Flunisolide Side Effects

Brand Names: AeroBid, Aerobid

Please note - some side effects for Flunisolide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Flunisolide - for the Consumer

Flunisolide 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 Flunisolide 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Flunisolide Aerosol Inhaler:

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Flunisolide HFA 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 Flunisolide HFA Inhaler:

Cough; runny nose; sinus inflammation; stomach pain or upset; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur when using Flunisolide HFA Inhaler:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; ear or eye pain or discharge; mental or mood changes; new or worsening breathing problems (eg, shortness of breath, increased wheezing); nosebleeds; severe stomach pain; signs of infection (eg, fever, chills, persistent sore throat); sore mouth; unusual weakness or fatigue; vision changes; white patches in the mouth or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Flunisolide Spray

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 Flunisolide Spray:

Aftertaste; cough; nasal burning, dryness, or stinging; nausea; nosebleed; sore throat.

Seek medical attention right away if any of these SEVERE side effects occur when using Flunisolide Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sense of smell; excessive sneezing; muscle weakness; nasal discomfort or irritation; repeated nosebleeds; unusual weight gain, especially in the face; white patches in the mouth, nose, or throat.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

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Flunisolide Side Effects - for the Professional

Flunisolide

Adverse reactions reported in controlled clinical trials and long-term open studies in 595 patients treated with Flunisolide nasal solution are described below. Of these patients, 409 were treated for 3 months or longer, 323 for 6 months or longer, 259 for 1 year or longer, and 91 for 2 years or longer.

In general, side effects elicited in the clinical studies have been primarily associated with the nasal mucous membranes. The most frequent complaints were those of mild transient nasal burning and stinging, which were reported in approximately 45% of the patients treated with Flunisolide nasal solution in placebo-controlled and long-term studies. These complaints do not usually interfere with treatment; in only 3% of patients was it necessary to decrease dosage or stop treatment because of these symptoms. Approximately the same incidence of mild transient nasal burning and stinging was reported in patients on placebo as was reported in patients treated with Flunisolide nasal solution in controlled studies, implying that these complaints may be related to the vehicle or the delivery system. The incidence of complaints of nasal burning and stinging decreased with increasing duration of treatment.

Other side effects reported at a frequency of 5% or less were: nasal congestion, sneezing, epistaxis and/or bloody mucous, nasal irritation, watery eyes, sore throat, nausea and/or vomiting, and headaches. As with other nasally inhaled corticosteroids, nasal septal perforations have been reported in rare instances with the use of Flunisolide nasal solutions. Temporary or permanent loss of the sense of smell and taste have also been reported with the use of Flunisolide nasal solutions.

Systemic corticosteroid side effects were not reported during the controlled clinical trials. If recommended doses are exceeded, or if individuals are particularly sensitive, symptoms of hypercorticism, i.e., Cushing’s syndrome, could occur. Cases of growth suppression have been reported for intranasal corticosteroids (including Flunisolide nasal solution).

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