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Adzenys XR-ODT

(amphetamine)

Adzenys XR-ODT (amphetamine); CII

Full Prescribing Information DailyMed Drug Information

Summary

Adzenys XR-ODT is an extended-release amphetamine orally disintegrating tablet approved for ADHD from age 6, taken once daily in the morning. It carries a 3:1 ratio of d- to l-amphetamine, pairing an immediate-release half with a delayed-release half in a tablet that dissolves on the tongue without water. Its differentiator is a full-day amphetamine for a child who will not swallow a capsule; its trap is that strengths are amphetamine base. Schedule II; brand and generic.

Forms & Strengths

  • Extended-release orally disintegrating tablets (orange; blister packed; amphetamine base): 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg

Dosing

  • Age: ≥ 6 y/o
  • Onset: 30 to 60 min
  • Duration: ~ 12 hours
  • Release Profile: 50% immediate-release / 50% delayed-release amphetamine in one tablet. Delayed, not extended
  • Initial Dose:
    • 6-17 y/o: 6.3 mg once daily in the morning
    • ≥ 18 y/o: 12.5 mg once daily, the recommended adult dose rather than a starting dose
  • Titration: 3.1 mg or 6.3 mg every 7 days, patients 6-17
  • Max Dose:
    • 6-12 y/o: 18.8 mg/day
    • 13-17 y/o: 12.5 mg/day
    • ≥ 18 y/o: 12.5 mg/day recommended; no separate adult maximum is stated
  • Considerations: The adolescent ceiling is LOWER than the child ceiling, and is not a typo: a 13 year old cannot exceed 12.5 mg/day. Strengths are amphetamine base; never convert milligram for milligram.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate
  • Delivery / Release: 50% immediate-release / 50% delayed-release, from ion-exchange resin particles of which half carry a methacrylic acid coat
  • Disintegration in saliva is a delivery convenience and does not change absorption
  • Formulation: 3:1 d- to l-amphetamine, strengths as amphetamine base where the mixed-salt products state salts
  • Metabolism: CYP2D6 forms active 4-hydroxyamphetamine. d-amphetamine half-life 9-10 h in children 6-12 and 11 h in adults; l-amphetamine 10-11 h and 14 h; excretion is pH dependent
  • Class Positioning: pharmacokinetically Adderall XR delivered differently, 18.8 mg matching its 30 mg profile; choose it for route, not kinetics
  • Against Dyanavel XR, the other base-dosed amphetamine: no bottle or measuring device, but fixed steps rather than continuous titration

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o

Off-Label Uses

  • None established for this formulation by graded pediatric evidence.

  • Where the evidence does not support use:

    • Children under 6: argued against by this label; the 3.1 mg strength makes a small dose look available, but the age floor applies.
    • Above 12.5 mg/day at 13 to 17 y/o: the lower ceiling is deliberate. Not supported.
    • Non-ADHD indications in youth: AHRQ CER 267 graded none (AHRQ 2024).
    • Cognitive enhancement without ADHD: not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses or by non-oral routes. Assess risk before prescribing; reassess throughout.
  • Contraindicated:
    • Known hypersensitivity to amphetamine or components
    • MAOI use, current or within 14 days, including linezolid and IV methylene blue
  • Use with caution (Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death
    • Pre-existing hypertension, because BP and HR rise
    • Pre-existing psychosis; bipolar disorder, for treatment-emergent mania
    • Motor or verbal tics, Tourette syndrome, or peripheral vasculopathy including Raynaud phenomenon
    • Hereditary fructose intolerance; this tablet lists fructose as an inactive ingredient, unlike the swallowed capsule alternatives
    • Substance use disorder in the patient or the household
  • Screen before starting:
    • Cardiac history, family history of sudden death or arrhythmia, and exam
    • Personal and family history of tics or Tourette syndrome
    • Mania risk: personal or family depression, bipolar disorder, suicide
    • Abuse and diversion risk
    • Baseline height, weight, BP, HR

Drug Interactions

  • MAOIs (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Confirm a 14 day washout.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone): serotonin syndrome. Start lower; stop both drugs if symptoms appear.
  • CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower.
  • Urinary pH agents: acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs a dose adjustment either way.
  • Sympathomimetics (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants.
  • Laboratory assays: amphetamines interfere with urinary steroid determinations; interpret rather than repeat.

