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Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, and other serious cardiac problems. Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious cardiac problems when taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Dyanavel XR, Quillivant XR, and QuilliChew ER.

CNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Dyanavel XR, Quillivant XR, or QuilliChew ER.

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with Dyanavel XR, Quillivant XR, and QuilliChew ER. Treatment may need to be interrupted in children not growing or gaining weight as expected.

CNS stimulants are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.

Serotonin syndrome risk is increased when Dyanavel XR is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue Dyanavel XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.

QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).

Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.

Based on limited experience with Dyanavel XR in controlled trials, the adverse reaction profile of Dyanavel XR appears similar to other amphetamine extended-release products. The most common (≥2% in the Dyanavel XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (Dyanavel XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).

Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased.

There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.

Dyanavel XR, Quillivant XR, and QuilliChew ER use during pregnancy may cause fetal harm.