Safety assessment of Yasmin: Real-world adverse event analysis using the FAERS database

• Published in: European journal of obstetrics & gynecology and reproductive biology Vol. 301; pp. 12 - 18
• Main Authors: Xu, Wenting, Zhu, Lili, Wang, Jiahui, Shi, Lingli, Tang, Xiuqin, Chen, Qingli, Wang, Lihong
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01.10.2024
• Subjects: Adverse events; Disproportionality analysis; FAERS; Real-world; Signal strength; Yasmin; FAERS; Yasmin; Adverse events; Disproportionality analysis; Signal strength; Real-world
• ISSN: 0301-2115; 1872-7654; 1872-7654
• DOI: 10.1016/j.ejogrb.2024.07.048

•This study analyzes Yasmin-related adverse events (AEs) using FAERS database data from 2004 to 2023.•Hepatobiliary, vascular, and psychiatric disorders were the top reported AEs for Yasmin users.•Novel adverse reactions like fear of disease and acute cor pulmonale identified with high signal strength.•Results emphasize the need for cautious prescribing and patient awareness of potential AEs with Yasmin. This study aimed to elucidate the scope and nature of adverse events (AEs) associated with Yasmin. Among the 17,035,572 AE reports collected from the Food and Drug Administration Adverse Event Reporting System (FAERS) database between January 2004 and September 2023, 25,949 reports involved Yasmin. The demographic details, clinical outcomes, and sources of reports were extracted, and four algorithms were used to evaluate adverse drug reactions. The majority of the AE reports involved females aged 18–45 years. Hospitalization was the most frequently reported serious outcome (46.84 %), with death occurring in 292 patients (1.82 %). The highest number of reports originated from the United States. Adverse reactions spanned across 24 system organ categories (SOCs), and hepatobiliary, vascular, and psychiatric disorders were the most frequently reported AEs. A total of 229 Preferred Terms (PTs) were identified for adverse reactions, with high signal strength observed for conditions such as post-cholecystectomy syndrome. In addition, fear of disease, which has not been previously identified as an AE related to Yasmin, was also identified as a high signal strength side effect. The findings of the present study underscore the importance of monitoring and identifying potential AEs in patients receiving Yasmin, including those not currently listed in the medication instructions.