FDA label 3c983533-3be0-4b49-b516-e0127030dfd8
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- a37ccef8-18e8-4194-9618-1b5657ade6ca
- SPL ID
- 3c983533-3be0-4b49-b516-e0127030dfd8
- Version
- 5
- Effective date
- 2025-09-01
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:16:37
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 3c983533-3be0-4b49-b516-e0127030dfd8 | id | |
| spl set id | a37ccef8-18e8-4194-9618-1b5657ade6ca | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency, and in addition some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms. The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis. A drug interaction study 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 and PRECAUTIONS: 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. Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Avoid spraying in eyes.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
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 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 Fluticasone Propionate Nasal Spray, USP. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking Fluticasone Propionate Nasal Spray, USP, 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 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. 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 Fluticasone Propionate Nasal Spray, USP, 100 mcg once daily for 2 to 4 weeks. 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) % Headache 14.6 6.6 16.1 Pharyngitis 7.2 6.0 7.8 Epistaxis 5.4 6.0 6.9 Nasal burning/nasal irritation 2.6 2.4 3.2 Nausea/vomitting 2.0 4.8 2.6 Asthma symptoms 2.9 7.2 3.3 Cough 2.8 3.6 3.8 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 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. Eye Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts. Cases of growth suppression have been reported for intranasal corticosteroids, including Fluticasone Propionate Nasal Spray, USP (see PRECAUTIONS: Pediatric Use ).
adverse reactions table
<table ID="_Refid_f65c0aef-ee42-45ea-b55f-fefca6b31" width="100%"><caption>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</caption><col width="25%"/><col width="24%"/><col width="24%"/><col width="24%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Toprule " valign="middle"><paragraph>Adverse Experience</paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="middle"><paragraph>Vehicle Placebo</paragraph><paragraph>(n=758)</paragraph><paragraph>%</paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="middle"><paragraph>Fluticasone Propionate Nasal Spray, USP</paragraph><paragraph>100 mcg Once Daily</paragraph><paragraph>(n=167)</paragraph><paragraph>%</paragraph></td><td align="center" styleCode="Botrule Toprule " valign="middle"><paragraph>Fluticasone Propionate Nasal Spray, USP</paragraph><paragraph>200 mcg Once Daily</paragraph><paragraph>(n=782)</paragraph><paragraph>%</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Headache</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>14.6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>6.6</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>16.1</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Pharyngitis</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>7.2</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>6.0</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>7.8</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Epistaxis</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>5.4</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>6.0</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>6.9</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Nasal burning/nasal irritation</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2.6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2.4</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>3.2</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Nausea/vomitting</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2.0</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>4.8</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>2.6</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Asthma symptoms</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2.9</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>7.2</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>3.3</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="middle"><paragraph>Cough</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>2.8</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="middle"><paragraph>3.6</paragraph></td><td align="center" styleCode="Botrule " valign="middle"><paragraph>3.8</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.