Does Aerospan HFA (flunisolide) cause side effects?
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
- bloody or cloudy urine,
- fast or irregular heartbeats,
- slow heartbeat, and
- unusual weight gain or loss.
No drug interactions have been described with Aerospan HFA.
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:
- nasal irritation and itching,
- nausea or
- sore throat,
- nasal congestion,
- flu-like symptoms,
- nasal burning,
- unpleasant taste,
- bloody nasal discharge, and
- nasal dryness.
Other adverse effects include:
Aerospan HFA (flunisolide) side effects list for healthcare professionals
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
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)
(n = 220)
|Aerospan Inhalation Aerosol|
(n = 189)
(n = 217)
(n = 113)
|BODY AS AWHOLE|
|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.
- 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
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.
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COPD vs. Asthma (Differences and Similarities)
COPD (chronic obstructive pulmonary disease) and asthma both have common symptoms like coughing, wheezing, shortness of breath, and a tight feeling in the chest. COPD is caused by tobacco smoking, while asthma is caused by your inherited genetic makeup and their interactions with the environment. Risk factors for asthma are obesity, exposure to cigarette smoke (even secondhand smoke), and personal history of hay fever. There is no cure for either disease, but symptoms can be managed with medication. A person with asthma has a better prognosis and life expectancy than someone with COPD.
Asthma is a condition in which hyperreactive airways constrict and result in symptoms like wheezing, coughing, and shortness of breath. Causes of asthma include genetics, environmental factors, personal history of allergies, and other factors. Asthma is diagnosed by a physician based on a patient's family history and results from lung function tests and other exams. Inhaled corticosteroids (ICS) and long-acting bronchodilators (LABAs) are used in the treatment of asthma. Generally, the prognosis for a patient with asthma is good. Exposure to allergens found on farms may protect against asthma symptoms.
Asthma Over-the-Counter Treatment
Patients who have infrequent, mild bouts of asthma attacks may use over-the-counter (OTC) medications to treat their asthma symptoms. OTC asthma medicines are limited to epinephrine and ephedrine. These OTC drugs are best used with the guidance of a physician, as there may be side effects and the drugs may not be very effective.
There are two types of asthma medications: long-term control with anti-inflammatory drugs and quick relief from bronchodilators. Asthma medicines may be inhaled using a metered-dose inhaler or nebulizer or they may be taken orally. People with high blood pressure, diabetes, thyroid disease, or heart disease shouldn't take OTC asthma drugs like Primatene Mist and Bronkaid.
Asthma in Children
Asthma in children manifests with symptoms such as coughing and wheezing. Rates of asthma in children are increasing. Asthma in children is usually diagnosed based on the description of symptoms. Lung function tests may also be used. A variety of medications are used for the treatment of childhood asthma.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.