PLoS One

Haloperidol not linked to increased cardiac risk, meta-analysis finds

August 18, 2025

Study details: This meta-analysis evaluated 84 randomized trials (N=12,180, 46% female) to assess the risk of major adverse cardiac events (MACE) associated with haloperidol. MACE was defined using an FDA-adapted composite including death, non-fatal cardiac arrest, ventricular arrhythmias, seizure, or syncope. Trials included diverse populations, with nearly half (44%) involving psychiatric diagnoses and over half incorporating ECG monitoring (60%).

Results: Haloperidol wasn’t associated with an increased risk of MACE compared with placebo (risk ratio [RR], 0.93; 95% confidence interval [CI], 0.80–1.08). IV haloperidol also showed no excess mortality risk (RR 0.88; 95% CI, 0.72–1.08). Arrhythmic events were rare, and no high-risk subgroups were identified based on age, sex, or clinical setting.

Clinical impact: These findings challenge longstanding concerns about haloperidol’s arrhythmogenic potential, particularly related to QT prolongation. Routine ECG monitoring may not be necessary for all patients, supporting more confident, evidence-based use of haloperidol in acute care settings, including psychiatry, geriatrics, and critical care.

Source:

Garcia MC, et al. (2025, June 25). PLoS One. Major adverse cardiac events with haloperidol: A meta-analysis. https://pubmed.ncbi.nlm.nih.gov/40561150/