Drug · FAERS side-effect profile with label screen
Fluticasone Propionate Nasal side effects: what 30,091 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Fluticasone Propionate
openFDA label
Who reports
30,091 reports · 59% serious · 1,733 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion itchy, watery eyes itchy nose runny nose sneezing
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 2Lab value / disease marker 3No label text to screen 35
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,169 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 89 | 286.5 223.8–366.9ROR 287.4 · calibrated p 3e-11 ✓ | 194.0 EB05 162.5 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=89 · ♀ 100% (drug 65%) | not reported in cached trials |
| Salpingo-oophorectomy unilateral | 25 | 204.1 130.6–318.9ROR 204.3 · calibrated p 2e-9 ✓ | 140.8 EB05 100.3 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · ♀ 100% (drug 65%) | not reported in cached trials |
| Fractional exhaled nitric oxide increased | 30 | 145.9 98.4–216.3ROR 146.0 · calibrated p 2e-8 ✓ | 112.1 EB05 82.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 65%) | not reported in cached trials |
| Appendicolith | 40 | 81.9 59.0–113.6ROR 82.0 · calibrated p 9e-7 ✓ | 70.9 EB05 54.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Adrenal suppression | 75 | 67.8 53.5–86.0ROR 68.0 · calibrated p 2e-6 ✓ | 60.9 EB05 50.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=75 | not reported in cached trials |
| Cardiospasm | 44 | 59.5 43.7–81.0ROR 59.6 · calibrated p 7e-6 ✓ | 53.6 EB05 41.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=44 · ♀ 100% (drug 65%) | not reported in cached trials |
| Epidural lipomatosis | 27 | 58.4 39.4–86.5ROR 58.5 · calibrated p 1e-5 ✓ | 52.0 EB05 37.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · ♀ 0% (drug 65%) · 100% clinician | not reported in cached trials |
| Temperature regulation disorder | 169 | 58.3 49.8–68.2ROR 58.6 · calibrated p 5e-6 ✓ | 53.5 EB05 47.1 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=169 · ♀ 100% (drug 65%) · 91% clinician | not reported in cached trials |
| Female genital tract fistula | 127 | 55.4 46.3–66.4ROR 55.6 · calibrated p 8e-6 ✓ | 51.0 EB05 43.9 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=127 · ♀ 100% (drug 65%) | not reported in cached trials |
| Cushing's syndrome | 49 | 51.9 38.9–69.4ROR 52.0 · calibrated p 2e-5 ✓ | 47.5 EB05 37.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=48 · 100% clinician | not reported in cached trials |
| Immunisation | 29 | 49.8 34.2–72.6ROR 49.9 · calibrated p 3e-5 ✓ | 45.2 EB05 33.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · ♀ 100% (drug 65%) | not reported in cached trials |
| Mite allergy | 41 | 47.7 34.8–65.5ROR 47.8 · calibrated p 3e-5 ✓ | 43.8 EB05 33.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=40 · ♀ 38% (drug 65%) | not reported in cached trials |
| Palmoplantar keratoderma | 43 | 44.1 32.4–60.1ROR 44.2 · calibrated p 4e-5 ✓ | 40.8 EB05 31.6 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 · ♀ 100% (drug 65%) | not reported in cached trials |
| Multiple drug therapy | 41 | 43.4 31.7–59.5ROR 43.4 · calibrated p 5e-5 ✓ | 40.2 EB05 30.9 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=41 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Infusion site discharge | 95 | 40.9 33.3–50.3ROR 41.0 · calibrated p 5e-5 ✓ | 38.4 EB05 32.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=72 · ♀ 85% (drug 65%) · 84% consumer | not reported in cached trials |
| Chronic sinusitis | 207 | 40.7 35.4–46.8ROR 40.9 · calibrated p 5e-5 ✓ | 38.3 EB05 34.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=198 | not reported in cached trials |
| Product delivery mechanism issue | 251 | 37.8 33.3–42.9ROR 38.1 · calibrated p 7e-5 ✓ | 35.8 EB05 32.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | 86% consumer | not reported in cached trials |
