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Introduction <p>Antipsychotic-associated sexual adverse drug reactions (ADRs) are well known in clinical practice, although efforts to understand differences between antipsychotics and distinct types of sexual ADRs are limited.</p> Objective <p>The aim of this study was to assess and prioritize the profile of each antipsychotic regarding sexual ADRs reporting, and to account for potential confounders.</p> Methods <p>We used VigiBase<sup>®</sup> to conduct a case/non-case study using a customized clinically guided search strategy of antipsychotic-related sexual ADRs. The reporting odds ratio (ROR) and Bayesian information component (IC) with relevant 95% confidence intervals (95%&#xa0;CIs) were used as disproportionality measures to identify signals of disproportionate reporting (SDRs). Antipsychotics were compared with all other drugs and with thiazides (positive control). Sensitivity analyses included non-serious reports, excluding patients with potentially confounding co-medication(s), excluding adolescent and elderly patients, and including cases with co-reported hyperprolactinemia. Analyses were stratified by sex. Antipsychotics were ranked in terms of clinical priority using qualitative and quantitative criteria.</p> Results <p>We included 5195 cases of antipsychotic-related sexual ADRs (43.1% serious, median time to onset of 61 days, 36.1% physician-reported). Several SDRs emerged in males (erectile dysfunction [3487 reports; ROR 2.49, 95%&#xa0;CI 2.40–2.57]; priapism [2372 reports; ROR 15.55, 95%&#xa0;CI 14.82–16.32]) and females (decreased libido [373 reports; ROR 1.61, 95%&#xa0;CI 1.46–1.79]) for all antipsychotic classes, except for muscarinic antagonists in females (ROR 0.64, 95%&#xa0;CI 0.55–0.73; IC − 0.65, 95%&#xa0;CI − 0.86 to − 0.45). In both sexes, the highest number of reports were for risperidone, aripiprazole and olanzapine. The SDRs disappeared in the sensitivity analysis including only non-serious cases and cases with co-reported hyperprolactinemia. Sexual ADRs for all antipsychotics were classified as of moderate priority, with the exception of fluspirilene (low priority).</p> Conclusions <p>Notwithstanding limitations, including inability to infer causality, these findings raise the hypothesis that sexual ADRs could be a class effect of antipsychotics, yet possibly reversible, in both women and men.</p> Registration <p>The protocol is registered to the Open Science Framework: <a href="https://osf.io/96eq7">https://osf.io/96eq7</a>.</p>

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Sexual Dysfunction with Antipsychotics: Emerging Clues from a Disproportionality Analysis of the World Health Organization VigiBase

  • 期刊论文

  • 发表日期：

    2026年4月14日

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  • Efstathios Pavlidis,
  • Spyridon Siafis,
  • Elena Arzenton,
  • Salvatore Crisafulli,
  • Emanuel Raschi,
  • Ugo Moretti,
  • Andrea M. Isidori,
  • Emmanuele A. Jannini,
  • Gianluca Trifirò,
  • Erich Seifritz,
  • Corrado Barbui,
  • Chiara Gastaldon,
  • Georgios Schoretsanitis

摘要

Introduction

Antipsychotic-associated sexual adverse drug reactions (ADRs) are well known in clinical practice, although efforts to understand differences between antipsychotics and distinct types of sexual ADRs are limited.

Objective

The aim of this study was to assess and prioritize the profile of each antipsychotic regarding sexual ADRs reporting, and to account for potential confounders.

Methods

We used VigiBase® to conduct a case/non-case study using a customized clinically guided search strategy of antipsychotic-related sexual ADRs. The reporting odds ratio (ROR) and Bayesian information component (IC) with relevant 95% confidence intervals (95% CIs) were used as disproportionality measures to identify signals of disproportionate reporting (SDRs). Antipsychotics were compared with all other drugs and with thiazides (positive control). Sensitivity analyses included non-serious reports, excluding patients with potentially confounding co-medication(s), excluding adolescent and elderly patients, and including cases with co-reported hyperprolactinemia. Analyses were stratified by sex. Antipsychotics were ranked in terms of clinical priority using qualitative and quantitative criteria.

Results

We included 5195 cases of antipsychotic-related sexual ADRs (43.1% serious, median time to onset of 61 days, 36.1% physician-reported). Several SDRs emerged in males (erectile dysfunction [3487 reports; ROR 2.49, 95% CI 2.40–2.57]; priapism [2372 reports; ROR 15.55, 95% CI 14.82–16.32]) and females (decreased libido [373 reports; ROR 1.61, 95% CI 1.46–1.79]) for all antipsychotic classes, except for muscarinic antagonists in females (ROR 0.64, 95% CI 0.55–0.73; IC − 0.65, 95% CI − 0.86 to − 0.45). In both sexes, the highest number of reports were for risperidone, aripiprazole and olanzapine. The SDRs disappeared in the sensitivity analysis including only non-serious cases and cases with co-reported hyperprolactinemia. Sexual ADRs for all antipsychotics were classified as of moderate priority, with the exception of fluspirilene (low priority).

Conclusions

Notwithstanding limitations, including inability to infer causality, these findings raise the hypothesis that sexual ADRs could be a class effect of antipsychotics, yet possibly reversible, in both women and men.

Registration

The protocol is registered to the Open Science Framework: https://osf.io/96eq7.