Dasatinib-Associated Chylothorax: A Scoping Review and Pharmacovigilance Analysis
Abstract
Background: Dasatinib, a second-generation tyrosine kinase inhibitor widely used for chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph + ALL), has been reported in association with rare cases of chylothorax.
Objective: To systematically summarize published case reports and complement these findings with pharmacovigilance data in order to characterize the clinical presentation, management, and outcomes of dasatinib-associated chylothorax.
Methods: A scoping review was conducted in accordance with PRISMA 2020 recommendations. PubMed/MEDLINE and an institutional discovery platform were searched for case reports and case series published up to February 13, 2026. Eligible reports included patients developing chylothorax during dasatinib therapy. In parallel, data from the FDA Adverse Event Reporting System (FAERS) were analyzed through September 30, 2024. Descriptive analyses were performed. FAERS data were interpreted as hypothesis-generating only.
Results: Forty-two publications describing 44 patients met the inclusion criteria. Patients ranged from 5 to 90 years of age, with a slight male predominance. Time from dasatinib initiation to chylothorax onset varied from 2 months to 10 years. Management most commonly involved drug discontinuation and thoracentesis, frequently followed by clinical resolution. FAERS analysis identified 104 unique reports of chylothorax associated with dasatinib, all classified as serious adverse…
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