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FDA-ApprovedExtended-release tablet (OROS osmotic delivery)

Concerta

methylphenidate ER · Janssen

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Key Facts

Form

Extended-release tablet (OROS osmotic delivery)

Frequency

Once daily (morning)

Available Doses

18mg27mg36mg54mg

FDA Approval Date

August 1, 2000

Mechanism

Methylphenidate (CNS stimulant) via OROS delivery system

Manufacturer

Janssen

Cost

Self-Pay

$150–$350/mo (brand); $30–$60/mo (generic)

With Savings Card

Janssen co-pay card available for brand Concerta

Medicare

Commonly covered with prior authorization

List Price

$380/mo

Multiple generic methylphenidate ER products available; not all use true OROS technology

Side Effects

Side EffectRateSource
Decreased appetite22%FDA label
Headache14%FDA label
Insomnia12%FDA label
Abdominal pain7%FDA label
Nausea7%FDA label
Dizziness5%FDA label
Irritability4%FDA label
Increased heart rate3%FDA label

Source: Concerta FDA Prescribing Information and pivotal clinical trials

Weight Loss Results

OROS Methylphenidate Pivotal Trial (Pediatric)

ADHD-RS improvement: −17.4 points vs −5.8 placebo

4 weeks · Treatment regimen (ITT)

4 weeks

Double-blind, placebo-controlled trial in 282 children aged 6–12 demonstrating significant symptom improvement across all dose groups.

OROS Methylphenidate Adult ADHD Trial

ADHD-RS improvement: −15.2 points vs −4.3 placebo

6 weeks · Treatment regimen (ITT)

6 weeks

Randomized, double-blind, placebo-controlled trial in adults aged 18–65.

How It Works

Concerta delivers methylphenidate using an osmotic pump mechanism. The outer coating dissolves quickly, providing a rapid initial dose. The inner core uses osmotic pressure to push the remaining medication through a laser-drilled hole in the tablet over 10–12 hours. Methylphenidate blocks the reuptake of dopamine and norepinephrine, increasing their availability in the prefrontal cortex to improve attention and reduce impulsivity.

Mechanism: Concerta uses the OROS (Osmotic-Controlled Release Oral Delivery System) to deliver methylphenidate in two phases: an immediate-release outer coating provides 22% of the dose for rapid onset, while the remaining 78% is delivered gradually via osmotic pressure over 10–12 hours. The non-absorbable tablet shell passes intact in stool.

Who It's For

Indication

ADHD in patients aged 6–65

Children (6+), adolescents, and adults with ADHD who need reliable, long-acting stimulant therapy. Well-suited for school-aged children who need coverage through the school day and homework hours. The OROS delivery system minimizes peaks and troughs, reducing rebound effects.

Food & Water Restrictions

✅ No Restrictions

This medication can be taken at any time of day, with or without food and water.

Comparisons

Comparison

Vyvanse vs Concerta

Read comparison

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Cost & Insurance

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Medical Disclaimer: This information is for educational purposes only and does not constitute medical advice. Clinical trial data referenced comes from published studies and FDA prescribing information. Side effect rates are from specific clinical trials and may not reflect real-world experience. Always consult your healthcare provider before starting, stopping, or switching any medication.