Abstract:
Objective To analyze the characteristics and distribution patterns of adverse drug reactions(ADRs) associated with anticoagulants in Weifang City from 2020 to 2025, and to provide references for clinical medication safety.
METHODS A retrospective study was conducted using ADR reports for four categories of anticoagulants(heparins, direct factor Ⅹa inhibitors, vitamin K antagonists, and direct thrombin inhibitors) collected by the Weifang City ADR Monitoring Center from January 2020 to October 2025. Statistical analysis was performed on demographic characteristics, reasons for medication, ADR types, systems affected, and outcomes.
RESULTS A total of 684 ADR reports were included. Heparins accounted for the highest number of reports(513 cases, 75.00%). ADRs were primarily concentrated in patients aged ≥65 years(55.85%), with a slightly higher proportion in females(55.56%). The proportion of serious ADRs was high(48.54%), with direct factor Ⅹa inhibitors having the highest percentage of serious reports(58.42%). Bleeding was the most common ADR. The proportion of bleeding-related ADRs for direct factor Ⅹa inhibitors reached 55.46%, significantly higher than that for heparins(23.92%) and vitamin K antagonists(33.33%). Non-bleeding ADRs showed category-specific differences: skin and hepatobiliary system reactions were predominant for heparins, while gastrointestinal symptoms were common for direct factor Ⅹa inhibitors.
CONCLUSION ADRs associated with anticoagulants in this region exhibits distinct inter-class variation and population characteristics, reflecting their different clinical application patterns and safety profiles. This study provides important data for subsequent drug safety evaluation and rational drug use. It is recommended that clinicians individualize the selection of anticoagulants based on the patient’s bleeding risk, age, liver and kidney function, and concomitant medications, strengthen the monitoring of bleeding events and specific drug-related non-bleeding reactions, and improve the ADR reporting system to enhance the safety of anticoagulant therapy.