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Levodopa Side Effects

For the Consumer

Applies to levodopa: inhalation capsule

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Trouble breathing that is new or worse.
  • Change in the way you act.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling confused.
  • Feeling agitated.
  • Restlessness.
  • Trouble sleeping.
  • Strange or odd dreams.
  • Strong urges that are hard to control (such as eating, gambling, sex, or spending money).
  • Trouble controlling body movements that is new or worse.
  • Dizziness or passing out.
  • Very upset stomach or throwing up.
  • Sweating a lot.
  • Change in eyesight.
  • Eye pain.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Cough.
  • Change in color of sputum.
  • Signs of a common cold.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to levodopa: compounding powder, inhalation capsule, oral capsule, oral tablet

General

The more commonly occurring adverse reactions have included cough, nausea, upper respiratory tract infection, and discolored sputum.[Ref]

Respiratory

Very common (10% or more): Cough (15%)

Common (1% to 10%): Discolored sputum, nasal discharge discoloration, oropharyngeal pain, upper respiratory tract infection, nasopharyngitis, bronchitis/pneumonia

In a crossover clinical study in subjects with mild or moderate asthma on a stable regimen of asthma medication (n=25), patients received orally inhaled drug 84 mg every 4 hours for a total of 3 doses and placebo. Cough was reported by 60% of subjects following drug administration compared with 0% following placebo. Ten subjects (40%) had temporary FEV1 reductions from baseline (between 15% and 59%), and 4 of these subjects also had a reduction in FEV1 following placebo. Subjects with a reduction in FEV1 remained asymptomatic and did not require rescue treatment.

Nervous system

Common (1% to 10%): Dyskinesia, headache

Frequency not reported: Falling asleep during activities of daily living, somnolence

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Psychiatric

During clinical trials, hallucinations were reported in less than 2% of patients receiving orally inhaled levodopa.

Common (1% to 10%): Insomnia

Frequency not reported: Hallucinations

Cardiovascular

Common (1% to 10%): Chest discomfort, orthostatic hypotension/blood pressure decreased

Dermatologic

Dermatologic

Common (1% to 10%): Laceration, skin abrasion

Hepatic

Common (1% to 10%): Increased blood bilirubin

Musculoskeletal

Common (1% to 10%): Extremity pain

Other

Common (1% to 10%): Fall

Fever, altered consciousness, autonomic dysfunction and muscle rigidity are the hallmarks of the neuroleptic malignant syndrome. The neuroleptic malignant syndrome (NMS) is associated with a case fatality rate of about 20%. If withdrawal of dopaminergic therapy is suspected as the cause of NMS, dopaminergic therapy should be restarted. If a neuroleptic agent is suspected as the cause, the neuroleptic agent should be immediately discontinued. For patients with NMS suspected to be due to neuroleptic therapy, consideration should be given to dantrolene (or bromocriptine) administration. Intensive monitoring and supportive care are indicated for all patients with NMS.

Hematologic

Common (1% to 10%): Decreased red blood cell count

References

1. "Product Information. Inbrija (levodopa)." Acorda Therapeutics, Hawthorne, NY.

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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