Safety of eribulin: A real-world study based on a pharmacovigilance database
- 1The Second Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China
- 2The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China
- 3Hunan Academy of Chinese Medicine, Changsha, Hunan, China
Abstract
Eribulin is used to treat metastatic breast cancer, but its adverse event (AE) profile requires comprehensive analysis using FDA Adverse Event Reporting System (FAERS) data to guide clinical use. We analyzed eribulin-related AE reports in FAERS (Q1 2011 - Q2 2024). Disproportionality analyses (ROR, PRR, MGPS, BCPNN) identified significant AE signals. Our study finalized 3570 AE reports with eribulin as the primary suspect drug from the FAERS database, including 7455 coded AE records. The included patients were predominantly female (90.1%) and aged 35–59 years (42.61%). Eribulin-associated AEs spanned 26 organ systems. Only “Blood and lymphatic system disorders” (n = 1,788) met significance across all four algorithms. At the preferred term level, 95 positive disproportionality signals emerged. Common expected AEs included neutropenia, febrile neutropenia, and leukopenia. Critically, serious unexpected AEs not consistently referenced in drug inserts were identified, such as pleural effusion, respiratory failure, and cardiac failure. Clinical use of eribulin requires great attention to blood and lymphatic adverse events, as well as enhanced monitoring and reporting of adverse events not mentioned in the insert to prevent serious AEs.
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BibTeX
@article{zhou2026safety,
title = {{Safety of eribulin: A real-world study based on a pharmacovigilance database}},
author = {Yao Zhou and Jie Gong and Lele Shen and Jie Ling and Shiting Wu and Anqi Ge and Lin Qi and Lifang Liu},
journal = {PLOS One},
year = {2026},
month = sep,
doi = {10.1371/journal.pone.0356800},
url = {https://doi.org/10.1371/journal.pone.0356800},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Safety of eribulin: A real-world study based on a pharmacovigilance database
AU - Yao Zhou
AU - Jie Gong
AU - Lele Shen
AU - Jie Ling
AU - Shiting Wu
AU - Anqi Ge
AU - Lin Qi
AU - Lifang Liu
PY - 2026
DA - 2026/09/17
JO - PLOS One
DO - 10.1371/journal.pone.0356800
UR - https://doi.org/10.1371/journal.pone.0356800
AB - Eribulin is used to treat metastatic breast cancer, but its adverse event (AE) profile requires comprehensive analysis using FDA Adverse Event Reporting System (FAERS) data to guide clinical use. We analyzed eribulin-related AE reports in FAERS (Q1 2011 - Q2 2024). Disproportionality analyses (ROR, PRR, MGPS, BCPNN) identified significant AE signals. Our study finalized 3570 AE reports with eribulin as the primary suspect drug from the FAERS database, including 7455 coded AE records. The included patients were predominantly female (90.1%) and aged 35–59 years (42.61%). Eribulin-associated AEs spanned 26 organ systems. Only “Blood and lymphatic system disorders” (n = 1,788) met significance across all four algorithms. At the preferred term level, 95 positive disproportionality signals emerged. Common expected AEs included neutropenia, febrile neutropenia, and leukopenia. Critically, serious unexpected AEs not consistently referenced in drug inserts were identified, such as pleural effusion, respiratory failure, and cardiac failure. Clinical use of eribulin requires great attention to blood and lymphatic adverse events, as well as enhanced monitoring and reporting of adverse events not mentioned in the insert to prevent serious AEs.
SN - 1932-6203
ER -