Concerta Side Effects
Generic Name: methylphenidate
Note: This page contains information about the side effects of methylphenidate. Some of the dosage forms included on this document may not apply to the brand name Concerta.
Common side effects of Concerta include: insomnia, nausea, xerostomia, and decreased appetite. Other side effects include: anxiety, irritability, and hyperhidrosis. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to methylphenidate: oral capsule extended release, oral powder for suspension extended release, oral solution, oral tablet, oral tablet chewable, oral tablet extended release
Other dosage forms:
In addition to its needed effects, some unwanted effects may be caused by methylphenidate (the active ingredient contained in Concerta). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking methylphenidate:More common:
- Fast heartbeat
- Chest pain
- joint pain
- skin rash or hives
- Black, tarry stools
- blood in the urine or stools
- blurred vision or other changes in vision
- 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 (uncontrolled and repeated body movements)
- unusual bleeding or bruising
- feeling like surroundings are not real
- numbness of the hands
- painful or difficult urination
- pale skin
- paleness or cold feeling in the fingertips and toes
- red, irritated eyes
- red, swollen, or scaly skin
- 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
- weight loss
- yellow skin or eyes
Minor Side Effects
Some of the side effects that can occur with methylphenidate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common:
- Abdominal or stomach pain
- loss of appetite
- stuffy nose
- trouble sleeping
- unusually warm skin
- muscle aches
- runny nose
- scalp hair loss
- talking, feeling, and acting with excitement
For Healthcare Professionals
Applies to methylphenidate: oral capsule extended release, oral powder for reconstitution extended release, oral solution, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet extended release, transdermal film extended release
Nervous system side effects have frequently included tic. Convulsions and migraine have also been reported. Dizziness, drowsiness, dyskinesia, and Tourette's syndrome have been reported rarely. Neuroleptic malignant syndrome (NMS) and reversible ischemic neurological deficit have been reported very rarely.[Ref]
Most reported cases of neuroleptic malignant syndrome (NMS) involved patients who were treated concomitantly with other drugs associated with NMS.
Nervousness and insomnia may be controllable by reducing the dosage and omitting the drug in the afternoon or evening.
It is unclear whether CNS stimulant drugs (i.e., dextroamphetamine, methylphenidate, amphetamine-dextroamphetamine) have a role in either the development or worsening of tic disorders such as Tourette's syndrome. According to several case reports, use of CNS stimulant medications may have precipitated or exacerbated tic disorders in some patients with ADHD. Based on these cases, in Tourette's-susceptible patients, CNS stimulants may exacerbate motor and phonic tics that do not subside following discontinuation of the offending agent. In several controlled studies involving patients with ADHD and tic disorders, in the majority of patients, tics did not increase following use of CNS stimulants. In addition, controlled studies have not found that methylphenidate worsens motor tics in Tourette's syndrome nor has it increased tics in patients without Tourette's. However, it should be noted that tics were reported in 7% of patients using the methylphenidate patch compared to 1% to those taking it orally. Additional studies are required in order to clarify this association.[Ref]
Gastrointestinal side effects have included nausea, vomiting, and abdominal pain. Nausea and vomiting appears to occur more frequently with the transdermal patch compared with oral administration. Postmarketing side effects include bruxism.[Ref]
Cardiovascular side effects have rarely included changes in blood pressure and pulse rate, cerebral arteritis, occlusion, angina, arrhythmia, palpitations, bradycardia, extrasystoles, ventricular extrasystoles, supraventricular tachycardia, Raynaud's phenomenon, and tachycardia. A case of cardiac arrest has also been reported. Additionally, cerebrovascular vasculitis, cerebral hemorrhages, and cerebrovascular accidents have been reported.[Ref]
Other side effects have rarely included headache, peripheral coldness, and auricular swelling. A withdrawal syndrome has been reported with the abrupt discontinuation of methylphenidate (the active ingredient contained in Concerta) [Ref]
Hepatic side effects have rarely included abnormal liver function ranging from transaminase elevation to hepatic coma; however, causality has not been established. Increased blood alkaline phosphatase, increased blood bilirubin, and increased hepatic enzymes have also been reported.[Ref]
Hematologic side effects have rarely included leukopenia, anemia, pancytopenia, thrombocytopenic purpura, and thrombocytopenia; however, causality has not been established.[Ref]
Psychiatric side effects have frequently included emotional lability and insomnia. Hallucination, mania, obsessive-compulsive disorder, and nervousness have also been reported. Emotional lability and insomnia appear to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of insomnia was 30%. Transient depressed mood and aggressive behavior have been reported rarely; however, causality has not been determined. Postmarketing side effects include logorrhea.[Ref]
Dermatologic side effects have included bullous conditions, exfoliative conditions, urticarias, pruritus, rashes, eruptions, erythema, and exanthemas. Scalp hair loss has been reported rarely; however, causality has not been determined.[Ref]
Methylphenidate topical patch is a dermal irritant. The resulting erythema does not typically cause an interference or discontinuation of treatment. However, further evaluation should be sought, if erythema, edema, and/or papules do not resolve or significantly reduce within 24 hours of patch removal. Consideration should be given to sensitization if erythema is accompanied by edema, papules, vesicles, or other evidence of more intense local reactions. Diagnosis of allergic contact dermatitis should include appropriate diagnostic testing.[Ref]
Ocular side effects have included visual disturbances, mydriasis, difficulties with accommodation, diplopia, and blurring of vision.[Ref]
Respiratory side effects associated with methylphenidate (the active ingredient contained in Concerta) topical patch have frequently included nasopharyngitis and nasal congestion.[Ref]
Metabolic side effects have included anorexia, decreased appetite, and weight loss (primarily with prolonged therapy). Anorexia, decreased appetite, and weigh loss appears to occur more frequently with the transdermal patch compared with oral administration. In patients wearing the transdermal patch for 12 hrs a day, the incidence of anorexia was 46%.[Ref]
Local side effects associated with the topical patch have included application site reactions such as bleeding, bruising, burn, burning, dermatitis, discharge, discoloration, discomfort, dryness, eczema, edema, erosion, erythema, excoriation, exfoliation, fissure, hyperpigmentation, hypopigmentation, induration, infection, inflammation, irritation, pain, papules, paresthesia, pruritus, rash, scab, swelling, ulcer, urticaria, vesicles, and warmth.
One subject has been reported to have experienced erythema and edema at methylphenidate (the active ingredient contained in Concerta) transdermal system application sites with concurrent urticarial lesions on the abdomen and legs resulting in treatment discontinuation. This subject was not transitioned to oral methylphenidate.
Hypersensitivity side effects including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis have been reported.
Musculoskeletal side effects including arthralgia, myalgia, and muscle twitching have been reported.
Genitourinary side effects have included in rare instances prolonged and painful erections known as priapism.
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4. Greenhill LL, Pliszka S, Dulcan MK, et al. "Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults." J Am Acad Child Adolesc Psychiatry 41(2 Suppl) (2002): 26S-49S
5. Anderson VR, Scott LJ "Methylphenidate transdermal system : in attention-deficit hyperactivity disorder in children." Drugs 66 (2006): 1117-26
6. Lowe TL, Cohen DJ, Detlor J, Kremenitzer MW, Shaywitz BA "Stimulant medications precipitate Tourette's syndrome." JAMA 247 (1982): 1729-31
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8. Daly MW, Custer G, McLeay PD "Cardiac arrest with pulseless electrical activity associated with methylphenidate in an adolescent with a normal baseline echocardiogram." Pharmacotherapy 28 (2008): 1408-12
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Not all side effects for Concerta may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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