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Comtan

"Using data from over 18,000 patients, scientists have identified more than two dozen genetic risk factors involved in Parkinson's disease, including six that had not been previously reported. The study, published in Nature Genetics, was partially"...

Comtan

Comtan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Comtan (entacapone) is used together with carbidopa and levodopa to treat "wearing-off" symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. It belongs to a class of drugs known as COMT inhibitors. Common side effects include nausea, vomiting, diarrhea, unwanted/uncontrolled movements, increased sweating, drowsiness, tiredness, dry mouth, gas, and abdominal pain.

The recommended dose of Comtan is one 200 mg tablet taken together with each levodopa/carbidopa dose to a maximum of 8 times daily (200 mg x 8 = 1600 mg per day). Comtan may interact with apomorphine, bitolterol, cholestyramine, dobutamine, epinephrine, isoetharine, isoproterenol, methyldopa, probenecid, or antibiotics. Tell your doctor all medications you are taking. During pregnancy, Comtan should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Comtan (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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Comtan in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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;
  • fever, stiff muscles, confusion, and sweating (especially when you first start taking entacapone);
  • new or worsening cough, fever, trouble breathing;
  • hallucinations;
  • severe or ongoing diarrhea, extreme thirst, increased urination, weight loss, leg discomfort, muscle weakness or limp feeling, uneven heart rate;
  • worsening symptoms such as tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin
  • unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Less serious side effects may include:

  • mild dizziness;
  • constipation;
  • back pain;
  • feeling tired;
  • mild diarrhea; or
  • mild nausea or stomach pain.

You may notice that your urine appears orange, red, brown, or black in color. This is not a harmful side effect.

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 Comtan (Entacapone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Comtan Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, unwanted/uncontrolled movements, increased sweating, drowsiness, tiredness, dry mouth, gas, and abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Lightheadedness or dizziness upon standing may also occur, especially during the first few weeks of treatment. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized.

Some people using this medication have reported falling asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk is increased with use of alcohol or other medications that can make you drowsy.

Your urine may turn brownish-orange. This effect is harmless.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as confusion, hallucinations), unusual urges (such as increased gambling, sexual urges), fever, muscle stiffness, persistent diarrhea.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, sore/painful muscles, muscle weakness, trouble breathing, pain with breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Comtan (Entacapone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Comtan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

A total of 1,450 patients with Parkinson's disease were treated with Comtan in pre-marketing clinical studies. Included were patients with fluctuating symptoms, as well as those with stable responses to levodopa therapy. All patients received concomitant treatment with levodopa preparations, however, and were similar in other clinical aspects.

The most commonly observed adverse reactions (incidence at least 3% greater than placebo) in double-blind, placebo-controlled studies (N=1,003) associated with the use of Comtan were: dyskinesia, urine discoloration, diarrhea, nausea, hyperkinesia, abdominal pain, vomiting, and dry mouth. Approximately 14% of the 603 patients given entacapone in the double-blind, placebo-controlled studies discontinued treatment due to adverse reactions, compared to 9% of the 400 patients who received placebo. The most frequent causes of discontinuation in decreasing order were: psychiatric reasons (2% vs. 1%), diarrhea (2% vs. 0%), dyskinesia and hyperkinesia (2% vs. 1%), nausea (2% vs. 1%), and abdominal pain (1% vs. 0%).

Adverse Event Incidence In Controlled Clinical Studies

Table 4 lists treatment-emergent adverse events that occurred in at least 1% of patients treated with entacapone participating in the double-blind, placebo-controlled studies and that were numerically more common in the Comtan group, compared to placebo. In these studies, either Comtan or placebo was added to levodopa and carbidopa (or levodopa and benserazide).

Table 4: Summary of Patients with Adverse Events after Start of Trial Drug Administration At least 1% in Comtan Group and Greater Than Placebo

SYSTEM ORGAN CLASS Preferred term Comtan
(n = 603)
% of patients
Placebo
(n = 400)
% of patients
SKIN AND APPENDAGES DISORDERS
  Sweating increased 2 1
MUSCULOSKELETAL SYSTEM DISORDERS
  Back pain 2 1
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 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
  Back pain 4 2
  Fatigue 6 4
  Asthenia 2 1
RESISTANCE MECHANISM DISORDERS
  Infection bacterial 1 0

Effects Of Gender And Age On Adverse Reactions

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

Postmarketing Reports

The following spontaneous reports of adverse events temporally associated with Comtan have been identified since market introduction and are not listed in Table 4 above. 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 Comtan exposure.

Hepatitis with mainly cholestatic features has been reported.

Drug Abuse And Dependence

Comtan is not a controlled substance. Animal studies to evaluate the drug abuse and potential dependence have not been conducted. Although clinical studies have not revealed any evidence of the potential for abuse, tolerance or physical dependence, systematic studies in humans designed to evaluate these effects have not been performed.

Read the entire FDA prescribing information for Comtan (Entacapone) »

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Comtan - User Reviews

Comtan User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Comtan sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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