Note: This document contains side effect information about levodopa. Some dosage forms listed on this page may not apply to the brand name Inbrija.

Applies to levodopa: inhalation capsule.

Serious side effects of Inbrija

Along with its needed effects, levodopa (the active ingredient contained in Inbrija) 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 levodopa:

More common

• Body aches or pain
• chills
• cough
• difficulty in breathing
• ear congestion
• fever
• headache
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

Less common

• Blurred vision
• chest pain or discomfort
• confusion
• cough producing mucus
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• muscle aches
• sneezing
• sweating
• tightness in the chest
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Other side effects of Inbrija

Some side effects of 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:

Less common

• Discolored sputum or nasal discharge
• falls
• mouth or throat pain
• nausea
• pain in the arms or legs
• skin scraping or tearing
• trouble sleeping
• vomiting

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

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.

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

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 (the active ingredient contained in Inbrija)

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

Hematologic

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

Other

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.

Common (1% to 10%): Fall