Fluticasone Furoate side effects: what 12,024 FDA adverse event reports show

Fluticasone Furoate · Arnuity Ellipta · 1,108 reaction terms · 70,959 drug–reaction co-reports · data 2026-09-14

Drug class

Inhaled corticosteroid

FDA label, Indications wording

Brand names

Arnuity Ellipta

openFDA label

Who reports

12,024 reports · 58% serious · 596 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older. Limitations of Use ARNUITY ELLIPTA is NOT indicated for the relief of acute bronchospasm. ARNUITY ELLIPTA is an inhaled corticosteroid indicated for the maintenance treatment of asthma in adult and pediatric patients aged 5 years and older.

FDA label, Indications and Usage

What it is

ARNUITY ELLIPTA is an inhalation powder drug product for delivery of fluticasone furoate (an ICS) to patients by oral inhalation. Fluticasone furoate, a synthetic trifluorinated corticosteroid.

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 (related wording) 4Likely indication confounding 2Reporting / coding artifact 7Lab value / disease marker 3Not in label — unassessed 24

What the badges mean

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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,068 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pituitary stalk interruption syndrome	11	4,722.4 1,503.9–14,828.8ROR 4,726.7 · χ² 12,615 / p <1e-300	394.1 EB05 234.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Plethysmography	17	3,243.7 1,446.2–7,275.3ROR 3,248.2 · χ² 17,969 / p <1e-300	494.8 EB05 327.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Sars-cov-2 sepsis	14	1,092.8 559.3–2,135.2ROR 1,094.1 · χ² 8,677 / p <1e-300	349.0 EB05 221.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Appendicolith	145	1,082.6 880.1–1,331.7ROR 1,095.8 · χ² 95,441 / p <1e-300	610.5 EB05 531.6 · IC025 +7.4 3/3 methods agree	Not in label — unassessed	serious n=145 · ♀ 0% (drug 66%) · 94% clinician	no trial arm names this drug
Vaginal flatulence	113	1,026.7 813.8–1,295.3ROR 1,036.4 · χ² 71,826 / p <1e-300	579.4 EB05 495.2 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 100% (drug 66%)	no trial arm names this drug
Malignant mediastinal neoplasm	40	1,025.2 693.3–1,516.1ROR 1,028.6 · χ² 24,991 / p <1e-300	490.8 EB05 375.9 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=40 · ♀ 100% (drug 66%)	no trial arm names this drug
Radioallergosorbent test positive	10	954.0 440.5–2,066.3ROR 954.8 · χ² 5,522 / p <1e-300	282.5 EB05 164.0 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=10	no trial arm names this drug
Hyper ige syndrome	38	870.1 589.2–1,284.9ROR 872.8 · χ² 21,320 / p <1e-300	447.2 EB05 340.1 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious n=38 · ♀ 100% (drug 66%)	no trial arm names this drug
Sleep disorder therapy	56	751.3 549.1–1,027.9ROR 754.8 · χ² 28,670 / p <1e-300	443.4 EB05 354.2 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious n=56 · ♀ 0% (drug 66%) · 100% clinician	no trial arm names this drug
Antacid therapy	29	553.3 364.2–840.6ROR 554.7 · χ² 11,678 / p <1e-300	328.0 EB05 239.5 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=29 · ♀ 0% (drug 66%) · 100% clinician	no trial arm names this drug
Analgesic therapy	58	406.5 305.5–540.9ROR 408.5 · χ² 18,645 / p <1e-300	296.7 EB05 238.0 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=58 · ♀ 0% (drug 66%) · 95% clinician	no trial arm names this drug
Bronchial neoplasm	25	390.3 252.9–602.3ROR 391.1 · χ² 7,595 / p <1e-300	256.0 EB05 182.4 · IC025 +4.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=25 · ♀ 100% (drug 66%)	no trial arm names this drug
Drug therapy	52	338.2 251.4–455.1ROR 339.7 · χ² 14,327 / p <1e-300	256.2 EB05 202.9 · IC025 +5.8 3/3 methods agree	Reporting / coding artifact	serious n=52 · ♀ 0% (drug 66%) · 94% clinician	no trial arm names this drug
Total lung capacity increased	41	307.5 220.6–428.5ROR 308.5 · χ² 10,364 / p <1e-300	232.7 EB05 178.8 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=41 · ♀ 100% (drug 66%)	no trial arm names this drug
Fungal disease carrier	15	303.0 175.1–524.5ROR 303.4 · χ² 3,586 / p <1e-300	194.3 EB05 125.0 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious n=15	no trial arm names this drug
Bacteroides infection	32	245.3 169.5–355.1ROR 246.0 · χ² 6,601 / p <1e-300	190.5 EB05 141.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 0% (drug 66%) · 100% clinician	no trial arm names this drug
