ArticleTherapeutics and clinical risk management2018
Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010-2015.
Article in Therapeutics and clinical risk management, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Association between concomitant use of direct oral anticoagulants with antidepressants and an increased risk of hemorrhage: analysis of the food and drug administration adverse event reporting system database.Frontiers in medicine · 2026Article
- Real-World Safety Concerns of Tirzepatide: A Retrospective Analysis of FAERS Data (2022-2025).Healthcare (Basel, Switzerland) · 2025Article
- Suicidality Risks Associated with Finasteride, a 5-Alpha Reductase Inhibitor: An Evaluation of Real-World Data from the FDA Adverse Event Reports.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Diabetic Ketoacidosis and the Use of New Hypoglycemic Groups: Real-World Evidence Utilizing the Food and Drug Administration Adverse Event Reporting System.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System.Frontiers in medicine · 2025Article
- The use and safety risk of repurposed drugs for COVID-19 patients: lessons learned utilizing the Food and Drug Administration's Adverse Event Reporting System.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2023Article
- Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.International journal of clinical pharmacy · 2021Article
- Medication errors associated with direct-acting oral anticoagulants: analysis of data from national pharmacovigilance and local incidents reporting databases.Journal of pharmaceutical policy and practice · 2021Article
- Association between oral anticoagulants and osteoporosis: Real-world data mining using a multi-methodological approach.International journal of medical sciences · 2020Article
- A comparative analysis of the safety profile of direct oral anticoagulants using the FDA adverse event reporting system.European journal of haematology · 2019Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years.
methodsReports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases.
resultsA total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65-12.97) for dabigatran, 15.61 (95% CI 14.42-16.90) for warfarin, and 18.86 (95% CI 15.31-23.23) for rivaroxaban.
conclusionsThe signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.
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