Methylin (Methylphenidate Hydrochloride) - Side Effects and Adverse Reactions

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; 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, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO METHYLIN

Possible Methylin side effects / adverse reactions in 31 year old male

Reported by a physician from Netherlands on 2007-03-21

Patient: 31 year old male

Reactions: Adrenergic Syndrome, Mydriasis, Hallucination, Auditory, Dyskinesia, Confabulation, Alcohol Poisoning, Drug Toxicity, Blood Potassium Decreased, Psychomotor Skills Impaired, Suicide Attempt, Urinary Retention, Feeling Abnormal

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ethanol (Ethanol)
    Dosage: 2 bottles of wine, oral
    Administration route: Oral

Ibuprofen
    Dosage: 20 tablets, oral
    Administration route: Oral

Methylin
    Dosage: see image
    Administration route: Oral

Possible Methylin side effects / adverse reactions in 48 year old female

Reported by a physician from United States on 2007-05-14

Patient: 48 year old female weighing 66.2 kg (145.7 pounds)

Reactions: Agitation, Drug Effect Decreased, Disturbance in Attention, Depression, Aggression

Suspect drug(s):
Methylin
    Dosage: 20mg qid oral
    Administration route: Oral
    Indication: Attention Deficit/hyperactivity Disorder
    Start date: 2007-01-30

Methylin
    Dosage: 20mg qid oral
    Administration route: Oral
    Indication: Narcolepsy
    Start date: 2007-01-30

Methylphenaline
    Start date: 2007-04-07

Possible Methylin side effects / adverse reactions in 11 year old male

Reported by a consumer/non-health professional from United States on 2007-06-25

Patient: 11 year old male weighing 40.8 kg (89.8 pounds)

Reactions: Lactose Intolerance, Vomiting, Reaction TO Drug Excipients, Pharmaceutical Product Complaint

Suspect drug(s):
Methylin

Other drugs received by patient: Metadate CD; Zyrtec; Prevacid; Remeron; Pulmicort; Nasonex