Carbuncle	34	238.3 166.6–341.0ROR 239.0 · χ² 6,849 / p <1e-300	187.5 EB05 140.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=34 · ♀ 100% (drug 66%)	no trial arm names this drug
Anticoagulant therapy	28	195.5 132.3–288.8ROR 195.9 · χ² 4,690 / p <1e-300	157.0 EB05 114.0 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=28 · ♀ 0% (drug 66%) · 100% clinician	no trial arm names this drug
Lung diffusion disorder	15	182.7 107.3–311.0ROR 182.9 · χ² 2,288 / p <1e-300	136.8 EB05 88.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Malignant melanoma stage 0	16	168.6 100.9–281.6ROR 168.8 · χ² 2,277 / p <1e-300	130.1 EB05 84.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Bronchial haemorrhage	26	156.7 104.9–234.0ROR 157.0 · χ² 3,544 / p <1e-300	130.1 EB05 93.3 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=26 · ♀ 100% (drug 66%)	no trial arm names this drug
Asthma-chronic obstructive pulmonary disease overlap syndrome	41	148.9 108.2–204.7ROR 149.4 · χ² 5,406 / p <1e-300	129.0 EB05 99.1 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=41 · ♀ 92% (drug 66%)	no trial arm names this drug
Forced expiratory volume abnormal	11	142.0 76.8–262.6ROR 142.2 · χ² 1,295 / p 6e-284	107.3 EB05 64.0 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious n=11	no trial arm names this drug
Congenital hiatus hernia	16	135.3 81.4–225.1ROR 135.5 · χ² 1,855 / p <1e-300	109.5 EB05 71.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Nasal turbinate hypertrophy	26	129.4 86.9–192.7ROR 129.7 · χ² 2,963 / p <1e-300	110.8 EB05 79.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 100% (drug 66%)	no trial arm names this drug
Female genital tract fistula	118	128.2 106.4–154.4ROR 129.4 · χ² 13,738 / p <1e-300	117.1 EB05 100.4 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=118 · ♀ 100% (drug 66%)	no trial arm names this drug
Endometrial ablation	24	126.4 83.6–191.3ROR 126.7 · χ² 2,666 / p <1e-300	107.9 EB05 76.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 100% (drug 66%)	no trial arm names this drug
Respiratory gas exchange disorder	24	120.5 79.7–182.2ROR 120.7 · χ² 2,547 / p <1e-300	103.6 EB05 73.3 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 100% (drug 66%) · 79% consumer	no trial arm names this drug
Chronic sinusitis	240	119.2 104.7–135.7ROR 121.6 · χ² 26,195 / p <1e-300	110.6 EB05 99.3 · IC025 +6.3 3/3 methods agree	Labeled (related wording) related wording	serious n=237 · ♀ 90% (drug 66%)	no trial arm names this drug
Secondary hypogonadism	20	113.0 71.9–177.6ROR 113.2 · χ² 1,979 / p <1e-300	96.5 EB05 66.0 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=20	no trial arm names this drug
Eosinophilic bronchitis	12	109.6 61.2–196.4ROR 109.7 · χ² 1,114 / p 2e-244	88.9 EB05 54.2 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious n=12	no trial arm names this drug
Nsaid exacerbated respiratory disease	21	109.6 70.5–170.3ROR 109.8 · χ² 2,024 / p <1e-300	94.5 EB05 65.2 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=21 · ♀ 100% (drug 66%)	no trial arm names this drug
Breast conserving surgery	30	108.5 75.0–156.8ROR 108.7 · χ² 2,904 / p <1e-300	96.0 EB05 70.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 100% (drug 66%)	no trial arm names this drug
Immune-mediated nephritis	25	101.7 68.0–152.2ROR 101.9 · χ² 2,260 / p <1e-300	89.7 EB05 63.9 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 0% (drug 66%) · 100% clinician	no trial arm names this drug
Macular degeneration	635	98.0 90.7–106.0ROR 103.4 · χ² 57,621 / p <1e-300	92.5 EB05 86.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 99.0 · ♀ 100% (drug 66%)	no trial arm names this drug
Eosinophilic pneumonia chronic	15	91.3 54.4–153.5ROR 91.5 · χ² 1,188 / p 1e-260	78.4 EB05 50.4 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Trisomy 18	19	90.6 57.2–143.7ROR 90.8 · χ² 1,516 / p <1e-300	79.5 EB05 53.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Inguinal hernia repair	15	81.5 48.6–136.8ROR 81.6 · χ² 1,063 / p 2e-233	71.1 EB05 45.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Victim of child abuse	11	81.1 44.3–148.4ROR 81.1 · χ² 756 / p 1e-166	68.6 EB05 40.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=11	no trial arm names this drug
Monoclonal immunoglobulin present	34	81.0 57.4–114.2ROR 81.2 · χ² 2,489 / p <1e-300	74.3 EB05 55.6 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious n=34 · ♀ 100% (drug 66%)	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Fluticasone Furoate (searched FLUTICASONE FUROATE).

