Does Aerospan HFA (flunisolide) cause side effects?

Aerospan HFA (flunisolide) is a corticosteroid administered in an oral metered-dose inhaler used to treat asthma

In asthmatic patients, the suppression of inflammation within the airways reduces the swelling caused by inflammation that narrows the airways. At the same time, mucus is reduced. Approximately 50% of flunisolide is absorbed into the blood. 

Common side effects of Aerospan HFA include

Serious side effects of Aerospan HFA include

No drug interactions have been described with Aerospan HFA. 

There are no studies with Aerospan HFA in pregnant women to inform a drug-associated risk for birth defects or miscarriage

There is no information on the presence of flunisolide in human milk, or the effects on the breastfed child, or the effects on milk production following use of flunisolide. Because other corticosteroids are excreted in human milk, caution should be exercised when Aerospan HFA is administered to nursing women. Consult your doctor before breastfeeding

What are the important side effects of Aerospan HFA (flunisolide)?

The most common side effects of flunisolide are:

Other adverse effects include:

Aerospan HFA (flunisolide) side effects list for healthcare professionals

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

  • 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 trials, 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 reactions that occurred at a rate of > 3% in any Aerospan Inhalation Aerosol 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 Reactions with > 3% incidence reported in controlled clinical studies with Aerospan Inhalation Aerosol (% of patients)

ADVERSE REACTION PLACEBO
(n = 220)
Aerospan Inhalation Aerosol
80 MCG
(n = 189)
160 MCG
(n = 217)
320 MCG
(n = 113)
BODY AS AWHOLE
  Headache 12.7 9.0 13.8 8.8
  Allergic Reaction 2.3 4.2 4.6 4.4
  Infection, Bacterial 0.9 3.7 0.9 0.9
DIGESTIVESYSTEM
  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
UROGENITAL SYSTEM
  Urinary Tract Infection 0.5 1.1 0.9 3.5

The following other adverse reactions occurred in patients in these clinical trials using Aerospan Inhalation Aerosol with an incidence of 1 to 3% and were more common in Aerospan Inhalation Aerosol than in the placebo group.

Long-Term Clinical Trials

Two 52-week open label safety trials 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 reaction profile exhibited in these trials was similar to that seen in the two 12-week studies.

Adverse Reactions from Other Sources

The following additional adverse reactions were derived from clinical trials conducted with flunisolide CFC inhalation aerosol with a frequency of ≥ 1% and not described above:

What drugs interact with Aerospan HFA (flunisolide)?

No information provided.

Summary

Aerospan HFA (flunisolide) is a corticosteroid administered in an oral metered-dose inhaler used to treat asthma. Common side effects of Aerospan HFA include sore throat, runny nose, headache, sinusitis, and increased cough. No drug interactions have been described with Aerospan HFA. There are no studies with Aerospan HFA in pregnant women to inform a drug-associated risk for birth defects or miscarriage. There is no information on the presence of flunisolide in human milk, or the effects on the breastfed child, or the effects on milk production following use of flunisolide.

Treatment & Diagnosis

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Medically Reviewed on 11/11/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.