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Aerospan (Flunisolide Hemihydrate Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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)
ADVERSE EVENT PLACEBO
(n = 220)
AEROSPAN Inhalation Aerosol
80 MCG
(n = 189)
160 MCG
(n = 217)
320 MCG
(n = 113)
BODY AS A WHOLE
Headache12.79.013.88.8
Fever5.06.93.70.9
Allergic Reaction2.34.24.64.4
Pain3.62.64.61.8
Accidental Injury2.33.73.73.5
Infection, Bacterial0.93.70.90.9
Back Pain2.30.53.21.8
DIGESTIVE SYSTEM
Vomiting4.14.24.60.0
Dyspepsia1.42.13.23.5
RESPIRATORY SYSTEM
Pharyngitis13.217.516.616.8
Rhinitis10.09.015.73.5
Cough Increased7.78.55.51.8
Sinusitis5.57.44.18.8
Epistaxis0.93.20.90.0
SKIN AND APPENDAGES
Rash3.22.63.71.8
UROGENITAL SYSTEM
Urinary Tract Infection0.51.10.93.5

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.)

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:

  •  Body as a Whole: flu, decreased appetite, chills, increased appetite, weight gain, malaise, peripheral edema, sweating, weakness
  •  Gastrointestinal System: upset stomach, heartburn, constipation, gas, abdominal fullness
  •  Cardiovascular System: palpitations, hypertension, tachycardia
  •  Nervous System: headache, irritability, shakiness, anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity, moodiness, numbness, vertigo,
  •  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
  •  Skin and Appendages: eczema, pruritus, acne, urticaria
  •  Special Senses: loss of smell, loss of taste, ear infection, blurred vision, eye discomfort, eye infection
  •  Hemic and Lymph: capillary fragility, enlarged lymph nodes
  •  Mouth and Throat: sore throat, dry throat, glossitis, mouth irritation, phlegm, throat irritation
Drug label data at the top of this Page last updated: 2007-05-28

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