Flunisolide inhalation Side Effects

Please note - some side effects for Flunisolide inhalation 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 by Body System

General

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

Gastrointestinal

Gastrointestinal side effects have included oropharyngeal candidiasis in approximately 3% to 9% of patients treated, as well as nausea and vomiting (25%), diarrhea (10%), and upset stomach (10%). In addition, flunisolide has produced a bitter taste in most patients.

To reduce the incidence of thrush, patients should be instructed to rinse their mouths following the use of flunisolide. Limited data suggest that the incidence of thrush secondary to inhaled corticosteroids may be lower in patients utilizing a spacer device and good inhalation technique.

Respiratory

Many patients who experience coughing and wheezing may benefit from pretreatment with an inhaled beta-agonist prior to administration of flunisolide.

Respiratory side effects have included dysphonia, sore throat, and cold symptoms. Coughing and wheezing have also been frequently reported, especially in patients whose disease is poorly controlled. Nasal irritation, burning and stinging, congestion, epistaxis, sneezing, and rarely, nasal septal perforations have been reported with intranasal administration. Temporary or permanent loss of the sense of smell and taste have occurred with both oral inhalation and intranasal formulations. Upper respiratory tract infections are also more common in patients receiving flunisolide.

Nervous system

Nervous system side effects have generally been limited to headache, which has occurred in up to 25% of patients. Dizziness, nervousness, shakiness, depression, and insomnia have been reported in less than 10% of patients.

Endocrine

Endocrine side effects have rarely included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression has been less than that associated with systemic corticosteroids and, generally, has been only of concern when using higher than recommended doses.

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested the FDA review their decision concerning the relabeling of inhaled corticosteroids with respect to 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.

Immunologic side effects have included the danger of infections from immune suppression associated with inhaled corticosteroids. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled corticosteroids.

Musculoskeletal

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

Ocular

Ocular side effects have included occasional reports of capsular cataracts, especially with long-term use. In addition, one epidemiologic study suggested that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of flunisolide) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

Dermatologic

Dermatologic side effects have included eczema, acne, rash, and urticaria. Easy bruising has also been associated with flunisolide use in some patients.

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