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Entacapone Side Effects

For the Consumer

Applies to entacapone: oral tablet

Along with its needed effects, entacapone 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 entacapone:

More Common

  • Absence of or decrease in body movements
  • hyperactivity
  • increase in body movements
  • seeing, hearing, or feeling things that are not there
  • twisting
  • twitching
  • uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Less Common

  • Cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination

Rare

  • Confusion
  • muscle cramps
  • pain
  • shortness of breath
  • stiffness
  • unusual tiredness or weakness

Some side effects of entacapone 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

Less Common

  • Acid or sour stomach
  • anxiety
  • belching
  • bruising
  • burning feeling in the chest or stomach
  • difficult or labored breathing
  • dry mouth
  • heartburn
  • indigestion
  • irritability
  • loss of strength or energy
  • muscle pain or weakness
  • passing gas
  • restlessness
  • sleepiness or unusual drowsiness
  • small, red spots on the skin
  • stomach discomfort, upset, or tenderness
  • sweating increased
  • tightness in the chest
  • tremor
  • trouble sleeping
  • unusual or unpleasant (after) taste
  • unusual weak feeling

For Healthcare Professionals

Applies to entacapone: oral tablet

Nervous system

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]

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]

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

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

Postmarketing reports: Rhabdomyolysis[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]

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

2. "Product Information. Comtan (entacapone)" Novartis Pharmaceuticals, East Hanover, NJ.

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.

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