| Obstructive sleep apnoea syndrome | 62 | 32.3 25.0–41.7ROR 32.4 · calibrated p 2e-4 ✓ | 30.6 EB05 24.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=62 · ♀ 35% (drug 65%) | not reported in cached trials |
| Food allergy | 333 | 32.1 28.7–35.8ROR 32.4 · calibrated p 2e-4 ✓ | 30.6 EB05 28.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=317 · ♀ 95% (drug 65%) | not reported in cached trials |
| Blood cortisol decreased | 27 | 30.2 20.5–44.4ROR 30.2 · calibrated p 4e-4 ✓ | 28.5 EB05 20.5 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Allergic granulomatous angiitis | 34 | 29.6 21.0–41.8ROR 29.7 · calibrated p 4e-4 ✓ | 28.0 EB05 21.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=34 · 100% clinician | not reported in cached trials |
| Spirometry abnormal | 24 | 29.6 19.7–44.5ROR 29.6 · calibrated p 5e-4 ✓ | 27.9 EB05 19.7 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=24 · ♀ 0% (drug 65%) | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 82 | 29.4 23.6–36.7ROR 29.5 · calibrated p 3e-4 ✓ | 28.1 EB05 23.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=81 · ♀ 0% (drug 65%) | not reported in cached trials |
| Sinusitis fungal | 32 | 29.4 20.7–41.9ROR 29.4 · calibrated p 4e-4 ✓ | 27.8 EB05 20.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
| Eosinophil count abnormal | 30 | 29.1 20.2–42.0ROR 29.2 · calibrated p 5e-4 ✓ | 27.6 EB05 20.2 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 65%) | not reported in cached trials |
| Nasal oedema | 71 | 28.7 22.6–36.3ROR 28.7 · calibrated p 4e-4 ✓ | 27.4 EB05 22.4 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=62 · ♀ 100% (drug 65%) | not reported in cached trials |
| Mycotic allergy | 32 | 27.4 19.3–39.0ROR 27.5 · calibrated p 6e-4 ✓ | 26.1 EB05 19.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 0% (drug 65%) | not reported in cached trials |
| Radiculopathy | 98 | 26.8 21.9–32.8ROR 26.9 · calibrated p 5e-4 ✓ | 25.7 EB05 21.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 65%) | not reported in cached trials |
| Infusion site reaction | 106 | 26.3 21.7–31.9ROR 26.4 · calibrated p 6e-4 ✓ | 25.3 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 65%) | not reported in cached trials |
| Dust allergy | 35 | 26.2 18.7–36.7ROR 26.2 · calibrated p 7e-4 ✓ | 24.9 EB05 18.7 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 0% (drug 65%) | not reported in cached trials |
| Infusion site mass | 38 | 25.6 18.6–35.4ROR 25.7 · calibrated p 8e-4 ✓ | 24.5 EB05 18.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · ♀ 100% (drug 65%) | not reported in cached trials |
| Infusion site haemorrhage | 108 | 24.0 19.8–29.0ROR 24.0 · calibrated p 9e-4 ✓ | 23.1 EB05 19.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=67 · 79% consumer | not reported in cached trials |
| Proctitis | 90 | 23.0 18.7–28.4ROR 23.1 · calibrated p 0.001 ✓ | 22.2 EB05 18.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=90 · ♀ 100% (drug 65%) | not reported in cached trials |
| Foetal death | 164 | 22.7 19.4–26.5ROR 22.8 · calibrated p 0.001 ✓ | 22.0 EB05 19.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=164 · ♀ 100% (drug 65%) · 94% clinician | not reported in cached trials |
| Sputum increased | 66 | 22.4 17.5–28.6ROR 22.4 · calibrated p 0.001 ✓ | 21.6 EB05 17.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=61 | not reported in cached trials |
| Peripheral venous disease | 123 | 22.1 18.5–26.4ROR 22.2 · calibrated p 0.001 ✓ | 21.4 EB05 18.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=123 · ♀ 100% (drug 65%) | not reported in cached trials |
| Respiratory symptom | 84 | 21.5 17.3–26.7ROR 21.5 · calibrated p 0.002 ✓ | 20.8 EB05 17.3 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=82 | not reported in cached trials |
| Infusion site bruising | 62 | 20.9 16.2–26.9ROR 20.9 · calibrated p 0.002 ✓ | 20.2 EB05 16.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=54 | not reported in cached trials |
