Signal detection and comparative risk assessment of bleeding adverse events associated with enoxaparin and dalteparin based on the FAERS database

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Author:  WU Jin ¹ LOU Yiyun ¹ LI Haoying ¹

Affiliation: 1.Department of TCM Gynecology, Hangzhou Chinese Medicine Hospital, Hangzhou 310000, China

Keywords: Enoxaparin Dalteparin Low-molecular-weight heparin Bleeding Pharmacovigilance FAERS Signal detection

DOI: 10.12173/j.issn.1005-0698.202607063

Reference: WU Jin, LOU Yiyun, LI Haoying. Signal detection and comparative risk assessment of bleeding adverse events associated with enoxaparin and dalteparin based on the FAERS database[J]. Chinese Journal of Pharmacoepidemiology, 2026, 35(10): 1128-1135.[Article in Chinese]  Copied

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Abstract

Objective To analyze the reporting characteristics and potential risk differences of bleeding events associated with enoxaparin and dalteparin in the US Food and Drug Administration Adverse Event Reporting System (FAERS), thereby providing evidence for individualized anticoagulant therapy and safety monitoring.

Methods Reports submitted to FAERS from the first quarter of 2004 through the first quarter of 2026 in which enoxaparin or dalteparin was designated as the primary suspect drug were retrieved. Adverse drug events (ADEs) were coded using the Medical Dictionary for Regulatory Activities, version 29.0. Safety signals were detected using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker methods. The two drugs were directly compared using the comparative reporting odds ratio, and the time to onset of bleeding events was also analyzed.

Results A total of 19,186 and 2,998 ADE reports were identified for enoxaparin and dalteparin, respectively, yielding 106 and 52 robust positive signals of bleeding preferred terms. Enoxaparin showed higher relative reporting proportions for unspecified or systemic bleeding, gastrointestinal or intra-abdominal bleeding, skin, soft tissue and muscle bleeding, and bleeding at administration or puncture sites. In contrast, dalteparin showed a higher relative reporting proportion for central nervous system bleeding. The median time to onset of bleeding ADEs was 7 days for enoxaparin and 8 days for dalteparin, and both showed an early-onset pattern.

Conclusion Multiple bleeding-related safety signals were identified for both enoxaparin and dalteparin, although the specific bleeding sites, reporting frequencies, and signal strengths may differ between the two drugs. Individualized risk assessment should consider patient age, renal function, body weight, underlying diseases, recent surgery or invasive procedures, and concomitant antithrombotic therapy. Particular attention should be paid to serious organ bleeding and bleeding events occurring early after treatment initiation.

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