Comtan Side Effects
Generic name: entacapone
Medically reviewed by Drugs.com. Last updated on May 24, 2021.
Note: This document contains side effect information about entacapone. Some dosage forms listed on this page may not apply to the brand name Comtan.
Common side effects of Comtan include: urine discoloration. Continue reading for a comprehensive list of adverse effects.
Applies to entacapone: oral tablets.
Side effects include:
For Healthcare Professionals
Applies to entacapone: oral tablet.
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%)
Frequency not reported: Falling asleep during activities of daily living
Postmarketing reports: Neuroleptic malignant syndrome[Ref]
Very common (10% or more): Nausea (up to 14%), diarrhea (up to 11%)
Very rare (less than 0.01%): Anorexia
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]
Very common (10% or more): Urine discoloration (10%)[Ref]
The most commonly reported adverse reactions included dyskinesia, urine discoloration, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, and dry mouth.[Ref]
Common (1% to 10%): Dyspnea
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]
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]
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]
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]
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]
Uncommon (0.1% to 1%): Myocardial infarction[Ref]
Rare (less than 0.1%): Abnormal liver function tests
Postmarketing reports: Hepatitis with mainly cholestatic features[Ref]
Frequently asked questions
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- Drug class: dopaminergic antiparkinsonism agents
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Related treatment guides
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
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.