Drug · FAERS side-effect profile with label screen
Fluticasone and Salmeterol side effects: what 59,667 FDA adverse event reports show
Drug class
Inhaled corticosteroid (ics)
FDA label, Indications wording of the closest related product
Label matched
Fluticasone Propionate (Flovent Diskus)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
59,667 reports · 58% serious · 3,579 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm. FLOVENT DISKUS is an inhaled corticosteroid (ICS) indicated for: • Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
FDA label, Indications and Usage
What it is
FLOVENT DISKUS inhalation powder is a dry powder inhaler for oral inhalation. The active component of FLOVENT DISKUS 50 mcg, FLOVENT DISKUS 100 mcg, and FLOVENT DISKUS 250 mcg is fluticasone p.
FDA label, Description section
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
Labeled adverse reaction 1Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 7Not in label — unassessed 23
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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). 1,183 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 55 | 463.6 309.4–694.6ROR 464.0 · calibrated p 1e-12 ✓ | 185.8 EB05 148.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Central nervous system mass | 47 | 360.9 239.8–543.2ROR 361.2 · calibrated p 1e-11 ✓ | 165.3 EB05 129.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 0% (drug 68%) · 100% clinician | no trial arm names this drug |
| Spirometry abnormal | 281 | 324.8 276.0–382.1ROR 326.3 · calibrated p 6e-12 ✓ | 166.0 EB05 150.4 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=279 · ♀ 11% (drug 68%) | no trial arm names this drug |
| Airway remodelling | 58 | 308.4 216.4–439.3ROR 308.7 · calibrated p 3e-11 ✓ | 155.2 EB05 124.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=58 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Mite allergy | 283 | 281.8 240.9–329.7ROR 283.2 · calibrated p 2e-11 ✓ | 154.1 EB05 139.6 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=283 · ♀ 10% (drug 68%) | no trial arm names this drug |
| Wall motion score index abnormal | 47 | 262.0 179.3–382.7ROR 262.2 · calibrated p 1e-10 ✓ | 141.0 EB05 110.3 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=47 · ♀ 0% (drug 68%) · 100% clinician | no trial arm names this drug |
| Dust allergy | 320 | 175.0 153.0–200.1ROR 175.9 · calibrated p 1e-9 ✓ | 115.7 EB05 105.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=320 · ♀ 16% (drug 68%) | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 168 | 167.8 139.6–201.7ROR 168.3 · calibrated p 2e-9 ✓ | 111.9 EB05 98.4 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=165 · ♀ 40% (drug 68%) | no trial arm names this drug |
| Prolonged expiration | 84 | 164.0 126.5–212.6ROR 164.2 · calibrated p 4e-9 ✓ | 108.8 EB05 90.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=84 | no trial arm names this drug |
| Mycotic allergy | 267 | 163.3 141.2–188.9ROR 164.0 · calibrated p 3e-9 ✓ | 110.4 EB05 99.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=265 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Bronchial neoplasm | 40 | 145.5 100.6–210.5ROR 145.6 · calibrated p 2e-8 ✓ | 98.0 EB05 75.1 · IC025 +5.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Total lung capacity abnormal | 107 | 137.5 109.9–171.9ROR 137.7 · calibrated p 1e-8 ✓ | 97.0 EB05 82.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Pulmonary vasculitis | 137 | 123.0 101.2–149.4ROR 123.2 · calibrated p 3e-8 ✓ | 89.9 EB05 77.9 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=137 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Total lung capacity increased | 66 | 111.8 84.7–147.6ROR 111.9 · calibrated p 8e-8 ✓ | 82.8 EB05 67.3 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Atopy | 66 | 109.1 82.8–143.9ROR 109.2 · calibrated p 1e-7 ✓ | 81.3 EB05 66.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=65 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Capillaritis | 63 | 107.8 81.2–143.0ROR 107.9 · calibrated p 1e-7 ✓ | 80.4 EB05 65.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 0% (drug 68%) · 100% clinician | no trial arm names this drug |
| Forced expiratory volume decreased | 624 | 99.1 90.7–108.3ROR 100.1 · calibrated p 1e-7 ✓ | 77.1 EB05 72.1 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=622 | no trial arm names this drug |
| Temperature regulation disorder | 463 | 94.5 85.3–104.6ROR 95.2 · calibrated p 2e-7 ✓ | 74.2 EB05 68.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=462 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Conjunctivitis allergic | 289 | 86.5 76.0–98.3ROR 86.9 · calibrated p 4e-7 ✓ | 69.1 EB05 62.6 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=285 · ♀ 9% (drug 68%) | no trial arm names this drug |
