222 Adverse Reaction Reports of Factor Xa Inhibitors

doi:10.19803/j.1672-8629.20250163

Abstract

Abstract: Objective To analyze the reports of adverse drug reactions (ADR) caused by factor Xa inhibitors in Beijing, find out about the characteristics of ADR associated with these drugs, and provide references for rational clinical use. Methods ADR reports of factor Xa inhibitors (rivaroxaban, edoxaban and apixaban) collected by Beijing Center for ADR Monitoring from January 2019 to June 2024 were retrieved. The gender and age of patients, organs and systems involved, clinical manifestations, management and outcomes of ADR, and severe cases of the ADR were statistically analyzed. Results A total of 199 ADR reports concerning rivaroxaban and 23 concerning edoxaban were collected, with no ADR reports related to apixaban. The male-to-female ratio was 1.05∶1 for rivaroxaban and 1∶1 for edoxaban based on these ADR. The age of these patients averaged over 70 years. The proportion of severe ADR was 6.14% for rivaroxaban, compared with 16.00% for edoxaban. The ADR of rivaroxaban involved blood vessels, bleeding and coagulation disorders, gastrointestinal disorders and urinary disorders, with bleeding-related adverse reactions accounting for 58.77% of the cases. The ADR of edoxaban included gastrointestinal disorders, blood vessel disorders, bleeding and coagulation disorders and respiratory system disorders, with bleeding-related adverse reactions making up 76.00% of the reported cases. Conclusion Bleeding is the most significant ADR caused by factor Xa inhibitors. Patients at high risk of bleeding should be closely monitored. Meanwhile, ADR not explicitly stated in drug inserts require more attention and research.

Key words: Oral, Factor Xa Inhibitors, Rivaroxaban, Edoxaban, Vascular, Bleeding, Coagulation Disorders, Drug Adverse Reactions

CLC Number:

R972
R994.11

ZHENG Jinfeng, WU Jiani, LIN Jingyu, YANG Xueqing. 222 Adverse Reaction Reports of Factor Xa Inhibitors[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1024-1028.

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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20250163

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I9/1024

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