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Adderall XR

(dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate, amphetamine aspartate)

Adderall XR (mixed amphetamine salts, extended-release); CII

Full Prescribing Information DailyMed Drug Information

Summary

Adderall XR is a once-daily extended-release amphetamine capsule approved for ADHD from age 6, using immediate- and delayed-release beads to reproduce immediate-release Adderall taken twice, four hours apart. It is a fixed 3:1 ratio of dextroamphetamine to levoamphetamine salts, and unlike methylphenidate it both blocks reuptake and drives catecholamine release. Its differentiator against Mydayis is the age floor: this is the mixed-salts option for a school-age child, where Mydayis starts at 13. Schedule II; brand and generic.

Forms & Strengths

  • Extended-release capsules: 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

Dosing

  • Age: ≥ 6 y/o; not recommended below 6 years
  • Onset: 30-60 min, from the immediate-release bead fraction
  • Duration: 10-12 hours
  • Release Profile: Biphasic; immediate-release plus delayed-release beads in one capsule, Tmax about 7 hours
  • Initial Dose:
    • 6-12 y/o: 10 mg once daily in the morning; 5 mg where a lower start is judged appropriate
    • 13-17 y/o: 10 mg once daily in the morning
    • ≥ 18 y/o: 20 mg once daily in the morning
    • Severe renal impairment (GFR 15 to < 30): 5 mg, 6-17 y/o; 15 mg, adults. ESRD not recommended
  • Titration:
    • 6-12 y/o: increase by 5 mg or 10 mg at weekly intervals
    • 13-17 y/o: a single increase to 20 mg after one week if control is inadequate
  • Max Dose:
    • 6-12 y/o: 30 mg/day; doses above 30 mg/day have not been studied in children. Severe renal impairment: 20 mg/day
    • 13-17 y/o: no numeric maximum in the label; no added benefit above 20 mg/day in the adolescent trial
    • ≥ 18 y/o: no numeric maximum; same finding above 20 mg/day
  • Considerations: Give on awakening and avoid afternoon doses; a capsule may not be divided, and the patient must not take less than one whole capsule per day.

Pharmacology

  • Mechanism: Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component is what distinguishes amphetamines from methylphenidate
  • Delivery / Release: Immediate-release plus delayed-release beads, giving a profile comparable to IR Adderall taken twice, 4 hours apart; Tmax about 7 hours
  • Formulation: Fixed 3:1 dextro- to levoamphetamine; the levo isomer carries more peripheral and noradrenergic effect
  • Metabolism: CYP2D6 to 4-hydroxyamphetamine. d-amphetamine half-life 9-11 h, l-amphetamine 11-14 h across pediatric ages. Renal excretion is pH dependent
  • Pharmacogenomics: No genotype-directed dosing in the label; the actionable consequence is the CYP2D6-inhibitor interaction
  • Class Positioning: One dose instead of two versus Adderall. Mydayis runs to about 16 hours but starts at 13; this is the mixed-salts ER option below that age

Indications

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

Off-Label Uses

  • Narcolepsy (ICD-10: G47.419): off-label at every age; insufficient. Use an approved product: Adderall, Zenzedi, Dexedrine Spansule.
  • ADHD under 6 years (ICD-10: F90.x): insufficient. AAP names behavioral intervention first-line, and methylphenidate if medication is added (AAP 2019).
  • Where the evidence does not support use: depression augmentation and post-TBI attention; no pediatric evidence for ER mixed salts (AHRQ 2024).
  • Cognitive enhancement without ADHD: not an indication; not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse, and addiction; risk of overdose and death, rising with higher doses and non-oral routes. Assess abuse risk before prescribing and monitor throughout.
  • Contraindicated:
    • Known hypersensitivity or idiosyncrasy to amphetamine or any component
    • MAOI use, current or within 14 days
  • Use with caution (label Warnings, not contraindications):
    • Structural cardiac abnormality, cardiomyopathy or serious arrhythmia; the label says avoid
    • Hypertension; expect mean rises of 2-4 mmHg and 3-6 bpm
    • Psychosis or bipolar disorder; new psychotic or manic symptoms in about 0.1%
    • Prior seizure or EEG abnormality
    • Peripheral vasculopathy including Raynaud phenomenon
    • Tics or Tourette syndrome, personal or family
    • Substance use disorder, patient or household
    • Severe renal impairment; ESRD not recommended
  • Screen before starting:
    • Cardiac and family history of sudden death; ECG only if positive
    • Tics, Tourette syndrome and mania risk factors, including family history
    • Abuse and diversion risk
    • Baseline height, weight, blood pressure and heart rate
    • Renal function where impairment is suspected

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, IV methylene blue): hypertensive crisis; do not give within 14 days.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, buspirone, St John's Wort): serotonin syndrome; counsel on symptoms and stop both if it occurs.
  • CYP2D6 inhibitors (fluoxetine, paroxetine, bupropion, quinidine): raise exposure; start lower.
  • Alkalinizing agents (sodium bicarbonate, acetazolamide): raise levels; the label says avoid.
  • Acidifying agents (ascorbic acid, fruit juices): lower levels; adjust on response, not assumed failure.
  • Tricyclics (desipramine, protriptyline): sustained rise in brain d-amphetamine with potentiated cardiovascular effect; monitor and adjust.
  • Proton pump inhibitors (omeprazole): shorten Tmax, so the dose lands and fades earlier; adjust timing.

