Evidence map›Paper›PMID 41938683›Full record

ArticleDrug, healthcare and patient safety2026

Trend of Reported Bleeding in Warfarin Compared with Direct Oral Anticoagulants in Japan.

Akina Takami, Gen Terashima, Takumi Tajima, Koki Yamashita, Ataru Igarashi

Abstract read
In one paragraph

Article in Drug, healthcare and patient safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

5 authors.

Akina TakamiDepartment of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, the University of Tokyo, Tokyo, Japan.
Gen TerashimaJMDC, Inc., Tokyo, Japan.
Takumi TajimaJMDC, Inc., Tokyo, Japan.ORCID 0009-0007-9633-5831
Koki YamashitaMaxwell International, Inc., Chiba, Japan.
Ataru IgarashiDepartment of Health Policy and Public Health, Graduate School of Pharmaceutical Sciences, the University of Tokyo, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Evidence on bleeding events associated with oral anticoagulants in real-world settings is limited. Thus, we compared the incidence rate of oral anticoagulant-associated bleeding between warfarin and direct oral anticoagulants (DOACs). Methods: This is a retrospective observational study using the Japanese Adverse Drug Event Report Database (JADER) and the nationwide health insurance claims database. We investigated the number of case reports with "bleeding" or "hemorrhage" using the JADER. The drugs of interest included warfarin, dabigatran, edoxaban, rivaroxaban, or apixaban. Main outcome measures included the number of case reports of bleeding and the estimated annual incidence rate of oral anticoagulant-associated bleeding using the Japanese Adverse Drug Event Report (JADER) and the nationwide estimated number of patients with prescriptions. Results: In JADER, we found 16,125 oral anticoagulant-associated bleeding in 15,970 case reports of patients between April 1, 2004, and March 31, 2024. The most common suspected oral anticoagulant administered to patients was apixaban (33.4%), followed by rivaroxaban (26.0%), warfarin (16.6%), edoxaban (13.3%), and dabigatran (10.7%). The incidence rates of anticoagulant-associated bleeding in patients who were prescribed dabigatran, edoxaban, rivaroxaban, and apixaban were higher compared to those in patients who were prescribed warfarin. The estimated annual incidence rate was remarkably high in patients who received apixaban, reaching 1976.90 per 1,000,000 patients. Conclusion: Compared with warfarin, the incidence rates of oral anticoagulant-associated bleeding were higher with dabigatran, edoxaban, rivaroxaban, or apixaban. In a real-world setting in Japan, the risk of oral anticoagulant-associated bleeding appears to be higher with DOACs than with warfarin.

Indexed as

bleedingdirect oral anticoagulants (DOACs)drug safetyJapanese adverse drug event report (JADER)oral anticoagulants

Identifiers

PMID41938683
PMCPMC13049600

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