Chinese Journal of Pharmacovigilance ›› 2021, Vol. 18 ›› Issue (8): 780-783.
DOI: 10.19803/j.1672-8629.2021.08.18

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Comparison Analysis of Adverse Drug Reactions of Rivaroxaban and Apixaban Based on OpenFDA

LING Tao1,2, XU Ruijuan1, GE Weihong1,*   

  1. 1Department of Pharmacy, Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing Jiangsu 210008, China;
    2School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 210009, China
  • Received:2019-12-30 Online:2021-08-15 Published:2021-08-17

Abstract: Objective To search for reports of adverse reactions caused by oral anticoagulant drugs-rivaroxaban and apixaban by using openFDA, and compare the adverse reactions of the two drugs in order to provide reference for clinical rational drug use. Methods Reports of adverse reactions caused by rivaroxaban and apixaban that were submitted between January 1, 2004 and August 12, 2019 to the openFDA database were searched for using the interactive chart section access API for Adverse Drug Reaction Endpoints. Relevant data and charts were retrieved and analyzed. Results There were 6 676 and 10 513 ADR reports of rivaroxaban and apixaban respectively, which were mostly reported by doctors. The adverse reactions occurred in the United States, and the affected population ranged from 65 to 82 years old. Rivaroxaban and apixaban could be used for the prevention and treatment of deep vein thrombosis and pulmonary embolism, but the main adverse reaction was bleeding. Conclusion Based on the openFDA large databases, the ADR related information of the two drugs can be analyzed, which provides data for effective drug monitoring and immediate treatment of adverse reactions, but the data has some flaws and needs to be improved.

Key words: rivaroxaban, apixaban, openFDA, adverse drug reactions

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