Stalevo Warnings and Precautions

Specific Stalevo Warnings and Precautions

Warnings and precautions to be aware of prior to taking Stalevo include the following:
  • There is some early evidence that may suggest an increased risk of prostate cancer with Stalevo. It is unclear if this is a true finding or just a coincidental occurrence in one study. The U.S. Food and Drug Administration (FDA) is reviewing the results but has not made any conclusions or recommendations at this time.


  • Stopping Stalevo too quickly can cause a dangerous condition known as neuroleptic malignant syndrome (NMS). Do not stop taking the drug without your healthcare provider's approval and supervision. Let your healthcare provider know if you develop any signs of NMS, such as:
    • A high fever
    • Irregular pulse or blood pressure
    • A fast heart rate (tachycardia)
    • Sweating
    • Stiff muscles
    • Confusion
    • Irregular heart rhythms (arrhythmias).
  • Stalevo often causes diarrhea. Sometimes, it can be severe enough to require hospitalization. This diarrhea can occur at any time, not just when starting the medication.
  • The medication can cause low blood pressure (hypotension). Be sure to let your healthcare provider know if you develop signs of low blood pressure, such as lightheadedness, dizziness, or fainting.
  • Stalevo can cause hallucinations (seeing, hearing, or feeling things that are not really there). Let your healthcare provider know if you develop hallucinations while taking the drug.
  • Because Stalevo can activate a malignant melanoma, it should not be used by anyone with a suspicious undiagnosed skin lesion or a history of melanoma.


  • Intense, unusual urges have been reported in people taking Parkinson's disease medications. Examples include an intense desire to gamble or to engage in risky sexual behavior. Let your healthcare provider know right away if you experience any of these urges.


  • Stalevo can cause involuntary muscle movements called dyskinesias. Although not usually dangerous, dyskinesias can be quite disturbing and intolerable. If you develop a dyskinesia while taking the drug, your healthcare provider may need to decrease your Stalevo dosage, or you may need to stop taking it altogether.
  • The medication can cause or worsen many mental illnesses, due to its effects on dopamine (a brain chemical). Let your healthcare provider know if you have a history of such problems before taking the drug.
  • If you have bile or gallbladder problems, heart problems, lung problems, ulcers, or kidney or liver disease, check with your healthcare provider before taking Stalevo. In some cases, this medication may not be the best choice for you.
  • People with glaucoma may not be able to take Stalevo safely. The drug is not recommended for people with narrow-angle glaucoma. People with adequately treated wide-angle glaucoma may take Stalevo, although careful monitoring of the condition may be necessary.
  • The medication may cause you to fall asleep during the day, sometimes without warning. This can be especially dangerous if you are driving a car or operating heavy machinery. In addition, this can happen long after you start taking Stalevo. Ask your healthcare provider if you should stop driving a car or operating heavy machinery while taking it.
  • Stalevo can cause dark (red, brown, or black) saliva, sweat, or urine. Although this is not dangerous, it can be bothersome.
  • Stalevo can potentially interact with several medications (see Stalevo Drug Interactions).
  • Stalevo is considered a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are not known (see Stalevo and Pregnancy).
  • The medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Stalevo and Breastfeeding).
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Stalevo Drug Information

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