Concerta Risks, Warnings, and Complications

POTENTIAL FOR ABUSE AND ADDICTION: Concerta is a federally controlled substance (Schedule II) with a high potential for abuse and misuse. This medication is habit-forming, and taking it without a doctor’s prescription can lead to physical dependence and drug addiction. Misuse and abuse of CNS stimulants, including Concerta, can put you at risk of a possibly fatal overdose. This risk of overdose and death is greater if you take high doses or inject or snort the drug. 

Before prescribing Concerta, your healthcare provider will assess your risk for misuse and abuse of stimulant drugs like methylphenidate and other substances. Tell your doctor if you have a personal or family history of substance abuse (alcohol, street drugs, or prescription drug abuse). 

Make sure you store Concerta safely to prevent misuse, diversion, or accidental ingestion by others. Keep track of the number of Concerta tablets so you know if any are missing. Do not give or sell your Concerta to others - this is against the law. Do not obtain Concerta from illegal sources. 

 Do not take a higher dose or more frequent doses of Concerta than prescribed. Never use Concerta in unapproved ways, such as snorting or injecting it.

RISK IN PATIENTS WITH HEART DISEASE: There are reports of sudden death in people with severe heart disease, such as structural heart abnormalities, cardiomyopathy, coronary artery disease, and cardiac arrhythmias, after treatment with CNS stimulants. Your doctor will avoid prescribing Concerta to you if you have a history of serious heart disease.

  Seek emergency medical attention if you develop symptoms such as chest pain, chest pressure, or difficulty breathing while you are on Concerta.

INCREASED BLOOD PRESSURE AND HEART RATE: Taking stimulant medications, including Concerta, can cause an increase in blood pressure and heart rate and raise the risk of heart problems. Your doctor will monitor blood pressure and heart rate while you are on this medication. Talk to your doctor about the need to adjust the dose of your blood pressure medication if you take one.

ADVERSE PSYCHIATRIC REACTIONS: CNS stimulants can cause worsening symptoms in people with pre-existing psychotic disorders. These drugs can also trigger a manic or mixed episode in people with bipolar disorder. In addition, Concerta can cause new psychotic symptoms or manic symptoms in some people, such as paranoia, delusions, hallucinations, or mania. 

Before starting Concerta, tell your doctor if you have a personal or family history of depression, bipolar illness, psychosis, or suicide attempts. Tell your doctor immediately if you develop any unusual changes in mood or behavior problems. You may need to stop taking Concerta if you develop adverse psychiatric effects.

SEIZURES: CNS stimulants can lower the seizure threshold in people with a history of seizure disorders (epilepsy) or abnormal EEG (abnormal brain wave test). Very rarely, this can also happen in people with no prior history of seizures or EEG abnormalities. You will need to stop treatment with Concerta if you develop seizures (convulsions).

PRIAPISM: There are reports of priapism (painful or prolonged erections lasting more than 4 hours) in people who took Concerta and other CNS stimulants. This is a medical emergency and can result in permanent damage to the penile tissue without prompt medical attention. Seek emergency medical care if you experience a prolonged or painful erection that does not go away. This is more likely to occur after an increase in the dose of Concerta.

PERIPHERAL VASCULAR DISEASE: Concerta can cause circulation problems (peripheral vasculopathy), including Raynaud's phenomenon. Call your doctor right away if you develop signs and symptoms of blood flow problems in your fingers and toes, such as color changes (pale or blue), numbness and tingling, temperature sensitivity, or unexplained wounds. These symptoms usually improve after the dose of Concerta is reduced or the drug is discontinued.

LONG-TERM SUPPRESSION OF GROWTH IN CHILDREN: Concerta is a prescription stimulant medicine that can cause a decreased rate of growth in children. Your child’s healthcare provider will have your child’s height and weight checked and recorded during treatment with Concerta. They may advise interrupting Concerta therapy if your child has negative side effects (if they are not gaining height or weight as expected for age).

RISK OF GASTROINTESTINAL OBSTRUCTION: The Concerta tablet is non-deformable and passes through the digestive tract intact without changing shape. You may see an empty tablet shell in your stool and this is normal. However, Concerta tablets are not safe for use in people with narrowing of the gastrointestinal tract, gastrointestinal motility disorders, short gut syndrome, peritonitis, inflammatory bowel disease, cystic fibrosis, Meckel’s diverticulum, or chronic intestinal pseudo-obstruction, because of a risk of digestive tract obstruction (blockage). Also, Concerta is a controlled-release formulation (the dose of the medicine is released slowly over time in the body). It should, therefore, only be used by people who can swallow the tablet whole.

MONITORING OF BLOOD CELL COUNTS: People receiving Concerta long-term should undergo periodic monitoring of blood cell counts including a complete blood count (CBC) with differential and platelet count. 

RISK OF GLAUCOMA: There are reports of angle-closure glaucoma and increased intraocular pressure in people treated with methylphenidate (the active ingredient in Concerta). Your healthcare provider may send you to an ophthalmologist (eye specialist) for evaluation before starting Concerta if you are at a high risk of glaucoma. Seek immediate medical care if you develop eye pain or eyesight changes while on this medicine.

VERBAL AND MOTOR TICS: Concerta and other CNS stimulants can cause or worsen motor and verbal tics (involuntary movements or sounds) and worsen symptoms of Tourette's syndrome. Tell your healthcare provider if there is a personal or family history of tics or Tourette's syndrome before starting Concerta.