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Concerta

(methylphenidate hydrochloride extended-release, OROS)

Concerta (methylphenidate hydrochloride extended-release, OROS); CII

Full Prescribing Information DailyMed Drug Information

Summary

Concerta is a long-acting methylphenidate tablet using an OROS osmotic pump to deliver an immediate overcoat dose followed by ascending release from the core, approved for ADHD from age 6 through 65. It is the reference long-acting methylphenidate and the one with a labeled conversion table from immediate-release dosing. Its differentiator is that ascending profile: levels rise across the day rather than plateauing. Schedule II; brand and generic.

Forms & Strengths

  • Extended-release tablets (OROS, swallow whole): 18 mg, 27 mg, 36 mg, 54 mg, 72 mg

Dosing

  • Age: 6 to 65 y/o
  • Onset: ~ 1 hour
  • Duration: up to 12 hours
  • Release Profile: 22% IR / 78% ER via OROS osmotic delivery
  • Initial Dose:
    • 6 to 17 y/o, new to methylphenidate: 18 mg once daily in the morning
    • 18 to 65 y/o, new to methylphenidate: 18 mg or 36 mg once daily
    • From IR methylphenidate, per dose given 2-3 times daily: 5 mg to 18 mg; 10 mg to 36 mg; 15 mg to 54 mg; 20 mg to 72 mg (13 y/o and older only)
  • Titration: 18 mg every 7 days; use 27 mg for a smaller step
  • Max Dose:
    • 6 to 12 y/o: 54 mg/day
    • 13 to 17 y/o: 72 mg/day, not to exceed 2 mg/kg/day
    • 18 to 65 y/o: 72 mg/day
  • Considerations: Swallow whole; splitting or chewing destroys the extended release. The nondeformable tablet is unsuitable in severe GI narrowing, and the empty shell passing in stool is not a failed dose.

Pharmacology

  • Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
  • Delivery / Release: 22% IR / 78% ER via OROS osmotic delivery. An overcoat dissolves within an hour, then a push layer forces drug through a laser-drilled orifice; two core layers make release ascending.
  • Metabolism: De-esterified to PPAA (ritalinic acid), inactive. Not a CYP substrate. Half-life ~3.5 hours, ~90% recovered in urine, no accumulation.
  • Class Positioning: Ascending, not two-peaked, so no interpeak trough unlike Ritalin LA or Metadate CD. Relexxii is a different OROS product (18% IR overcoat, Tmax 5.5 h), not interchangeable.
  • Alcohol: no increased release in vitro up to 40%, unlike Metadate CD, which dose-dumps.

Indications

  • ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 to 65 y/o

Off-Label Uses

  • ADHD in children 4 to 5 years old (ICD-10: F90.x): behavioral parent training first line; if medication is needed use IR methylphenidate, not OROS. Expert consensus. (AAP 2019)
  • Narcolepsy (ICD-10: G47.419): IR methylphenidate carries this indication, Concerta does not. Insufficient.
  • Where the evidence does not support use: treatment-resistant depression, binge eating disorder, cancer-related and chronic fatigue. Adult literature only; insufficient in children. (AHRQ 2024)
  • Cognitive enhancement in a youth without ADHD: not an indication and not supported.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and with non-oral routes. Assess abuse risk before prescribing and reassess throughout treatment.
  • Contraindicated:
    • Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
    • MAOI use, current or within 14 days: hypertensive crisis
  • Use with caution:
    • Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
    • Pre-existing hypertension: mean rises 2 to 4 mm Hg and 3 to 6 bpm
    • Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
    • Severe GI narrowing: obstruction reported with nondeformable tablets
    • Significant hyperopia or angle-closure risk: refer to ophthalmology
    • Personal or family history of tics or Tourette's syndrome
    • Substance use disorder in the patient or the household
  • Screen before starting:
    • Cardiac history and exam including family sudden death; the label requires no routine ECG
    • Tics, and mania risk factors: depressive symptoms, family history of bipolar disorder
    • Abuse and diversion risk in patient and household
    • Ability to swallow a tablet whole; any GI stricture or bowel surgery
    • Baseline height, weight, blood pressure and heart rate

Drug Interactions

  • MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
  • Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
  • Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
  • Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
  • Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only, not in the interaction table. Counsel on symptoms rather than avoiding.