| Infusion site pruritus | 89 | 20.4 16.5–25.2ROR 20.5 · calibrated p 0.002 ✓ | 19.8 EB05 16.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=61 · 78% consumer | not reported in cached trials |
| Facet joint syndrome | 90 | 20.4 16.6–25.2ROR 20.5 · calibrated p 0.002 ✓ | 19.8 EB05 16.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=90 · ♀ 100% (drug 65%) · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Fluticasone Propionate Nasal as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00883168 — A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies (N=1791, PHASE3; 10 AE terms posted; arms: MP29-02; Azelastine Hcl; Fluticasone Propionate; Placebo)
- NCT02246920 — Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhi (N=1474, PHASE3; 4 AE terms posted; arms: Investigational Test Product; Reference Listed Drug; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 2,426 | 3.0 2.9–3.1ROR 3.2 · calibrated p 0.574 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,383 | 1.3 1.2–1.3ROR 1.3 · calibrated p 0.496 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Headache | 2,283 | 2.5 2.4–2.6ROR 2.7 · calibrated p 0.744 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | NCT00883168: 8/450 (1.8%) on Fluticasone Propionate Nasal; 4/451 (0.9%) control |
| Fatigue (tiredness) | 2,122 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.929 | 1.9 EB05 1.8 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Off label use (used outside approved label) | 1,893 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.677 | 1.5 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Pain | 1,870 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.955 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | NCT00883168: 6/450 (1.3%) on Fluticasone Propionate Nasal; 2/451 (0.4%) control |
| Nausea | 1,841 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.748 | 1.6 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | not reported in cached trials |
| Cough | 1,735 | 4.3 4.1–4.5ROR 4.5 · calibrated p 0.291 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | not reported in cached trials |
| Asthma | 1,652 | 10.4 9.9–10.9ROR 10.9 · calibrated p 0.024 ✓ | 10.2 EB05 9.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,629 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.835 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | not reported in cached trials |
| Product dose omission issue | 1,463 | 3.6 3.4–3.8ROR 3.7 · calibrated p 0.434 | 3.6 EB05 3.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 73% consumer | not reported in cached trials |
| Pneumonia (lung infection) | 1,438 | 3.1 3.0–3.3ROR 3.2 · calibrated p 0.562 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Dizziness | 1,378 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.929 | 1.9 EB05 1.8 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | not reported in cached trials |
| Malaise (feeling unwell) | 1,242 | 2.0 1.9–2.1ROR 2.0 · calibrated p 0.950 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | not reported in cached trials |
| Vomiting | 1,206 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.845 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Fluticasone Propionate Nasal?
In FDA FAERS, the most frequently co-reported reaction terms for Fluticasone Propionate Nasal are dyspnoea, headache, fatigue, pain, nausea, cough. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Fluticasone Propionate Nasal have an FDA boxed warning?
No. The FDA label retrieved for Fluticasone Propionate Nasal has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluticasone Propionate Nasal causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0107ad1c-1d8e-434c-a91f-dd2caf4fa5e5, effective 20260717; matched on
openfda.generic_name.exact:"FLUTICASONE PROPIONATE NASAL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,209 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
FLUTICASONE PROPIONATE NASAL, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.