(100) Urinary and Gynecologic Adverse Events Associated with Ssri Use

Abstract

Abstract Introduction SSRIs are the most prescribed psychiatric drug in the United States, with approximately 40% of patients reporting side effects to their provider (1,2). It is accepted that side effects of SSRIs may include sexual dysfunction, including decreased libido and anorgasmia (3,4). However, the safety of SSRIs on the functions of the genitourinary and reproductive systems in real-world settings remains unclear. Objective The aim of this study was to identify urinary and gynecologic adverse events associated with SSRIs using data from the FDA Adverse Events Reporting System (FAERS). Secondarily, we identify variability of adverse events across individual SSRIs. Methods A specialized software to analyze adverse events, OpenVigil 2.1, was used to query the FAERS data. We defined 445 search terms related to genitourinary and reproductive system related events. We performed disproportionality analysis to identify associations between search terms and SSRIs as a class, then each SSRI (fluoxetine, sertraline, paroxetine, escitalopram, citalopram). Subgroup analysis was performed to stratify adverse events by age. Results Adverse events related to SSRI usage include a variety of genitourinary and reproductive system related side effects, not limited to sexual dysfunction. Gynecologic bleeding, urinary retention, hypersexuality emerged as surprisingly statistically significant signals across females. Statistically significant adverse events related to sexual dysfunction were present up to age 60, with the strongest signals found in the 40-59 years age group. Urinary symptoms were most prevalent in the 0-18 years and over 60 years age group. Of the SSRIs, citalopram had the strongest association with sexual disorders and dysfunction. Conclusions In this study, we offer the most granular side effect profile of SSRIs related to the urinary and reproductive systems to date. While the pathophysiology of each adverse event remains unclear, an understanding of potential risks of these drugs is valuable in the management of patients taking SSRIs, particularly in the event of rare side effects that are often not associated with SSRI use. These are important considerations for clinical practice as side effects of SSRIs can impact treatment compliance and patient quality of life.