Carbidopa / entacapone / levodopa Side Effects

Some side effects of carbidopa / entacapone / levodopa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to carbidopa / entacapone / levodopa: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking carbidopa / entacapone / levodopa: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• nausea, sweating, feeling like you might pass out (especially when you first start taking this medication);

• depression, confusion, hallucinations, unusual thoughts or behavior, thoughts about hurting yourself;

• worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• fast, pounding, or uneven heartbeats;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling;

• tight feeling in your chest, new or worsening cough, fever, trouble breathing;

• easy bruising or bleeding, bloody or tarry stools, coughing up blood;

• pain or burning when you urinate; or

• unexplained muscle pain, tenderness, or weakness.

Less serious side effects of carbidopa / entacapone / levodopa may include:

• stomach pain or upset, loss of appetite, constipation;

• dry mouth, changes in your sense of taste;

• unusual skin changes. mild rash or itching;

• dizziness or drowsiness, headache, blurred vision;

• muscle cramps, back pain; or

• agitation or anxiety, sleep problems (insomnia), strange dreams.

You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to carbidopa / entacapone / levodopa: oral tablet

Nervous system

Nervous system side effects most commonly reported with carbidopa-levodopa-entacapone have included dyskinesias (choreiform, dystonic, and involuntary movements) and headache. Hyperkinesia, hypokinesia, and dizziness have been reported with entacapone.

Convulsions have also been reported; however, a causal relationship with carbidopa-levodopa has not been established.

Ocular

Ocular side effects reported with various carbidopa-levodopa products have included blurred vision, dilated pupils, diplopia, and oculogyric crisis.

Psychiatric

Psychiatric side effects have included reports of psychotic episodes (including delusions, hallucinations, and paranoid ideation), agitation, anxiety, confusion, dream abnormalities including nightmares, depression (with or without development of suicidal tendencies), somnolence, and dementia.

Respiratory

Respiratory side effects have included dyspnea, upper respiratory infection, pharyngeal pain, cough, pharyngitis, and rhinitis.

Cardiovascular

Cardiovascular side effects have included reports of cardiac irregularities, myocardial infarction, and orthostatic effects (hypotension, hypertension, and syncope), and palpitations.

Dermatologic

Dermatologic side effects have included rash, increased sweating, alopecia, dark sweat, and malignant melanoma.

Gastrointestinal

Gastrointestinal (GI) side effects have included dark saliva, GI bleeding, development of duodenal ulcer, abdominal pain, anorexia, nausea, vomiting, diarrhea, constipation, dyspepsia, dry mouth, dysphagia, sialorrhea, flatulence, gastritis, taste alterations, heartburn, and hiccups.

Hematologic

Hematologic side effects have included hemolytic and nonhemolytic anemia, agranulocytosis, thrombocytopenia, leukopenia, and purpura. Laboratory abnormalities reported have included decreased hemoglobin and hematocrit, serum potassium, Coombs' test, lactic dehydrogenase, bilirubin, and blood urea nitrogen (BUN); and elevated serum glucose.

Hypersensitivity

Hypersensitivity side effects have included angioedema, urticaria, pruritus, and Henoch-Schonlein purpura, bullous lesions (with pemphigus- like reactions).

Musculoskeletal

Musculoskeletal side effects have included asthenia, fatigue, back pain, shoulder pain, leg pain, and muscle cramps.

Genitourinary

Genitourinary side effects have included dark urine, blood in the urine, urinary incontinence, urinary retention, urinary tract infection, and priapism,

Hepatic

Hepatic side effects have included abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), and lactic dehydrogenase.

Renal

Renal side effects have included increases in serum creatinine and uric acid.

Metabolic

Metabolic side effects have included edema, weight gain, and weight loss.

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