AeroBid Side Effects

Generic Name: flunisolide

Please note - some side effects for AeroBid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of AeroBid - for the Consumer

Aerobid-M Aerosol Inhaler

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aerobid-M Aerosol Inhaler:

Bad taste in mouth; decreased appetite; decreased smell or taste; diarrhea; dizziness; dry mouth; flu; headache; hoarseness; indigestion; nausea; nervousness; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fainting; fever, chills, or persistent sore throat; fast or irregular heartbeat; lack of energy; menstrual changes; mental or mood changes; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

Aerobid Aerosol Inhaler

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aerobid Aerosol Inhaler:

Bad taste in mouth; decreased appetite; decreased smell or taste; diarrhea; dizziness; dry mouth; flu; headache; hoarseness; indigestion; nausea; nervousness; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fainting; fever, chills, or persistent sore throat; fast or irregular heartbeat; lack of energy; menstrual changes; mental or mood changes; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

AeroBid Side Effects - for the Professional

Aerobid

Adverse events reported in controlled clinical trials and long-term open studies in 514 patients treated with Aerobid (flunisolide) are described below. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer, and 122 for 2 years or longer.

Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered. This is a well-known effect of steroid withdrawal.

Incidence 10% or greater:

 

Gastrointestinal: diarrhea (10%), nausea and/or vomiting (25%), upset stomach (10%)

 

General: flu (10%)

 

Mouth and Throat: sore throat (20%)

 

Nervous System: headache (25%)

 

Respiratory: cold symptoms (15%), nasal congestion (15%), upper respiratory infection

 

(25%)

 

Special Senses: unpleasant taste (10%)

Incidence 3-9%

 

Cardiovascular: palpitations

 

Gastrointestinal: abdominal pain, heartburn

 

General: chest pain, decreased appetite, edema, fever

 

Mouth and Throat: Candida infection

 

Nervous System: dizziness, irritability, nervousness, shakiness

 

Reproductive: menstrual disturbances

 

Respiratory: chest congestion, cough*, hoarseness, rhinitis, runny nose, sinus congestion,

 

sinus drainage, sinus infection, sinusitis, sneezing, sputum, wheezing1

 

Skin: eczema, itching (pruritus), rash

 

Special Senses: ear infection, loss of smell or taste

Incidence 1-3%

 

General: chills, increased appetite and weight gain, malaise, peripheral edema, sweating,

 

weakness

 

Cardiovascular: hypertension, tachycardia

 

Gastrointestinal: constipation, dyspepsia, gas

 

Hemic/Lymph: capillary fragility, enlarged lymph nodes

 

Mouth and Throat: dry throat, glossitis, mouth irritation, pharyngitis, phlegm, throat irritation

 

Nervous System: anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity,

 

insomnia, moodiness, numbness, vertigo

 

Respiratory: bronchitis, chest tightness*, dyspnea, epistaxis, head stuffiness, laryngitis,

 

nasal irritation, pleurisy, pneumonia, sinus discomfort

 

Skin: acne, hives or urticaria

 

Special Senses: blurred vision, earache, eye discomfort, eye infection

Incidence less than 1%, judged by investigators as possibly or probably drug related:

 

abdominal fullness, shortness of breath.

1

The incidences as shown of cough, wheezing, and chest tightness were judged by investigators to be possibly or probably drug related. In placebo-controlled trials, the overall incidences of these adverse events (regardless of investigators' judgement of drug relationship) were similar for drug and placebo-treated groups. They may be related to the vehicle or delivery system.

Side Effects by Body System

General

Flunisolide has been generally well tolerated and, due to the nature of its administration, has not been inclined to produce the adverse effects generally associated with the systemic use corticosteroids.

Gastrointestinal

Gastrointestinal side effects have included oropharyngeal candidiasis in approximately 3% to 9% of patients treated, as well as nausea and vomiting (25%), diarrhea (10%), and upset stomach (10%). In addition, flunisolide has produced a bitter taste in most patients.

To reduce the incidence of thrush, patients should be instructed to rinse their mouths following the use of flunisolide. Limited data suggest that the incidence of thrush secondary to inhaled corticosteroids may be lower in patients utilizing a spacer device and good inhalation technique.

Respiratory

Many patients who experience coughing and wheezing may benefit from pretreatment with an inhaled beta-agonist prior to administration of flunisolide.

Respiratory side effects have included dysphonia, sore throat, and cold symptoms. Coughing and wheezing have also been frequently reported, especially in patients whose disease is poorly controlled. Nasal irritation, burning and stinging, congestion, epistaxis, sneezing, and rarely, nasal septal perforations have been reported with intranasal administration. Temporary or permanent loss of the sense of smell and taste have occurred with both oral inhalation and intranasal formulations. Upper respiratory tract infections are also more common in patients receiving flunisolide.

Nervous system

Nervous system side effects have generally been limited to headache, which has occurred in up to 25% of patients. Dizziness, nervousness, shakiness, depression, and insomnia have been reported in less than 10% of patients.

Endocrine

Endocrine side effects have rarely included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression has been less than that associated with systemic corticosteroids and, generally, has been only of concern when using higher than recommended doses.

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested the FDA review their decision concerning the relabeling of inhaled corticosteroids with respect to the risk of their use during severe viral infections. The AAAI's request was based on the lack of data linking inhaled corticosteroids to increases in complications of viral infections.

Immunologic side effects have included the danger of infections from immune suppression associated with inhaled corticosteroids. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled corticosteroids.

Musculoskeletal

Musculoskeletal side effects have included the potential of reduction in bone density with the long term use of inhaled corticosteroids. This effect may have been dose-related and has been reported with high dosages of orally inhaled beclomethasone and budesonide (>= 800 mcg/day for >= 1 year). Reduced levels of total body calcium have also been demonstrated in patients receiving lower dosages.

Ocular

Ocular side effects have included occasional reports of capsular cataracts, especially with long-term use. In addition, one epidemiologic study suggested that prolonged use of high-dose inhaled corticosteroids (>= 1500 mcg of flunisolide) may be associated with increased risk of ocular hypertension and open-angle glaucoma.

Dermatologic

Dermatologic side effects have included eczema, acne, rash, and urticaria. Easy bruising has also been associated with flunisolide use in some patients.

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