Veramyst Side Effects

Please note - some side effects for Veramyst 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 Veramyst - for the Consumer

Veramyst 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 Veramyst Spray:

Back pain; cough; headache; minor nosebleed; sore throat.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fever; severe or persistent nosebleed; severe or persistent pain in the nose or throat; slow wound healing; vision changes.

Veramyst Side Effects - for the Professional

Veramyst

• The most common adverse reactions (>1% incidence) included headache, epistaxis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, and cough. (6.1)

Side Effects by Body System

Endocrine

Endocrine side effects have included suppression of the hypothalamic-pituitary-adrenal axis. The risk of adrenal suppression is less than that associated with systemic corticosteroids and should be of concern only when using higher than recommended doses. Slight suppression of plasma cortisol has been noted following 250 mcg intranasal doses of fluticasone.

Due to extensive first-pass metabolism of fluticasone to an inactive carboxylic acid, significant systemic effects are not expected from any amount of the drug that may be swallowed via intranasal administration of normally recommended dosages. In one study involving 61 patients, no significant difference was demonstrated in the hypothalamic-pituitary-adrenal axis function among patients given intranasal fluticasone 200 mcg/day or placebo for 1 year.

Local

Local side effects have included nasal irritation including burning, dryness, and soreness in 1% to 6% of patients. Nose bleed has been reported in up to 15% of treated patients and sore throat in 2%. Intranasal fluticasone may also cause sneezing. Nasal candidiasis has been reported in at least one patient. Alteration or loss of sense of taste or smell has been reported rarely. Nasal septal perforation has also been reported rarely.

Nervous system

Nervous system adverse effects have included headache in 2% to 4% of patients. Some studies have reported headache in as many as 32% of patients. Dizziness has also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and dry mouth.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of a systemic eosinophilic condition. Clinical features of this condition have included a vasculitis consistent with Churg-Strauss syndrome, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy. These events have usually been associated with a reduction and/or discontinuation of oral corticosteroid therapy following introduction of fluticasone.

Rarely, hypersensitivity reactions have been reported including angioedema, rash, face and tongue edema, pruritus, urticaria, bronchospasm, wheezing, dyspnea and anaphylaxis.

Cases of serious eosinophilic conditions also have been reported with other inhaled corticosteroids in this clinical setting.

Ocular

Ocular side effects have included occasional reports of posterior capsular cataracts with inhaled corticosteroids.

Immunologic

In 1993, the American Academy of Allergy and Immunology (AAAI) requested that the FDA review its decision regarding the labeled risks of the use of inhaled corticosteroids 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.

The danger of infections from immune suppression associated with inhaled corticosteroids has been debated. No conclusive evidence is available to support an increase in tuberculosis or viral infections in patients receiving inhaled fluticasone.

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