Tidomet/Tidomet CR Adverse Reactions

Gastrointestinal effects, notably nausea, vomiting, and anorexia are common early in treatment with levodopa, particularly if the dosage is increased too rapidly. Gastrointestinal bleeding has been reported in patients with a history of peptic ulcer disease.
The commonest cardiovascular effect is orthostatic hypotension, which is usually asymptomatic, but may be associated with faintness and dizziness. Cardiac arrhythmias have been reported and hypertension has occasionally occurred.
Psychiatric symptoms occur in a high proportion of patients, especially the elderly, and include agitation, anxiety, euphoria, nightmares, insomnia or sometimes drowsiness, and depression. More serious effects, usually requiring a reduction in dosage or withdrawal of levodopa, include aggression, paranoid delusions, hallucinations, delirium, severe depression, with or without suicidal behaviour, and unmasking of psychoses. Psychotic reactions are more likely in patients with postencephalitic parkinsonism or a history of mental disorders. Excessive daytime sleepiness and sudden onset of sleep have been reported very rarely.
Abnormal involuntary movements or dyskinesias are the most serious dose-limiting adverse effects of levodopa and are very common at the optimum dose required to control parkinsonism; their frequency increases with duration of treatment. Involuntary movements of the face, tongue, lips, and jaw often appear first and those of the trunk and extremities later.
Severe generalized choreoathetoid and dystonic movements may occur after prolonged use. Muscle twitching and blepharospasm may be early signs of excessive dosage. Exaggerated respiratory movements and exacerbated oculogyric crises have been reported in patients with postencephalitic parkinsonism. Bradykinesia and akinesia, in the form of 'end-of-dose' deterioration and the 'on-off' phenomenon, may reemerge in patients with parkinsonism as a complication of long-term treatment, but may be due to progression of the disease rather than to levodopa.
A positive response to the direct Coombs' test may occur, usually without evidence of haemolysis although auto-immune haemolytic anaemia has occasionally been reported. Transient leucopenia and thrombocytopenia have occurred rarely. The effects of levodopa on liver and kidney function are generally slight; transient increases in liver enzymes, and in blood-urea nitrogen and serum-uric acid concentrations, have been reported. Levodopa may cause discoloration of the urine; reddish at first then darkening on standing. Other body fluids may also be discoloured.
Some of the adverse effects reported may not be attributable directly to levodopa, but rather to the use of antimuscarinics, to increased mobility, or to the unmasking of underlying conditions as parkinsonism improves. Use with a peripheral dopa-decarboxylase inhibitor may reduce the severity of peripheral symptoms such as gastrointestinal and cardiovascular effects, but central effects such as dyskinesias and mental disturbances may occur earlier in treatment.
Patient to seek medical attention immediately at the first sign of any adverse drug reaction shall appear.