Fluocinonide side effects: what 5,565 FDA adverse event reports show

Fluocinonide · 391 reaction terms · 11,592 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) · compare the class

Who reports

5,565 reports · 43% serious · 259 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecut.

FDA label, Indications and Usage

What it is

Fluocinonide cream USP, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.

FDA label, Description section

Boxed warning

Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

FDA 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 — boxed warning 3Labeled adverse reaction 2Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 28

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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. 351 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
Sleep disorder due to a general medical condition	71	16.6 13.2–20.9ROR 16.8 · χ² 1,021 / p 2e-224	16.4 EB05 13.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 2.5 · 90% clinician	no trial data cached
Psoriasis	544	15.7 14.5–17.0ROR 17.3 · χ² 7,504 / p <1e-300	15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.3	no trial data cached
Dermatitis atopic	192	14.5 12.6–16.7ROR 15.0 · χ² 2,401 / p <1e-300	14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial data cached
End stage renal disease	54	11.1 8.5–14.4ROR 11.2 · χ² 484 / p 2e-107	10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Skin fissures	49	9.8 7.4–12.9ROR 9.9 · χ² 378 / p 2e-84	9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Psoriatic arthropathy	104	9.8 8.1–11.8ROR 9.9 · χ² 808 / p 4e-178	9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Skin lesion	63	8.7 6.8–11.2ROR 8.8 · χ² 423 / p 3e-94	8.4 EB05 6.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Skin haemorrhage	33	8.6 6.1–12.1ROR 8.7 · χ² 215 / p 7e-49	8.0 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Eczema	114	8.6 7.1–10.3ROR 8.7 · χ² 753 / p 5e-166	8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	no trial data cached
Chronic kidney disease	160	7.9 6.8–9.2ROR 8.1 · χ² 955 / p 6e-210	7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Impaired quality of life	30	7.9 5.5–11.2ROR 7.9 · χ² 173 / p 1e-39	7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Skin exfoliation	170	7.7 6.7–8.9ROR 7.9 · χ² 989 / p 2e-217	7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Dermatitis	42	7.6 5.7–10.3ROR 7.7 · χ² 236 / p 2e-53	7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.8	no trial data cached
Discomfort	113	7.0 5.9–8.4ROR 7.2 · χ² 579 / p 3e-128	6.9 EB05 5.8 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Dermatitis contact	21	7.0 4.5–10.7ROR 7.0 · χ² 101 / p 4e-24	6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious n=16	no trial data cached
Hyperlipidaemia	22	6.9 4.6–10.5ROR 6.9 · χ² 105 / p 5e-25	6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.1	no trial data cached
Tenderness	19	6.9 4.4–10.8ROR 6.9 · χ² 89 / p 2e-21	6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Scratch	18	6.6 4.1–10.4ROR 6.6 · χ² 79 / p 3e-19	5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Intervertebral disc degeneration	16	6.5 4.0–10.6ROR 6.5 · χ² 69 / p 6e-17	5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.9	no trial data cached
Economic problem	26	6.4 4.3–9.3ROR 6.4 · χ² 112 / p 2e-26	5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 9.2	no trial data cached
Scab	19	6.3 4.0–9.9ROR 6.3 · χ² 80 / p 2e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Therapeutic product effect incomplete	118	6.3 5.3–7.5ROR 6.4 · χ² 521 / p 1e-115	6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.4	no trial data cached
Tooth abscess	15	5.5 3.3–9.2ROR 5.5 · χ² 51 / p 4e-13	4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Treatment failure	118	5.4 4.5–6.5ROR 5.5 · χ² 422 / p 5e-94	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1 · 92% clinician	no trial data cached
Seasonal allergy	20	5.3 3.4–8.3ROR 5.4 · χ² 66 / p 2e-16	4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious n=10 · 75% consumer	no trial data cached
Anhedonia	36	5.1 3.7–7.1ROR 5.1 · χ² 115 / p 3e-27	4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Basal cell carcinoma	21	5.1 3.3–7.8ROR 5.1 · χ² 65 / p 5e-16	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Sleep disorder	92	5.0 4.0–6.1ROR 5.0 · χ² 287 / p 1e-64	4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Nodule	17	4.9 3.1–7.9ROR 4.9 · χ² 49 / p 1e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Oral herpes	25	4.8 3.3–7.2ROR 4.9 · χ² 72 / p 8e-18	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.0 · ♀ 83% (drug 60%)	no trial data cached
