Flonase Side Effects

Generic name: fluticasone nasal

Please note - some side effects for Flonase 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 Flonase - for the consumer

Flonase 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 Flonase Spray:

Dizziness; headache; nasal irritation or burning; nausea; nosebleed; sore throat; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; frequent, severe, or persistent nosebleeds or nasal irritation; loss of sense of smell or taste; shortness of breath; sores in the nose; unusual nasal discharge; voice changes; wheezing.

For the professional

Flonase

In controlled US studies, more than 3,300 patients with seasonal allergic, perennial allergic, or perennial nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical studies have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by patients treated with the vehicle itself. The complaints did not usually interfere with treatment. Less than 2% of patients in clinical trials discontinued because of adverse events; this rate was similar for vehicle placebo and active comparators.

Systemic corticosteroid side effects were not reported during controlled clinical studies up to 6 months’ duration with Flonase Nasal Spray. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking Flonase Nasal Spray in conjunction with administration of other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.

The following incidence of common adverse reactions (>3%, where incidence in fluticasone propionate-treated subjects exceeded placebo) is based upon 7 controlled clinical trials in which 536 patients (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) were treated with Flonase Nasal Spray 200 mcg once daily over 2 to 4 weeks and 2 controlled clinical trials in which 246 patients (119 female and 127 male adolescents and adults) were treated with Flonase Nasal Spray 200 mcg once daily over 6 months. Also included in the table are adverse events from 2 studies in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with Flonase Nasal Spray 100 mcg once daily for 2 to 4 weeks.

Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate in Controlled Clinical Trials With Flonase Nasal Spray in Patients≥4 Years With Seasonal or Perennial Allergic Rhinitis

Other adverse events that occurred in ≤3% but ≥1% of patients and that were more common with fluticasone propionate (with uncertain relationship to treatment) included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, bronchitis.

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of intranasal fluticasone propionate in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/anaphylactoid reactions, which in rare instances were severe.

Alteration or loss of sense of taste and/or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts.

Cases of growth suppression have been reported for intranasal corticosteroids, including Flonase.

By body system

Endocrine side effects

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 side effects

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 side effects

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 side effects

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

Hypersensitivity side effects

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 side effects

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

Immunologic side effects

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.

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.

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