Pulmicort Side Effects

Please note - some side effects for Pulmicort 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 - for the consumer

Pulmicort Turbuhaler 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 Turbuhaler Powder:

Bad taste in mouth; back pain; cough; fever; headache; hoarseness; indigestion; nausea; pain; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear infection; fainting; increased wheezing; infection (fever, chills, sore throat); mental/mood changes; severe dizziness; shortness of breath after using Pulmicort Turbuhaler Powder; sinus infection; sudden weight loss; tightness in the lungs; vomiting; white patches in mouth or on throat.

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); ear pain or discharge; new or worsening asthma symptoms (eg, increased wheezing); depression; mental or mood changes; 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 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:

Coughing; diarrhea; nosebleed; rash; redness of the eyes; runny nose; stomach pain; stomach problems; throat irritation; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); depression; ear infection; fainting; increased wheezing; infection (fever, chills, sore throat); irritability; mental/mood changes; personality change; severe dizziness; sinus infection; sudden weight loss; tightness in the lungs; unusual weakness; vomiting; white patches in the mouth or throat.

For the professional

Pulmicort

The following adverse reactions were reported in patients treated with Pulmicort TURBUHALER.

The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with Pulmicort TURBUHALER (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.

The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).

The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one Pulmicort TURBUHALER group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Pulmicort TURBUHALER patients should be taken into account.

The following other adverse events occurred in these clinical trials using Pulmicort TURBUHALER with an incidence of 1 to 3% and were more common on Pulmicort TURBUHALER than on placebo.

Body As A Whole: neck pain

Cardiovascular: syncope

Digestive: abdominal pain, dry mouth, vomiting

Metabolic and Nutritional: weight gain

Musculoskeletal: fracture, myalgia

Nervous: hypertonia, migraine

Platelet, Bleeding and Clotting: ecchymosis

Psychiatric: insomnia

Resistance Mechanisms: infection

Special Senses: taste perversion

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of 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. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the Pulmicort TURBUHALER group and which occurred more frequently with Pulmicort TURBUHALER than placebo are shown below (% Pulmicort TURBUHALER and % placebo). In considering these data, the increased average duration of exposure for Pulmicort TURBUHALER patients (78 days for Pulmicort TURBUHALER vs. 41 days for placebo) should be taken into account.

Body As A Whole:asthenia (9% and 2%)

headache (12% and 2%)

pain (10% and 2%)

Digestive:dyspepsia (8% and 0%)

nausea (6% and 0%)

oral candidiasis (10% and 0%)

Musculoskeletal:arthralgia (6% and 0%)

Respiratory:cough increased (6% and 2%)

respiratory infection (32% and 13%)

rhinitis (6% and 2%)

sinusitis (16% and 11%)

Patients Receiving Pulmicort TURBUHALER Once Daily

The adverse event profile of once-daily administration of Pulmicort TURBUHALER 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of Pulmicort TURBUHALER when compared with twice-daily dosing.

Pediatric Studies

In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for Pulmicort TURBUHALER (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

Adverse Event Reports From Other Sources

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.

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

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 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.

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