Side effects and interactions with the use of rivaroxaban: Global pharmacovigilance data

This study aimed to review literature data on the side effects and interactions when using rivaroxaban according to global pharmacovigilance data as of March 23, 2022. The data obtained are based on the VigiLyze expert-level analytical system and the use of the international VigiBase database of the WHO International Drug Monitoring Program.

Data processing and storage were performed using Microsoft Excel. The authors provided a consolidated expert opinion based on professional experience in clinical and scientific work. The received data contained 112,654 individual case safety reports (ICSR) about cases of adverse reactions to drugs, particularly rivaroxaban. When processing the ICSR database, duplicates and reports containing incomplete information that were not comparable with the Medical Dictionary for Regulatory Activities were excluded.

After processing, 32,779 ICSRs were extracted according to the criteria, which accounted for 29.1% of the total number of all ICSRs. Basic data on ICSR were recorded from the USA, Germany, France, Great Britain, and Japan. Most often, adverse reactions were observed in patients aged >75 years (31.9%), followed by patients aged 65–74 (20.0%) and 45–64 (15.3%). By age, more adverse reactions were observed in male (46.0%) patients. Countries that have developed pharmacomonitoring system contributed significantly to the development of the ICSR of the adverse reactions of rivaroxaban, namely, USA (n=62,992; 55.3%), Germany (n=9912; 8.8%), France (n=6983; 6.2%), Great Britain (n=5632; 5.0%), and Japan (n=5294; 4.7%). Adverse reactions were reported by 57.8% of ICSRs from medical and pharmaceutical professionals, including doctors, pharmacists, pharmacists, and other healthcare professionals. Adverse reactions with rivaroxaban include hospitalizations or its prolongation (47.8%), deaths (12.4%), and gastrointestinal bleeding (14.1%). Serious adverse reactions were observed in 99.4% of the cases. Drugs that were used in parallel or were not discontinued during the prescription of rivaroxaban were acetylsalicylic acid, clopidogrel, warfarin, and enoxaparin sodium. The risks of side effects increase when rivaroxaban is combined with other drugs, which must be taken into account when writing prescriptions.