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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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.

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

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