Pulmicort Flexhaler Side Effects

Generic Name: budesonide,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.

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.

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