Carbidopa has not been demonstrated to have any overt
pharmacodynamic actions in the recommended doses. The only adverse reactions
that have been observed have been with concomitant use of carbidopa with other
drugs such as levodopa, and with carbidopalevodopa combination products.
When LODOSYN is administered concomitantly with levodopa
or carbidopa-levodopa combination products, the most common adverse reactions
have included dyskinesias such as choreiform, dystonic, and other involuntary
movements, and nausea. Other adverse reactions reported with LODOSYN when
administered concomitantly with levodopa alone or carbidopa-levodopa
combination products were psychotic episodes including delusions,
hallucinations, and paranoid ideation, depression with or without development
of suicidal tendencies, and dementia. Convulsions also have occurred; however,
a causal relationship with concomitant use of LODOSYN and levodopa has not been
The following other adverse reactions have been reported
with levodopa and carbidopalevodopa combination products. These same adverse
reactions may also occur when LODOSYN is administered with these products.
Body as a Whole: abdominal pain and distress,
asthenia, chest pain, fatigue.
Cardiovascular: cardiac irregularities,
hypertension, myocardial infarction, hypotension including orthostatic
hypotension, palpitation, phlebitis, syncope.
Gastrointestinal: anorexia, bruxism, burning
sensation of the tongue, constipation, dark saliva, development of duodenal
ulcer, diarrhea, dry mouth, dyspepsia, dysphagia, flatulence, gastrointestinal
bleeding, gastrointestinal pain, heartburn, hiccups, sialorrhea, taste
Hematologic: hemolytic and non-hemolytic anemia,
leukopenia, thrombocytopenia, agranulocytosis.
Hypersensitivity: angioedema, urticaria, pruritus,
Henoch-Schonlein purpura, bullous lesions (including pemphigus-like reactions).
Metabolic: edema, weight gain, weight loss.
Musculoskeletal: back pain, leg pain, muscle
cramps, shoulder pain.
Nervous System/Psychiatric: Psychotic episodes
including delusions, hallucinations and paranoid ideation, neuroleptic
malignant syndrome (NMS, see WARNINGS), 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 LODOSYN and
levodopa, has not been established.
Respiratory: upper respiratory infection, dyspnea,
pharyngeal pain, cough.
Skin: flushing, increased sweating, malignant
melanoma (see also CONTRAINDICATIONS), rash, alopecia, dark sweat.
Special Senses: oculogyric crises, diplopia,
blurred vision, dilated pupils.
Urogenital: dark urine, priapism, urinary
frequency, urinary incontinence, urinary retention, urinary tract infection.
Laboratory Tests: abnormalities in alkaline phosphatase,
SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen
(BUN), Coombs test; elevated serum glucose; decreased hemoglobin and
hematocrit; decreased white blood cell count and serum potassium; increased
serum creatinine and uric acid; white blood cells, bacteria and blood in the
urine; protein and glucose in the urine.
Miscellaneous: bizarre breathing patterns,
faintness, hoarseness, hot flashes, malaise, neuroleptic malignant syndrome,
sense of stimulation.