What are the side effects of Flonase (fluticasone propionate)?

From the Guidelines

Flonase (fluticasone propionate) nasal spray is generally well-tolerated, but it can cause mild side effects such as nasal irritation, burning, stinging, dryness, nosebleeds, headache, and unpleasant taste or smell, as reported in studies 1.

Common Side Effects

• Nasal irritation
• Burning or stinging sensation
• Dryness
• Nosebleeds
• Headache
• Unpleasant taste or smell These side effects are usually mild and improve with continued use as the body adjusts to the medication.

Serious Side Effects

More serious but rare side effects include:

• Severe or frequent nosebleeds
• White patches in the nose or throat (indicating fungal infection)
• Vision changes
• Severe nasal pain
• Signs of adrenal suppression (fatigue, weakness, dizziness)

Minimizing Side Effects

To minimize side effects, it is recommended to:

• Use the proper spraying technique (away from the nasal septum)
• Clean the nozzle regularly
• Not exceed the recommended dose (typically 1-2 sprays per nostril daily) If persistent or severe side effects occur, it is advised to contact a healthcare provider, as they may recommend reducing the dose or switching to a different medication 1.

Quality of Life

The use of Flonase has been shown to improve quality of life in patients with seasonal allergic rhinitis, with a significant reduction in symptom scores compared to placebo 1.

Safety Profile

The safety profile of Flonase is well-established, with a low rate of adverse events reported in clinical studies 1.

Conclusion Not Applicable - Direct Answer Only

The most common side effects associated with Flonase are a result of local irritation, and patients should be advised to use the medication properly to minimize these effects 1.

From the FDA Drug Label

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda. gov/medwatch. 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 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 Fluticasone Propionate Nasal Spray, USP, 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 Fluticasone Propionate Nasal Spray, USP, 200 mcg once daily over 6 months Overall Adverse Experiences With >3% Incidence on Fluticasone Propionate in Controlled Clinical Trials With Fluticasone Propionate Nasal Spray, USP, in Patients ≥4 Years With Seasonal or Perennial Allergic Rhinitis Adverse Experience Vehicle Placebo (n=758) % Fluticasone Propionate Nasal Spray, USP 100 mcg Once Daily (n=167) % Fluticasone Propionate Nasal Spray, USP 200 mcg Once Daily (n=782) % Headache14.66.616.1 Pharyngitis7.26.07.8 Epistaxis5.46.06.9 Nasal burning/nasal irritation2.62.43.2 Nausea/vomitting2.04.82.6 Asthma symptoms2.97.23.3 Cough2.83.63.8

The common side effects of Flonase include:

• Headache (16.1%)
• Pharyngitis (7.8%)
• Epistaxis (6.9%)
• Nasal burning/nasal irritation (3.2%)
• Nausea/vomiting (2.6%)
• Asthma symptoms (3.3%)
• Cough (3.8%) 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 Serious side effects may include:
• Hypersensitivity reactions
• Angioedema
• Skin rash
• Edema of the face and tongue
• Pruritus
• Urticaria
• Bronchospasm
• Wheezing
• Dyspnea
• Anaphylaxis/anaphylactoid reactions 2 2

From the Research

Flonase Side Effects

• The most common drug-related adverse event associated with Fluticasone Furoate Nasal Spray (Flonase) is epistaxis, which occurred in 28% of patients in a study comparing it to a placebo 3.
• Other potential side effects of Flonase include nasal discomfort, nasal congestion, and headache, although these were not specifically reported in the provided studies.
• A study comparing Azelastine and Fluticasone nasal sprays found that Azelastine had lesser side effects, making it a safer option for long-term use in patients with allergic rhinitis 4.
• Fluticasone Furoate Nasal Spray has a good safety profile due to its reduced systemic exposure, with a low oral bioavailability and low absolute bioavailability after intranasal administration 5.

Ocular Safety

• A 2-year study evaluating the ocular effects of Fluticasone Furoate Nasal Spray found no statistically significant difference in the time to first occurrence of posterior subcapsular opacity or intraocular pressure events between the treatment and placebo groups 3.
• The study concluded that the data neither support nor negate current recommendations for regular ophthalmic monitoring in patients treated with intranasal corticosteroids.

Comparison to Other Treatments

• A study comparing as-needed and regular use of Fluticasone Furoate Nasal Spray found that both groups had similar improvements in total nasal symptom score and Rhinoconjunctivitis Quality of Life-36 Questionnaire score, although the regular use group tended towards a greater improvement in total nasal symptom score 6.
• A systematic review and meta-analysis found that combination therapy with intranasal Azelastine and Fluticasone propionate was superior to monotherapy or placebo in reducing total nasal symptom score in patients with allergic rhinitis 7.