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No. 1 (2026)

GENERAL THERAPY QUESTIONS AND REVIEWS

Cardiovascular Safety of Risperidone: An Umbrella Review of Systematic Reviews and Meta-Analyses

https://doi.org/10.48612/psyph/x77r-mr19-p381

Published 2026-03-30

  • V.Yu. Skryabin
    • ,
  • S.I. Sokolova
    • ,
  • D.A. Sychev

V.Yu. Skryabin
Russian Medical Academy of Continuous Professional Education

S.I. Sokolova
Moscow Research and Practical Center on Addictions

D.A. Sychev
Russian Medical Academy of Continuous Professional Education

Abstract

Relevance. The cardiovascular safety of risperidone remains debated due to conflicting data from individual systematic reviews.

Aim — to conduct a comprehensive assessment of the cardiovascular risk of risperidone through an umbrella review of existing systematic reviews and meta-analyses.

Materials and Methods. An umbrella review was conducted in accordance with PRISMA 2020. The search was performed in the EMBASE, MEDLINE/PubMed, Scopus, and Web of Science databases. The methodological quality of the included reviews was assessed using AMSTAR-2, and the certainty of evidence was evaluated using the GRADE system.

Results. Seven systematic reviews were included in the analysis. Their methodological quality according to AMSTAR-2 was rated as low or critically low, and the certainty of evidence for key outcomes according to GRADE was low or very low. The review found no convincing data on a significant effect on blood pressure; however, a statistically significant signal for increased tachycardia risk versus placebo, with very low certainty of evidence (GRADE). A statistically significant but small increase in the QTc interval was found, as well as a signal of a possible increased risk of cerebrovascular events in elderly patients with dementia.

Conclusion. The body of available evidence does not confirm a significant universal cardiovascular risk of risperidone but indicates the need for caution when prescribing it to patients with risk factors for QTc prolongation and the elderly with dementia.

Keywords

risperidone, cardiovascular safety, umbrella review, systematic review, meta-analysis, AMSTAR-2, GRADE, QTc interval, cerebrovascular events, dementia

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