Unveiling the Hidden Risks: An Update Decade-Long Analysis of Abraxane-Related Adverse Events from the FAERS Database

Sep 22, 2026

Abraxane (nanoparticle albumin-bound paclitaxel) is widely used for multiple cancers yet is associated with adverse events requiring close monitoring. This study evaluates the adverse-event profile using FDA Adverse Event Reporting System (FAERS) data from January 2004 to December 2023. Reporting odds ratios and proportional reporting ratios were calculated to assess associations. Results identified 10,310 Abraxane-related reports with frequent hematologic, hepatobiliary, infectious, and gastrointestinal disorders, including serious outcomes such as hospitalization and death. The analysis confirms known reactions and detects additional signals, supporting robust post-marketing surveillance and ongoing investigation.

LanguageEnglish

CategoryHealthcare

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Pages12

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Patients and Methods

Results

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Introduction

International Journal of Nanomedicine Dovepress Open Access Full Text Article ORIGINAL RESEARCH Unveiling the Hidden Risks: An Update Decade-Long Analysis of Abraxane-Related Adverse Events from the FAERS Database Yue-Chen Zhao 1 , 2 , Xin Li 3 , Chao-Qun Wang4 , Yan Jiao 5 , Yan-Nan Shen2 , Tie-Jun Wang 1 , 2 , *, Chao-He Zhang 6 , * 1Department of Radiation Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People’s Republic of China; 2NHC Key Laboratory of Radiobiology, School of Public Health, Jilin University, Changchun, Jilin, People’s Republic of China; 3Department of Radiology, The Second Hospital of Jilin University, Changchun, Jilin, People’s Republic of China; 4Department of Gynaecology, Aviation General Hospital, Beijing, People’s Republic of China; 5Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, First Hospital of Jilin University, Changchun, People’s Republic of China; 6Department of Hematology and Oncology, The Second Hospital of Jilin University, Changchun, Jilin, People’s Republic of China *These authors contributed equally to this work Correspondence: Tie-Jun Wang, Department of Radiation Oncology, The Second Hospital of Jilin University, NO. 218 Ziqiang Street, Changchun, 130041, People’s Republic of China, Email [tjwang@jlu.edu.cn](tjwang@jlu.edu.cn); Chao-He Zhang, Department of Hematology and Oncology, The Second Hospital of Jilin University, NO. 218 Ziqiang Street, Changchun, 130041, People’s Republic of China, Email [zhangchaohe@jlu.edu.cn](zhangchaohe@jlu.edu.cn) | Purpose: Abraxane (nanoparticle albumin-bound paclitaxel) is a chemotherapeutic employed commonly for the management of various cancers including breast cancer, non-small cell lung cancer, and pancreatic adenocarcinoma. Although it has clinically beneficial properties, Abraxane is accompanied by multiple adverse events (AEs) that require close observation. This study aims to evaluate the AE profile of Abraxane using recently available data from January 2004 through December 2023 in the FDA Adverse Event Reporting System (FAERS) .
Patients and Methods: The data for Abraxane-related AEs were obtained from the FAERS database. The dataset consisted of patient demographic characteristics as well as information on the types and outcomes of AEs reported. Reporting odds ratios (ROR) as well as proportional reporting ratio (PRR), considering the used definition of anti-cancer agent and AEs, were calculated to investigate any association with Abraxane.
Results: A total of 10,310 reports associated with Abraxane AEs were identified. Blood and lymphatic system disorders were the most frequent (ROR 6.44), followed by hepatobiliary (ROR 3.16), infections (ROR 1.45), and gastrointestinal disorders (ROR 1.42) . Serious outcomes included hospitalization in 36.35% and death in 29.76% of cases. The top adverse reactions matched known profiles, including peripheral sensory neuropathy (ROR: 49.48) . The analysis also found new adverse reactions, such as scleroderma-like
reactions (ROR: 95.4) and vascular pseudoaneurysm ruptures (ROR: 87.71) .
Conclusion: Our results re-emphasize the importance of a robust Post Marketing Surveillance system and suggest this FAERS database based analysis provides an updated, independent information on Abraxane related AEs to enrich its safety profile. A process of continuous vigilance and additional investigations on specific areas that may have some undesired events are imperative to increase our knowledge on how Abraxane should be handled in terms of its safety.
Keywords: Abraxane, FAERS database, adverse events, signal detection, pharmacovigilance | | --- | | Introduction
In recent years, with the rapid development of nanomedicine, several nanomedicine-based drugs have been approved for clinical use, significantly advancing the field of oncology by enhancing drug delivery and reducing side effects.1 ,2 Nanomedicine represents a breakthrough in cance

FAQs

What was the purpose of this FAERS-based study on Abraxane?

To evaluate Abraxane’s adverse event profile using recently available FAERS data and quantify associations through disproportionality analyses.

How were Abraxane-related adverse events analyzed in this study?

Adverse-event reports were retrieved from the FAERS database, and patient demographics plus adverse-event types and outcomes were used to calculate reporting odds ratios (ROR) and proportional reporting ratios (PRR).

What did the study find about known and new adverse reaction signals?

It matched several known adverse reaction patterns and also identified additional signals, including scleroderma-like reactions and vascular pseudoaneurysm ruptures, alongside major serious outcomes such as hospitalization and death.

Sep 22, 2026

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