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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 (fluticasone propionate) Nasal Spray. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking FLONASE (fluticasone propionate) 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 to11 years, 137 female and 234 male adolescents and adults) were treated with FLONASE (fluticasone propionate) 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 (fluticasone propionate) 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 to11 years) were treated with FLONASE (fluticasone propionate) 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 (fluticasone propionate) Nasal Spray in Patients ≥4 Years With Seasonal or Perennial Allergic Rhinitis
|Adverse Experience||Vehicle Placebo
(n = 758)
|FLONASE (fluticasone propionate nasal spray)
100 mcg Once Daily
(n = 167)
|FLONASE (fluticasone propionate nasal spray)
200 mcg Once Daily
(n = 782)
|Nasal burning/nasal irritation||2.6||2.4||3.2|
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.
General: 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.
Ear, Nose, and Throat: 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.
Cases of growth suppression have been reported for intranasal corticosteroids, including FLONASE (fluticasone propionate) (see PRECAUTIONS: Pediatric Use).
Read the Flonase (fluticasone propionate nasal spray) Side Effects Center for a complete guide to possible side effects
Fluticasone propionate is a substrate of cytochrome P450 3A4. A drug interaction study with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations (see CLINICAL PHARMACOLOGY: Drug Interactions). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
In a placebo-controlled, crossover study in 8 healthy volunteers, coadministration of a single dose of orally inhaled fluticasone propionate (1,000 mcg; 5 times the maximum daily intranasal dose) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased plasma fluticasone propionate exposure, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. Caution should be exercised when FLONASE (fluticasone propionate) Nasal Spray is coadministered with ketoconazole and other known potent cytochrome P450 3A4 inhibitors.
Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.
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