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Concerta Side Effects

Generic Name: methylphenidate

Note: This document contains side effect information about methylphenidate. Some of the dosage forms listed on this page may not apply to the brand name Concerta.

In Summary

Common side effects of Concerta include: insomnia, nausea, decreased appetite, and xerostomia. Other side effects include: anxiety, hyperhidrosis, and irritability. 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, oral tablet extended release chewable

Along with its needed effects, methylphenidate (the active ingredient contained in Concerta) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking methylphenidate:

More common
  • Fast heartbeat
Less common
  • 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
  • crusting, dryness, or flaking of the skin
  • muscle cramps
  • pinpoint red spots on the skin
  • scaling, severe redness, soreness, or swelling of the skin
  • seizures
  • uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
  • unusual bleeding or bruising
Incidence not known
  • Confusion
  • depression
  • 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
  • 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking methylphenidate:

Symptoms of overdose
  • Agitation
  • anxiety
  • bigger, dilated, or enlarged pupils of the eyes
  • confusion as to time, place, or person
  • dark-colored urine
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry eyes, mouth, nose, or throat
  • false or unusual sense of well-being
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • holding false beliefs that cannot be changed by fact
  • increased sensitivity of the eyes to light
  • loss of consciousness
  • muscle pain or stiffness
  • muscle twitching
  • nervousness
  • overactive reflexes
  • pounding in the ears
  • rapid, shallow breathing
  • sweating
  • tremors
  • unusual excitement, nervousness, or restlessness

Some side effects of methylphenidate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Headache
  • loss of appetite
  • nervousness
  • stomach pain
  • stuffy nose
  • trouble sleeping
  • unusually warm skin
Less common
  • Anger
  • decreased appetite
  • dizziness
  • drowsiness
  • fear
  • irritability
  • muscle aches
  • nausea
  • runny nose
  • scalp hair loss
  • talking, feeling, and acting with excitement
  • vomiting

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 disintegrating extended release, oral tablet extended release, transdermal film extended release

Nervous system

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.


1. "Product Information. Ritalin (methylphenidate)." Novartis Pharmaceuticals, East Hanover, NJ.

2. "Transdermal methylphenidate (Daytrana) for ADHD." Med Lett Drugs Ther 48 (2006): 49-51

3. Lowe TL, Cohen DJ, Detlor J, Kremenitzer MW, Shaywitz BA "Stimulant medications precipitate Tourette's syndrome." JAMA 247 (1982): 1168-9

4. Anderson VR, Scott LJ "Methylphenidate transdermal system : in attention-deficit hyperactivity disorder in children." Drugs 66 (2006): 1117-26

5. 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

6. Lowe TL, Cohen DJ, Detlor J, Kremenitzer MW, Shaywitz BA "Stimulant medications precipitate Tourette's syndrome." JAMA 247 (1982): 1729-31

7. "Multum Information Services, Inc. Expert Review Panel"

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

9. Wilens TE, Hammerness PG, Biederman J, et al. "Blood pressure changes associated with medication treatment of adults with attention-deficit/hyperactivity disorder." J Clin Psychiatry 66 (2005): 253-9

Some side effects of Concerta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.