ADVERSE REACTIONS
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, 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. 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; 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, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.
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REPORTS OF SUSPECTED METHYLPHENIDATE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Methylphenidate. The information is not vetted and should not be considered as verified clinical evidence.
Possible Methylphenidate side effects / adverse reactions in 10 year old female
Reported by a consumer/non-health professional from United States on 2011-10-06
Patient: 10 year old female weighing 36.3 kg (79.8 pounds)
Reactions: Product Substitution Issue, Vision Blurred
Suspect drug(s):
Methylphenidate
Possible Methylphenidate side effects / adverse reactions in 90 year old female
Reported by a health professional (non-physician/pharmacist) from Belgium on 2011-10-10
Patient: 90 year old female
Reactions: Hypothermia, Coma, General Physical Health Deterioration, Delirium, Death, Hallucination, Visual, Dementia With Lewy Bodies, Attention Deficit/hyperactivity Disorder
Adverse event resulted in: death
Suspect drug(s):
Methylphenidate
Possible Methylphenidate side effects / adverse reactions in 50 year old female
Reported by a individual with unspecified qualification from United States on 2011-10-12
Patient: 50 year old female
Reactions: Pharyngeal Oedema
Suspect drug(s):
Methylphenidate
Other drugs received by patient: Iron
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