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No. 2 (2025)

ORIRGINAL RESEARCH

Risk of Rhabdomyolysis during Therapy with Atypical Antipsychotics: Evaluation of Safety Signals

https://doi.org/10.48612/psyph/tu5p-ntrb-x62h

Published 2025-06-30

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

V.Yu. Skryabin
Moscow Research and Practical Centre on Addictions of the Moscow Department of Healthcare

D.A. Sychev
Russian Medical Academy of Continuous Professional Education of the Ministry of Health of the Russian Federation

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

A.S. Serova
Pirogov Russian National Research Medical University

M.V. Zuzenkov
Pirogov Russian National Research Medical University

Abstract

Background. Rhabdomyolysis is a rare but potentially life-threatening complication associated with the use of atypical antipsychotics.

The aim of this study was to evaluate the association between the use of atypical antipsychotics and the development of rhabdomyolysis using the FDA Adverse Event Reporting System (FAERS) data.

Material and Methods. A disproportionate analysis of reports of rhabdomyolysis in FAERS (Q1 2004 to Q4 2023) was performed, and reported odds ratios (ROR) and median time to adverse reaction (TTO) were calculated.

Results. Olanzapine showed the strongest association with rhabdomyolysis (ROR = 4.02, 95 % confidence interval (CI): 3.72–4.35). All medications corresponded to the early risk type (β < 1). Hospital admission was required in >40 % of cases, and mortality was less frequent when aripiprazole was administered.

Conclusion. Atypical antipsychotics may increase the risk of rhabdomyolysis, especially during the first weeks of therapy. The findings emphasize the need for patient
monitoring and further research into this complication.

Keywords

atypical antipsychotics, rhabdomyolysis, ADRs, adverse drug reactions, FAERS, pharmacovigilance, olanzapine, quetiapine, adverse effects, drug safety

PDF (Русский)

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