Sexual dysfunctions associated with antipsychotic drug intake: a retrospective analysis of the FDA adverse events reporting system (FAERS)

Johanna Engel; Lamin Jeridi; Lilly Auerbach; Oliver Zolk; Timo Greiner; Martin Heinze; Pichit Buspavanich; Michael Schneider

doi:10.1007/s00210-024-03763-8

Sexual dysfunctions associated with antipsychotic drug intake: a retrospective analysis of the FDA adverse events reporting system (FAERS)

Naunyn Schmiedebergs Arch Pharmacol. 2025 Jan 11. doi: 10.1007/s00210-024-03763-8. Online ahead of print.

Authors

Johanna Engel¹, Lamin Jeridi², Lilly Auerbach², Oliver Zolk³, Timo Greiner², Martin Heinze², Pichit Buspavanich^{4

5

6

7}, Michael Schneider^{2

8}

Affiliations

¹ University Clinic for Psychiatry and Psychotherapy, Brandenburg Medical School Immanuel Klinik Rüdersdorf, Seebad 82/83, Rüdersdorf bei Berlin, 15562, Rüdersdorf, Germany. [email protected].
² University Clinic for Psychiatry and Psychotherapy, Brandenburg Medical School Immanuel Klinik Rüdersdorf, Seebad 82/83, Rüdersdorf bei Berlin, 15562, Rüdersdorf, Germany.
³ Institute of Clinical Pharmacology of the Brandenburg Medical School, Brandenburg Medical School Immanuel Klinik Rüdersdorf, Seebad 82/83, Rüdersdorf bei Berlin, 15562, Rüdersdorf, Germany.
⁴ Research Unit Gender in Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁵ Institute of Sexology and Sexual Medicine, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁶ Department of Psychiatry and Neuroscience, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
⁷ Department of Psychiatry, Psychotherapy and Psychosomatics, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.
⁸ Faculty of Health Sciences, Joint Faculty of the University of Potsdam, The Brandenburg Medical School Theodor Fontane and the Brandenburg University of Technology Cottbus -Senftenberg, Karl-Liebknecht-Str. 24-25, 14476, Potsdam, Germany.

PMID: 39797988
DOI: 10.1007/s00210-024-03763-8

Abstract

Sexual dysfunctions (SD) are common and debilitating side effects of antipsychotics. The current study analyzes the occurrence of antipsychotic-related SD using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). FAERS was queried for sexual dysfunction adverse events (encoded by 35 different MedDRA preferred terms) secondary to amisulpride, aripiprazole, chlorprothixene, clozapine, haloperidol, loxapine, olanzapine, pipamperone, quetiapine, risperidone, and ziprasidone from 2000 to 2023. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). During the observation period, 9203 cases of SD were reported in association with the antipsychotic drug use. Men reported these dysfunctions more frequently (68.4% of all cases) than women. Ziprasidone had the highest ROR for sexual dysfunction in FAERS, at $84.86; 95 % C I (77.50, 92.94))$ , followed by aripirazole for sexual dysfunction $(R O R = 34.17; 95 % C I (32.06, 36.43))$ . In general, aripiprazole, olanzapine, risperidone, ziprasidone, and quetiapine had higher risk signals across multiple adverse events (AEs), whereas chlorprothixene, loxapine, and amisulpride showed lower risk signals. The pathogenesis of SD does not appear to be limited to specific pathomechanisms and therefore not to specific substances. The differing report distributions by sex and the impact of polypharmacy on the symptoms warrant further investigations.

Keywords: Adverse drug reaction; Antipsychotic drugs; FAERS database; Sexual dysfunction.