{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T06:04:49Z","timestamp":1789538689292,"version":"build-2803163510"},"reference-count":33,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pediatr."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Pediatric attention-deficit\/hyperactivity disorder (ADHD) medications have been analyzed in the FDA Adverse Event Reporting System (FAERS), yet systematic age-stratified signal profiling under ICH E11(R1) developmental categories, covering the recently approved agents viloxazine and serdexmethylphenidate, remains unreported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We performed a retrospective disproportionality analysis of pediatric (age &amp;lt;18 years) FAERS reports, 2014Q1\u20132024Q4, after FDA-standard three-step deduplication. Ten active ingredients (eight in the main analysis, two in a new-drug branch) were identified. Reporting odds ratios (ROR), proportional reporting ratios (PRR), information components (IC, Bate 1998 uniform prior), and empirical Bayesian geometric means (EBGM, DuMouchel 1999) were computed. A signal was classified as Strong when positive across all four methods. Seven prespecified sensitivity analyses were conducted.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 15,301 pediatric ADHD cases, 100 Strong signals were identified (71 in adolescents, 29 in children).\n                      <jats:italic>\u03b1<\/jats:italic>\n                      2-agonists accounted for 79\/100 (clonidine-ER 52, guanfacine-ER 27). A novel dextroamphetamine\u2013posterior reversible encephalopathy syndrome (PRES) signal was reproducible across three independent sensitivity analyses. Methylphenidate showed no Strong signals under within-class or full-pediatric comparators.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Distinct age-specific safety signals emerged for ADHD medications, with dextroamphetamine\u2013PRES warranting targeted pharmacovigilance attention.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fped.2026.1865791","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T05:31:56Z","timestamp":1789536716000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Age-stratified safety signal mining of ADHD medications in pediatric populations using the FAERS database (2014\u20132024): a pharmacovigilance study using multi-method disproportionality 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