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Stalevo

Last reviewed on RxList: 2/10/2016
Stalevo Side Effects Center

Last reviewed on RxList 11/21/2016

Stalevo (carbidopa, levodopa and entacapone) is a combination of several medications used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. Levodopa is converted to a chemical called dopamine in the brain. Symptoms of Parkinson's disease may be caused by low levels dopamine in the brain. Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect. When used with carbidopa and levodopa, entacapone increases levels of levodopa in the body. Common side effects of Stalevo include:

  • diarrhea,
  • nausea,
  • vomiting,
  • headache,
  • dizziness,
  • drowsiness,
  • blurred vision,
  • stomach pain or upset,
  • loss of appetite,
  • constipation,
  • dry mouth,
  • changes in your sense of taste,
  • skin rash or itching,
  • unusual skin changes,
  • muscle cramps,
  • back pain,
  • agitation,
  • anxiety,
  • difficulty sleeping (insomnia), or
  • strange dreams.

Tell your doctor if you have serious side effects of Stalevo including:

  • involuntary movements (especially twitching of the eyelid),
  • fainting or falling,
  • difficulty swallowing,
  • stomach/abdominal pain,
  • persistent diarrhea,
  • vision changes (including blurred vision),
  • black/tarry stools,
  • muscle pain,
  • changes in the amount of urine,
  • mental/mood changes (such as confusion, hallucinations, thoughts of suicide),
  • signs of infection (e.g., persistent sore throat), or
  • unusual strong urges (such as increased gambling, increased sexual urges).

The optimum daily dosage of Stalevo must be determined for each patient. Therapy should be individualized and adjusted according to the desired therapeutic response. Stalevo may interact with apomorphine, cholestyramine, dobutamine, epinephrine, isoniazid, isoproterenol, methyldopa, metoclopramide, papaverine, phenytoin, probenecid, antibiotics, blood pressure medication, antidepressants, medicines to treat psychiatric disorders, cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, medicine for seizures, or anti-anxiety medications. Tell your doctor all medications you are taking. Stalevo should be used only when prescribed during pregnancy. Levodopa passes into breast milk. It is unknown if carbidopa or entacapone pass into breast milk. Consult your doctor before breastfeeding.

Our Stalevo (carbidopa, levodopa and entacapone) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Stalevo Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Stalevo (Carbidopa, Levodopa and Entacapone)

Stalevo Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS sections of labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment/total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in clinical practice.

Entacapone

The most commonly observed adverse reactions (incidence at least 3% greater than placebo incidence) in the double-blind, carbidopa-levodopa-placebo-controlled trials of entacapone (N=1,003 patients) associated with the use of carbidopa-levodopa-entacapone alone and not seen at an equivalent frequency among the placebo-treated patients were: dyskinesia, urine discoloration, diarrhea, nausea, hyperkinesia, vomiting, and dry mouth.

The treatment difference incidence for premature study discontinuation for entacapone with levodopa and dopa decarboxylase inhibitor in the double-blind, placebo-controlled trials was 5%. The treatment difference incidence for the most frequent causes of study discontinuation was 2% for diarrhea, and 1% for other specific adverse reactions including psychiatric reasons, dyskinesia/ hyperkinesia, nausea, or abdominal pain.

Adverse Reaction Incidence in Controlled Clinical Studies of Entacapone

Table 2 lists treatment emergent adverse reactions that occurred in at least 1% of patients treated with carbidopa/levodopa and 200 mg of entacapone who participated in the double-blind, placebo-controlled studies, and that were numerically more common in this group than in the carbidopa/levodopa plus placebo group. In these studies, either entacapone or placebo was added to carbidopa/levodopa (or benserazide/levodopa).

Table 2: Summary of Patients With Adverse Reactions After Start of Trial Drug Administration At Least 1% in Entacapone Group and Greater Than Placebo

SYSTEM ORGAN CLASS
Preferred Term
Carbidopa/levodopa plus Entacapone
(n=603) % of patients
Carbidopa/levodopa plus Placebo
(n=400) % of patients
SKIN AND APPENDAGES DISORDERS
  Sweating Increased 2 1
MUSCULOSKELETAL SYSTEM DISORDERS
  Back Pain 5 3
CENTRAL AND 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 AND CLOTTING DISORDERS
  Purpura 2 1
URINARY SYSTEM DISORDERS
  Urine Discoloration 10 0
BODY AS A WHOLE-GENERAL DISORDERS
  Fatigue 6 4
  Asthenia 2 1
RESISTANCE MECHANISM DISORDERS
  Infection Bacterial 1 0

Postmarketing Experience

The following spontaneous reports of adverse events temporally associated with entacapone or Stalevo have been identified since market introduction and are not listed in Table 2. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish causal relationship to entacapone or Stalevo exposure.

Hepatitis with mainly cholestatic features has been reported.

Effects of Gender and Age on Adverse Reactions

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

Read the entire FDA prescribing information for Stalevo (Carbidopa, Levodopa and Entacapone)

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© Stalevo Patient Information is supplied by Cerner Multum, Inc. and Stalevo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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