AEROSPAN HFA SIDE EFFECTS

SIDE EFFECTS

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