What does this research mean for the field?

Apixaban and edoxaban are associated with significantly higher reporting risks for gastrointestinal hemorrhage compared to dabigatran, with RORs of 2.32 and 2.95, respectively. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This analysis investigates the sex-specific safety profiles of direct oral anticoagulants (DOACs).

February 12, 2026Open Access

Thrombotic and Hemorrhagic Adverse Events of Direct Oral Anticoagulants: An Analysis of Sex-Related Differences Using Food and Drug Administration Adverse Event Reporting System

Key Result

Direct oral anticoagulants exhibit significant sex-specific differences in thrombotic and hemorrhagic adverse events, impacting safety profiles.

Key Points

This analysis investigates the sex-specific safety profiles of direct oral anticoagulants (DOACs).
Utilized the Food and Drug Administration adverse event reporting system data.
Conducted a comparison of adverse events between sexes.
Analyzed thrombotic and hemorrhagic incidents specifically.
Identified significant differences in adverse event rates between sexes.
Highlighted specific thrombotic and hemorrhagic risks for each sex.

Structured PICO

Do Factor Xa inhibitors (rivaroxaban, apixaban, edoxaban) have different sex-specific reporting rates for thrombotic and hemorrhagic adverse events compared to dabigatran?

Population

148,490 adverse event reports from the FDA Adverse Event Reporting System (FAERS) where a single DOAC (dabigatran, rivaroxaban, apixaban, edoxaban) was the primary suspect, submitted by a healthcare professional, from each drug's approval date through 2024.

Intervention

Factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)

Comparator

Dabigatran (Factor IIa inhibitor)

Outcome

Reporting odds ratios (RORs) for six major adverse events: gastrointestinal hemorrhage, intracerebral hemorrhage, pulmonary embolism, deep vein thrombosis, ischemic stroke, and myocardial infarctionsafety

Significant sex-specific differences exist in the reporting of DOAC-related hemorrhagic and thrombotic adverse events, highlighting the need for individualized anticoagulant selection.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Significant sex-specific differences exist in DOAC safety profiles. Recognizing these patterns may inform individualized anticoagulant selection and enhance pharmacovigilance-driven personalized medicine.

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Cite This Study

Şahinbaş et al. (Thu,) reported a other. Direct oral anticoagulants exhibit significant sex-specific differences in thrombotic and hemorrhagic adverse events, impacting safety profiles.

synapsesocial.com/papers/698d6dc15be6419ac0d52f07 https://doi.org/https://doi.org/10.14744/anatoljcardiol.2025.5827

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