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Sinemet (Carbidopa / Levodopa) - Side Effects and Adverse Reactions

 
 



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.



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



See index of all Sinemet side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-17

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