CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 3: 250 - 250-256

DOI: https://doi.org/10.2095-3593.2026.050001

Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD

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  • 1.School of Pharmaceutical Science， Kunming Medical University， Yunnan Key Laboratory of Pharmacology
         for Natural Products， Yunnan Kunming 650500，China；
    2.Department of Pharmacy， Kunming Children′s Hospital， Yunnan Kunming 650228， China；
    3.Research Center of Clinical Pharmacology， Yunnan Provincial Hospital of Traditional Chinese Medicine，
         Yunnan Kunming 650000， China

Received date: 2026-01-21

  Revised date: 2026-03-15

  Accepted date: 2026-08-05

  Online published: 2026-08-12

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Abstract

Objective： To evaluate the safety profile of luspatercept and identify potential adverse reaction signals based on the FDA Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD)， providing evidence-based support for safe medication use. Methods： Adverse event（AE） reports for luspatercept were extracted from FAERS and CVARD. Reporting odds ratio (ROR) analysis and Bayesian confidence propagation neural network (BCPNN) were applied to process and analyze drug-related AE reports. Results： In FAERS， the most freqment AE of luspatercept are general disorders and administration site conditions. CVARD data showed SOCs as Surgical and medical procedures. In addition to labeled adverse reactions， such as bone pain and hypertension， novel signals including death and fractures were detected. Conclusion： In real-world use， luspatercept is associated with potential adverse drug reaction signals beyond its known safety profile， including fracture. Targeted monitoring should be strengthened in clinical practice to optimize risk management and ensure medication safety.

Key words： ; font-size:medium; "> ; Luspatercept； Drug adverse event； Signal mining； Reporting odds ratio； Real-world studies

Cite this article

CUN Shuhua, YANG Yanming, MA Xiaoling, CHEN Jiong, FAN Jincheng, WENG Zhiying . Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(3) : 250 -250-256 . DOI: 10.2095-3593.2026.050001

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