ArticleFrontiers in medicine2026
Adverse event profile of fondaparinux sodium: a disproportionality analysis based on FAERS, JADER, and VigiAccess databases.
Article in Frontiers in medicine, 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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Abstract
Background: Fondaparinux sodium, a synthetic pentose sugar, selectively inhibits factor Xa and is mainly used to prevent venous thromboembolism during major lower extremity orthopedic surgeries. It is also utilized for treating unstable angina pectoris and non-ST-segment-elevation myocardial infarction (NSTEMI). Given its extensive clinical application, comprehensive evaluation of its safety profile in clinical practice is essential. Methods: This pharmacovigilance investigation systematically evaluated the post-marketing safety profile of fondaparinux sodium by leveraging real-world data from the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q3 2024), where fondaparinux sodium was the primary suspected drug. To further validate the robustness and generalizability of our findings, we cross-referenced the identified signals with data from two external sources: the VigiAccess database (Q2 2003 to Q4 2025) and the Japanese Adverse Drug Event Report (JADER) database (Q2 2007 to Q2 2025). Disproportionality analyses employed the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multiple empirical Bayes Gamma-Poisson shrinker (MGPS). Furthermore, sensitivity analyses were conducted to ensure the robustness of the results. Finally, the optimal parametric model was applied to estimate the temporal risk of adverse events (AEs). Results: In the FAERS database, we identified 5,700 fondaparinux sodium-related AE reports, corresponding to 17,061 unique Preferred Terms (PTs). Time-to-onset analysis ( Conclusion: This study serves as a hypothesis-generating inquiry into the real-world safety of fondaparinux sodium. While our findings align with established adverse reaction profiles, they also highlight potential novel signals that warrant further investigation. These insights provide valuable reference points for clinical monitoring, particularly in special populations, though further epidemiological studies are needed to verify causality.
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