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The Safety of CONCERTA®
Overview:
A Well-Tolerated Treatment
Clinical studies have proven CONCERTA® to be effective and well tolerated
Like all ADHD medications, CONCERTA® has side effects
CONCERTA® has low incidence of insomnia (12.3%) and mood changes (1.4%)
Over 53 million prescriptions of CONCERTA® have been filled
READ FULL ARTICLE
The Safety of CONCERTA®
A Well-Tolerated Treatment
Clinical studies have proven CONCERTA® to be effective and well tolerated
Like all ADHD medications, CONCERTA® has side effects
CONCERTA® has low incidence of insomnia (12.3%) and mood changes (1.4%)
Over 53 million prescriptions of CONCERTA® have been filled
The safety of CONCERTA® in adults has been studied in a long-term, open label study for up to 12 months. Over 1,000 adults have participated in clinical studies that have proven CONCERTA® to be effective and well tolerated. Methylphenidate, the medication in CONCERTA®, has been prescribed for more than 50 years.
Adults with ADHD are typically started on a daily dose of 18 or 36 mg of CONCERTA®. But like many ADHD medications, your dose may need to be adjusted to achieve better results.
Many adults with ADHD may have concerns that their ADHD medication will affect their sleep. If this is a concern for you, ask your healthcare professional if CONCERTA® may be the right choice for you. CONCERTA® has a low incidence of insomnia.
Like all ADHD medications, CONCERTA® has side effects.
- 4.3% of adults had initial insomnia
- 12.3% experienced insomnia
- 1.4% experienced mood changes
The most common (greater than 10%) side effects are dry mouth, nausea, decreased appetite, headache, and insomnia.
CONCERTA is approved for the treatment of ADHD as part of a total treatment program that may include counseling or other therapies.
More than 53 million prescriptions of CONCERTA® have been filled for patients. If you're diagnosed with ADHD, ask your healthcare professional about managing the everyday challenges of ADHD with CONCERTA®.
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.
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®.
Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had problems with alcohol or drugs; 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. 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®. 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 (>5%) reported in children and adolescents was upper abdominal pain. The most common adverse reactions (>10%) reported in adults were dry mouth, nausea, decreased appetite, headache, and insomnia.
CONCERTA® and OROS® are registered trademarks of ALZA Corporation
© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2009. All rights reserved.
This site is published by McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This site and its contents are intended for USA audiences only.
Questions or comments? Call 1-888-440-7903
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
For information on free or discounted prescription medications, visit Access2Wellness Patient Assistance Program or call 866-317-2775.
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