Beconase AQ Side Effects

Please note - some side effects for Beconase AQ 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 Beconase AQ - for the Consumer

Beconase AQ Spray

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 Beconase AQ Spray:

Bad taste; coughing; headache; hoarseness; nasal irritation or dryness; nausea; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; continuing nose discomfort; excessive sneezing; increased pressure in the eye; infection (fever, chills, sore throat); irregular menstrual period; loss of taste or smell; nosebleeds or soreness; pounding in the chest; unusual weight gain, especially in the face; vision changes; wheezing.

Beconase AQ Side Effects - for the Professional

Beconase Aq

In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes.

Adverse reactions reported in controlled clinical trials and open studies in patients treated with Beconase Aq Nasal Spray are described below.

Mild nasopharyngeal irritation following the use of beclomethasone aqueous nasal spray has been reported in up to 24% of patients treated, including occasional sneezing attacks (about 4%) occurring immediately following use of the spray. In patients experiencing these symptoms, none had to discontinue treatment. The incidence of transient irritation and sneezing was approximately the same in the group of patients who received placebo in these studies, implying that these complaints may be related to vehicle components of the formulation.

Fewer than 5 per 100 patients reported headache, nausea, or lightheadedness following the use of Beconase Aq Nasal Spray. Fewer than 3 per 100 patients reported nasal stuffiness, nosebleeds, rhinorrhea, or tearing eyes.

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported.

Reports of dryness and irritation of the nose and throat and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate.

Rare cases of immediate and delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.

Cases of growth suppression have been reported for intranasal corticosteroids, including Beconase Aq.

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.

Respiratory

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.

Pulmonary eosinophilia, apparently associated with beclomethasone use, has been reported in at least two patients. Nasal candidiasis has been reported in a woman with undiagnosed chronic lymphocytic leukemia. Nasal perforation has been reported rarely.

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

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.

Nervous system

Nervous system side effects including headache have also been reported.

Endocrine

Endocrine abnormalities associated with beclomethasone rarely include suppression of the hypothalamic-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.

Immunologic

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 danger of infections 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 beclomethasone.

Musculoskeletal

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.

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

Ocular

Ocular adverse effects are more commonly seen with systemic administration of corticosteroids. However, posterior capsular cataracts have been occasionally reported with beclomethasone, especially with long-term use. In addition, prolonged use of high-dose inhaled corticosteroids ( >= 400 mcg of beclomethasone nasal) may be associated with increased risk of ocular hypertension and open angle glaucoma.

Dermatologic

Dermatologic adverse effects may include acne. Easy bruising has been associated with beclomethasone use in some patients.

Rosacea, presenting as new-onset facial eruptions, has been reported.

Psychiatric

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

Hypersensitivity

Hypersensitivity side effects have included rare cases of immediate and delayed anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm.

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