Drug-induced neutropenia: A comprehensive pharmacovigilance study of the FAERS database.

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Reporting odds ratios varied by drug (specific values not provided in abstract)

• Primary Outcome: 254 drugs identified as potentially associated with neutropenia

• Nnt Or Sensitivity: Top signal drugs: calcium levofolinate, vinorelbine, gemtuzumab ozogamicin, fludarabine, daunorubicin

• Confidence Interval: Not reported in abstract

Clinical Application

Results can inform clinical monitoring protocols and prescribing decisions Relevant to Australian practice as most identified drugs are PBS-listed; findings support TGA pharmacovigilance and RACGP prescribing guidelines for neutropenia monitoring Patients receiving medications identified in the study, particularly oncology and immunosuppressed patients

Abstract

Drug-induced neutropenia (DIN) deserves both clinicians' and researchers' attention for the serious clinical consequences. This study aimed to conduct an exploratory analysis of DIN reports in the United States Food and Drug Administration Adverse Event Reporting System database to identify drugs associated with neutropenia. A disproportionality analysis of DIN was conducted using reports submitted to the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2004 to the fourth quarter of 2024. Both the reporting odds ratio algorithms and the information component were applied to identify an association between target drugs and DIN events. A total of 223,736 DIN cases were found, and 254 drugs were identified as potentially associated with neutropenia. The top-ranked drug categories were "monoclonal antibodies and antibody-drug conjugates," "other antineoplastic agents," "protein kinase inhibitors," "direct-acting antivirals," "antimetabolites," "alkylating agents," and "immunosuppressants." The top 5 drugs ranked by number of cases were clozapine, lenalidomide, rituximab, palbociclib, and carboplatin. The top 5 drugs ranked by reporting odds ratio signal strength were calcium levofolinate, vinorelbine, gemtuzumab ozogamicin, fludarabine, and daunorubicin. This comprehensive pharmacovigilance study identified drugs potentially associated with neutropenia, which can help clinicians and researchers further understand DIN.

References

1. 1.Li, J., Wang, Y., Gao, L., Jia, J., Liu, J., & Jiang, Z. (2026). Drug-induced neutropenia: A comprehensive pharmacovigilance study of the FAERS database. Medicine, 105(16), e48434. https://doi.org/10.1097/MD.0000000000048434