Introduction
TEAEs, upper abdominal pain, pharyngitis, decreased appetite, insomnia, attention-deficit/hyperactivity disorder, ADHD, headache, irritability
ADVERSE EVENTS, PHARYNGITIS, ADVERSE EVENT
Methylphenidate (MPH) has been in use for the treatment of attention-deficit/hyperactivity disorder (ADHD) for more than a half century. It is the most commonly prescribed medication for the treatment of patients with ADHD because of its effects on mitigating the core symptoms of ADHD in children and its overall favorable safety record (Storebø et al, Serdexmethylphenidate/dexmethylphenidate (SDX/d-MPH; AzstarysResults of a pivotal, 1-month, randomized, placebo-controlled, double-blind (DB), dose-optimized, laboratory classroom study of children aged 6–12 years with ADHD demonstrated that SDX/d-MPH was well tolerated, with adverse events (AEs) that were comparable with those of other stimulant treatments (Kollins et al, The safety analysis of the pivotal study showed that 67% of subjects experienced at least one treatment-emergent adverse event (TEAE) during the dose optimization (DO) phase, and 22.7% of subjects experienced at least one TEAE during the DB phase. TEAEs were mostly mild (56.8%) to moderate (29.7%); 3.2% had severe TEAEs. There were no serious adverse events (SAEs) in either phase. The most common AEs occurring in ≥2% of subjects during the DO phase were decreased appetite (24.5%), insomnia (15.5%), affect lability (11.6%), upper abdominal pain (9.7%), headache (7.7%), and irritability (7.7%).During the treatment phase, the most common TEAEs were headache (5.4%), upper abdominal pain (4.1%), and insomnia and pharyngitis (both 2.7%) (Kollins et al, 