Pulmicort Respules Side Effects
Generic Name: budesonide
Please note - some side effects for Pulmicort Respules may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Pulmicort Respules - for the Consumer
Pulmicort Respules Suspension
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pulmicort Respules Suspension:
Seek medical attention right away if any of these SEVERE side effects occur when using Pulmicort Respules Suspension:Cough; diarrhea; nosebleed; runny or stuffy nose; throat irritation.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone or joint pain; depression; ear pain or discharge; fainting; increased wheezing; infection (fever, chills, persistent cough or sore throat); mental or mood changes (eg, aggressiveness, anxiety, irritability); red, swollen, itchy, or watery eyes; severe dizziness; sudden weight loss; tightness in the lungs; unusual weakness; vision changes; white patches in the mouth or throat.
Pulmicort Respules Side Effects - for the Professional
Pulmicort Respules
The following adverse reactions were reported in pediatric patients treated with Pulmicort Respules.
The incidence of common adverse reactions is based on three double-blind, placebo-controlled, 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 (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 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.
Adverse Events with ≥ 3% Incidence Reported by Patients on Pulmicort Respules
|
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 table above shows all adverse events with an incidence of 3% or more in at least one active treatment group where the incidence was higher with Pulmicort Respules than with placebo.
The following adverse events occurred with an incidence of 3% or more in at least one Pulmicort Respules group where the incidence was equal to or less than that of the placebo group: fever, sinusitis, pain, pharyngitis, bronchospasm, bronchitis, and headache.
Incidence 1% to ≤3% (by body system)
The information below includes all adverse events with an incidence of 1 to ≤3%, in at least one Pulmicort Respules treatment group where the incidence was higher with Pulmicort Respules than with placebo, regardless of relationship to treatment.
Body as a whole: allergic reaction, chest pain, fatigue, flu-like disorder
Respiratory system: stridor
Resistance mechanisms: herpes simplex, external ear infection, infection
Central & peripheral nervous system: dysphonia, hyperkinesia
Skin & appendages: eczema, pustular rash, pruritus
Hearing & vestibular: earache
Vision: eye infection
Psychiatric: anorexia, emotional lability
Musculoskeletal system: fracture, myalgia
Application site: contact dermatitis
Platelet, bleeding & clotting: purpura
White cell and resistance: cervical lymphadenopathy
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.
Cases of growth suppression have been reported for inhaled corticosteroids including post-marketing reports for Pulmicort Respules.
Less frequent adverse events (<1%) reported in the published literature, long-term, open-label clinical trials, or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety, and psychosis; and bone disorders including avascular necrosis of the femoral head and osteoporosis.
TopSide Effects by Body System
General
Budesonide is generally well tolerated. Due to the nature of its administration (inhalation or enteric-coated capsules), it is not likely to cause the systemic adverse effects generally associated with the use of corticosteroids. General side effects of oral budesonide have included fatigue, flu-like disorder, viral infection, malaise, ear infection, fever, abscess, and pain .
Respiratory
Respiratory side effects of inhaled budesonide have included dysphonia and sore throat. Cough, rhinitis, and sinusitis have also been reported. Respiratory side effects of oral enteric-coated budesonide have included respiratory infection, bronchitis, dyspnea, pharynx disorder, rhinitis, and sinusitis.
Endocrine
Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal (HPA) axis. The risk of adrenal suppression from inhaled or enteric-coated budesonide is less than that associated with systemic corticosteroids and may occur less frequently with lower daily doses.
Immunologic
In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the relabeling of inhaled corticosteroids following concerns about the risk of their use during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.
The danger of infection from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled budesonide. There are no data concerning immune suppression form oral enteric-coated budesonide.
Gastrointestinal
Gastrointestinal side effects of inhaled budesonide have included oropharyngeal candidiasis, dry mouth, taste perversion, nausea, dyspepsia, and abdominal pain. Gastrointestinal side effects of oral enteric-coated budesonide have included nausea, diarrhea, dyspepsia, abdominal pain, flatulence, anus disorder, aggravation of Crohn's disease, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder, and vomiting.
Nervous system
Nervous system side effects of inhaled budesonide have included headache, asthenia, and pain. Nervous system side effects of oral enteric-coated budesonide have included headache, dizziness, hyperkinesia, paresthesia, tremor, vertigo, asthenia, and pain. Benign intracranial hypertension has been reported with oral budesonide.
Psychiatric
Psychiatric side effects of inhaled budesonide have included rare reports of depression, aggression, irritability, anxiety, and psychosis. Psychiatric side effects of oral budesonide have included agitation, increased appetite, confusion, insomnia, nervousness, sleep disorder, amnesia, and somnolence.
Hypersensitivity
Hypersensitivity side effects of inhaled budesonide have included immediate and delayed reactions including rash, contact dermatitis, urticaria, angioedema, and bronchospasm. Postmarketing experience has included very reports of cough, wheezing, or bronchospasm in patients with severe milk protein hypersensitivity. Anaphylactic reactions have been reported with oral budesonide.
Musculoskeletal
Musculoskeletal side effects of inhaled budesonide have included a reduction in bone density. This effect may be dose-related and has been reported with high dosages and prolonged use (over 1 year). Musculoskeletal side effects of oral enteric-coated budesonide have included back pain and arthralgia.
Cardiovascular
Cardiovascular side effects of oral budesonide have included chest pain, palpitations, tachycardia, dependent edema, face edema, hypertension, flushing, and increased C-reactive protein.
Metabolic
Metabolic side effects of oral budesonide have included hypokalemia and weight increase.
Hematologic
Hematologic side effects of oral budesonide have included leukocytosis and purpura.
Ocular
Ocular side effects of oral budesonide have included conjunctivitis, eye abnormality, and abnormal vision. Glaucoma and cataracts have also been reported.
Genitourinary
Genitourinary side effects of oral budesonide have included dysuria, increased micturition frequency, nocturia, urinary tract infection, intermenstrual bleeding, and menstrual disorder.
Dermatologic
Dermatologic side effects of oral budesonide have included acne, alopecia, dermatitis, eczema, increased sweating and skin disorder.
TopMore Pulmicort Respules resources
- Pulmicort Respules Detailed Consumer Information (PDR)
- Pulmicort Respules Prescribing Information (FDA)
- Pulmicort Respules Advanced Consumer (Micromedex) - Includes Dosage Information
- Pulmicort Respules Concise Consumer Information (Cerner Multum)
- Pulmicort Respules Suspension Medfacts Consumer Leaflet (Wolters Kluwer)
- Budesonide Professional Patient Advice (Wolters Kluwer)
- Budesonide Powder Medfacts Consumer Leaflet (Wolters Kluwer)
- budesonide Concise Consumer Information (Cerner Multum)
- Entocort EC Prescribing Information (FDA)
- Entocort EC Sustained-Release Capsules Medfacts Consumer Leaflet (Wolters Kluwer)
- Entocort EC Advanced Consumer (Micromedex) - Includes Dosage Information
- Entocort EC Detailed Consumer Information (PDR)
- Pulmicort Flexhaler Prescribing Information (FDA)
- Pulmicort Turbuhaler Powder Medfacts Consumer Leaflet (Wolters Kluwer)
- Pulmicort Turbuhaler Detailed Consumer Information (PDR)
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