| Reversible airways obstruction | 100 | 84.7 68.1–105.4ROR 84.8 · calibrated p 5e-7 ✓ | 67.4 EB05 57.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=100 | no trial arm names this drug |
| Inhalation therapy | 123 | 83.8 68.9–102.1ROR 84.0 · calibrated p 5e-7 ✓ | 67.0 EB05 57.6 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=36 · 86% consumer | no trial arm names this drug |
| Smoke sensitivity | 48 | 65.3 48.0–88.9ROR 65.4 · calibrated p 4e-6 ✓ | 54.0 EB05 42.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Lung diffusion test decreased | 62 | 65.1 49.7–85.4ROR 65.2 · calibrated p 4e-6 ✓ | 54.1 EB05 43.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=61 | no trial arm names this drug |
| Nasal oedema | 252 | 57.4 50.2–65.5ROR 57.6 · calibrated p 6e-6 ✓ | 49.2 EB05 44.3 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=247 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Bronchial haemorrhage | 40 | 51.0 36.6–71.1ROR 51.0 · calibrated p 2e-5 ✓ | 43.7 EB05 33.5 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 92 | 50.7 40.7–63.1ROR 50.8 · calibrated p 2e-5 ✓ | 44.0 EB05 36.9 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=92 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Eosinophilic granulomatosis with polyangiitis | 254 | 50.5 44.3–57.6ROR 50.7 · calibrated p 1e-5 ✓ | 44.0 EB05 39.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=254 · ♀ 24% (drug 68%) | no trial arm names this drug |
| Nasal turbinate hypertrophy | 46 | 48.9 35.9–66.6ROR 48.9 · calibrated p 2e-5 ✓ | 42.3 EB05 33.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Blood immunoglobulin e increased | 291 | 47.6 42.1–53.8ROR 47.8 · calibrated p 2e-5 ✓ | 41.8 EB05 37.9 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=283 · ♀ 39% (drug 68%) | no trial arm names this drug |
| Forced vital capacity decreased | 76 | 46.6 36.7–59.2ROR 46.6 · calibrated p 3e-5 ✓ | 40.8 EB05 33.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=75 · 100% clinician | no trial arm names this drug |
| Obstructive airways disorder | 1,306 | 46.5 43.9–49.2ROR 47.5 · calibrated p 2e-5 ✓ | 41.1 EB05 39.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 47.4 · serious PRR 42.1 | no trial arm names this drug |
| Endometrial ablation | 40 | 44.6 32.1–62.0ROR 44.6 · calibrated p 4e-5 ✓ | 38.9 EB05 29.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 100% (drug 68%) · 100% clinician | no trial arm names this drug |
| Perfume sensitivity | 63 | 44.5 34.3–57.9ROR 44.6 · calibrated p 4e-5 ✓ | 39.1 EB05 31.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Peak expiratory flow rate decreased | 47 | 41.8 30.9–56.5ROR 41.8 · calibrated p 6e-5 ✓ | 36.9 EB05 28.8 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=40 · 100% clinician | no trial arm names this drug |
| Eosinophil count abnormal | 77 | 40.4 31.9–51.1ROR 40.4 · calibrated p 6e-5 ✓ | 36.0 EB05 29.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=72 · ♀ 100% (drug 68%) | no trial arm names this drug |
| Lung hyperinflation | 86 | 38.7 31.0–48.4ROR 38.8 · calibrated p 8e-5 ✓ | 34.7 EB05 29.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=84 | no trial arm names this drug |
| Neuritis | 151 | 38.1 32.2–45.1ROR 38.2 · calibrated p 8e-5 ✓ | 34.3 EB05 30.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=150 · ♀ 0% (drug 68%) | no trial arm names this drug |
| Hoarseness | 47 | 37.4 27.7–50.6ROR 37.5 · calibrated p 1e-4 ✓ | 33.5 EB05 26.2 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | 100% consumer | no trial arm names this drug |
| Restrictive pulmonary disease | 112 | 37.2 30.6–45.2ROR 37.2 · calibrated p 9e-5 ✓ | 33.5 EB05 28.6 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=111 | no trial arm names this drug |
| Respiratory symptom | 265 | 36.6 32.3–41.6ROR 36.8 · calibrated p 9e-5 ✓ | 33.1 EB05 29.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=259 · ♀ 21% (drug 68%) | no trial arm names this drug |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Serious infection | 6,990 | 3.23.1–3.3 | signal |
| Interstitial lung disease | 575 | 2.11.9–2.3 | raised |
| Fall / fracture | 2,133 | 2.01.9–2.1 | raised |
| Opportunistic infection | 676 | 1.71.6–1.9 | raised |
| Heart failure | 837 | 1.61.5–1.8 | raised |
| Tendon disorder | 175 | 1.61.4–1.9 | raised |
| Venous thromboembolism | 991 | 1.61.5–1.7 | raised |
| Gi bleeding | 793 | 1.51.4–1.6 | raised |
| Anaphylaxis / angioedema | 516 | 1.41.3–1.6 | raised |
| Depression | 1,116 | 1.41.3–1.5 | raised |
| Arrhythmia / qt | 735 | 1.31.2–1.4 | raised |
| Hyperglycaemia / diabetes | 1,246 | 1.31.2–1.3 | raised |
| Myocardial infarction | 670 | 1.21.1–1.2 | raised |
| Kidney injury | 1,493 | 1.11.1–1.2 | raised |
| Hyponatraemia | 255 | 1.11.0–1.3 | no difference |
| Liver injury | 933 | 1.11.0–1.2 | raised |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Fluticasone and Salmeterol (searched FLUTICASONE PROPIONATE).
