An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system

Abstract Drug-induced mental disorders in children and adolescents are a significant concern, and the relationship between medications and severe mental disorders is not well understood. Utilizing the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS), a comprehensive real-wo...

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Main Authors: Linlin Tang, Qian Li, Xue Zhao, Liangxia Ding, Hui Li, Chuanhua Ding, Lijuan Teng
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Scientific Reports
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Online Access:https://doi.org/10.1038/s41598-025-06403-0
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author Linlin Tang
Qian Li
Xue Zhao
Liangxia Ding
Hui Li
Chuanhua Ding
Lijuan Teng
author_facet Linlin Tang
Qian Li
Xue Zhao
Liangxia Ding
Hui Li
Chuanhua Ding
Lijuan Teng
author_sort Linlin Tang
collection DOAJ
description Abstract Drug-induced mental disorders in children and adolescents are a significant concern, and the relationship between medications and severe mental disorders is not well understood. Utilizing the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS), a comprehensive real-world investigation of drug-induced psychiatric disorders in children and adolescents is conducted. We reviewed all adverse event (AE) reports related to mental disorders in children and adolescents in the FAERS database from 2004 to 2024. After data cleansing and standardization, we quantified the statistical association between drugs and mental disorders using the Reporting Odds Ratio (ROR) method. A total of 29,622 AE reports related to drug-induced mental disorders in children and adolescents were identified in the FAERS database, uncovering 252 drugs with positive signals for mental disorders. These medications are primarily used to treat conditions such as Attention Deficit Hyperactivity Disorder (ADHD), psychiatric disorders, acne, asthma, allergic diseases, narcolepsy, contraception, and constipation. Our analysis revealed potential associations between various drugs and mental disorders, with isotretinoin, montelukast, risperidone, methylphenidate, atomoxetine and antidepressants showing higher ROR values, indicating a possible risk of mental disorders. Additionally, we found that some drugs did not explicitly list the risk of mental disorders in their instructions for use.
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spelling doaj-art-e0e1177a7ef24fceb6bb305443550da12025-08-20T03:45:26ZengNature PortfolioScientific Reports2045-23222025-07-0115111210.1038/s41598-025-06403-0An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting systemLinlin Tang0Qian Li1Xue Zhao2Liangxia Ding3Hui Li4Chuanhua Ding5Lijuan Teng6Department of Pharmacy, Affiliated Hospital of Shandong Second Medical UniversityDepartment of Pharmacy, Affiliated Hospital of Shandong Second Medical UniversityWeifang People’s HospitalWeifang People’s HospitalDepartment of Pharmacy, Affiliated Hospital of Shandong Second Medical UniversityDepartment of Pharmacy, Affiliated Hospital of Shandong Second Medical UniversityWeifang People’s HospitalAbstract Drug-induced mental disorders in children and adolescents are a significant concern, and the relationship between medications and severe mental disorders is not well understood. Utilizing the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS), a comprehensive real-world investigation of drug-induced psychiatric disorders in children and adolescents is conducted. We reviewed all adverse event (AE) reports related to mental disorders in children and adolescents in the FAERS database from 2004 to 2024. After data cleansing and standardization, we quantified the statistical association between drugs and mental disorders using the Reporting Odds Ratio (ROR) method. A total of 29,622 AE reports related to drug-induced mental disorders in children and adolescents were identified in the FAERS database, uncovering 252 drugs with positive signals for mental disorders. These medications are primarily used to treat conditions such as Attention Deficit Hyperactivity Disorder (ADHD), psychiatric disorders, acne, asthma, allergic diseases, narcolepsy, contraception, and constipation. Our analysis revealed potential associations between various drugs and mental disorders, with isotretinoin, montelukast, risperidone, methylphenidate, atomoxetine and antidepressants showing higher ROR values, indicating a possible risk of mental disorders. Additionally, we found that some drugs did not explicitly list the risk of mental disorders in their instructions for use.https://doi.org/10.1038/s41598-025-06403-0Drug-Induced mental disordersChildren and adolescentsFAERSPharmacovigilanceAdverse events
spellingShingle Linlin Tang
Qian Li
Xue Zhao
Liangxia Ding
Hui Li
Chuanhua Ding
Lijuan Teng
An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
Scientific Reports
Drug-Induced mental disorders
Children and adolescents
FAERS
Pharmacovigilance
Adverse events
title An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
title_full An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
title_fullStr An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
title_full_unstemmed An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
title_short An investigation of drug-induced mental disorders in the children and adolescents population utilizing the FDA adverse event reporting system
title_sort investigation of drug induced mental disorders in the children and adolescents population utilizing the fda adverse event reporting system
topic Drug-Induced mental disorders
Children and adolescents
FAERS
Pharmacovigilance
Adverse events
url https://doi.org/10.1038/s41598-025-06403-0
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