Aerospan Side Effects

Please note - some side effects for Aerospan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Aerospan - for the Consumer

Aerospan HFA Inhaler

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 Aerospan HFA Inhaler:

Cough; runny nose; sinus inflammation; stomach pain or upset; throat irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; ear or eye pain or discharge; mental or mood changes; new or worsening breathing problems (eg, shortness of breath, increased wheezing); nosebleeds; severe stomach pain; signs of infection (eg, fever, chills, persistent sore throat); sore mouth; unusual weakness or fatigue; vision changes; white patches in the mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Aerospan Side Effects - for the Professional

Aerospan

The following table shows the adverse reactions that were reported in patients previously receiving bronchodilators and/or orally inhaled corticosteroids in two double-blind, placebo-controlled US clinical studies, in which 519 adult and pediatric patients age 4-78 years (279 males and 240 females) were treated with the Aerospan Inhalation Aerosol (80 mcg to 320 mcg twice daily for 12 weeks) or placebo. The mean duration of exposure was 76.7, 78.2, 80.5, and 69.4 days for Aerospan Inhalation Aerosol 80 mcg, 160 mcg, 320 mcg, and placebo, all dosed twice daily, respectively. The table includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of >3% in any Aerospan Inhalation Aerosol group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Aerospan Inhalation Aerosol patients should be taken into account, compared with placebo-treated patients.

The following other adverse events occurred in patients in these clinical studies using Aerospan Inhalation Aerosol with an incidence of 1 to 3% and were more common in Aerospan Inhalation Aerosol than in the placebo group.

 

Body As A Whole: abdominal pain, chest pain, infection, neck pain

 

Digestive System: diarrhea, gastroenteritis, nausea, oral moniliasis

 

Metabolic And Nutritional Disorders: edema

 

Musculoskeletal System: myalgia

 

Nervous System: dizziness, insomnia, migraine

 

Respiratory System: bronchitis, laryngitis, voice alteration

 

Skin And Appendages: erythema multiforme

 

Special Senses: conjunctivitis, ear pain, taste perversion

 

Urogenital System: dysmenorrhea, vaginitis

Cases of growth suppression have been reported for orally inhaled corticosteroids

Side Effects by Body System - for Healthcare Professionals

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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