Safety of antidepressants commonly used in 6–17-year-old children and adolescents: A disproportionality analysis from 2014–2023 on the basis of the FAERS database

作者：Yan Zhou, Yun Lu, Yu Wu, Wenqiang Kong, Lu Zhou, Xirui Guo, Hua Wei, Hongju Wang, Fangqing Xie, Shihao Yan, Fang Yang, Chun Liu, Qinchuan Li, Na Li, Ya Zou, Jia Chen · 发表于：PLoS ONE · 年份：2025 · DOI：10.1371/journal.pone.0330025 · 被引用次数：5 · 研究领域：Attention Deficit Hyperactivity Disorder、Child and Adolescent Psychosocial and Emotional Development、Pharmaceutical studies and practices

BACKGROUND: Depression is a common mental disorder in children and adolescents, and antidepressants are widely used for treatment. This study aimed to explore and analyze adverse events (AEs) associated with antidepressant use in this population, providing insights for safety assessment. METHODS: This study extracted AE reports from the US FDA Adverse Event Reporting System (FAERS) for children and adolescents aged 6-17 years from 2014-2023, with fluoxetine, escitalopram, and sertraline as the primary suspected drugs. The study used the International Dictionary of Medical Terminology (MedDRA) to encode and classify AEs, and employed the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods for data mining. RESULTS: The FAERS database included 9,845 AE reports involving fluoxetine, escitalopram, and sertraline among children and adolescents aged 6-17 years. After removing duplicates, the analysis yielded 1,604, 352, and 571 AEs for fluoxetine, escitalopram, and sertraline, respectively. The study population demonstrated a sex distribution with approximately twice as many female patients as male patients, with most patients aged 12-17 years. At the system organ class (SOC) level, the AEs predominantly involved psychiatric disorders and nervous system disorders. Within the psychiatric disorders category at the high level group term (HLGT) level, the most frequently reported AE signals across all three medications were suicidal and self-injurious behaviors (no...