Administration

  • Once daily in the morning, with or without food; a high-fat breakfast changes nothing.
  • Swallow whole. Splitting, crushing or chewing destroys the extended release.
  • No sprinkle option. If the child cannot swallow a tablet, use a bead capsule or a liquid (Quillivant XR).
  • The intact shell is often visible in stool; it is the spent pump, not a lost dose.
  • Never substitute milligram-for-milligram; use the labeled conversion table.
  • Missed dose: skip it; a mid-afternoon OROS dose costs that night's sleep.
  • Store locked; household diversion of a Schedule II product is a real risk.

Side Effects

  • Common, pediatric 6 to 17 y (>= 2%): upper abdominal pain 6%, insomnia 3%, nasopharyngitis 3%, vomiting 3%, pyrexia 2%.
  • Common, adults: decreased appetite 25%, headache 22%, dry mouth 14%, nausea 13%, insomnia 12%, anxiety 8%, weight loss 7%, dizziness 7%, irritability 6%, tachycardia 5%.
  • Serious:
    • Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
    • New psychosis or mania, ~0.1% in pooled trials versus 0% on placebo: consider discontinuing
    • Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
    • Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits at each visit
    • Growth suppression: about 2 cm and 2.7 kg less over 3 years; GI obstruction in pre-existing narrowing
    • Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
    • Postmarketing: convulsion, hepatocellular injury, rhabdomyolysis, pancytopenia, angioedema, anaphylaxis

Monitoring & Labs

  • Cardiovascular: BP and HR at baseline, at every dose change, and at least every 6 months. Investigate a sustained rise beyond 2 to 4 mm Hg or 3 to 6 bpm.
  • Growth: height, weight and BMI at baseline and every 6 months, every visit if losing weight. Crossing two percentile channels triggers interruption.
  • Appetite and sleep: at every visit and dose change; appetite suppression is worst at midday.
  • Psychiatric and tics: screen for psychosis, mania, aggression, depressed mood and tics at baseline and every visit.
  • Abuse and diversion: at every refill, pill count, ask about sharing and selling, check the PDMP. A boxed-warning obligation.
  • Where diversion risk decides, neither non-stimulant (Strattera, Qelbree) is a controlled substance.
  • Gastrointestinal: ask about obstructive symptoms each visit where there is a stricture history. No routine labs; CBC and chemistry are not label-directed.

Discontinuation & Taper

  • No taper required; the label gives no tapering schedule.
  • Discontinue if no improvement after appropriate dose adjustment over one month.
  • Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite.
  • Priapism has occurred during drug holidays; mention it when planning one.
  • Drug holidays are reasonable where growth or appetite limits treatment; an interrupted day is fully unmedicated.

Pregnancy & Lactation

  • Pregnancy: human data are inconsistent on major birth defects and miscarriage. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
  • Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant serum in every reported case, including Concerta 36 mg. Not a reason to stop breastfeeding. (LactMed 2025)
  • Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. Monitor the infant for agitation, insomnia and poor weight gain. (LactMed 2025)
  • Exposure Registry: National Pregnancy Registry for ADHD Medications, 1-866-961-2388, womensmentalhealth.org/adhd-medications.

Counseling Points

  • Counsel the family on:

    • Seeing the intact shell in the stool. Say it before the first dose, or families stop the drug.
    • Half an 18 mg tablet is not 9 mg, it is a broken pump. The 27 mg strength exists to avoid cutting.
    • The ascending release: effect builds through the day; the hardest hours are the first and the last.
    • Moving the largest meal to breakfast and the evening. Upper abdominal pain, the only pediatric reaction above 5%, usually settles.
    • Locked storage; sharing or selling a Schedule II medication is a felony, and adolescents are the ones being asked.

  • Advise them to call for:

    • Chest pain, fainting, or a racing heart that does not settle.
    • New hallucinations, or suspicious or fearful thinking; eye pain with halos around lights.
    • Numbness, coldness or colour change in fingers or toes, or a sore that will not heal.
    • A new or markedly worse tic, including throat clearing and blinking.
    • A painful erection lasting more than a few hours, including during a planned break.
    • Severe abdominal pain, vomiting or constipation, especially with bowel narrowing.
    • Clothes fitting more loosely, or no weight gain across a few months.

References

  1. DailyMed. Concerta (methylphenidate hydrochloride) extended-release tablets prescribing information. Janssen Pharmaceuticals. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a88218c-5b18-4220-8f56-526de1a276cd
  2. FDA. openFDA National Drug Code Directory, generic_name methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22&limit=1000
  3. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
  4. American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
  5. AHRQ. Attention deficit hyperactivity disorder: 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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