Qvar Side Effects

Please note - some side effects for Qvar 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 Qvar - for the Consumer

Qvar Aerosol Solution

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 Qvar Aerosol Solution:

Back pain; headache; dry mouth; hoarseness; nausea; runny nose; throat irritation; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; severe dizziness; sudden weight loss; unusual weakness; vomiting; white curd-like patches in the mouth.

Qvar Side Effects - for the Professional

QVAR

The following reporting rates of common adverse experiences are based upon four clinical trials in which 1196 Patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. The table below includes all events reported by patients taking QVAR (whether considered drug related or not) that occurred at a rate over 3% for either QVAR or CFC-BDP. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.

Other adverse events that occurred in these clinical trials using QVAR with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were: dysphonia, dysmenorrhea and coughing.

No patients treated with QVAR in the clinical development program developed symptomatic oropharyngeal candidiasis.

If such an infection develops, treatment with appropriate antifungal therapy or discontinuance of treatment with QVAR may be required.

Pediatric Studies: In two 12-week placebo controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally.

Adverse Event Reports from Other Sources: Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.

Side Effects by Body System

General

Beclomethasone is generally well tolerated and, due to the nature of its administration, is not inclined to produce the systemic adverse effects generally associated with the use of corticosteroids.

Gastrointestinal

Gastrointestinal adverse effects due to beclomethasone are reported most commonly. Oropharyngeal candidiasis occurs in approximately 5% to 14% of patients treated with beclomethasone and occurs more often at higher dosages greater than 800 mcg per day. Candidiasis is generally limited to the oropharyngeal area.

Although candidiasis is generally limited to the oropharyngeal area, rare cases of esophageal candidiasis have been reported. To reduce the incidence of thrush, patients should be instructed to rinse their mouths following the use of beclomethasone. Limited data suggest that the incidence of thrush may be lower in patients utilizing a spacer device and good inhalation technique.

Respiratory

Respiratory side effects have commonly included dysphonia and sore throat in patients receiving beclomethasone. This may or may not occur in the presence of oral thrush. Coughing and wheezing have frequently been reported with inhaled beclomethasone use, especially in patients whose disease is under poor control.

One study suggests that dysphonia occurring in the absence of oral thrush may be due to a vocal cord abnormality attributable to inhaled steroid use. In some cases, dysphonia and vocal cord abnormalities persisted for months following discontinuation of beclomethasone.

Many patients experiencing coughing and wheezing may benefit from pretreatment with an inhaled beta agonist prior to administration of beclomethasone.

Pulmonary eosinophilia, apparently associated with beclomethasone use, has been reported in at least two patients.

Endocrine

Endocrine abnormalities associated with beclomethasone rarely include suppression of the hypothalamus-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and occurs less frequently with daily doses of 2 mg per day or lower. The use of a large-volume spacer may also help minimize HPA suppression when beclomethasone is inhaled orally.

Immunologic

Immunologic effects of infection from immune suppression associated with inhaled corticosteroids have been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled beclomethasone.

In a study of 548 asthmatic patients receiving beclomethasone, eight patients developed tuberculosis. Two patients who agreed to resume beclomethasone use following treatment experienced a reactivation of tuberculosis within 2 weeks.

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.

Musculoskeletal

The reduction in bone density may be due to suppressed osteoblast function, as evidenced by decreased serum osteocalcin levels.

Musculoskeletal side effects from long-term use of inhaled beclomethasone may be associated with a reduction in bone density. This effect may be dose-related and has been reported with high dosages (>=800 mcg/day for >= 1 year). Reduced levels of total body calcium have also been demonstrated in patients receiving lower dosages.

Ocular

Ocular adverse effects are more commonly seen with systemic administration of corticosteroids. However, posterior capsular cataracts have been occasionally reported with beclomethasone use, especially with long-term use. In addition, one epidemiologic study suggests that prolonged use of high-dose inhaled corticosteroids (>= 1600 mcg of beclomethasone) may be associated with increased risk of ocular hypertension and open angle glaucoma.

Dermatologic

Dermatologic adverse effects may include acne. Skin atrophy and easy bruising has been associated with beclomethasone use in some patients.

In one prospective study, patients receiving at least 1 mg/day of inhaled beclomethasone (or 800 mcg of budesonide) for 3 months or more had a significantly higher incidence of ecchymosis than matched controls. In addition, the severity was more pronounced in the treatment group. Older patients were more likely to be affected. The presence of skin bruising was associated with lower urinary cortisol levels, suggesting systemic absorption of the inhaled drug.

Psychiatric

Psychiatric adverse effects include rare cases of mania precipitated by beclomethasone.

Nervous system

Nervous system side effects have included headache.

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