Data Mining for Adverse Events of Macrolide Antibiotics in Children Based on the FAERS Database
10.3870/j.issn.1004-0781.2025.04.013
- VernacularTitle:基于FAERS数据库对儿童用大环内酯类抗生素的不良事件信号挖掘
- Author:
Wenxue WANG
1
;
Li TANG
;
Lan LIU
Author Information
1. 华中科技大学同济医学院附属武汉儿童医院(武汉市妇幼保健院)药剂科,武汉 430015
- Publication Type:Journal Article
- Keywords:
Macrolide antibiotics;
Children;
Real world;
FDA Adverse Event Reporting System;
Signal mining
- From:
Herald of Medicine
2025;44(4):576-583
- CountryChina
- Language:Chinese
-
Abstract:
Objective To analyze signals of adverse events(AEs)related to macrolide antibiotic in children from the US FDA Adverse Event Reporting System(FAERS),and provide a reference for clinical safe medication in children.Methods The AEs reports of children(less than 18 years old)were extracted from FAERS during January 2004 to March 2024,and the reports of odds ratio(ROR)and information component of Bayesian confidence propagation neural network(IC)were used to analyze the signals of macrolide antibiotics in children.Results There were 2 133 648 reports of children from FAERS,including azithromycin(7 589 cases),clarithromycin(3 673 cases),and erythromycin(820 cases).The significant signals of system organ class(SOC)were 16 in total,such as skin disorders,ear and labyrinth disorders,gastrointestinal disorders,nervous system,immune system disorders,etc.A proportional imbalance analysis was performed on macrolide antibiotics(azithromycin and clarithromycin),and obtained relevant positive signals,including azithromycin(232)and clarithromycin(194).The most frequently reported AEs included rash,vomiting,diarrhea,hypersensitivity and so on.The strongest signals of azithromycin were Stevens-Johnson syndrome(SJS),hypersensitivity reactions,drug-induced liver injury,etc.,while the strongest signals of clarithromycin were dysgeusia,lip swelling,toxic epidermal necrolysis(TEN),nightmare,psychotic disorder,etc.17 unlisted signals of azithromycin and 21 of clarithromycin were found.The same PT of azithromycin and clarithromycin had significant difference,such as dyspnea,hypersensitivity,rash,SJS,vomiting,and more.Conclusions To ensure the safety of children's treatment,children using macrolide should pay attention to skin,gastrointestinal,ear and other toxicity and hypersensitivity reactions,especially serious skin reactions,unlisted suspicious AEs and psychiatric disorders.
