Side Effects of Aerospan HFA (flunisolide)

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

• sore throat,
• runny nose,
• headache,
• sinusitis, and
• increased cough.

Serious side effects of Aerospan HFA include

• bloody or cloudy urine,
• chills,
• fast or irregular heartbeats,
• slow heartbeat, and
• unusual weight gain or loss.

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. 

The most common side effects of flunisolide are:

• nasal irritation and itching,
• cough,
• nausea or
• vomiting,
• sore throat,
• nasal congestion,
• sneezing,
• flu-like symptoms,
• nasal burning,
• diarrhea,
• unpleasant taste,
• bloody nasal discharge, and
• nasal dryness.

Other adverse effects include:

• headache,
• dizziness,
• watery eyes,
• upset stomach
• heart palpitations,
• fungal infections, and
• growth.

Systemic and local corticosteroid use may result in the following:

• Candida albicans infection
• Immunosuppression, increased risk of infections
• Hypercorticism and adrenal suppression
• Reduction in bone mineral density
• Effects on growth
• Glaucoma, increased intraocular pressure and cataracts
• Bronchospasm

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)

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.

• 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

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:

• 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

No information provided.