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    DEA Class; Rx

    Common Brand Names; Azstarys

    • ADHD Agents; 
    • Stimulants

    Dexmethylphenidate (d-MPH): CNS stimulant; blocks reuptake of norepinephrine and dopamine, causing an increase of their release into the extraneuronal space; mode of therapeutic action for ADHD is unknown

    Serdexmethylphenidate: Prodrug of d-MPH formulated with immediate-release d-MPH

    Indicated for attention-deficit hyperactivity disorder (ADHD)

    Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components; bronchospasm, rash, and pruritus reported with serdexmethylphenidate/methylphenidate; hypersensitivity reactions (eg, angioedema) and anaphylactic reactions reported in patients treated with other methylphenidate products

    Concomitant use with MAOIs or within 14 days following discontinuation with an MAOI

    • Clinical trials with other methylphenidate products in pediatric and adult patients with ADHD commonly reported (≥5% and at least twice the rate of placebo) the following:
    • Decreased appetite
    • Decreased weight
    • Nausea
    • Abdominal pain
    • Dyspepsia
    • Vomiting
    • Insomnia
    • Anxiety
    • Affect lability
    • Irritability
    • Dizziness
    • Increased blood pressure
    • Tachycardia
    • Blood and lymphatic system disorders: Pancytopenia, thrombocytopenia, thrombocytopenic purpura
    • Cardiac disorders: Angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate
    • Eye disorders: Diplopia, mydriasis, visual impairment, blurred vision
    • General disorders: Chest pain, chest discomfort, hyperpyrexia
    • Gastrointestinal disorders: Dry mouth
    • Hepatobiliary disorders: Hepatocellular injury, acute hepatic failure
    • Immune system disorders: Hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, eruptions, and exanthemas
    • Investigations: Alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased, platelet count decreased, white blood cell count abnormal
    • Musculoskeletal, connective-tissue and bone disorders: Arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps
    • Nervous system: Convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo
    • Psychiatric disorders: Disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation
    • Skin and subcutaneous tissue disorders: Alopecia, erythema, hyperhidrosis
    • Urogenital system: Priapism
    • Vascular disorders: Raynaud phenomenon

    CNS stimulants have a high potential for abuse and dependence; assess risks before prescribing and carefully monitor while on therapy

    Priapism, sometimes requiring surgical intervention, reported with methylphenidate in both pediatric and adults patients; not reported upon initiating, but may develop after some time on the drug (often subsequent to increased dose or during drug withdrawal); seek immediate medical attention for abnormally sustained or frequent and painful erections

    Peripheral vasculopathy, including Raynaud phenomenon, reported with CNS stimulants; signs and symptoms generally improve after dose reduction or discontinuation; observe for digital changes during treatment; further clinical evaluation (eg, rheumatology referral) may be necessary

    Monitor growth in pediatric patients during treatment with stimulants; patients who are not growing or gaining weight as expected may need to have their treatment interrupted

    Periodically reevaluate long-term use and adjust dose; periodically discontinue to assess patient’s condition

    No data are available on use in pregnant females; dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Serdexmethylphenidate: Data are unavailable on presence in human milk, effects on breastfed infants, or effects on milk production


    Initial: 39.2 mg/7.8 mg PO qAM

    After 1 week: Increase to 52.3 mg/10.4 mg PO qAM

    Not to exceed 52.3 mg/10.4 mg PO qAM


    <6 years: Safety and efficacy not established

    6-12 years

    • Initial: 39.2 mg/7.8 mg PO qAM
    • After 1 week: May increase to 52.3 mg/10.4 mg PO qAM OR decrease to 26.1 mg/5.2 PO qAM, depending on response and tolerability
    • Not to exceed 52.3 mg/10.4 mg PO qAM

    13-17 years

    • Initial: 39.2 mg/7.8 mg PO qAM
    • After 1 week: Increase to 52.3 mg/10.4 mg PO qAM
    • Not to exceed 52.3 mg/10.4 mg PO qAM


    capsule: Schedule II

    • 26.1mg/5.2mg
    • 39.2mg/7.8mg
    • 52.3mg/10.4mg
    • Dexmethylphenidate is a Schedule II controlled substance; controlled substance schedule pending for serdexmethylphenidate