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Does Flonase (fluticasone) cause side effects?
The exact mechanism of action of Flonase is not known; however, it stimulates glucocorticoid receptors in humans that produces a potent anti-inflammatory response. Flonase also works on multiple cells and mediators that are responsible for the inflammatory symptoms of allergic rhinitis (sneezing, runny nose, etc.).
Common side effects of Flonase include
- sore throat,
- nasal burning or nasal irritation,
- asthma symptoms, and
Serious side effects of Flonase include
- growth suppression from the use of inhaled steroids in some children.
There are no adequate studies of Flonase to determine its safety and effectiveness in pregnant women. It is unknown if Flonase enters breast milk; therefore, it is best to be cautious before using it in breastfeeding mothers.
Flonase (fluticasone) side effects list for healthcare professionals
Systemic and local corticosteroid use may result in the following:
- Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, and impaired wound healing
- Cataracts and glaucoma
- Hypercorticism and adrenal suppression
- Effect on growth
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
(n = 167) %
|Flonase 200 mcg
(n = 782) %
(n = 758) %
|Nasal burning/nasal irritation||2.4||3.2||2.6|
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,
- flu-like symptoms,
- aches and pains,
- dizziness, and
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
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.
What drugs interact with Flonase (fluticasone)?
Inhibitors Of Cytochrome P450 3A4
- Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, conivaptan, lopinavir, nefazodone, voriconazole) with Flonase Nasal Spray is not recommended because increased systemic corticosteroid adverse effects may occur.
- A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations.
- During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate products, including Flonase, with ritonavir, resulting in systemic corticosteroid effects including Cushing's syndrome and adrenal suppression.
- Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
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Related Disease Conditions
An allergy refers to a misguided reaction by our immune system in response to bodily contact with certain foreign substances. When these allergens come in contact with the body, it causes the immune system to develop an allergic reaction in people who are allergic to it. It is estimated that 50 million North Americans are affected by allergic conditions. The parts of the body that are prone to react to allergies include the eyes, nose, lungs, skin, and stomach. Common allergic disorders include hay fever, asthma, allergic eyes, allergic eczema, hives, and allergic shock.
Fragrances and preservatives in cosmetics may cause allergic reactions in some people. Symptoms include redness, itching, and swelling after the product comes in contact with the person's skin. Treatment typically involves the use of over-the-counter cortisone creams.
Insect Sting Allergies
The majority of stinging insects in the United States are from bees, yellow jackets, hornets, wasps, and fire ants. Severity of reactions to stings varies greatly. Avoidance and prompt treatment are essential. In selected cases, allergy injection therapy is highly effective.
Sinus Infection vs. Allergies
Both sinus infections and allergies (allergic rhinitis) cause symptoms such as runny or stuffy nose and fatigue. Sinus infection (known as sinusitis) is inflammation of the sinuses, caused by infection from bacteria, viruses, and/or fungi (molds). Allergic rhinitis occurs when certain allergies cause nasal symptoms. When a person with allergies breathes in an allergen, such as pollen, dust, or animal dander, symptoms such as runny or stuffy nose, itching, sneezing, and fatigue occur.
COVID-19 vs. Allergies
Though there is some overlap in allergy and COVID-19 signs and symptoms there are also significant differences. Symptoms that they have in common include headache, fatigue, tiredness, shortness of breath, wheezing, and sore throat. Fever does not occur with allergies but is one of the defining symptoms of COVID-19 infections.
Drug Allergy (Medication Allergy)
Drug or medication allergies are caused when the immune system mistakenly creates an immune response to a medication. Symptoms of a drug allergic reaction include hives, rash, itchy skin or eyes, dizziness, nausea, diarrhea, fainting, and anxiety. The most common drugs that people are allergic to include penicillins and penicillin type drugs, sulfa drugs, insulin, and iodine. Treatment may involve antihistamines or corticosteroids. An EpiPen may be used for life-threatening anaphylactic symptoms.
Treatment & Diagnosis
- Allergy: Taking the Sting Out of Insect Allergies
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.