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
Drug ineffective (drug did not work)	2,090	2.8 2.7–2.9ROR 3.1 · χ² 2,510 / p <1e-300	2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5	no trial arm names this drug
Dyspnoea (shortness of breath)	1,589	4.9 4.7–5.1ROR 5.5 · χ² 5,055 / p <1e-300	4.9 EB05 4.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial arm names this drug
Asthma	1,318	20.7 19.7–21.8ROR 23.1 · χ² 24,536 / p <1e-300	20.5 EB05 19.6 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 26.2	no trial arm names this drug
Off label use (used outside approved label)	1,057	2.1 2.0–2.2ROR 2.2 · χ² 652 / p 4e-144	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial arm names this drug
Cough	936	5.8 5.5–6.2ROR 6.2 · χ² 3,789 / p <1e-300	5.8 EB05 5.5 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.8	no trial arm names this drug
Wheezing	908	27.1 25.5–28.9ROR 29.3 · χ² 22,533 / p <1e-300	26.7 EB05 25.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 33.9	no trial arm names this drug
Therapeutic product effect incomplete	787	19.6 18.3–21.0ROR 20.9 · χ² 13,753 / p <1e-300	19.4 EB05 18.3 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious PRR 34.9	no trial arm names this drug
Product use in unapproved indication	723	5.2 4.8–5.5ROR 5.4 · χ² 2,446 / p <1e-300	5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial arm names this drug
Nausea	719	1.6 1.5–1.7ROR 1.6 · χ² 162 / p 2e-37	1.6 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 2.6	no trial arm names this drug
Headache	701	2.0 1.8–2.1ROR 2.0 · χ² 333 / p 9e-75	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 2.9	no trial arm names this drug
Pain	696	2.0 1.8–2.1ROR 2.0 · χ² 341 / p 2e-76	2.0 EB05 1.8 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.8 · ♀ 90% (drug 66%)	no trial arm names this drug
Pneumonia (lung infection)	646	3.5 3.2–3.8ROR 3.6 · χ² 1,158 / p 5e-254	3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.6	no trial arm names this drug
Malaise (feeling unwell)	644	2.6 2.4–2.8ROR 2.6 · χ² 619 / p 6e-137	2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · ♀ 87% (drug 66%)	no trial arm names this drug
Macular degeneration	635	98.0 90.7–106.0ROR 103.4 · χ² 57,621 / p <1e-300	92.5 EB05 86.6 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious PRR 99.0 · ♀ 100% (drug 66%)	no trial arm names this drug
Vomiting	591	2.2 2.0–2.4ROR 2.3 · χ² 392 / p 1e-87	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	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.

Appendicolith — n=145, PRR 1,082.6
Vaginal flatulence — n=113, PRR 1,026.7
Malignant mediastinal neoplasm — n=40, PRR 1,025.2
Total lung capacity increased — n=41, PRR 307.5
Bacteroides infection — n=32, PRR 245.3
Carbuncle — n=34, PRR 238.3
Asthma-chronic obstructive pulmonary disease overlap syndrome — n=41, PRR 148.9
Nasal turbinate hypertrophy — n=26, PRR 129.4
Female genital tract fistula — n=118, PRR 128.2
Endometrial ablation — n=24, PRR 126.4

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 Furoate?

In FDA FAERS, the most frequently co-reported reaction terms for Fluticasone Furoate are dyspnoea, asthma, cough, wheezing, nausea, headache. 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 Furoate have an FDA boxed warning?

No. The FDA label retrieved for Fluticasone Furoate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Fluticasone Furoate 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 50f193ee-1691-486d-9370-a664df63695c, effective 20231018; matched on openfda.generic_name.exact:"FLUTICASONE FUROATE")
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, field patient.drug.openfda.generic_name.exact, 1,108 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 FUROATE, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. 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.