Stalevo 125 Side Effects

Generic name: carbidopa / entacapone / levodopa

Medically reviewed by Drugs.com. Last updated on Aug 15, 2024.

Note: This document provides detailed information about Stalevo 125.

Applies to carbidopa / entacapone / levodopa: oral tablet Side Effects associated with carbidopa / entacapone / levodopa. Some dosage forms listed on this page may not apply specifically to the brand name Stalevo 125.

Applies to carbidopa / entacapone / levodopa: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to allow changes in your dose and to check for any unwanted effects.

Do not take this medicine if you have taken a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®] or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not Stop taking carbidopa / entacapone / levodopa without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you are having convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause dizziness, drowsiness, trouble in controlling movements, or trouble in concentrating or seeing clearly. It may even cause you to fall asleep without warning while you drive, talk, or eat. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur with this medicine, especially when you get up from a lying or sitting position suddenly. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased. Getting up slowly may also help. If this problem continues or gets worse, check with your doctor.

This medicine will add to the effects of other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medications, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

This medicine may cause diarrhea, and in some cases it can be severe. It can occur months after starting this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

If you develop any unusual or strange thoughts and behavior while receiving this medicine, be sure to discuss it with your doctor. Other changes might be confusion, worsening of depression, visual hallucinations (seeing things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Check with your doctor right away if you have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These may be symptoms of a condition called rhabdomyolysis.

Check with your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

It is important that your doctor check your skin regularly for signs of a skin cancer called melanoma. If you notice any unusual red, brown, or black spots on your skin, talk to your doctor right away.

It is possible that a dark color (red, brown, or black) may appear in saliva, urine, or sweat after taking this medicine. The color may cause some of your garments to become discolored. This is normal and nothing to worry about.

It is possible that you may become nauseous, especially when you are first starting your medicine.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor right away if you start having problems with gambling or an increased interest in sex while using this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Stalevo 125

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 125

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 adverse events

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]

See also:

Further information

Stalevo 125 side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer