Objective: Medications are frequently reported in association with suicidality in youth, yet age-specific risks within reported cases remain unclear. We aimed to analyze drug-related suicide among children and adolescents in the FDA Adverse Event Reporting System (FAERS).
Methods: We conducted a retrospective study of FAERS reports from 1997 to 2024 that involved 5-19-year-olds and any suicide-related events. We described demographics and age-/sex-stratified adjusted reporting-odds ratios (aOR) for fatality; a 2014-2024 window confirmed robustness.
Results: We identified 18,779 cases, most from 13 to 17-years; girls constituted the majority (58.3%) except in the 5-12-years group. Completed-suicide reports accounted for 22.3% overall, rising from 6.9% (5-12 years) to 32.0% (18-19 years). Diphenhydramine showed the highest odds of reported death (aOR 8.2, 95% CI: 6.3-10.7), followed by oxycodone (6.7, 4.7-9.5) and bupropion (5.6, 4.6-6.9), stable in the last-decade subset. Age-dependent increase in reporting odds of death for risperidone (7.4, 3.3-16.5), atomoxetine (3.3, 1.6-7.1), and montelukast (2.8, 1.2-6.3) reversed after 18 years. Fluoxetine and quetiapine were associated with death predominantly in girls, whereas venlafaxine and paroxetine were more prominent in boys.
Conclusion: Across FAERS youth suicide reports, drug-associated fatality risk varies markedly by drug, surges in mid- to late adolescence, diverges by sex and shifts at both age extremes. These heterogeneities underscore the need for age-appropriate pharmacovigilance and trial strategies rather than direct extrapolation from adult data, particularly regarding the safety of drugs associated with suicide.
Keywords: Bupropion; Diphenhydramine; FAERS; Oxycodone; Pediatric suicide; Pharmacovigilance.
Copyright © 2026. Published by Elsevier B.V.