Pharmaceutical Name

Trade (marketing or proprietary) name: Ritalin®

Generic (nonproprietary or active ingredient) name: Methylphenidate hydrochloride tablets

Indication and Usage

Reason the product has been approved for sale on the market.

FDA approved this central nervous system (CNS) stimulant for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy.

Manufacturer Insert

Ingredients

Methylphenidate HCl, USP, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Abuse and dependence, Psychotic or manic symptoms in patients with no prior history or exacerbation of symptoms in patients with preexisting psychiatric illness, Long-term suppression of growth, Tachycardia, Palpitations, Headache, Insomnia, Anxiety, Abdominal pain, Weight loss, Decreased appetite, Thrombocytopenic purpura, Arthralgia, Muscle cramps, Rhabdomyolysis, Sudden death, Stroke, Myocardial infarction, Painful and prolonged penile erections/priapism sometimes requiring surgical intervention, Peripheral vasculopathy including Raynaud’s phenomenon, Dry mouth, Nausea, Hyperhidrosis (abnormally increased sweating), Angioedema (swelling), Anaphylactic reactions, Hallucinations, Delusional thinking, Nasopharyngitis (inflammation of the nasal passages and throat), Restlessness, Agitation, Psychosis (sometimes with visual and tactile hallucinations), Depressed mood, Blurred vision, Difficulties in visual accommodation, Increased blood pressure, Arrhythmias (abnormal hearbeat), Angina pectoris (chest pain), Cough, Vomiting, Dyspepsia (indigestion), Pruritus (itchy skin), Urticaria (hives), Exfoliative dermatitis, Leukopenia, Thrombocytopenia, Anemia, Suppression of growth during prolonged use in pediatric patients, Tremor, Dyskinesia including choreoatheetoid movements, Drowsiness, Convulsions, Cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), Serotonin syndrome in combination with serotonergic drugs, Abnormal liver function ranging from transaminase elevation to severe hepatic injury, Scalp hair loss, Erythema multiforme rash, Pancytopenia (significant reduction in the number of almost all blood cells), Auricular swelling, Bullous conditions, Eruptions, Exanthemas (reactive rash), Libido changes, Affect lability, Disorientation, Migraine, Diplopia (double vision), Mydriasis (dilated pupils), Pharyngolaryngeal pain, Dyspnea (shortness of breath), Raynaud’s phenomenon (fingers and toes feel numb or cold), Sudden cardiac death, Myocardial infarction, Bradycardia (slow resting heart rate), Extrasystole (premature ventricular contractions), Peripheral coldness, Diarrhea, Constipation, Muscle twitching, Myalgia (muscle pain), Erythema, Hematuria (blood in the urine), Gynecomastia (enlarged male breasts, Fatigue, Hyperpyrexia (high fever)

Analytical Deep Dive

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