Drug · FAERS side-effect profile with label screen

Mometasone side effects: what 22,270 FDA adverse event reports show

Mometasone · 1,216 reaction terms · 103,364 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording of the closest related product

Label matched

Mometasone Furoate (Mometasone Furoate)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

22,270 reports · 75% serious · 1,058 with death outcome · 62% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone furoate cream, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients ≥ 2 years of age. ( 1 )

FDA label, Indications and Usage

What it is

Mometasone Furoate Cream USP, 0.1% contains mometasone furoate, USP for topical use. Mometasone furoate, USP is a synthetic corticosteroid with anti-inflammatory activity.

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) 3Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 31

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.
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). 1,176 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
Cftr gene mutation	20	5,668.3 1,937.6–16,582.1ROR 5,674.5 · calibrated p 4e-18 ✓	495.3 EB05 338.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Fractional exhaled nitric oxide increased	123	2,905.0 2,081.7–4,053.9ROR 2,924.7 · calibrated p 3e-22 ✓	723.6 EB05 622.5 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Heart sounds	38	742.7 493.5–1,117.8ROR 744.3 · calibrated p 9e-15 ✓	366.1 EB05 278.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ejection fraction	213	663.4 560.5–785.1ROR 671.2 · calibrated p 4e-15 ✓	403.6 EB05 360.1 · IC025 +7.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sensitisation	270	629.8 543.1–730.3ROR 639.3 · calibrated p 6e-15 ✓	393.9 EB05 356.0 · IC025 +7.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Topical steroid withdrawal reaction	129	585.0 473.2–723.1ROR 589.1 · calibrated p 2e-14 ✓	365.2 EB05 315.3 · IC025 +7.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Polycystic ovaries	273	242.2 212.7–275.7ROR 245.8 · calibrated p 7e-11 ✓	197.0 EB05 178.1 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Prolonged expiration	39	199.2 141.8–279.8ROR 199.6 · calibrated p 1e-9 ✓	156.7 EB05 119.6 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Anal prolapse	16	177.8 105.0–301.2ROR 178.0 · calibrated p 1e-8 ✓	130.3 EB05 85.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Obstructive sleep apnoea syndrome	183	173.6 148.7–202.7ROR 175.4 · calibrated p 2e-9 ✓	148.4 EB05 131.2 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bronchopulmonary aspergillosis allergic	111	158.5 130.0–193.2ROR 159.4 · calibrated p 4e-9 ✓	136.0 EB05 116.0 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Dust allergy	108	145.1 118.8–177.1ROR 145.9 · calibrated p 8e-9 ✓	125.9 EB05 107.2 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Spirometry abnormal	54	116.4 88.0–153.9ROR 116.7 · calibrated p 6e-8 ✓	101.9 EB05 81.1 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Mite allergy	58	115.0 87.8–150.5ROR 115.3 · calibrated p 6e-8 ✓	101.1 EB05 81.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Congenital hiatus hernia	19	107.7 67.3–172.4ROR 107.8 · calibrated p 3e-7 ✓	89.8 EB05 60.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Myoglobin blood increased	124	101.1 84.2–121.5ROR 101.8 · calibrated p 1e-7 ✓	91.7 EB05 78.9 · IC025 +5.8 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Ejection fraction abnormal	99	100.7 82.1–123.7ROR 101.3 · calibrated p 1e-7 ✓	91.0 EB05 76.9 · IC025 +5.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Alveolar osteitis	33	96.4 67.6–137.5ROR 96.6 · calibrated p 3e-7 ✓	84.7 EB05 63.1 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Steroid withdrawal syndrome	75	91.4 72.3–115.6ROR 91.8 · calibrated p 3e-7 ✓	82.9 EB05 68.4 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Urinary tract discomfort	33	90.4 63.4–128.8ROR 90.5 · calibrated p 5e-7 ✓	80.0 EB05 59.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Rhinitis allergic	321	89.6 80.0–100.3ROR 91.2 · calibrated p 2e-7 ✓	82.7 EB05 75.4 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mycotic allergy	60	88.1 67.8–114.5ROR 88.4 · calibrated p 4e-7 ✓	79.8 EB05 64.3 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pulmonary vasculitis	35	81.5 57.8–114.8ROR 81.6 · calibrated p 1e-6 ✓	73.2 EB05 55.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Breast conserving surgery	31	74.1 51.6–106.6ROR 74.3 · calibrated p 2e-6 ✓	66.9 EB05 49.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Nephrectomy	88	72.5 58.5–89.9ROR 72.8 · calibrated p 1e-6 ✓	67.3 EB05 56.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Eosinophilic granulomatosis with polyangiitis	110	66.2 54.7–80.2ROR 66.6 · calibrated p 3e-6 ✓	62.0 EB05 52.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Allergy to animal	51	58.7 44.3–77.7ROR 58.9 · calibrated p 7e-6 ✓	54.8 EB05 43.