Concerta is currently approved to treat attention deficit hyperactivity disorder (ADHD). The medication affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

What is Concerta?

Concerta is marketed by Janssen Pharmaceuticals and was approved by the U.S. Food & Drug Administration (FDA) in August 2000 to treat children with ADHD. In 2008, the agency expanded Concerta’s approved indications to include the treatment of ADHD in adults.

Methylphenidate is the active ingredient in Concerta. Other medications that contain methylphenidate include Ritalin, Aptensio, Biphentin, Daytrana, Equasym, Medikinet, Metadate, Methylin, and generics.  Other drugs indicated for the treatment of ADHD include Adderall XR, Biphentin, Strattera, Intuniv XR, and Dexedrine.

Concerta Side Effects

Common side effects of Concerta may include nausea, insomnia, xerostomia, and decreased appetite. Others may include anxiety, irritability, and hyperhidrosis.

Concerta patients should check with their doctor if they experience:

  • Rapid heart beat
  • Chest pain
  • Fever
  • Joint pain
  • Skin rash or hives
  • Black, tarry stools
  • Blood in the urine or stools
  • Blurred vision or other changes in vision
  • Convulsions
  • Crusting, dryness, or flaking of the skin
  • Muscle cramps
  • Pinpoint red spots on the skin
  • Scaling, severe redness, soreness, or swelling of the skin
  • Uncontrolled vocal outbursts or tics
  • Unusual bleeding or bruising
  • Confusion
  • Depression
  • Feeling like surroundings are not real
  • Numbness of the hands
  • Difficult or painful urination
  • Pale skin
  • Paleness or coldness in the fingertips and toes
  • Red, irritated eyes
  • Seeing, hearing, or feeling things that are not there
  • Severe or sudden headache
  • Shortness of breath
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Sudden loss of coordination
  • Sudden slurring of speech
  • Tingling or pain in the fingers or toes when exposed to cold
  • Unusual behavior
  • Unusual tiredness or weakness
  • Unexplained weight loss
  • Yellowing of skin or eyes

Concerta is contraindicated for patients who suffer from glaucoma, tics or Tourette’s syndrome, or severe anxiety, tension, or agitation. Do not use the medication if you have taken an MAO inhibitor in the past 14 days.

Concerta can be habit forming, and should not be used by those with a history of drug addiction. Misusing Concerta can result in death or serious heart side effects.

Abuse of ADHD Drugs A Growing Problem

According to a joint investigation conducted by the Milwaukee Journal-Sentinel and MedPage Today,the abuse of Concerta and other ADHD drugs has become a growing problem, thanks to relaxed standards for diagnosing the condition in adults.  Read More

Concerta and Suicidal Behavior

In 2005, the FDA announced that it was planning to strengthen warnings about possible psychiatric side effects from Concerta, Ritalin and other forms of methylphenidate-containing medications. An FDA review of Concerta use among children had turned up an unexpected number of reports linking the drug to suicidal thoughts, hallucinations and violent behavior. A review of other methylphenidate drugs, including Ritalin, produced similar findings. The FDA said it was also is investigating whether these types of  behaviors are seen with other  ADHD treatments, including Adderall and Strattera.

In 2015, regulators in Canada announced that the labels for Concerta and other ADHD drugs were being modified to include stronger, clearer warnings regarding the risk of suicidal thoughts and behaviors. “The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs,” Health Canada said in a statement.  “The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.”

In addition to Concerta, other ADHD medications subject to the label modifications included:

  • Adderall XR
  • Biphentin
  • Dexedrine
  • Intuniv XR
  • Ritalin
  • Ritalin SR
  • Strattera
  • Vyvanse

While Health Canada noted that there was s little evidence to establish that the drugs actually cause suicidal thoughts and behaviors, the regulator voiced concern that they may contribute to the risk.

  1. Janssen Pharmaceuticals (2016) “Concerta Prescribing Information”
  2. Associated Press (2005) “FDA Probing ADHD Drug Side Effects”
  3. Health Canada (2015) “ADHD drugs may increase risk of suicidal thoughts and behaviours in some people; benefits still outweigh risks”
Last Modified: September 16, 2016

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