Aerospan HFA Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aerospan HFA FDA Prescribing Information: Side Effects
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.
Adverse Events with > 3% incidence reported in controlled
clinical studies with AEROSPAN Inhalation Aerosol (% of patients)
(n = 220)
|AEROSPAN Inhalation Aerosol|
(n = 189)
(n = 217)
(n = 113)
|BODY AS A WHOLE|
|SKIN AND APPENDAGES|
|Urinary Tract Infection||0.5||1.1||0.9||3.5|
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.
Metabolic And Nutritional Disorders: edema
Musculoskeletal System: myalgia
Skin And Appendages: erythema multiforme
Urogenital System: dysmenorrhea, vaginitis
Cases of growth suppression have been reported for orally inhaled corticosteroids (see PRECAUTIONS, Pediatric Use section.)
Adverse Events From Other Sources
Two 52-week open label safety studies of AEROSPAN Inhalation Aerosol were conducted in 162 asthma patients 12 to 60 years of age and in 152 asthma patients 4 to 11 years of age. The adverse event profile exhibited in these studies was similar to that seen in the two 12-week studies.
The following additional adverse events were derived from clinical studies conducted with flunisolide CFC inhalation aerosol with a frequency of ≥ 1% and not described above:
Respiratory System: cold symptoms, nasal congestion, upper respiratory tract infection, chest congestion, hoarseness, runny nose, sinus congestion, sinus drainage, sinus infection, sneezing, sputum, wheezing, chest tightness, bronchospasm, dyspnea, head stuffiness, nasal irritation, pleurisy, pneumonia, sinus discomfort
Special Senses: loss of smell, loss of taste, ear infection, blurred vision, eye discomfort, eye infection
Hemic and Lymph: capillary fragility, enlarged lymph nodes
Read the entire FDA prescribing information for Aerospan HFA (Flunisolide Hemihydrate) »
Additional Aerospan HFA Information
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