The Real-World Safety Profile of Haloperidol: A Comprehensive Pharmacovigilance Analysis Using the Large-Scale FAERS Database.

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.