Inbrija Side Effects Center

Last updated on RxList: 7/18/2022
Inbrija Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Inbrija?

Inbrija (levodopa inhalation powder) is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease treated with carbidopa/levodopa.

What Are Side Effects of Inbrija?

Common side effects of Inbrija include:

  • cough,
  • nausea,
  • upper respiratory tract infection, and
  • discolored mucus

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Inbrija

The dose of Inbrija is oral inhalation of the contents of two Inbrija capsules (84 mg) as needed for OFF symptoms, up to 5 times daily.

What Drugs, Substances, or Supplements Interact with Inbrija?

Inbrija may interact with monoamine oxidase inhibitors (MAOIs), dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts. Tell your doctor all medications and supplements you use.

Inbrija During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Inbrija; it may harm a fetus. Inbrija passes into breast milk and may interfere with lactation. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Inbrija.

Additional Information

Our Inbrija (levodopa inhalation powder), for Oral Inhalation Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer
Inbrija Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using levodopa inhalation and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling this medicine.

Call your doctor at once if you have:

  • extreme drowsiness, falling asleep suddenly (even after feeling alert);
  • nausea, sweating, and a light-headed feeling (like you might pass out);
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • confusion, paranoia, hallucinations (seeing or hearing things that are not real);
  • unusual thoughts or behavior;
  • trouble sleeping, or increased dreaming;
  • agitation, aggression; or
  • increased sexual urges, unusual urges to gamble, or other intense urges.

Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with levodopa inhalation. Tell your doctor if you have any problems with daytime drowsiness.

Common side effects may include:

  • cough;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • nausea; or
  • sweat, urine, or saliva that appears dark in color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Inbrija (Levodopa Inhalation Powder)

SLIDESHOW

Dementia, Alzheimer's Disease, and Aging Brains See Slideshow
Inbrija Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed below and elsewhere in the labeling:

  • Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
  • Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
  • Hallucinations/Psychosis [see WARNINGS AND PRECAUTIONS]
  • Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
  • Dyskinesia [see WARNINGS AND PRECAUTIONS]
  • Bronchospasm in Patients with Lung Disease [see WARNINGS AND PRECAUTIONS]
  • Glaucoma [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions In Study 1

Table 1 lists the adverse reactions that occurred in at least 2% of patients with Parkinson's disease who were treated with INBRIJA 84 mg and higher than placebo for OFF periods in Study 1 [see Clinical Studies]. Study 1 was a double-blind, placebo-controlled study, in which 114 patients received INBRIJA 84 mg (two 42 mg capsules) for an average of 2 doses per day, to a maximum of 5 times a day, and 112 patients received placebo. INBRIJA-treated patients were 45-82 years of age (mean 63.5 years of age) and were predominantly male (72%) and white (94%). All patients were also treated with oral carbidopa/levodopa. The most common adverse reactions (≥ 5% and higher than placebo) in Study 1 were cough, nausea, upper respiratory tract infection, and sputum discolored.

Table 1: Adverse Reactions at an Incidence ≥2% and More Frequent with INBRIJA than with Placebo in Study 1

Adverse ReactionsINBRIJA 84 mg
N=114
%
Placebo
N=112
%
Respiratory, thoracic and mediastinal disorders
Cough152
Sputum discolored50
Nasal discharge discoloration20
Oropharyngeal pain20
Gastrointestinal disorders
Nausea53
Vomiting30
Infections and infestations
Upper respiratory tract infection63
Nasopharyngitis32
Bronchitis/pneumonia20
Nervous system disorders
Dyskinesia41
Headache20
Injury, poisoning and procedural complications
Fall32
Laceration20
Skin abrasion20
General disorders and administration site conditions
Chest discomfort20
Investigations
Blood bilirubin increased20
Red blood cell count decreased20
Musculoskeletal and connective tissue disorders
Pain in extremity21
Psychiatric disorders
Insomnia21
Vascular disorders
Orthostatic hypotension/blood pressure decreased20

Adverse Reactions Leading to Discontinuation in Study 1

In Study 1, 6 of 114 patients (5%) in the INBRIJA 84 mg group and 3 of 112 patients (3%) in the placebo group discontinued because of adverse reactions. The most common of these adverse reactions was cough, which lead to discontinuation in 2% of patients in the INBRIJA 84 mg group and none in the placebo group.

Read the entire FDA prescribing information for Inbrija (Levodopa Inhalation Powder)

© Inbrija Patient Information is supplied by Cerner Multum, Inc. and Inbrija Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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