Metadate ER Side Effects

Generic Name: methylphenidate hydrochloride

Please note - some side effects for Metadate ER may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Metadate ER Side Effects - for the Professional

Metadate ER

Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, pruritus, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette's syndrome and obsessive-compulsive disorder. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; aggressive behavior; 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.

Postmarketing Experience

In addition to the adverse events listed above, the following have been reported in patients receiving methylphenidate worldwide. The list is alphabetized: abnormal behavior, aggression, anxiety, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, migraine, obsessive-compulsive disorder, peripheral coldness, Raynaud's phenomenon, reversible ischaemic neurological deficit, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.

Side Effects by Body System - for Healthcare Professionals

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.

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.

Gastrointestinal

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

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.

Other

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

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

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

Psychiatric

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.

Dermatologic

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.

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.

Ocular

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

Respiratory

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

Metabolic

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%.

Local

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.

Hypersensitivity

One subject has been reported to have experienced erythema and edema at methylphenidate 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

Musculoskeletal side effects including arthralgia, myalgia, and muscle twitching have been reported.

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