Concerta Side Effects

Generic name: methylphenidate

Generic Name: Methylphenidate

Please note - some side effects for Concerta may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Concerta - for the consumer

Concerta Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Concerta Extended-Release Tablets:

Dizziness; drowsiness; dry mouth; headache; increased sweating; loss of appetite; nausea; nervousness; stomach pain; trouble sleeping; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; joint pain; purple or brownish red spots on the skin); behavior changes (eg, aggression, hostility); blurred vision or other vision problems; chest pain or discomfort; confusion; dark urine; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; mental or mood changes (eg, abnormal thoughts, agitation, anxiety, depression, irritability, persistent crying, unresponsiveness, unusual sadness); seizures; severe or persistent dizziness or headache; suicidal thoughts or attempts; uncontrolled speech or muscle movements; yellowing of the eyes or skin.

For the professional

Concerta

The development program for Concerta® included exposures in a total of 2121 participants in clinical trials (1797 patients, 324 healthy adult subjects). These participants received Concerta® 18, 36, 54 and/or 72 mg/day. Children, adolescents, and adults with ADHD were evaluated in four controlled clinical studies, three open-label clinical studies and two clinical pharmacology studies. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings in Clinical Trials with Concerta®

In the 4-week placebo-controlled, parallel-group trial in children (Study 3) one Concerta®-treated patient (0.9%; 1/106) and one placebo-treated patient (1.0%; 1/99) discontinued due to an adverse event (sadness and increase in tics, respectively).

In the 2-week placebo-controlled phase of a trial in adolescents (Study 4), no Concerta®-treated patients (0%; 0/87) and 1 placebo-treated patient (1.1%; 1/90) discontinued due to an adverse event (increased mood irritability).

In the two open-label, long-term safety trials (Studies 5 and 6: one 24-month study in children aged 6 to 13 and one 9-month study in child, adolescent and adult patients treated with Concerta®) 6.7% (101/1514) of patients discontinued due to adverse events. These events with an incidence of >0.5% included: insomnia (1.5%), twitching (1.0%), nervousness (0.7%), emotional lability (0.7%), abdominal pain (0.7%), and anorexia (0.7%).

Table 2 enumerates, for a 4-week placebo-controlled, parallel-group trial (Study 3) in children with ADHD at Concerta® doses of 18, 36, or 54 mg/day, theincidence of treatment-emergent adverse events. The table includes only those events that occurred in 1% or more of patients treated with Concerta® where the incidence in patients treated with Concerta® was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 3 lists the incidence of treatment-emergent adverse events for a 2-week placebo-controlled trial (Study 4) in adolescents with ADHD at Concerta® doses of 18, 36, 54 or 72 mg/day.

In a long-term uncontrolled study (n=432 children), the cumulative incidence of new onset of tics was 9% after 27 months of treatment with Concerta®.

In a second uncontrolled study (n=682 children) the cumulative incidence of new onset tics was 1% (9/682 children). The treatment period was up to 9 months with mean treatment duration of 7.2 months.

In the laboratory classroom clinical trials in children (Studies 1 and 2), both Concerta ® qd and methylphenidate tid increased resting pulse by an average of 2-6 bpm and produced average increases of systolic and diastolic blood pressure of roughly 1-4 mm Hg during the day, relative to placebo.

In the placebo-controlled adolescent trial (Study 4), mean increases from baseline in resting pulse rate were observed with Concerta ® and placebo at the end of the double-blind phase (5 and 3 beats/minute, respectively). Mean increases from baseline in blood pressure at the end of the double-blind phase for Concerta ® and placebo-treated patients were 0.7 and 0.7 mm Hg (systolic) and 2.6 and 1.4 mm Hg (diastolic), respectively.

Post-marketing experiences with Concertaâ have revealed spontaneous reports of the following adverse events: difficulties in visual accommodation; mydriasis; blurred vision; blood alkaline phosphatase increased; blood bilirubin increased; abnormal liver function test (e.g., transaminase elevation); bradycardia; palpitations; arrhythmia; chest discomfort; restlessness; Raynaud’s phenomenon; erythema; hyperhidrosis; arthralgia; myalgia; muscle twitching; therapeutic response decreased; drug effect decreased; hyperpyrexia; weight decreased; leucopenia; white blood cell count abnormal; pancytopenia; thrombocytopenia; platelet count decreased; confusional state; disorientation; alopecia; and hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions, and exanthemas NEC.

Adverse Events with Other Methylphenidate HCl Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: hepatic coma; isolated cases of cerebral arteritis and/or occlusion; anemia; transient depressed mood; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

By body system

Nervous system side effects

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.

Nervous system side effects have frequently included tic. Convulsions 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.

Gastrointestinal side effects

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.

Cardiovascular side effects

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.

Other side effects

Other side effects have rarely included headache, peripheral coldness, and auricular swelling. A withdrawal syndrome has been reported with the abrupt discontinuation of methylphenidate.

Hepatic side effects

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.

Hematologic side effects

Hematologic side effects have rarely included leukopenia, anemia, pancytopenia, thrombocytopenic purpura, and thrombocytopenia; however, causality has not been established.

Psychiatric side effects

Psychiatric side effects have frequently included emotional lability and insomnia. Hallucination, mania, 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.

Dermatologic side effects

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.

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.

Ocular side effects

Ocular side effects have included visual disturbances, mydriasis, difficulties with accommodation, diplopia, and blurring of vision.

Respiratory side effects

Respiratory side effects associated with methylphenidate topical patch have frequently included nasopharyngitis and nasal congestion.

Metabolic side effects

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%.

Hypersensitivity side effects

Hypersensitivity side effects including generalized erythematous and urticarial rashes, allergic contact dermatitis, angioedema, and anaphylaxis have been reported.

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