Analysis of adverse drug events of everolimus based on US FAERS database

doi:10.12092/j.issn.1009-2501.2018.05.011

Abstract

Abstract:

AIM: To reveal the rules of adverse events of everolimus and provide references for the risk control and rational clinical use of the drug by statistical analysis of adverse drug events of everolimus based on US FAERS database. METHODS: A retrospective and statistical analysis of 1 868 cases of adverse events of everolimus from FAERS database was conducted. RESULTS: Among 1 868 cases of everolimus adverse event reports, death, life danger, disability, hospitalization or duration of hospitalization amounted to 67.71%; nearly half of the reports of adverse events were from consumers, and USA, Japan, France, Germany were the most reported country; the top three clinical reported adverse events were death (382 cases, 20.45%); stomatitis (168 cases, 8.99%); malignant tumor progression (154 cases, 8.24%). CONCLUSION: The adverse reactions of everolimus is relatively serious, so close attention is required to the process of clinical use; and the number of reports of adverse events is associated with the economic level of the submitted country.

Key words: everolimus, adverse drug reaction, FAERS database, pharmacovigilance

CLC Number:

R969

LU Qing，ZENG Qingzhang, ZHOU Yaping, YU Peiming, LI Haona. Analysis of adverse drug events of everolimus based on US FAERS database[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2018, 23(5): 547-551.

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