What does this research mean for the field?

Fondaparinux is associated with significant adverse events, particularly in vascular and blood systems, with heightened risks noted in elderly females and during the first month of use. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

This analysis aims to assess the safety profile of fondaparinux through adverse event reports.

February 12, 2026PLoS ONE0 citationsOpen Access

Disproportionality analysis of fondaparinux associated adverse events based on the FDA adverse event reporting system

FKFengjiao KangUniversity of Electronic Science and Technology of China YWYin WangUniversity of Electronic Science and Technology of China FCFengqun CaiUniversity of Electronic Science and Technology of China

Key Result

Fondaparinux is associated with strong adverse event signals like abnormal coagulation factor X, thrombosis with thrombocytopenia, and hematoma, especially in elderly females within the first month.

Key Points

This analysis aims to assess the safety profile of fondaparinux through adverse event reports.
Utilized FDA Adverse Event Reporting System (FAERS) database for analysis
Examined data from Q1 2004 to Q3 2024
Applied Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), BCPNN, and EBGM methods
Analyzed reports related to fondaparinux and categorized adverse events by affected systems
Identified 5,788 reports related to fondaparinux with 17,523 adverse events
Most affected systems included vascular (2046 events) and blood/lymphatic (1125 events)
Abnormal coagulation factor X concentration and incision site hematoma showed the strongest signals
Adverse events were more frequent in females and elderly patients, especially within the first month
Additional signals included heparin-induced thrombocytopenia and eosinophilia.

Structured PICO

What are the adverse event profiles and safety signals associated with fondaparinux use in real-world practice?

Population

5,788 reports related to fondaparinux from the FDA Adverse Event Reporting System (FAERS) database (2004 Q1 to 2024 Q3)

Intervention

Fondaparinux

Outcome

Adverse events (AEs) reported in the FAERS databasesafety

Fondaparinux is associated with significant safety signals including thrombosis with thrombocytopenia syndrome and bleeding events, particularly in older adults and females within the first month of use.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Fondaparinux is a widely used anticoagulant for treating venous thromboembolism and acute coronary syndrome by inhibiting factor Xa. However, it carries a risk of bleeding. This study analyzes its safety using the FDA Adverse Event Reporting System (FAERS) database to guide clinical use and future research. Data from 2004 Q1 to 2024 Q3 were examined using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) methods. Among 21,483,491 reports, 5,788 were related to fondaparinux, with 17,523 adverse events (AEs). The most affected systems were vascular (n = 2046) and blood/lymphatic (n = 1125). Abnormal coagulation factor X concentration, thrombosis with thrombocytopenia syndrome, and incision site hematoma had the strongest signals. AEs were more frequent in females and elderly patients, especially within the first month. Additional Preferred Term (PT)–level signals defined in MedDRA were observed, including heparin induced thrombocytopenia and eosinophilia. Heightened pharmacovigilance particularly in older adults may be warranted. This study enhances understanding of fondaparinux’s safety, providing insights for reducing risks and ensuring safer clinical application.

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