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.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Stalevo:

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; fast or irregular heartbeat; fever; hallucinations; lack of response to environment; mental or mood changes; muscle pain, stiffness, or rigidity; new or increased involuntary movements; paranoia; seizures; severe or persistent dizziness; severe, persistent, or watery diarrhea; shortness of breath; 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Stalevo Side Effects - for the Professional

Stalevo

Carbidopa-levodopa

The most common adverse reactions reported with carbidopa-levodopa have included dyskinesias, such as choreiform, dystonic, and other involuntary movements and nausea.

The following other adverse reactions have been reported with carbidopa-levodopa:

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, neuroleptic malignant syndrome, 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, increased libido. Convulsions also have occurred; however, a causal relationship with carbidopa-levodopa 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), lactic dehydrogenase, bilirubin, blood urea nitrogen (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 Stalevo® (carbidopa, levodopa and entacapone) 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, failing, 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, flushing.

Special Senses: Oculogyric crisis, 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.

Entacapone

The most commonly observed adverse events (>5%) in the double-blind, placebo-controlled trials of entacapone (N=1003) associated with the use of entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia/hyperkinesia, nausea, urine discoloration, diarrhea, and abdominal pain.

Approximately 14% of the 603 patients given entacapone in the double-blind, placebo-controlled trials discontinued treatment due to adverse events compared to 9% of the 400 patients who received placebo. The most frequent causes of discontinuation in decreasing order are: psychiatric reasons (2% vs. 1%), diarrhea (2% vs. 0%), dyskinesia/hyperkinesia (2% vs. 1%), nausea (2% vs. 1%), abdominal pain (1% vs. 0%), and aggravation of Parkinson's disease symptoms (1% vs. 1%).

Adverse Event Incidence in Controlled Clinical Studies of Entacapone

Table 5 lists treatment emergent adverse events that occurred in at least 1% of patients treated with entacapone participating in the double-blind, placebo-controlled studies and that were numerically more common in the entacapone group, compared to placebo. In these studies, either entacapone or placebo was added to carbidopa-levodopa (or benserazide-levodopa).

Table 5 Summary of Patients With Adverse Events After Start of Trial Drug Administration At Least 1% in Entacapone Group and >Placebo

SYSTEM ORGAN CLASS   Preferred Term	Entacapone (n = 603) % of patients	Placebo (n = 400) % of patients
SKIN AND APPENDAGES DISORDERS
Sweating Increased	2	1
MUSCULOSKELETAL SYSTEM DISORDERS
Back Pain	2	1
CENTRAL & PERIPHERAL NERVOUS SYSTEM DISORDERS
Dyskinesia	25	15
Hyperkinesia	10	5
Hypokinesia	9	8
Dizziness	8	6
SPECIAL SENSES, OTHER DISORDERS
Taste Perversion	1	0
PSYCHIATRIC DISORDERS
Anxiety	2	1
Somnolence	2	0
Agitation	1	0
GASTROINTESTINAL SYSTEM DISORDERS
Nausea	14	8
Diarrhea	10	4
Abdominal Pain	8	4
Constipation	6	4
Vomiting	4	1
Mouth Dry	3	0
Dyspepsia	2	1
Flatulence	2	0
Gastritis	1	0
Gastrointestinal Disorders NOS	1	0
RESPIRATORY SYSTEM DISORDERS
Dyspnea	3	1
PLATELET, BLEEDING & CLOTTING DISORDERS
Purpura	2	1
URINARY SYSTEM DISORDERS
Urine Discoloration	10	0
BODY AS A WHOLE - GENERAL DISORDERS
Back Pain	4	2
Fatigue	6	4
Asthenia	2	1
RESISTANCE MECHANISM DISORDERS
Infection Bacterial	1	0

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures do, however, provide the prescriber with some basis for estimating the relative contribution of drug and nondrug factors to the adverse events observed in the population studied.

Effects of Gender and Age on Adverse Reactions

No differences were noted in the rate of adverse events attributable to entacapone alone by age or gender.

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Side Effects by Body System - for Healthcare Professionals

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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