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Nasal Inhaler

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

Adverse reactions reported in controlled clinical trials and long-term open studies in patients treated with beclomethasone dipropionate nasal inhaler are described below.

Sensations of irritation and burning in the nose (11 per 100 patients) following the use of beclomethasone dipropionate nasal inhaler have been reported. Also, occasional sneezing attacks (10 per 100 adult patients) have occurred immediately following the use of the intranasal inhaler. This symptom may be more common in children. Rhinorrhea may occur occasionally (1 per 100 patients).

Localized infections of the nose and pharynx with Candida albicans have occurred rarely (see PRECAUTIONS).

Transient episodes of epistaxis have been reported in 2 per 100 patients.

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

Reports of headache, light-headedness, 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 intranasal application of aerosolized corticosteroids (see PRECAUTIONS).

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.

Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, however, or if individuals are particularly sensitive, symptoms of hypercorticism (i.e., Cushing's syndrome, could occur).

Nasal Spray

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

Adverse reactions reported in controlled clinical trials and open studies in patients treated with beclomethasone dipropionate 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 beclomethasone dipropionate 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 (see PRECAUTIONS).

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 (see PRECAUTIONS).

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.