You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Non-neurogenic Voiding Dysfunction I (MP02)1 Sep 2021MP02-14 AN EVALUATION OF THE FEDERAL ADVERSE EVENTS REPORTING SYSTEM DATA ON ADVERSE EFFECTS OF OVERACTIVE BLADDER MEDICATIONS Siri Drangsholt, Michelina Stoddard, Stephanie Sansone, Ahra Cho, and Bilal Chughtai Siri DrangsholtSiri Drangsholt More articles by this author , Michelina StoddardMichelina Stoddard More articles by this author , Stephanie SansoneStephanie Sansone More articles by this author , Ahra ChoAhra Cho More articles by this author , and Bilal ChughtaiBilal Chughtai More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001963.14AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To investigate the side effects associated with exposure to overactive bladder medications in the post marketing world. METHODS: The FDA’s post marketing safety surveillance program (FAERs) for antimuscarinic and B agonist overactive bladder medications was analyzed from January 2005 to December 2019. Reports identified one or more adverse effects. Cases of monotherapy with the primary antimuscarinic or B agonist were identified. The frequency of adverse reactions was summarized between various drugs and dosages. Reporter type and age of patients with reactions was collected. RESULTS: A total of 19,607 case reports were obtained. 13,328 case reports of antimuscarinics (combined) and 6279 of B agonists. The average age of the patient was 71.8 years (SD-13.6), with 63% of all reports filed by a non-health care professional. On a per drug basis, oxybutynin (n=8,083) followed by mirabegron (n=6,279) had the highest number of adverse events and trospium (n=186) had the lowest. Neuropsychiatric followed by constitutional side effects were reported with the greatest frequency (see Table 1). Oxybutynin had the most side effects reported in 2014 with 2,777 reports, and mirabegron had the most reports submitted in 2018 with 901 reports. CONCLUSIONS: Analysis of FAERS data showed the greatest number of reports for oxybutynin and mirabegron medications. The causality and rate of AEs are not certain based on FAERS data. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e17-e17 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Siri Drangsholt More articles by this author Michelina Stoddard More articles by this author Stephanie Sansone More articles by this author Ahra Cho More articles by this author Bilal Chughtai More articles by this author Expand All Advertisement Loading ...