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ORIGINAL RESEARCH article

Front. Oncol.

Sec. Hematologic Malignancies

Volume 15 - 2025 | doi: 10.3389/fonc.2025.1618267

Disproportionality Analysis of Adverse Events Associated with Pacritinib: A Real-World Study Based on FDA Adverse Event Reporting System (FAERS) Database

Provisionally accepted
Huiling  ZhangHuiling Zhang1Yaping  HuangYaping Huang2Chengjie  KeChengjie Ke3Maohua  ChenMaohua Chen4*
  • 1First People's Hospital of Nanning, Nanning, Guangxi Zhuang Region, China
  • 2Fujian Provincial Hospital, Fuzhou, Fujian Province, China
  • 3First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian Province, China
  • 4Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China

The final, formatted version of the article will be published soon.

Pacritinib, a selective Janus kinase (JAK) inhibitor, is approved for the treatment of myelofibrosis in adults with severe thrombocytopenia. However, its safety profile in real-world populations remains unclear. The aim of study is provided a comprehensive profile of pacritinib's safety by evaluating the adverse events (AEs) using a real-world pharmacovigilance database. Data from the FDA Adverse Event Reporting System (FAERS) database, spanning from the first quarter of 2022 to the second quarter of 2024, served as the basis for this analysis. To identify potential AE risk signals, several disproportionality analysis methods were applied, including the reporting odds ratio, the proportional reporting ratio, the multi-item gamma Poisson shrinker, and the Bayesian confidence propagation neural network. A total of 4,304,335 AE reports were collected from the FAERS, with 1,940 reports identifying pacritinib as the primary suspect drug. Significant disproportionality was observed in the following system organ classes: gastrointestinal disorders, investigations, and surgical and medical procedures.Common preferred terms were identified, including diarrhoea, fatigue, death, nausea, platelet count decreased, and hemoglobin decreased.Notably, 26 off-label AEs were also identified. Our study would provide valuable insights for the post-marketing safety surveillance and assessment of pacritinib, and guide its clinical practice.

Keywords: Pacritinib, Adverse event, Disproportionality analysis, FAERS, Real-world study

Received: 25 Apr 2025; Accepted: 04 Jul 2025.

Copyright: © 2025 Zhang, Huang, Ke and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence: Maohua Chen, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China

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