Clinical Trials

• When Concerta was tested during its development, double-blind clinical trials identified one set of adverse reactions in children and adolescents, and a different group of effects in adults.
  
  

Adverse Reactions

• The most common adverse reaction in children is upper abdominal pain. In adults, Concerta may cause decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability and excess sweating.
  
  

Discontinuation

• When a child or adult stops taking Concerta, he may experience anxiety, irritability, insomnia and increased blood pressure.
  
  

Serious Side Effects

• While other adverse effects of Concerta are less common, they can be more serious. These effects include seizures, glaucoma, drug dependence, bowel obstruction and psychiatric disorders.
  
  

Warning

• Concerta may not be appropriate for people with a history of alcoholism or drug dependence, because those individuals are at higher risk for drug tolerance and abnormal behaviors that can include frank psychotic episodes.