Female Sexual Dysfunction Induced by Second-Generation Antipsychotic Drugs—A Disproportionality Analysis Based on the FAERS Database

Background Second-generation antipsychotics (SGAs) are widely prescribed for psychiatric disorders but frequently cause sexual dysfunction, particularly in women—a side effect often underrecognized. This study assessed the association between SGAs and female sexual dysfunction using the US Food and Drug Administration Adverse Event Reporting System (FAERS). Study Methods We analyzed FAERS data from Q1 2004 to Q4 2023, identifying female sexual dysfunction cases using predefined MedDRA Preferred Terms. Nine SGAs were included: aripiprazole, quetiapine, olanzapine, risperidone, paliperidone, lurasidone, brexpiprazole, asenapine, and ziprasidone. Disproportionality analyses were conducted using frequentist (ROR, PRR) and Bayesian (BCPNN, MGPS) methods. Results were stratified by symptom type and prolactin-related drug effects. Study Results A total of 11 786 reports were identified, peaking in 2017. Women aged 19-41 years accounted for the largest subgroup (n = 4787, 40.6%). Antipsychotics accounted for 9 of the top 50 drugs linked to sexual dysfunction, with aripiprazole, quetiapine, and olanzapine most frequently reported. Aripiprazole was strongly associated with compulsive sexual behavior (ROR: 296.23) and hypersexuality. Risperidone and paliperidone were linked to decreased libido and anorgasmia. Prolactin-elevating drugs were associated with older age, intramuscular use, and more serious outcomes. Conclusion This pharmacovigilance study highlights significant associations between specific SGAs and female sexual dysfunction. Disproportionality signals vary by drug, symptom type, and prolactin-related mechanisms. Clinicians should consider sexual side effects in treatment decisions and monitor patients accordingly. Further prospective studies are warranted.