Administration

  • Once daily in the morning, with or without food; food lowers Cmax about 19% and delays Tmax about 2 hours, which the label calls not clinically significant.
  • Open the blister with dry hands at the moment of dosing; peel the backing, never push the tablet through the foil.
  • Place the whole tablet on the tongue and let it disintegrate; do not chew or crush, and no water is needed.
  • Switching from Adderall XR only, at the equivalent once-daily dose; the label permits this for no other amphetamine.
    • Adzenys 3.1 mg = Adderall XR 5 mg
    • 6.3 = 10
    • 9.4 = 15
    • 12.5 = 20
    • 15.7 = 25
    • 18.8 = 30 mg
  • From any other amphetamine: stop the previous drug and titrate from the beginning.
  • Avoid late dosing; the delayed-release half puts an afternoon dose near bedtime.
  • Store securely, preferably locked.

Side Effects

  • Common, children 6-12 vs placebo: loss of appetite 22% vs 2%, insomnia 17% vs 2%, abdominal pain 14% vs 10%, emotional lability 9% vs 2%, vomiting 7% vs 4%.
  • Also common, same study: nervousness 6% vs 2%, fever 5% vs 2%, nausea 5% vs 3%, weight loss 4% vs 0%, dizziness, dyspepsia and fatigue each 2%.
  • Serious:
    • Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it.
    • Increased BP and HR, mean rise 2-4 mm Hg and 3-6 bpm; monitor rather than assume the mean applies.
    • Psychosis or mania, roughly 0.1% in pooled stimulant trials; consider discontinuing.
    • Serotonin syndrome; stop both drugs and treat supportively.
    • Angioedema and anaphylaxis; stop and do not rechallenge.
    • Peripheral vasculopathy including Raynaud phenomenon; reduce or stop.
    • Growth suppression; interrupt in a child not growing as expected.
    • New or worsening tics and Tourette syndrome.

Monitoring & Labs

  • Cardiovascular: HR and BP at baseline, each dose change, and every 6 months.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two percentile lines.
  • Appetite and sleep: every visit; at 22% and 17% these are the two commonest reasons for stopping.
  • Psychiatric: psychosis, mania, aggression and emotional lability at each visit and 2 weeks after any increase.
  • Tics and digits: ask about tics and inspect fingers and toes at each visit.
  • Dose ceiling at the 13th birthday: review the dose at the visit before a patient turns 13; a child stable at 15.7 or 18.8 mg is above the adolescent ceiling on their birthday.
  • Abuse and diversion: adherence, tablet counts and PDMP check at each refill.
  • Laboratory: none routinely.

Discontinuation & Taper

  • Can be stopped abruptly at therapeutic doses; no taper required.
  • Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite.
  • Evening rebound as the second pulse wears off is pharmacodynamic offset, not withdrawal.
  • Drug holidays suit appetite or growth as the limiting problem.

Pregnancy & Lactation

  • Pregnancy: Decades of data have not identified a drug-associated risk of major birth defects or miscarriage. Amphetamines vasoconstrict, may reduce placental perfusion, and stimulate uterine contractions.
  • Pregnancy, clinical: premature delivery and low birth weight reported; background risk 2% to 4% for defects, 15% to 20% for miscarriage. Weigh rather than abstain.
  • Neonate: monitor for withdrawal: feeding difficulty, irritability, agitation, drowsiness.
  • Lactation: in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5; no reported adverse infant effects; the label does not recommend breastfeeding.
  • Lactation, milk supply: prolactin suppressed 25% to 40%; large doses may impair production where lactation is not established. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for ADHD Medication, 1-866-961-2388, www.womensmentalhealth.org/pregnancyregistry

Counseling Points

  • Counsel the family on:

    • Peeling the blister backing with dry hands at the moment of dosing; pushing the tablet through the foil crumbles it, and moisture breaks it down.
    • Letting it dissolve on the tongue without chewing, and that no water is needed.
    • That the strength number will not match a previous amphetamine prescription, and is not a pharmacy error.
    • The ceiling dropping at age 13, so nobody is blindsided when the dose is reduced.
    • Appetite suppression, 22% of children; largest meal at breakfast and in the evening.
    • Storing it locked and away from younger siblings; the orange flavour looks like a sweet, and bringing a teacher rating scale to the next visit.

  • Advise them to call for:

    • Chest pain on exertion, fainting, or a racing heart that does not settle.
    • New hallucinations, or new suspicious or fearful thinking.
    • Swelling of the lips, tongue or face after a dose.
    • Numbness, coldness or colour change in the fingers or toes.
    • A new or worse tic; weight loss; mood swings new since the last dose change.

References

  1. DailyMed. Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets prescribing information. Neos Therapeutics Brands. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c1179269-00b5-48ea-972d-31e614e99b7e
  2. FDA. openFDA National Drug Code Directory, generic_name "amphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22amphetamine%22&limit=1000
  3. LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
  4. AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/
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