Administration

  • Once daily on awakening; afternoon doses cost sleep.
  • With or without food; a high-fat meal delays Tmax only.
  • Swallow whole, or sprinkle the entire contents on applesauce, eaten immediately without chewing. Do not store.
  • Do not divide a capsule; sprinkling is a swallowing accommodation, not a dose split.
  • Where neither route works, Adzenys XR-ODT has a published conversion from this product.
  • Switching from IR Adderall: same total daily dose once daily, then titrate weekly. The only conversion the label supports.
  • Do not substitute milligram-for-milligram for Mydayis or any other amphetamine.
  • If a dose is missed, skip it; do not double up.

Side Effects

  • Common, 6 to 12: loss of appetite 22%, insomnia 17%, abdominal pain 14%, emotional lability 9%, vomiting 7%, nervousness 6%, weight loss 4%
  • Common, 13 to 17: loss of appetite, insomnia, abdominal pain, weight loss, nervousness each ≥ 5%
  • Serious:
    • Sudden death with structural cardiac disease. Investigate exertional chest pain or syncope immediately.
    • Psychosis, mania and new aggression. Consider discontinuing.
    • Serotonin syndrome. Stop both drugs and treat supportively.
    • Seizures. Discontinue.
    • Peripheral vasculopathy with digital ulceration. Reduce or stop; refer if persistent.
    • Growth suppression; mean 4-week weight change -1.1 lbs at 10 mg, -2.8 lbs at 20 mg. Interrupt if growth falls behind.
    • New or worsening motor and verbal tics. Discontinue if clinically appropriate.

Monitoring & Labs

  • Cardiovascular: heart rate and blood pressure at baseline, each dose change, and every 6 months; act above the age-specific 95th percentile.
  • Growth: height, weight and BMI charted at baseline and every 6 months; interrupt if the child crosses two major percentile lines.
  • Appetite and Sleep: at every visit and every dose change.
  • Psychiatric and tics: psychosis, mania, aggression, emotional lability and new tics at every visit.
  • Peripheral vasculopathy: inspect fingers and toes at every visit.
  • Abuse and Diversion: adherence, pill counts and PDMP check at every refill.
  • Renal function: at baseline where impairment is suspected, and annually.
  • Laboratory: none routinely; amphetamines interfere with urinary steroid assays.

Discontinuation & Taper

  • May be stopped abruptly at therapeutic doses; no taper is required.
  • Withdrawal after abrupt stop following prolonged use: dysphoria, fatigue, vivid dreams, increased appetite.
  • Late-afternoon rebound irritability and hunger is offset, not withdrawal.
  • Interrupt treatment where growth falls behind; the label names interruption, not dose reduction.
  • Drug holidays are reasonable where appetite or growth suppression is limiting.

Pregnancy & Lactation

  • Pregnancy: No drug-associated risk of major birth defects or miscarriage. Premature delivery and low birth weight reported. Monitor exposed newborns for withdrawal.
  • Lactation: Label says breastfeeding is not recommended. Relative infant dose 2 to 13.8%, milk/plasma ratio 1.9 to 7.5; no reported infant adverse effects.
  • Milk supply: Dose-related prolactin suppression up to 40% may impair production before lactation is established. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388.

Counseling Points

  • Counsel the family on:

    • Sprinkling is a swallowing accommodation, not a dose split; use a lower strength instead.
    • The applesauce must be eaten immediately and completely.
    • The 10 to 12 hour window; ask what time the fade starts before changing the dose.
    • For adolescents, no added benefit above 20 mg/day in the label's own trial.
    • Vitamin C and fruit juice can mimic treatment failure; bicarbonate and antacids raise levels.
    • Move the largest meal to breakfast and to the evening.
    • Locked storage; sharing or selling a Schedule II medication is a felony.
    • Bring 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.
    • Numbness, coldness or colour change in the fingers or toes.
    • A new or markedly worse tic, or a seizure of any kind.
    • Weight loss, or clothes fitting more loosely over a few weeks.
    • Agitation, shivering, sweating or confusion after an antidepressant change.

References

  1. DailyMed. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate) extended-release capsules prescribing information. Takeda Pharmaceuticals America. Revised 4/2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aff45863-ffe1-4d4f-8acf-c7081512a6c0
  2. LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
  3. openFDA. NDC Directory, generic_name "amphetamine aspartate". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
  4. American Academy of Pediatrics. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics 144(4):e20192528. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis
  5. Agency for Healthcare Research and Quality. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
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