Urinary and gynecologic adverse events associated with SSRI use

Background Selective Serotonin Receptor Inhibitors (SSRIs) are the most prescribed psychiatric drug in the United States. However, the adverse effects of SSRIs related to the genitourinary and reproductive systems in real-world settings remains unclear. The aim of this study is to identify a comprehensive profile of adverse events (AEs) associated with SSRIs in females using data from the FDA Adverse Events Reporting System (FAERS) and variability of adverse events across individual SSRIs. Methods A software designed to analyze adverse drug events, OpenVigil 2.1, was used to query the FAERS data. We defined 445 genitourinary and reproductive system related adverse events related to genitourinary and reproductive systems. Proportional reporting ratio (PRR) was utilized to assess the strength of association between adverse events and SSRIs. Subgroup analysis was conducted to stratify adverse events by age. Results The majority of AEs were related to sexual dysfunction, such as issues of arousal, libido, and orgasm. Additional significant findings were related to gynecologic bleeding, urinary retention and incontinence, and hypersexuality. Citalopram exhibited the strongest signal strengths, as evidenced by the highest proportional reporting ratios (PRRs), particularly in relation to sexual dysfunction. The strongest signals related to sexual dysfunction were found in the 40-59 years age group. Urinary symptoms were most prevalent in the over 60 years age group. Conclusion According to our findings, the potential for genitourinary and reproductive system related AEs of SSRIs warrants further investigation of underlying mechanisms and monitoring in clinical practice. AEs are important considerations for clinical practice as side effects of SSRIs can impact treatment compliance and patient quality of life.