What does this research mean for the field?

While SSRIs share common psychiatric adverse event signals in children and adolescents, including suicidal ideation and self-injury, specific drugs exhibit distinct safety profiles, such as escitalopram showing higher disproportionality for psychiatric and cardiac events. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This study aims to assess the safety of SSRIs in children and adolescents, focusing on serious adverse events.

May 30, 2026Open Access

Pharmacovigilance of SSRIs in Children and Adolescents withDepression: Disproportionality Analysis of Serotonin Adverse EventsUsing the FAERS Database

Key Points

This study aims to assess the safety of SSRIs in children and adolescents, focusing on serious adverse events.
Analyzed pediatric adverse event reports from the FAERS database (Q1 2004-Q1 2025)
Focused on SSRI drugs listed as Primary Suspect and removed duplicates
Conducted disproportionality analyses using ROR, PRR, BCPNN, and MGPS.
Psychiatric events like suicidal ideation and self-injury showed consistent signals.
Escitalopram had higher disproportionality for psychiatric, cardiac, and perinatal events, while fluvoxamine indicated impulsive behaviors.
Neurological events, including serotonin syndrome, were frequently reported with limited stability in congenital signals.

Abstract

Introduction: Depression in minors is a growing global health concern with limited pharmacological options. This study evaluated the safety profiles of four selective serotonin reuptake inhibitors (SSRIs)-fluoxetine, sertraline, escitalopram, and fluvoxamine- in children and adolescents, focusing on serious adverse events (SAEs). Methods: Pediatric adverse event reports from the FAERS database (Q1 2004-Q1 2025) were analyzed. Only reports listing the study drugs as Primary Suspect were included; duplicates were removed. Events were coded using MedDRA 26.1 and analyzed at system organ class (SOC) and preferred term (PT) levels. Disproportionality analyses used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma-Poisson shrinker (MGPS), with Bayesian shrinkage (EBGM05) applied to low-frequency signals. Results: Psychiatric events, including suicidal ideation, suicide attempts, and self-injury, showed the most consistent signals. Fluoxetine and sertraline had broad profiles; escitalopram showed higher disproportionality for psychiatric, cardiac, and perinatal events; fluvoxamine showed elevated signals for impulsive behaviors and rare systemic events. Neurological events, such as serotonin syndrome and tremor, were consistently reported; congenital and perinatal signals had limited statistical stability. Discussion: SSRIs share common psychiatric AE signals in minors, but differences in strength and distribution likely reflect real-world exposure, metabolic pathways, and structural properties rather than causal differences. Conclusion: FAERS-based pharmacovigilance provides a comparative overview of SSRI safety, with multi-algorithm assessment and Bayesian shrinkage enhancing low-frequency signal reliability, informing safer SSRI use and guiding future studies integrating pharmacokinetics and pharmacogenomics.

Pharmacovigilance of SSRIs in Children and Adolescents withDepression: Disproportionality Analysis of Serotonin Adverse EventsUsing the FAERS Database

Key Points

Abstract

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