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Total lung capacity abnormal	18	57.0 35.5–91.5ROR 57.1 · calibrated p 2e-5 ✓	51.5 EB05 34.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Adrenal suppression	39	55.7 40.4–76.8ROR 55.8 · calibrated p 1e-5 ✓	51.9 EB05 39.6 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Skin weeping	139	50.1 42.3–59.4ROR 50.5 · calibrated p 1e-5 ✓	47.7 EB05 41.4 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Full blood count abnormal	440	50.1 45.5–55.0ROR 51.3 · calibrated p 1e-5 ✓	47.9 EB05 44.2 · IC025 +5.4 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Brain natriuretic peptide increased	125	48.6 40.6–58.1ROR 48.9 · calibrated p 2e-5 ✓	46.3 EB05 39.9 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Animal scratch	39	48.2 35.0–66.3ROR 48.3 · calibrated p 3e-5 ✓	45.3 EB05 34.6 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Conjunctivitis allergic	58	47.4 36.5–61.7ROR 47.6 · calibrated p 2e-5 ✓	44.9 EB05 36.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Plantar fasciitis	130	46.2 38.8–55.0ROR 46.5 · calibrated p 2e-5 ✓	44.1 EB05 38.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sleep disorder due to a general medical condition	619	45.7 42.3–49.5ROR 47.3 · calibrated p 2e-5 ✓	44.0 EB05 41.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pneumococcal infection	22	44.8 29.3–68.5ROR 44.8 · calibrated p 6e-5 ✓	41.7 EB05 29.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Obstructive airways disorder	415	44.4 40.3–48.9ROR 45.4 · calibrated p 3e-5 ✓	42.7 EB05 39.3 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Vaccination site pain	21	43.4 28.1–67.2ROR 43.5 · calibrated p 7e-5 ✓	40.5 EB05 27.9 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Total lung capacity decreased	58	43.2 33.2–56.1ROR 43.3 · calibrated p 4e-5 ✓	41.1 EB05 33.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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)	1,832	3.7 3.6–3.9ROR 4.0 · calibrated p 0.371	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Asthma	1,627	16.9 16.1–17.7ROR 18.5 · calibrated p 0.003 ✓	16.7 EB05 16.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug ineffective (drug did not work)	1,572	1.4 1.3–1.4ROR 1.4 · calibrated p 0.581	1.4 EB05 1.3 · IC025 +0.4	Reporting / coding artifact	–	no trial data cached
Headache	1,502	2.8 2.6–2.9ROR 2.9 · calibrated p 0.653	2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Cough	1,242	5.1 4.9–5.4ROR 5.4 · calibrated p 0.194	5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Fatigue (tiredness)	1,159	1.7 1.6–1.8ROR 1.8 · calibrated p 0.809	1.7 EB05 1.6 · IC025 +0.7	Not in label — unassessed	–	no trial data cached
Off label use (used outside approved label)	1,155	1.5 1.4–1.6ROR 1.6 · calibrated p 0.685	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	–	no trial data cached
Wheezing	1,021	20.2 19.0–21.4ROR 21.3 · calibrated p 0.001 ✓	19.8 EB05 18.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	995	14.4 13.6–15.3ROR 15.2 · calibrated p 0.007 ✓	14.3 EB05 13.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pruritus (itching)	974	3.0 2.8–3.2ROR 3.1 · calibrated p 0.601	3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Nausea	937	1.4 1.3–1.5ROR 1.4 · calibrated p 0.566	1.4 EB05 1.3 · IC025 +0.3	Not in label — unassessed	–	no trial data cached
Pain	859	1.6 1.5–1.7ROR 1.6 · calibrated p 0.729	1.6 EB05 1.5 · IC025 +0.6	Not in label — unassessed	–	no trial data cached
Pneumonia (lung infection)	858	3.1 2.9–3.3ROR 3.2 · calibrated p 0.577	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Rash	813	2.2 2.0–2.3ROR 2.2 · calibrated p 0.946	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Therapeutic product effect incomplete	778	12.8 11.9–13.7ROR 13.3 · calibrated p 0.011 ✓	12.6 EB05 11.9 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

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.

Cftr gene mutation — n=20, PRR 5,668.3
Fractional exhaled nitric oxide increased — n=123, PRR 2,905.0
Heart sounds — n=38, PRR 742.7
Ejection fraction — n=213, PRR 663.4
Sensitisation — n=270, PRR 629.8
Polycystic ovaries — n=273, PRR 242.2
Prolonged expiration — n=39, PRR 199.2
Obstructive sleep apnoea syndrome — n=183, PRR 173.6
Bronchopulmonary aspergillosis allergic — n=111, PRR 158.5
Dust allergy — n=108, PRR 145.1

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 Mometasone?

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

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

Do FAERS signals prove that Mometasone 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 031283ed-988b-4698-8a2e-00f3d41c0f71, effective 20190709; matched on openfda.generic_name:"MOMETASONE")
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, 1,216 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

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.