Pulmicort Flexhaler Side Effects

Generic Name: budesonide

Please note - some side effects for Pulmicort Flexhaler 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 Flexhaler - for the Consumer

Pulmicort Flexhaler Powder

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 Flexhaler Powder:

Nasal congestion; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; ear pain or discharge; mental or mood changes; new or worsening asthma symptoms (eg, increased wheezing); severe or persistent diarrhea or stomach pain; shortness of breath after using Pulmicort Flexhaler Powder; signs of infection (eg, fever, chills, or sore throat); vision changes; white patches in the mouth or throat.

Pulmicort Flexhaler Side Effects - for the Professional

Pulmicort Flexhaler

The following adverse reactions were reported in patients treated with Pulmicort Flexhaler 180 or 90 mcg in two double-blind, placebo-controlled clinical trials in which 226 patients age 6-80 years, previously receiving bronchodilators, inhaled corticosteroids, or both, were treated with Pulmicort Flexhaler, administered as 360 mcg twice daily for 12 weeks.

The following table shows the incidence of adverse events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥1% in the Pulmicort Flexhaler group and were more common than in the placebo group.

Long-Term Safety

Non-placebo controlled long-term studies in children (at doses up to 360 mcg daily), and adolescent and adult subjects (at doses up to 720 mcg daily), treated for up to one year with Pulmicort Flexhaler, revealed a similar pattern and incidence of adverse events.

Adverse Event Reports from Other Sources

The following other adverse events occurred in placebo-controlled clinical trials with similar or lower budesonide doses with PULMICORT TURBUHALER with an incidence of ≥1% in the budesonide group and were more common than in the placebo group:

≥3%: respiratory infection, sinusitis, headache, pain, back pain, fever.

≥1-3%: neck pain, syncope, abdominal pain, dry mouth, vomiting, weight gain, fracture, myalgia, hypertonia, migraine, ecchymosis, insomnia, infection, taste perversion, voice alteration.

Higher doses of PULMICORT TURBUHALER 800 mcg twice daily resulted in an increased incidence of voice alteration, flu syndrome, dyspepsia, gastroenteritis, nausea, and back pain, compared with doses of 400 mcg twice daily.

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of inhaled budesonide with PULMICORT TURBUHALER 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. In considering these data, the increased average duration of exposure for inhaled budesonide patients (78 days for inhaled budesonide vs. 41 days for placebo) should be taken into account. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the budesonide group and which occurred more frequently with budesonide than placebo are given (% inhaled budesonide and % placebo): asthenia (9% and 2%), headache (12% and 2%), pain (10% and 2%), dyspepsia (8% and 0%), nausea (6% and 0%), oral candidiasis (10% and 0%), arthralgia (6% and 0%), cough increased (6% and 2%), respiratory infection (32% and 13%), rhinitis (6% and 2%), sinusitis (16% and 11%).

Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled budesonide include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.

Side 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.

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