
This pharmacovigilance research confirmed haloperidol's established safety profile and highlighted under-characterized safety signals, offering valuable insight to inform clinical surveillance, risk mitigation, and future study endeavors to optimize the safe application of haloperidol across diverse patient demographics.
Related
- Safety Profile of Tirzepatide in Real‐World Clinical Practice: A Pharmacovigilance Study Using the FAERS Database
- Real-world safety profile of finerenone in patients with type 2 diabetes and chronic kidney disease: a multi-database pharmacovigilance analysis of the FAERS and JADER systems
- Safety of eribulin: A real-world study based on a pharmacovigilance database
- Safety signals of tocilizumab in pediatric patients: A real-world pharmacovigilance analysis based on the FAERS database with network pharmacology insights.
- Neuropsychiatric adverse event reporting with GLP-1-based therapies: a post-marketing pharmacovigilance analysis using the WHO global individual case safety report database (VigiBase).
BibTeX
@article{luo2026realworld,
title = {{The Real-World Safety Profile of Haloperidol: A Comprehensive Pharmacovigilance Analysis Using the Large-Scale FAERS Database.}},
author = {Nengping Luo and Lu Xiao and Ying Liu and Xiang Liu},
journal = {CNS neuroscience \& therapeutics},
year = {2026},
month = oct,
doi = {10.1002/cns.71217},
url = {https://europepmc.org/article/MED/42899698},
note = {CC BY},
}
RIS
TY - JOUR
TI - The Real-World Safety Profile of Haloperidol: A Comprehensive Pharmacovigilance Analysis Using the Large-Scale FAERS Database.
AU - Nengping Luo
AU - Lu Xiao
AU - Ying Liu
AU - Xiang Liu
PY - 2026
DA - 2026/10/01
JO - CNS neuroscience & therapeutics
DO - 10.1002/cns.71217
UR - https://europepmc.org/article/MED/42899698
AB - Objective Haloperidol is a widely prescribed antipsychotic, but its long-term safety profile across broad populations remains insufficiently researched. Using the large-scale FDA Adverse Event Reporting System (FAERS) database, this study sought to comprehensively characterize the real-world adverse event profile of haloperidol and identify potential safety signals.Methods Adverse event reports from FAERS spanning Q1 2004 through Q1 2026, with haloperidol listed as the primary suspect drug, were analyzed. Disproportionality analyses employing four complementary algorithms (ROR, PRR, BCPNN, and MGPS) were conducted. Time-to-onset and Weibull distribution analyses were also performed.Results A total of 9916 reports associated with haloperidol were analyzed, covering 27 System Organ Classes (SOC). The primary SOCs were nervous system disorders, psychiatric disorders, and cardiac disorders. At the preferred terms (PT) level, extrapyramidal disorder, weight increased, neuroleptic malignant syndrome, tremor, and dystonia were the most frequently reported adverse events. Cardiovascular-related adverse events (e.g., electrocardiogram QT prolonged, tachycardia, cardiac arrest, and torsade de pointes) were confirmed. Significantly, we identified signals for some under-recognized adverse events, including suicide-related behaviors (intentional self-injury, suicide attempt, suicidal ideation) and embolism venous. Most adverse events occurred within the first 30 days of treatment (72.03%), and the Weibull distribution indicated an early failure pattern, suggesting that the risk of adverse events gradually decreased over time.Conclusions This pharmacovigilance research confirmed haloperidol's established safety profile and highlighted under-characterized safety signals, offering valuable insight to inform clinical surveillance, risk mitigation, and future study endeavors to optimize the safe application of haloperidol across diverse patient demographics.
SN - 1755-5930
SN - 1755-5949
ER -