ADVERSE REACTIONS
The most common adverse reactions reported with SINEMET have included dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea.
The following other adverse reactions have been reported with SINEMET:
Body as a Whole
Chest pain, asthenia.
Cardiovascular
Cardiac irregularities, hypotension, orthostatic effects including orthostatic hypotension, hypertension, syncope, phlebitis, palpitation.
Gastrointestinal
Dark saliva, gastrointestinal bleeding, development of duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry mouth, taste alterations.
Hematologic
Agranulocytosis, hemolytic and non-hemolytic anemia, thrombocytopenia, leukopenia.
Hypersensitivity
Angioedema, urticaria, pruritus, Henoch-Schönlein purpura, bullous lesions (including pemphigus-like reactions).
Musculoskeletal
Back pain, shoulder pain, muscle cramps.
Nervous System/Psychiatric
Psychotic episodes including delusions, hallucinations, and paranoid ideation, bradykinetic episodes ("on-off" phenomenon), confusion, agitation, dizziness, somnolence, dream abnormalities including nightmares, insomnia, paresthesia, headache, depression with or without development of suicidal tendencies, dementia, pathological gambling, increased libido including hypersexuality, impulse control symptoms. Convulsions also have occurred; however, a causal relationship with SINEMET has not been established.
Respiratory
Dyspnea, upper respiratory infection.
Skin
Rash, increased sweating, alopecia, dark sweat.
Urogenital
Urinary tract infection, urinary frequency, dark urine.
Laboratory Tests
Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.
Other adverse reactions that have been reported with levodopa alone and with various carbidopa levodopa formulations, and may occur with SINEMET are:
Body as a Whole
Abdominal pain and distress, fatigue.
Cardiovascular
Myocardial infarction.
Gastrointestinal
Gastrointestinal pain, dysphagia, sialorrhea, flatulence, bruxism, burning sensation of the tongue, heartburn, hiccups.
Metabolic
Edema, weight gain, weight loss.
Musculoskeletal
Leg pain.
Nervous System/Psychiatric
Ataxia, extrapyramidal disorder, falling, anxiety, gait abnormalities, nervousness, decreased mental acuity, memory impairment, disorientation, euphoria, blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time), trismus, increased tremor, numbness, muscle twitching, activation of latent Horner's syndrome, peripheral neuropathy.
Respiratory
Pharyngeal pain, cough.
Skin
Malignant melanoma (see also CONTRAINDICATIONS), flushing.
Special Senses
Oculogyric crises, diplopia, blurred vision, dilated pupils.
Urogenital
Urinary retention, urinary incontinence, priapism.
Miscellaneous
Bizarre breathing patterns, faintness, hoarseness, malaise, hot flashes, sense of stimulation.
Laboratory Tests
Decreased white blood cell count and serum potassium; increased serum creatinine and uric acid; protein and glucose in urine.
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REPORTS OF SUSPECTED SINEMET SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Sinemet. The information is not vetted and should not be considered as verified clinical evidence.
Possible Sinemet side effects / adverse reactions in 70 year old male
Reported by a consumer/non-health professional from United States on 2011-10-03
Patient: 70 year old male
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Suspect drug(s):
Sinemet
Possible Sinemet side effects / adverse reactions in 79 year old male
Reported by a physician from United States on 2011-10-11
Patient: 79 year old male
Reactions: Haemoglobin Decreased, Mental Status Changes, Urinary Retention, Constipation
Adverse event resulted in: hospitalization
Suspect drug(s):
Revlimid
Administration route: Oral
Indication: 5Q Minus Syndrome
Start date: 2011-06-03
End date: 2011-06-29
Revlimid
Administration route: Oral
Start date: 2011-07-11
Sinemet
Administration route: Oral
Indication: Parkinson's Disease
Sinemet CR
Administration route: Oral
Indication: Parkinson's Disease
Other drugs received by patient: Docusate Sodium; Bisacodyl; Vitamin D (Unspecified); Quetiapine Fumarate; Pravastatin Sodium; Prevacid; Aspirin; Polyethylene Glycol; Seroquel; Finasteride; Lodosyn
Possible Sinemet side effects / adverse reactions in 59 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-10-14
Patient: 59 year old male
Reactions: Pathological Gambling
Adverse event resulted in: hospitalization
Suspect drug(s):
Ropinirole Hydrochloride
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2006-01-01
Sinemet
Administration route: Oral
Start date: 2008-12-19
Rasagiline Mesylate
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2010-09-01
End date: 2011-02-18
Sinemet
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2006-01-01
End date: 2008-12-18
Ropinirole Hydrochloride
Administration route: Oral
Start date: 2002-01-01
End date: 2006-01-01
Ropinirole Hydrochloride
Administration route: Oral
Start date: 2006-01-01
End date: 2011-02-18
Other drugs received by patient: Candesartan Cilexetil; Clozapine
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