Global large-scale real-world assessment of drug-associated galactorrhea based on FDA adverse drug reaction reports

Background: Galactorrhea, an abnormal milk secretion, is frequently triggered by medications that influence prolactin levels. Objectives: This study aimed to identify high-risk drugs for drug-associated galactorrhea (DAG) and explore their characteristics using data from the FDA Adverse Event Reporting System (FAERS). Methods: We analyzed 6,195 DAG reports by applying four disproportionality analysis algorithms (ROR, PRR, MGPS, BCPNN) to detect positive signals. Results: The analysis of 6,195 reports showed that DAG was most prevalent in patients aged 20-40 years, with a slight male predominance (55.52%). Oral medications were the primary cause (68.99%). A total of 32 drugs were strongly associated with DAG, with antipsychotics being the most frequently implicated class (N = 12), followed by antidepressants (N = 7) and hormone-related drugs (N = 6). Risperidone had the highest risk (ROR = 346.71) and report count (N = 3,378). Conclusion: This study provides a comprehensive list of high-risk drugs for DAG, offering critical data to guide safer prescribing and improve pharmacovigilance. Clinicians should be vigilant in monitoring for suggestive symptoms like galactorrhea, amenorrhea and sexual dysfunction, especially in high-risk individuals on long-term treatment with prolactin-elevating medications. These findings underscore the importance of patient safety and inform clinical practice.