ADEs of minocycline and high-risk factors in children aged 8-18 years based on data from FAERS
ZHANG Xusheng
WANG Xiaojun
WANG Li
REN Xiuli
SHEN Chengwu
LU Cuicui
Abstract：Objective To explore the adverse drug events(ADEs)of minocycline and high-risk factors in children aged 8 to 18 years based on the US Food and Drug Administration(FDA)adverse event reporting system(FAERS),and to provide reference for the safe use of minocycline in clinic.Methods Reports of minocycline as the"primary suspect-ed(PS)"ADE reports were retrieved from the FAERS from January 2004 to September 2023.High-risk factors for the oc-currence of minocycline ADEs were screened by utilizing both the reporting odds ratio(ROR)and the Medicines and Healthcare products Regulatory Agency(MHRA).Results that satisfied the a≥3,95%CI>1,PRR≥2,and χ2≥4 were identified as risk signals.ADEs were classified and analyzed by adopting the system organ class(SOC)and preferred term(PT)from the Medical Dictionary for Regulatory Activities(MedDRA).Results A total of 668 suspected cases of mino-cycline ADEs in children aged 8 to 18 were obtained,and 181 high-risk factors for minocycline ADEs were identified,in-volving 22 SOC,including neurological disorders,skin and subcutaneous tissue diseases,and general disorders and ad-ministration site conditions.The top 5 most frequent ADEs included drug reaction with eosinophilia and systemic symp-toms,pyrexia,headache,idiopathic intracranial hypertension,and arthralgia.The top 5 ADEs exhibiting the highest risk factors were thyroiditis acute,meningitis eosinophilic,vasculitis necrotizing,mononeuropathy multiplex,and eosinophilic myocarditis.Conclusions The high-risk factors for minocycline-induced ADEs in children aged 8-18 years include vari-ous neurological diseases,diseases of the skin and subcutaneous tissues,systemic diseases,and various reactions at the administration site,etc.Minocycline ADEs in clinical applications include acute thyroiditis,eosinophilic encephalitis,thyroiditis,and intestinal obstruction,etc.
Keywords：adverse drug eventtetracyclinesminocyclineUS Food and Drug Administration(FDA)adverse event reporting system
Publication Date：2024-10-25
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 14-18 )