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Entacapone Side Effects

Medically reviewed by Drugs.com. Last updated on May 24, 2021.

Summary

Commonly reported side effects of entacapone include: urine discoloration. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to entacapone: oral tablets

Side effects include:

Dyskinesia, nausea, hyperkinesia, diarrhea, urine discoloration, hypokinesia, dizziness, abdominal pain, constipation, fatigue.

For Healthcare Professionals

Applies to entacapone: oral tablet

Nervous system

There were no cases of neuroleptic malignant syndrome during clinical trials. Since market introduction, there have been isolated cases, especially following abrupt reduction or discontinuation of this drug and other concomitant dopaminergic drugs.[Ref]

Very common (10% or more): Dyskinesia (up to 27%), hyperkinesia (10%)

Common (1% to 10%): Hypokinesia, dizziness, somnolence, taste perversion, aggravated parkinsonism, dystonia, headache, tremor

Frequency not reported: Falling asleep during activities of daily living

Postmarketing reports: Neuroleptic malignant syndrome[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 14%), diarrhea (up to 11%)

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

Very rare (less than 0.01%): Anorexia

Postmarketing reports: Colitis[Ref]

In clinical trials, diarrhea occurred in approximately 10% of patients. It was generally mild to moderate, but in 1.3% of people it was severe. Upon discontinuation, diarrhea generally resolved. There have been postmarketing reports of drug-induced microscopic colitis, primarily lymphocytic colitis.[Ref]

Genitourinary

Very common (10% or more): Urine discoloration (10%)[Ref]

General

The most commonly reported adverse reactions included dyskinesia, urine discoloration, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, and dry mouth.[Ref]

Respiratory

Common (1% to 10%): Dyspnea

Frequency not reported: Pulmonary fibrosis[Ref]

Dermatologic

Common (1% to 10%): Increased sweating

Rare (less than 0.1%): Erythematous, maculopapular rash

Very rare (less than 0.01%): Urticaria

Frequency not reported: Skin hair, beard, and nail discolorations[Ref]

Musculoskeletal

Isolated cases of rhabdomyolysis have occurred in patients treated with this drug. The complicated nature of these cases makes it difficult to determine the role this drug may have had. Rhabdomyolysis has been reported secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) in patients with Parkinson's disease.[Ref]

Common (1% to 10%): Back pain, falls, leg cramps

Postmarketing reports: Rhabdomyolysis[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia, hallucinations, confusion, paranoia

Uncommon (0.1% to 1%): Agitation

Frequency not reported: Impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating[Ref]

Hematologic

Common (1% to 10%): Purpura, decreased hemoglobin[Ref]

A clinically significant decrease in hemoglobin has been observed in 1.8% of patients. The underlying mechanism may involve decreased absorption of iron from the gastrointestinal tract.[Ref]

Other

Common (1% to 10%): Fatigue, asthenia, pain, vertigo[Ref]

Cardiovascular

The incidence of myocardial infarction and other ischemic heart disease events was 0.43% and 1.54%, respectively, in an analysis of 13 double-blind studies involving 2082 patients.[Ref]

Common (1% to 10%): Ischemic heart disease events other than myocardial infarction (e.g., angina pectoris, postural hypotension

Uncommon (0.1% to 1%): Myocardial infarction[Ref]

Hepatic

Rare (less than 0.1%): Abnormal liver function tests

Postmarketing reports: Hepatitis with mainly cholestatic features[Ref]

References

1. "Product Information. Comtan (entacapone)." Novartis Pharmaceuticals (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

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.