Skip to main content

Stalevo 50 Side Effects

Generic name: carbidopa / entacapone / levodopa

Medically reviewed by Drugs.com. Last updated on Jan 13, 2024.

Note: This document contains side effect information about carbidopa / entacapone / levodopa. Some dosage forms listed on this page may not apply to the brand name Stalevo 50.

Applies to carbidopa / entacapone / levodopa: oral tablet.

Serious side effects of Stalevo 50

Along with its needed effects, carbidopa/entacapone/levodopa may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking carbidopa / entacapone / levodopa:

More common-Entacapone

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

Other side effects of Stalevo 50

Some side effects of carbidopa / entacapone / levodopa may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common-Entacapone

Less common-Entacapone

Incidence not known-Carbidopa and Levodopa and/or Levodopa alone

For Healthcare Professionals

Applies to carbidopa / entacapone / levodopa: oral tablet.

General

The most commonly reported adverse reactions have included dyskinesias, urine discoloration, diarrhea, nausea, abdominal pain, vomiting, and dry mouth.

Psychiatric

Common (1% to 10%): Anxiety, agitation, depression, abnormal dreams, insomnia

Uncommon (0.1% to 1%): Psychosis

Frequency not reported: Falling asleep during activities of daily living, hallucinations, suicidal behavior, dopamine dysregulation syndrome[Ref]

Hallucinations leading to drug withdrawal occurred in 0.8% and 0% of patients treated with carbidopa/levodopa/entacapone compared with carbidopa/levodopa, respectively; hallucinations led to hospitalization in 1% and 0.3% of patients, respectively.[Ref]

Nervous system

Very common (10% or more): Dyskinesia (25%), hyperkinesia (10%)

Common (1% to 10%): Hypokinesia, dizziness, somnolence, headache

Uncommon (0.1% to 1%): Taste perversion

Frequency not reported: Hyperpyrexia and confusion (resembling neuroleptic malignant syndrome)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (14%), diarrhea (10%)

Common (1% to 10%): Abdominal pain, constipation, vomiting, dry mouth, dyspepsia, flatulence, gastritis, gastrointestinal disorders (NOS)

Frequency not reported: Colitis, gastrointestinal hemorrhage[Ref]

During clinical trials, diarrhea developed in 10% and 4% of patients treated with carbidopa-levodopa-entacapone and carbidopa-levodopa plus placebo, respectively. For patients treated with entacapone, 8.6% reported diarrhea that was generally mild to moderate with 1.3% reporting it as severe. Diarrhea resulted in discontinuation in 1.7% of patients; 7 with mild and moderate diarrhea and 3 with severe diarrhea. Two patients with diarrhea were hospitalized. Postmarketing experience has shown that diarrhea may be a sign of drug-induced microscopic colitis, primarily lymphocytic colitis. In cases of drug-induced microscopic colitis, diarrhea was moderate to severe, watery and non-bloody, at times associated with dehydration, abdominal pain, weight loss, and hypokalemia. In most cases, diarrhea and other colitis-related symptoms resolved or significantly improved when entacapone was stopped.[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal hepatic test

Postmarketing reports: Hepatitis with mainly cholestatic features[Ref]

Respiratory

Common (1% to 10%): Dyspnea

Entacapone:

Frequency not reported: Pulmonary fibrosis[Ref]

Four cases of pulmonary fibrosis were reported during clinical development of entacapone. Three patients had been treated with pergolide and 1 with bromocriptine. The duration of treatment with entacapone ranged from 7 months to 17 months.[Ref]

Cardiovascular

Frequency not reported: Hypotension, orthostatic hypotension, syncope, irregular heart rhythm, ischemic heart disease events other than myocardial infarction[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Dermatologic

Common (1% to 10%): Increased sweating, rash

Uncommon (0.1% to 1%): Discolorations other than urine (e.g. skin, nail, hair, sweat)

Rare (less than 0.1%): Angioedema

Frequency not reported: Urticaria[Ref]

Hematologic

Common (1% to 10%): Purpura, anemia

Uncommon (0.1% to 1%): Thrombocytopenia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, muscle spasms, arthralgia

Frequency not reported: Rhabdomyolysis, muscle, musculoskeletal and connective tissue pain[Ref]

Genitourinary

Very common (10% or more): Discolored urine (10%)

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Urinary retention[Ref]

Metabolic

Frequency not reported: Weight gain, weight loss[Ref]

References

1. Product Information. Stalevo 50 (carbidopa / entacapone / levodopa). Novartis Pharmaceuticals. 2003.

2. Product Information. Stalevo 150 (carbidopa / entacapone / levodopa). Novartis Pharmaceuticals. 2003.

3. Hauser RA. Levodopa/carbidopa/entacapone (Stalevo). Neurology. 2004;62(1 Suppl 1):S64-71.

4. Product Information. Stalevo 100 (carbidopa / entacapone / levodopa). Novartis Pharmaceuticals. 2003.

5. Giner V, Rueda D, Salvador A, Hernandez JC, Esteban MJ, Redon J. Comments, opinions, and brief case reports: thrombocytopenia associated with levodopa treatment. Arch Intern Med. 2003;163:735-6.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.