2026 CONVENTION
The Korea Institute of Drug Safety and Risk Management (KIDS) conducts intensive monitoring of oral contraceptives because of concerns regarding thromboembolic risk. We reviewed adverse event reports submitted to the Korea Adverse Event Reporting System (KAERS) from January 2012 to December 2024. Thromboembolic events were identified using the MedDRA v27.1 SMQ “Embolic and thrombotic events.” Target drugs included gestodene/ethinyl estradiol (EE), desogestrel/EE, levonorgestrel, levonorgestrel/EE, drospirenone/EE, and ulipristal. Among 29,081 ADR reports related to oral contraceptives, 113 thromboembolic reports (0.39%) were identified, of which 91 (80.5%) were serious. Drospirenone/EE accounted for most serious reports (n=74). Reporter-entered causality assessments indicated that a causal association could not be excluded in 60 serious cases (65.9%). The continued reporting of serious thromboembolic events highlights the importance of ongoing pharmacovigilance and targeted intensive monitoring for the management of post-marketing safety concerns.