Rivaroxaban: comparative analysis of information on adverse reactions from Russian and international databases

Abstract

Information about rivaroxaban adverse reactions (ADRs) submitted to the national spontaneous reporting database from 1 January 2008 to 31 March 2016 was analyzed and compared with the international database (VigiBase) for the same time period. The marked increase in reporting ADRs after rivaroxaban treatment was detected in the Russian database. The comparison of the two databases showed that the relative ratio of ADRs from organs and body systems did not differ significantly except for ADRs of the cardiovascular system that predominated according to the Russian database. Moreover, the Russian database contained much fewer reports of hemorrhagic complications than the international database.