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
Body as a Whole
Chest pain, asthenia.
Cardiac irregularities, hypotension, orthostatic effects
including orthostatic hypotension, hypertension, syncope, phlebitis,
Dark saliva, gastrointestinal bleeding, development of
duodenal ulcer, anorexia, vomiting, diarrhea, constipation, dyspepsia, dry
mouth, taste alterations.
Agranulocytosis, hemolytic and non-hemolytic anemia,
Angioedema, urticaria, pruritus, Henoch-Schönlein purpura,
bullous lesions (including pemphigus-like reactions).
Back pain, shoulder pain, muscle cramps.
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.
Dyspnea, upper respiratory infection.
Rash, increased sweating, alopecia, dark sweat.
Urinary tract infection, urinary frequency, dark urine.
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.
Gastrointestinal pain, dysphagia, sialorrhea, flatulence,
bruxism, burning sensation of the tongue, heartburn, hiccups.
Edema, weight gain, weight loss.
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.
Pharyngeal pain, cough.
Malignant melanoma (see also CONTRAINDICATIONS),
Oculogyric crises, diplopia, blurred vision, dilated pupils.
Urinary retention, urinary incontinence, priapism.
Bizarre breathing patterns, faintness, hoarseness, malaise,
hot flashes, sense of stimulation.
Decreased white blood cell count and serum potassium;
increased serum creatinine and uric acid; protein and glucose in urine.