Beclomethasone Side Effects
Not all side effects for beclomethasone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to beclomethasone: aerosol solution
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking beclomethasone:
Headache; sinus or throat irritation; stuffy nose.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); fainting; fever, chills, or persistent sore throat; new or worsening asthma symptoms (eg, chest tightness, increased wheezing or coughing); redness or white patches in the mouth or throat; severe dizziness; shortness of breath after using this medicine; sudden weight loss; unusual weakness; vision changes (eg, cloudy vision, decreased vision); vomiting.
For Healthcare Professionals
Applies to beclomethasone: compounding powder, inhalation aerosol, inhalation aerosol with adapter
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 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 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 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 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.
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 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 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 adverse effects include rare cases of mania.
Postmarketing reports have included cases of psychiatric events and behavioral changes (aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation) primarily in children.
Nervous system side effects have included headache.
More about beclomethasone
- Other brands: Qvar
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