Aerospan tm (flunisolide hfa, 80 mcg) Inhalation Aerosol For Oral Inhalation Only Rx Only description

ADVERSE 
EVENT 
PLACEBO 
(n = 220)
 
80 MCG 
(n = 189) 
160 MCG 
(n = 217) 
320 MCG 
(n = 113) 
BODY AS A 
WHOLE 
Headache 
12.7
9.0
13.8 
8.8
Fever 5.0
6.9
3.7 0.9
Allergic Reaction 
2.3
4.2
4.6 
4.4
Pain 
3.6
2.6
4.6 
1.8
Accidental Injury 
2.3
3.7
3.7 
3.5
Infection, 
Bacterial 
0.9
3.7
0.9 0.9
Back Pain 
2.3
0.5
3.2 
1.8
DIGESTIVE 
SYSTEM 
Vomiting 
4.1
4.2
4.6 
0.0
Dyspepsia 
1.4
2.1
3.2 
3.5
RESPIRATORY 
SYSTEM 
Pharyngitis 
13.2
17.5
16.6 
16.8
Rhinitis 
10.0
9.0
15.7 
3.5
Cough Increased 
7.7
8.5
5.5 
1.8
Sinusitis 
5.5
7.4
4.1 
8.8
Epistaxis 
0.9
3.2
0.9 
0.0
SKIN AND 
APPENDAGES 
Rash 
3.2
2.6
3.7 
1.8
UROGENITAL 
SYSTEM 
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. 
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 (see 
PRECAUTIONS, Pediatric Use section.) 

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