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.

Summary

Common side effects of Stalevo 50 include: diarrhea, dyskinesia, hyperkinetic muscle activity, nausea, dark urine, and urine discoloration. Other side effects include: abdominal pain, and vomiting. Continue reading for a comprehensive list of adverse effects.

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

• Twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

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

• Bleeding gums
• bloody or black, tarry stools
• bloody or cloudy urine
• change in size, shape, or color of an existing mole
• changes in skin color
• chest pain, discomfort, or tightness
• constipation
• constricted pupil
• convulsions
• cough
• difficult or labored breathing
• difficulty with speaking
• drooling
• drooping eyelid (ptosis)
• facial dryness
• fast, irregular, or pounding heartbeat
• fever with or without chills
• general feeling of illness
• hallucinations (seeing, hearing, or feeling things that are not there)
• hoarseness
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• loss of bladder control
• lower abdominal or stomach pain
• lower back or side pain
• mole that leaks fluid or bleeds
• muscle cramps or spasms
• muscle pain or stiffness
• muscle trembling, jerking, or stiffness
• nausea
• pain
• painful or difficult urination
• pinpoint red spots on the skin
• raised red swellings on the skin, the buttocks, legs, or ankles
• restlessness
• severe mental changes
• shakiness and unsteady walk
• shuffling walk
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• swollen glands
• trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

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

• Absence of or decrease in body movement
• diarrhea
• dizziness
• urine discoloration

Less common-Entacapone

• Acid or sour stomach
• anxiety
• belching
• bitter, sour, or unusual taste in the mouth
• bloated
• burning feeling in the chest or stomach
• dry mouth
• excess air or gas in the stomach or intestines
• fear
• full feeling
• heartburn
• hyperventilation
• increased sweating
• indigestion
• irritability
• lack or loss of strength
• passing gas
• restlessness
• sleepiness or unusual drowsiness
• stomach discomfort or upset
• swollen mouth and tongue
• tenderness in the stomach area
• trouble sleeping
• urge to have bowel movement

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

• Being forgetful
• bladder pain
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning and upper abdominal or stomach pain
• burning sensation of the tongue
• clenching, gnashing, or grinding teeth
• confusion about identity, place, and time
• dark saliva
• dark sweat
• decreased mental acuity
• difficulty swallowing
• discouragement
• double vision
• ear congestion
• enlarged pupils
• excessive watering of the mouth
• fainting
• false or unusual sense of well-being
• feeling like you will pass out
• feeling of warmth
• feeling sad or empty
• flushing
• hair loss
• headache
• hiccups
• hives or welts
• increased blinking
• increased interest in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• lack of appetite
• large, hard skin blisters
• leg pain
• loss of voice
• muscle spasm, especially of the neck and back
• nasal congestion
• nightmares
• numbness
• pain in the chest below the breastbone
• painful or prolonged erection of the penis
• pharyngeal pain
• pounding in the ears
• problems with memory or speech
• redness of the face, neck, arms, and occasionally upper chest
• runny nose
• sense of stimulation
• skin rash
• sleeplessness
• slow movement
• slow or fast heartbeat
• slow reflexes
• sneezing
• swelling
• tremor, increased
• trouble concentrating
• trouble recognizing objects
• trouble thinking and planning
• urinary frequency
• urinary retention
• weight gain
• weight loss

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]