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Flonase

Last reviewed on RxList: 3/14/2017
Flonase Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/14/2017

Flonase (fluticasone) is a synthetic steroid of the glucocorticoid family of drugs and is prescribed for the control of symptoms of allergic and non-allergic rhinitis. Flonase is available as a generic drug, and dosing is usually administered as two sprays in each nostril once daily, or one spray in each nostril twice daily. The most common side effects of Flonase (fluticasone) include:

Flonase has also been associated with hypersensitivity reactions (for example, skin rash, itching, facial swelling, and anaphylaxis).

The recommended starting dosage of Flonase in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). Drug interactions and warnings include Norvir (ritonavir) and Nizoral (ketoconazole). Taking either one of these drugs with Flonase may increase the blood concentrations of Flonase and potentially increase its side effects. Flonase should only be used during pregnancy when it is absolutely necessary. There have not been adequate studies of Flonase and concentrations in breast milk; therefore, Flonase should be avoided while breastfeeding unless it is absolutely necessary.

Our Flonase Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Flonase Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, rash; feeling light-headed; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe or ongoing nosebleeds;
  • noisy breathing, runny nose, or crusting around your nostrils;
  • redness, sores, or white patches in your mouth or throat;
  • blurred vision, eye pain, or seeing halos around lights;
  • any wound that will not heal; or
  • signs of low adrenal gland hormones--flu-like symptoms, headache, depression, weakness, tiredness, diarrhea, vomiting, stomach pain, craving salty foods, and feeling light-headed.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

  • minor nosebleed, burning or itching in your nose;
  • sores or white patches inside or around your nose;
  • cough, trouble breathing;
  • headache, back pain;
  • sinus pain, sore throat, fever; or
  • nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Flonase (Fluticasone Propionate Nasal Spray)

Flonase Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled US clinical trials, more than 3,300 subjects with allergic and nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical trials have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by subjects treated with placebo. Less than 2% of subjects in clinical trials discontinued because of adverse reactions; this rate was similar for vehicle placebo and active comparators.

The safety data described below are based on 7 placebo-controlled clinical trials in subjects with allergic rhinitis. The 7 trials included 536 subjects (57 girls and 108 boys aged 4 to 11 years, 137 female and 234 male adolescents and adults) treated with FLONASE 200 mcg once daily over 2 to 4 weeks and 2 placebo-controlled clinical trials which included 246 subjects (119 female and 127 male adolescents and adults) treated with FLONASE 200 mcg once daily over 6 months (Table 1). Also included in Table 1 are adverse reactions from 2 trials in which 167 children (45 girls and 122 boys aged 4 to 11 years) were treated with FLONASE 100 mcg once daily for 2 to 4 weeks.

Table 1: Adverse Reactions with FLONASE Nasal Spray with > 3% Incidence and More Common than Placebo in Subjects ≥ 4 Years with Allergic Rhinitis

Adverse Reaction FLONASE 100 mcg
Once Daily
(n = 167) %
FLONASE 200 mcg
Once Daily
(n = 782) %
Placebo
(n = 758) %
Headache 6.6 16.1 14.6
Pharyngitis 6.0 7.8 7.2
Epistaxis 6.0 6.9 5.4
Nasal burning/nasal irritation 2.4 3.2 2.6
Nausea/vomiting 4.8 2.6 2.0
Asthma symptoms 7.2 3.3 2.9
Cough 3.6 3.8 2.8

Other adverse reactions with FLONASE Nasal Spray observed with an incidence less than or equal to 3% but greater than or equal to 1% and more common than with placebo included: blood in nasal mucus, runny nose, abdominal pain, diarrhea, fever, flu-like symptoms, aches and pains, dizziness, and bronchitis.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following adverse events have been identified during postapproval use of intranasal fluticasone propionate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 Disorders and Administration Site Conditions

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 and Labyrinth Disorders

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.

Eye Disorders

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

Cases of growth suppression have been reported for intranasal corticosteroids, including FLONASE [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Flonase (Fluticasone Propionate Nasal Spray)

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