Stalevo Side Effects

Please note - some side effects for Stalevo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Stalevo - for the Consumer

Stalevo

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Stalevo:

Change in taste; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; dark urine; depression with thoughts of suicide; fainting; fever; hallucinations; increased or irregular heart beat; lack of response to environment; mental or mood changes; muscle pain, stiffness, or rigidity; paranoia; seizures; severe or persistent diarrhea; severe or persistent dizziness; stomach pain; trouble sleeping; unusual or painful movements of the face, eyelids, mouth, tongue, arms, hands, or legs; unusual skin growths or change in the appearance of a mole; unusual sweating; vomiting; yellowing of the skin or eyes.

Side Effects by Body System

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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