Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate (see WARNINGS).

Suppression of HPA function (reduction of early morning plasma cortisol levels) has been reported in adult patients who received 1344-mcg daily doses (approximately twice the maximum recommended daily dose) of beclomethasone dipropionate by oral inhalation for 1 month. Some patients receiving orally inhaled beclomethasone dipropionate have complained of hoarseness or dry mouth.

42 mcg Inhalation Aerosol

The following adverse events have been reported spontaneously during worlwide postmarketing surveillance. Therefore, the frequency of events and causality cannot be reliably determined. The adverse events reported in association with beclomethasone dipropionate inhalation aerosol include:

General: Immediate and delayed hypersensitivity reactions including anaphylactic/anaphylactoid reactions, angioedema, bronchospasm, rash, urticaria.

Ear, Nose, and Throat: Dryness and irritation of the nose, throat, and mouth; hoarseness; localized infections with Candida or Aspergillus; unpleasant taste and smell; loss of taste and smell.

Endocrine and Metabolic: Cushingoid features, growth velocity reduction in children/adolescents, weight gain.

Eye: Cataracts, glaucoma, increased intraocular pressure.

Gastrointestinal: Nausea, vomiting.

Nervous: Dizziness, headache, lightheadedness.

Psychiatry: Agitation, depression, mental disturbances.

Respiratory: Paradoxical bronchospasm, wheezing.

Skin: Acneiform lesions, atrophy, bruising, pruritus, purpura, striae.

84 mcg Inhalation Aerosol

In a 4-week, randomized, double-blind, placebo-controlled clinical trial, the incidence of adverse events reported for beclomethasone dipropionate double strength inhalation aerosol was similar to that reported for placebo. Adverse event rates did not appear to differ significantly based on age, sex, or race. Adverse events that were reported by 2% or more of patients receiving this drug (regardless of relationship to treatment) and that occurred more frequently than placebo are displayed in TABLE 1.

In a 4-week, randomized, double-blind clinical study, there were no reports of oral candidasis in patients receiving this drug. (See WARNINGS).

In addition to those adverse events reported in TABLE 1, the following adverse events have been reported in fewer than 2% of patients receiving double strength beclomethasone dipropionate (regardless of relationship to treatment).

Autonomic Nervous System: Lacrimation.

Body as a Whole: Increased allergy symptoms, chest pain, fever, rigors.

Gastrointestinal: Diarrhea, nausea, rectal hemorrhage.

Hearing and Vestibular: Earache.

Heart Rate and Rhythm: Tachycardia.

Musculoskeletal: Arthralgia, pain.

Psychiatric: Depression, insomnia.

Respiratory: Bronchitis, bronchospasm, chest congestion, dysphonia, upper respiratory infection.

Skin and Appendages: Rash, skin discoloration, urticaria.

Special Senses: Taste perversion.

Urinary: Urinary tract infection.

Vascular (Extracardiac): Migraine.

White Cell and Reticuloendothelial: Lymphadenopathy.

Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to aerosol beclomethasone dipropionate. (See WARNINGS.)

Rare cases of immediate and delayed hypersensitivity reactions, including urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasones.

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

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 case of hypercorticism, adrenal insufficiency, growth inhibitory effects, cataracts, glaucoma, and hyperglcemia have been reported with inhaled corticosteriods.

No information provided.

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