Drug · FAERS side-effect profile with label screen
Fluocinonide Topical and 0.05% side effects: what 5,567 FDA adverse event reports show
Drug class
Corticosteroid
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Fluocinonide Topical Solution Usp, 0.05% (Fluocinonide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
5,567 reports · 43% serious · 259 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Fluocinonide topical solution, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
FDA label, Indications and Usage
What it is
DESCRIPTION Fluocinonide topical solution, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone .
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
Reporting / coding artifact 3No label text to screen 37
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 344 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 |
|---|---|---|---|---|---|---|
| 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 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 · 90% clinician | no trial data cached |
| Psoriasis | 546 | 15.8 14.6–17.1ROR 17.4 · χ² 7,560 / p <1e-300 | 15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 | no trial data cached |
| Dermatitis atopic | 192 | 14.5 12.6–16.7ROR 15.0 · χ² 2,400 / p <1e-300 | 14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| End stage renal disease | 54 | 11.1 8.5–14.4ROR 11.2 · χ² 483 / p 2e-107 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 | no trial data cached |
| Skin fissures | 49 | 9.8 7.4–12.9ROR 9.9 · χ² 377 / p 2e-84 | 9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Psoriatic arthropathy | 104 | 9.8 8.1–11.8ROR 9.9 · χ² 808 / p 5e-178 | 9.5 EB05 8.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Eczema | 114 | 8.5 7.1–10.3ROR 8.7 · χ² 752 / p 6e-166 | 8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 | no trial data cached |
| Chronic kidney disease | 160 | 7.9 6.8–9.2ROR 8.1 · χ² 954 / p 8e-210 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Skin exfoliation | 169 | 7.7 6.6–8.9ROR 7.9 · χ² 975 / p 2e-214 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | 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 | No label text to screen label has no adverse-reaction text | serious PRR 8.9 | no trial data cached |
| Discomfort | 113 | 7.0 5.9–8.4ROR 7.2 · χ² 579 / p 4e-128 | 6.8 EB05 5.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 10.2 | no trial data cached |
| Tenderness | 19 | 6.9 4.4–10.7ROR 6.9 · χ² 89 / p 2e-21 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 9.3 | no trial data cached |
| Therapeutic product effect incomplete | 118 | 6.3 5.3–7.5ROR 6.4 · χ² 521 / p 2e-115 | 6.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 | no trial data cached |
| Scab | 18 | 6.0 3.8–9.5ROR 6.0 · χ² 70 / p 3e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=11 | 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 | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Basal cell carcinoma | 21 | 5.1 3.3–7.8ROR 5.1 · χ² 64 / p 5e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | 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 | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Sleep disorder | 91 | 4.9 4.0–6.0ROR 5.0 · χ² 279 / p 6e-63 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Oral herpes | 25 | 4.8 3.3–7.2ROR 4.9 · χ² 72 / p 9e-18 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | 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 | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Gout | 21 | 4.4 2.9–6.7ROR 4.4 · χ² 52 / p 3e-13 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · ♀ 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 | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Obesity | 18 | 4.2 2.7–6.7ROR 4.3 · χ² 42 / p 6e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Pruritus (itching) | 425 | 4.2 3.9–4.6ROR 4.5 · χ² 1,066 / p 5e-234 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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) | 762 | 2.2 2.0–2.3ROR 2.4 · χ² 517 / p 9e-115 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Psoriasis | 546 | 15.8 14.6–17.1ROR 17.4 · χ² 7,560 / p <1e-300 | 15.7 EB05 14.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.3 | no trial data cached |
| Rash | 451 | 3.9 3.6–4.3ROR 4.2 · χ² 997 / p 4e-219 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Pruritus (itching) | 425 | 4.2 3.9–4.6ROR 4.5 · χ² 1,066 / p 5e-234 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Pain | 270 | 1.7 1.5–1.9ROR 1.7 · χ² 71 / p 2e-17 | 1.7 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Product use in unapproved indication | 219 | 3.4 3.0–3.8ROR 3.5 · χ² 368 / p 3e-82 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Arthralgia (joint pain) | 209 | 1.9 1.7–2.2ROR 1.9 · χ² 90 / p 1e-21 | 1.9 EB05 1.7 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Dermatitis atopic | 192 | 14.5 12.6–16.7ROR 15.0 · χ² 2,400 / p <1e-300 | 14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Erythema (skin redness) | 172 | 3.2 2.7–3.7ROR 3.2 · χ² 253 / p 2e-57 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Condition aggravated | 170 | 2.1 1.8–2.5ROR 2.2 · χ² 101 / p 5e-24 | 2.1 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.0 | no trial data cached |
| Skin exfoliation | 169 | 7.7 6.6–8.9ROR 7.9 · χ² 975 / p 2e-214 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Chronic kidney disease | 160 | 7.9 6.8–9.2ROR 8.1 · χ² 954 / p 8e-210 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | 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 | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | 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
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 Fluocinonide Topical and 0.05%?
In FDA FAERS, the most frequently co-reported reaction terms for Fluocinonide Topical and 0.05% 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 Topical and 0.05% have an FDA boxed warning?
No. The FDA label retrieved for Fluocinonide Topical and 0.05% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Fluocinonide Topical and 0.05% 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 38a36184-22b4-4e97-83e1-fdd984ef6ccb, effective 20260514; matched on
openfda.generic_name.exact:"FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%") - 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, 384 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.