Skin disorder	42	4.8 3.5–6.4ROR 4.8 · χ² 121 / p 2e-28	4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Dry eye	60	4.7 3.6–6.0ROR 4.7 · χ² 169 / p 5e-39	4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Scar	21	4.6 3.0–7.1ROR 4.6 · χ² 56 / p 4e-14	4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Sleep apnoea syndrome	23	4.5 3.0–6.8ROR 4.5 · χ² 60 / p 5e-15	4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.5	no trial data cached
Adrenal insufficiency	14	4.4 2.6–7.4ROR 4.4 · χ² 34 / p 4e-9	3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.9	no trial data cached
Gout	21	4.4 2.9–6.8ROR 4.4 · χ² 52 / p 3e-13	4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.7 · ♀ 38% (drug 60%)	no trial data cached
Conjunctivitis	21	4.3 2.8–6.6ROR 4.3 · χ² 50 / p 8e-13	4.0 EB05 2.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.0	no trial data cached
Rash pruritic	61	4.3 3.3–5.5ROR 4.3 · χ² 149 / p 1e-34	4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 6.4	no trial data cached
Obesity	18	4.3 2.7–6.7ROR 4.3 · χ² 42 / p 6e-11	3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Pruritus (itching)	422	4.2 3.8–4.6ROR 4.5 · χ² 1,047 / p 7e-230	4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	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
Drug ineffective (drug did not work)	761	2.2 2.0–2.3ROR 2.4 · χ² 515 / p 2e-114	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.8	no trial data cached
Psoriasis	544	15.7 14.5–17.0ROR 17.3 · χ² 7,504 / p <1e-300	15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.3	no trial data cached
Rash	453	3.9 3.6–4.3ROR 4.2 · χ² 1,009 / p 8e-222	3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9	no trial data cached
Pruritus (itching)	422	4.2 3.8–4.6ROR 4.5 · χ² 1,047 / p 7e-230	4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	no trial data cached
Pain	272	1.7 1.5–1.9ROR 1.7 · χ² 74 / p 5e-18	1.7 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 2.2	no trial data cached
Product use in unapproved indication	218	3.4 3.0–3.8ROR 3.5 · χ² 363 / p 3e-81	3.3 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2	no trial data cached
Arthralgia (joint pain)	210	1.9 1.7–2.2ROR 1.9 · χ² 92 / p 5e-22	1.9 EB05 1.7 · IC025 +0.7	Not in label — unassessed	serious PRR 2.7	no trial data cached
Dermatitis atopic	192	14.5 12.6–16.7ROR 15.0 · χ² 2,401 / p <1e-300	14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial data cached
Product dose omission issue	186	2.5 2.1–2.8ROR 2.5 · χ² 162 / p 2e-37	2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.4	no trial data cached
Erythema (skin redness)	171	3.1 2.7–3.6ROR 3.2 · χ² 249 / p 2e-56	3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8	no trial data cached
Skin exfoliation	170	7.7 6.7–8.9ROR 7.9 · χ² 989 / p 2e-217	7.6 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Condition aggravated	169	2.1 1.8–2.4ROR 2.1 · χ² 99 / p 1e-23	2.1 EB05 1.8 · IC025 +0.8	Reporting / coding artifact	serious PRR 1.9	no trial data cached
Chronic kidney disease	160	7.9 6.8–9.2ROR 8.1 · χ² 955 / p 6e-210	7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Dry skin	134	3.8 3.2–4.5ROR 3.9 · χ² 280 / p 4e-63	3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	no trial data cached
Treatment failure	118	5.4 4.5–6.5ROR 5.5 · χ² 422 / p 5e-94	5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.1 · 92% clinician	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.

Sleep disorder due to a general medical condition — n=71, PRR 16.6
End stage renal disease — n=54, PRR 11.1
Skin fissures — n=49, PRR 9.8
Psoriatic arthropathy — n=104, PRR 9.8
Skin lesion — n=63, PRR 8.7
Skin haemorrhage — n=33, PRR 8.6
Eczema — n=114, PRR 8.6
Chronic kidney disease — n=160, PRR 7.9
Impaired quality of life — n=30, PRR 7.9
Discomfort — n=113, PRR 7.0

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 Fluocinonide?

In FDA FAERS, the most frequently co-reported reaction terms for Fluocinonide are psoriasis, rash, pruritus, pain, arthralgia, dermatitis atopic. 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 Fluocinonide have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.

Do FAERS signals prove that Fluocinonide 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 16c7d142-e695-4e33-986f-78cb37f7b387, effective 20250703; matched on openfda.generic_name.exact:"FLUOCINONIDE")
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, 391 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 2026-10-08. 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.