Frontiers in immunology
Haematological toxicity associated with antineoplastic drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database
By Xu X and Ma L.
Abstract
Background
Antineoplastic drugs are effective for malignant tumours, but they frequently cause severe adverse drug reactions (ADRs), which seriously affect treatment continuity and patient prognosis. Post - marketing real - world safety monitoring is therefore critical.
Methods
We conducted a retrospective pharmacovigilance study using FAERS (FDA Adverse Event Reporting System) data covering the period from 2004 Q1 to 2025 Q4. Safety signals were detected via disproportionate analysis, and associations were identified through LASSO and multivariable logistic regression, followed by an analysis of time to onset (TTO) for haematotoxicity.
