FDA Approves Concerta (methylphenidate) for ADHD in Patients Aged 6 to 65 Years

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FDA Published April 15, 2026 Medically reviewed April 19, 2026 DOI ↗ By Dr. Ji-eun Park, MD · Brain, Mind & Pain

Key Takeaway

Consider Concerta for ADHD in patients aged 6 to 65 years, with once-daily dosing and age-specific maximums.

The FDA has approved Concerta (methylphenidate) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years. This approval provides a once-daily, extended-release formulation of methylphenidate, a CNS stimulant, expanding treatment options across a broad age range. Clinically, this approval matters as it addresses ADHD management from childhood through adulthood, with specific dosing guidelines and precautions tailored to different age groups, though use is not recommended in children under 6 due to higher plasma exposure and adverse reaction incidence. The drug's efficacy was demonstrated in trials including pediatric patients 6 to 12 years old, adolescents, and adults, supporting its role in standard ADHD therapy, but clinicians should note the need for pretreatment screening for cardiac disease and tics.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Not reported in label.

Indication & Patient Population

Concerta is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use: The use of Concerta is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Dosing & Administration

Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is 18 mg once daily. May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients: 6 to 12 years: 54 mg once daily; 13 to 17 years: 72 mg once daily. Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily. Patients currently using immediate-release methylphenidate: starting Concerta dosage is based on current dosage regimen. Prior to initiating treatment, assess for the presence of cardiac disease and family history of tics or Tourette's syndrome. If paradoxical aggravation of ADHD symptoms or adverse reactions occur, reduce dosage or discontinue.

Key Clinical Trial Data

Concerta was demonstrated to be effective in the treatment of ADHD in patients who met the DSM-IV criteria for ADHD in trials: three trials in pediatric patients 6 to 12 years old, one trial in adolescents (13 to 18 years old), and two trials in adults (18 to 65 years old). In pediatric patients 6 to 12 years, three double-blind, active- and placebo-controlled trials were conducted in 416 patients, with patients randomized to receive 18 mg, 36 mg, or 54 mg of oral Concerta given once daily, 5 mg. Specific efficacy outcomes are not detailed in the label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

Study Details

Study typeFda approval

PublishedAug 2000

View Original Abstract ↓

1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. ( 1 ) Limitations of Use The use of CONCERTA is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).