Abstract
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.