ArticleInternational journal of medical sciences2019
Adverse reaction profiles of hemorrhagic adverse reactions caused by direct oral anticoagulants analyzed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database.
Article in International journal of medical sciences, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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Who cites it
22 citing papers in PubMed, 45 citations in OpenAlex.
- Agent-specific bleeding signatures in non-hypertensive versus hypertensive patients exposed to oral anticoagulants: a real-world pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- 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
- Trend of Reported Bleeding in Warfarin Compared with Direct Oral Anticoagulants in Japan.Drug, healthcare and patient safety · 2026Article
- Real-world assessment of sparsentan's drug safety framework.Renal failure · 2025Article
- Vitamin K Antagonists (VKAs) and Novel Oral Anticoagulants (NOACs) Safety Comparison Based on Data from EudraVigilance Database.Hematology reports · 2025Article
- Toxicity profiles of cyclin-dependent kinase 4/6 inhibitors: safety analysis from clinical trials and the FDA adverse event reporting system.Frontiers in oncology · 2025Article
- Characteristics of Gastrointestinal Bleeding While Taking Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Differences Among Drugs-A Single-Center Retrospective Cohort Study.Journal of clinical medicine · 2024Article
- Evaluation of tolvaptan-associated hepatic disorder using different national pharmacovigilance databases.Scientific reports · 2024Article
- Exploring Novel Adverse Events of Nefecon.Kidney international reports · 2024Article
- Polypharmacy and Elevated Risk of Severe Adverse Events in Older Adults Based on the Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database.Journal of Korean medical science · 2024Article
- Article
- Risk Factors for Anticancer Drug-Induced Hyponatremia: An Analysis Using the Japanese Adverse Drug Report (JADER) Database.Medicina (Kaunas, Lithuania) · 2023Article
- Gastrointestinal bleeding during anticoagulation with direct oral anticoagulants compared to vitamin K antagonists.Global cardiology science & practice · 2022Article
- Article
- Adverse event profiles of microscopic colitis in the Japanese Adverse Drug Event Report (JADER) database.Scientific reports · 2022Article
- Adverse Reaction Profiles Related to Gastrointestinal Bleeding Events Associated with BCR-ABL Tyrosine Kinase Inhibitors.Medicina (Kaunas, Lithuania) · 2022Article
- Omeprazole Suppresses Oxaliplatin-Induced Peripheral Neuropathy in a Rodent Model and Clinical Database.International journal of molecular sciences · 2022Article
- Preventive effect of rebamipide on NSAID-induced lower gastrointestinal tract injury using FAERS and JADER.Scientific reports · 2022Article
- Hepatotoxicity reports in the FDA adverse event reporting system database: A comparison of drugs that cause injuryActa pharmaceutica Sinica. B · 2021Article
- Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.International journal of clinical pharmacy · 2021Article
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Authors and funding
12 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Direct oral anticoagulants (DOACs) are used in anticoagulant therapy. The purpose of this study was to evaluate the association of DOAC-induced gastrointestinal (GI) and nervous system hemorrhage using the FDA's Adverse Event Reporting System (FAERS) database and the Japanese Adverse Drug Event Report (JADER) database. We identified and analyzed the reports of hemorrhagic reactions between 2004 and 2016 from the FAERS and JADER databases, and calculated the adjusted reported odds ratio (ROR) using the multiple logistic regression method. Additionally, we used the time-to-onset analysis. In the FAERS database, the adjusted ROR of apixaban, rivaroxaban, and dabigatran for GI hemorrhage was 6.79 (5.84-7.91), 19.58 (18.85-20.34), and 14.51 (13.58-15.51), respectively. In the JADER database, the adjusted ROR of apixaban, rivaroxaban, edoxaban, and dabigatran for GI hemorrhage was 11.80 (9.50-14.64), 11.03 (9.18-13.26), 10.17 (6.95-14.88), and 9.85 (7.23-13.42), respectively. We found that the association of GI hemorrhage with DOACs was affected by sex (female). Additionally, 30% of GI hemorrhage was observed after 30 days. Hemorrhagic reactions of both GI and nervous systems were observed in both the spontaneous reporting system databases. We recommend that female patients who experience symptoms related to GI hemorrhage should be closely monitored and advised to adhere to an appropriate care plan. Additionally, our results show that patients should be closely monitored for hemorrhage even after a month.
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