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
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
LactMed. Amphetamine. Drugs and Lactation Database, National Institute of Child Health and Human Development. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/
openFDA. NDC Directory, generic_name "amphetamine aspartate". US Food and Drug Administration. 2026. https://api.fda.gov/drug/ndc.json
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
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/