ArticleFrontiers in pharmacology2024
Suspected adverse drug reactions of rivaroxaban reported in the United States food and drug administration adverse event reporting system database: a pharmacovigilance study.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Safety profile of ipilimumab in elderly patients: a disproportionate analysis based on the FDA Adverse Event Reporting System database.Frontiers in oncology · 2026Article
- Signal Detection and Pharmacovigilance Analysis of Tamoxifen, Clomiphene, and Letrozole in Polycystic Ovarian Syndrome: A FAERS Database Study.International journal of women's health · 2026Article
- Safety profiles of cyclosporine and tacrolimus in pregnancy: a pharmacovigilance analysis using the FDA Adverse Event Reporting System.Frontiers in medicine · 2026Article
- Signal mining for non-bleeding adverse event in novel oral anticoagulants: a pharmacovigilance study based on FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- A real-world safety evaluation of new oral anticoagulants in elderly patients: evidence from the Adverse Drug Reaction Monitoring Center of Henan Province.Journal of pharmaceutical policy and practice · 2025Article
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Authors and funding
11 authors.
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Abstract
Purpose: This study aimed to characterize the safety profiles of rivaroxaban-associated suspected adverse events by mining the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: A disproportionality analysis of spontaneously reported suspected adverse drug reactions (ADRs) was conducted. The reports in FAERS from 2014 to 2024 were compiled. Frequentist and Bayesian statistics were both applied to calculate drug-AE combinations in system organ classes and preferred-term levels. Reporting odds ratio (ROR), proportional reporting ratio (PRR), the Medicines and Healthcare products Regulatory Agency (MHRA), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) methods were analyzed and used to compare the suspected AEs. Results: Of 77,384 ADR reports, 66,705 (86.20%) were serious rivaroxaban AE reports. The most common age group was above 65 years. The suspected adverse effects of rivaroxaban emerging for system organ classes (SOCs) primarily included "Gastrointestinal disorders"; "Injury, poisoning, and procedural complications", "Nervous system disorders" and "Vascular disorders". Ranked by EBGM, the top signal strength of suspected AE signals of rivaroxaban under ROR algorithm at the preferred-term (PT) level were "Haemorrhagic arteriovenous malformation" ( Conclusion: Rivaroxaban has risks of various suspected adverse reactions while providing therapeutic effects and being used widely. Our pharmacovigilance study may provide valuable hints that practitioners should closely monitor occurrences of "Gastrointestinal disorders", "Injury, poisoning, and procedural complications" and "Nervous system disorders", and other events in clinical applications. Consequently, it remains to persist in monitoring rivaroxaban, assessing the associated risks in the future.
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