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The Safety of CONCERTA®

Overview: 

Proven Effective

CONCERTA® has over 9 years of clinical experience

Clinical trials have shown CONCERTA® to be effective for ADHD symptoms

CONCERTA® offers effective ADHD symptom control

Like all ADHD medications, CONCERTA® has side effects

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The Safety of CONCERTA®

Proven Effective

CONCERTA® has over 9 years of clinical experience

Clinical trials have shown CONCERTA® to be effective for ADHD symptoms

CONCERTA® offers effective ADHD symptom control

Like all ADHD medications, CONCERTA® has side effects

The medication in CONCERTA® is recommended among first-line therapies by the American Academy of Pediatrics as part of a comprehensive treatment program for ADHD. This includes both medication and behavioral therapy.

CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA®. Please see Important Safety Information or speak with your physician.

One time-released dose in the morning offers effective, tolerated ADHD symptom control to cover your child's busy day at school, at home, and at play. Children are typically started on a daily dose of 18 mg of CONCERTA®. Your child's dose may need to be adjusted to achieve better results. This approach is called titration. CONCERTA® is FDA approved in dosages up to 54 mg per day for children and 72 mg per day for adolescents.

Like all ADHD medications, CONCERTA® has side effects. Less than 3% of children and adolescents experienced insomnia, and less than 1% experienced a loss of appetite or moodiness. The most common adverse reaction was upper abdominal pain (5.9%).

If your child is diagnosed with ADHD, ask his or her healthcare professional about managing the everyday challenges of ADHD with CONCERTA®. CONCERTA® can help your child get on the path to success in managing ADHD.


CONCERTA® is a prescription product approved for the treatment of attention deficit hyperactivity disorder (ADHD) as part of a total treatment program that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION
Talk to your healthcare professional for a proper diagnosis and treatment of ADHD. Only a healthcare professional can decide whether medication is right for you or your child.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs. Keep CONCERTA® in a safe place to prevent misuse and abuse.

CONCERTA® should not be taken by patients who have: allergies to methylphenidate or other ingredients in CONCERTA®; significant anxiety, tension, or agitation; glaucoma; tics, Tourette's syndrome, or family history of Tourette's syndrome; current or past use of monoamine oxidase inhibitor (MAOI); esophagus, stomach, or intestinal narrowing. Children under 6 years of age should not take CONCERTA®.

Tell your healthcare professional if you or your child has had any heart problems, heart defects, high blood pressure, or a family history of these problems; has had depression, abnormal thoughts or visions, bipolar disorder, or seizure. Tell your doctor if you have or your child has numbness, pain, skin color change or sensitivity to temperature in fingers or toes. Contact your healthcare professional immediately if you or your child: develops abnormal thinking or hallucinations, abnormal or extreme moods and/or excessive activity; or if aggressive behavior or hostility develops or worsens while taking CONCERTA®. Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately. Your child's healthcare professional should check height and weight often and may interrupt CONCERTA® treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that CONCERTA® does not adversely affect your ability to engage in such activities.

The most common adverse reaction in double-blind clinical trials (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis.

CONCERTA® and OROS® are registered trademarks of ALZA Corporation.

© Janssen Pharmaceuticals, Inc. 2011. All rights reserved.

This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This site and its contents are intended for USA audiences only.