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) | 9,966 | 6.3 6.2–6.4ROR 7.3 · calibrated p 0.086 | 6.2 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.0 · serious PRR 6.2 | no trial arm names this drug |
| Asthma | 8,117 | 27.4 26.8–27.9ROR 31.5 · calibrated p 2e-4 ✓ | 25.4 EB05 25.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | age-adj. PRR 30.5 · serious PRR 31.2 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 5,475 | 1.5 1.4–1.5ROR 1.5 · calibrated p 0.647 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | age-adj. PRR 1.8 · serious PRR 2.0 | no trial arm names this drug |
| Pneumonia (lung infection) | 4,931 | 5.4 5.3–5.6ROR 5.8 · calibrated p 0.162 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.3 · serious PRR 5.4 | no trial arm names this drug |
| Cough | 4,924 | 6.3 6.1–6.4ROR 6.7 · calibrated p 0.109 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 6.7 · serious PRR 7.9 | no trial arm names this drug |
| Wheezing | 4,182 | 26.7 25.9–27.5ROR 28.6 · calibrated p 3e-4 ✓ | 24.8 EB05 24.2 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 27.5 · serious PRR 30.2 | no trial arm names this drug |
| Fatigue (tiredness) | 3,936 | 1.8 1.7–1.8ROR 1.8 · calibrated p 0.853 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.4 | no trial arm names this drug |
| Headache | 3,612 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.997 | 2.0 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.9 | no trial arm names this drug |
| Malaise (feeling unwell) | 3,603 | 2.9 2.8–3.0ROR 3.0 · calibrated p 0.621 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.3 · serious PRR 3.7 | no trial arm names this drug |
| Pain | 3,373 | 1.9 1.9–2.0ROR 2.0 · calibrated p 0.937 | 1.9 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 2.5 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,834 | 1.1 1.1–1.2ROR 1.2 · calibrated p 0.409 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 1.4 | no trial arm names this drug |
| Nausea | 2,734 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.459 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 1.5 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 2,210 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.451 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 1.5 | no trial arm names this drug |
| Vomiting | 2,169 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.739 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 2.0 | no trial arm names this drug |
| Nasopharyngitis (common cold) | 2,151 | 4.1 4.0–4.3ROR 4.2 · calibrated p 0.335 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | age-adj. PRR 4.6 · serious PRR 6.9 | no trial arm names this drug |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Heart sounds — n=55, PRR 463.6
- Central nervous system mass — n=47, PRR 360.9
- Airway remodelling — n=58, PRR 308.4
- Mite allergy — n=283, PRR 281.8
- Dust allergy — n=320, PRR 175.0
- Prolonged expiration — n=84, PRR 164.0
- Mycotic allergy — n=267, PRR 163.3
- Total lung capacity abnormal — n=107, PRR 137.5
- Total lung capacity increased — n=66, PRR 111.8
- Atopy — n=66, PRR 109.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Salmeterol Xinafoate ↔ Asthma.
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 and Salmeterol?
In FDA FAERS, the most frequently co-reported reaction terms for Fluticasone and Salmeterol are dyspnoea, asthma, pneumonia, cough, wheezing, fatigue. 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 and Salmeterol have an FDA boxed warning?
No. The FDA label retrieved for Fluticasone and Salmeterol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluticasone and Salmeterol 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 038e6c40-9421-40ef-874b-8f4d7110a74a, effective 20240111; matched on
openfda.generic_name.exact:"FLUTICASONE PROPIONATE") - 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, 1,223 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, 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.