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021247LBL
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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