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Pulmicort Respules

Last reviewed on RxList: 12/12/2018
Pulmicort Respules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/12/2018

Pulmicort Respules (budesonide) Inhalation suspension is a corticosteroid inhaler used for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Pulmicort Respules are available in the generic form budesonide. Common side effects of Pulmicort Respules are:

Serious side effects of Pulmicort Respules include:

  • fungal infections (especially Candida spp),
  • bacterial infections,
  • severe allergic reactions,
  • ear infections,
  • endocrine disorders,
  • growth disorders,
  • eye disorders,
  • depression, and
  • immune depression.

Pulmicort Respules (budesonide inhalation suspension) is available a sterile suspension for inhalation via jet nebulizer and is available in strengths of 0.25, 0.5, and 1 mg per 2 mL inside a respule ampule. Pulmicort Respules may interact with HIV /AIDS medicines, antibiotics, antifungals, or antidepressants. Tell your doctor all medications and supplements you use. Use in pregnancy should be done only if clearly needed. Pulmicort Respules can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding. The drug and dosages are designed for use in the pediatric population ages 12 months to 8 years.

Our Pulmicourt 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

Asthma is a chronic respiratory disease. See Answer
Pulmicort Respules Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash, severe itching; chest pain, difficult breathing, feeling anxious; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening asthma symptoms;
  • wheezing, choking, or other breathing problems after using this medication;
  • white patches or sores inside your mouth or on your lips;
  • blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • signs of infection--fever, chills, body aches, ear pain, nausea, vomiting; or
  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Budesonide inhalation can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • runny or stuffy nose, sneezing;
  • red, itchy, and watery eyes;
  • fever, sore throat, cough;
  • nausea, vomiting, diarrhea, stomach pain, loss of appetite;
  • nosebleed; or
  • headache, back pain.

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 Pulmicort Respules (Budesonide Inhalation Suspension)

SLIDESHOW

What Is Asthma? Symptoms, Causes, and Treatments See Slideshow
Pulmicort Respules Professional Information

SIDE EFFECTS

Systemic and inhaled corticosteroid use may result in the following:

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 practice.

The incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥ 12 months and < 2 years of age; 225 patients ≥ 2 and < 4 years of age; and 622 patients ≥ 4 and ≤ 8 years of age) were treated with PULMICORT RESPULES (budesonide inhalation suspension) (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for PULMICORT RESPULES (budesonide inhalation suspension) was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

Table 1 : Adverse Reactions occurring at an incidence of ≥ 3% in at least one active treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than placebo

Adverse Events Vehicle
Placebo
(n=227)
%
PULMICORT RESPULES Total Daily Dose

0.25 mg
(n=178)
%

0.5 mg
(n=223)
%

1 mg
(n=317)
%
Respiratory System Disorder
Respiratory Infection 36 34 35 38
Rhinitis 9 7 11 12
Coughing 5 5 9 8
Resistance Mechanism Disorders
Otitis Media 11 12 11 9
Viral Infection 3 4 5 3
Moniliasis 2 4 3 4
Gastrointestinal System Disorders
Gastroenteritis 4 5 5 5
Vomiting 3 2 4 4
Diarrhea 2 4 4 2
Abdominal Pain 2 3 2 3
Hearing and Vestibular Disorders
Ear Infection 4 2 4 5
Platelet, Bleeding and Clotting Disorders
Epistaxis 1 2 4 3
Vision Disorders
Conjunctivitis 2 < 1 4 2
Skin and Appendages Disorders
Rash 3 <1 4 2

The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one PULMICORT RESPULES (budesonide inhalation suspension) treatment group where the incidence was higher with PULMICORT RESPULES (budesonide inhalation suspension) than with placebo, regardless of relationship to treatment.

Blood and lymphatic system disorders: cervical lymphadenopathy

Ear and labyrinth disorders: earache

General disorders and administration site conditions: fatigue, flu-like disorder

Immune system disorders: allergic reaction

Infections and infestations: eye infection, herpes simplex, external ear infection, infection

Injury, poisoning and procedural complication: fracture

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: myalgia

Nervous system disorders: hyperkinesia

Psychiatric disorders: emotional lability

Respiratory, thoracic, and mediastinal disorders: chest pain, dysphonia, stridor

Skin and subcutaneous tissue disorders: contact dermatitis, eczema, pustular rash, pruritus, purpura

The incidence of reported adverse events was similar between the 447 PULMICORT RESPULES-treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open-label studies.

Post-marketing Experience

The following adverse reactions have been reported during post-approval use of PULMICORT RESPULES (budesonide inhalation suspension) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Some of these adverse reactions may also have been observed in clinical studies with PULMICORT RESPULES (budesonide inhalation suspension) .

Endocrine disorders: symptoms of hypocorticism and hypercorticism [see WARNINGS AND PRECAUTIONS]

Eye disorders: cataracts, glaucoma, increased intraocular pressure [see WARNINGS AND PRECAUTIONS]

General disorders and administration site conditions: fever, pain

Immune system disorders: immediate and delayed hypersensitivity reactions including, anaphylaxis, angioedema, bronchospasm, rash, contact dermatitis, and urticaria [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]

Infection and Infestation: sinusitis, pharyngitis, bronchitis

Musculoskeletal and connective tissue disorders: avascular necrosis of the femoral head, osteoporosis, growth suppression

Nervous system disorders: headache

Psychiatric disorders: psychiatric symptoms including psychosis, depression, aggressive reactions, irritability, nervousness, restlessness, and anxiety

Respiratory, thoracic, and mediastinal disorders: cough, dysphonia and throat irritation

Skin and subcutaneous tissue disorders: skin bruising, facial skin irritation

Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for PULMICORT RESPULES [see WARNINGS AND PRECAUTIONS and Use In Specific Populations, Pediatric Use].

Read the entire FDA prescribing information for Pulmicort Respules (Budesonide Inhalation Suspension)

Related Resources for Pulmicort Respules

Related Health

Read the Pulmicort Respules User Reviews »

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

QUESTION

Asthma is a chronic respiratory disease. See Answer

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