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. 2025 Jul 28:15:1618267.
doi: 10.3389/fonc.2025.1618267. eCollection 2025.

Disproportionality analysis of adverse events associated with pacritinib: a real-world study based on FDA Adverse Event Reporting System (FAERS) database

Huiling Zhang  1 , Yaping Huang  2 , Chengjie Ke  3   4 , Maohua Chen  5
Affiliations

Disproportionality analysis of adverse events associated with pacritinib: a real-world study based on FDA Adverse Event Reporting System (FAERS) database

Huiling Zhang et al. Front Oncol. .

Abstract

Introduction: 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.

Methods: 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.

Results: 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 diarrhea, fatigue, death, nausea, platelet count decreased, and hemoglobin decreased. Notably, 26 off--label AEs were also identified.

Discussion: Our study would provide valuable insights for the post-marketing safety surveillance and assessment of pacritinib, and guide its clinical practice.

Keywords: FAERS; adverse event; disproportionality analysis; pacritinib; real-world study.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The flowchart of the data analysis.
Figure 2
Figure 2
Time to onset of pacritinib-related AEs.
See this image and copyright information in PMC

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