Drug · FAERS side-effect profile with label screen

Fluocinolone Acetonide, Hydroquinone and Tretinoin side effects: what 544 FDA adverse event reports show

Fluocinolone Acetonide, Hydroquinone, And Tretinoin · 26 reaction terms · 834 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) · compare the class

Who reports

544 reports · 9% serious · 0 with death outcome · 92% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Fluocinolone acetonide topical oil is indicated for the treatment of psoriasis of the scalp in adults. Fluocinolone acetonide topical oil is a corticosteroid indicated for the treatment of psoriasis of the scalp in adults. ( 1 )

FDA label, Indications and Usage

What it is

Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6,9-difluoro-11, 21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use.

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 19 strongest signals

Labeled adverse reaction 1Labeled (related wording) 2Reporting / coding artifact 8Not in label — unassessed 8

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.
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. 7 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
Incorrect product storage	43	124.7 93.6–166.3ROR 135.4 · χ² 5,142 / p <1e-300	117.9 EB05 91.2 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=1 · 93% consumer	no trial data cached
Skin burning sensation	91	49.4 40.9–59.6ROR 59.1 · χ² 4,273 / p <1e-300	48.8 EB05 41.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 55.8 · 89% consumer	no trial data cached
Poor quality product administered	12	45.3 25.9–79.3ROR 46.3 · χ² 476 / p 7e-106	42.4 EB05 25.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Skin irritation	50	42.0 32.3–54.8ROR 46.2 · χ² 1,964 / p <1e-300	41.4 EB05 32.6 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 84% consumer	no trial data cached
Pain of skin	29	41.4 29.1–59.1ROR 43.7 · χ² 1,105 / p 2e-242	40.4 EB05 29.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 93% consumer	no trial data cached
Rash papular	21	36.1 23.7–54.9ROR 37.5 · χ² 681 / p 2e-150	35.0 EB05 24.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	95% consumer	no trial data cached
Skin exfoliation	69	32.0 25.7–39.9ROR 36.5 · χ² 2,050 / p <1e-300	31.8 EB05 25.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 27.5 · 90% consumer	no trial data cached
Erythema (skin redness)	161	30.3 26.6–34.4ROR 42.6 · χ² 4,566 / p <1e-300	30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2 · 89% consumer	no trial data cached
Drug ineffective for unapproved indication	43	29.8 22.3–39.6ROR 32.2 · χ² 1,169 / p 2e-256	29.4 EB05 22.7 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3 · 98% consumer	no trial data cached
Dermatitis	13	24.2 14.1–41.4ROR 24.8 · χ² 266 / p 3e-60	23.3 EB05 14.3 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 25.2	no trial data cached
Intentional product use issue	50	21.9 16.8–28.6ROR 24.0 · χ² 981 / p 1e-215	21.8 EB05 17.1 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Intentional product misuse	48	21.3 16.3–27.9ROR 23.3 · χ² 912 / p 1e-200	21.1 EB05 16.6 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	92% consumer	no trial data cached
Application site erythema	13	19.0 11.1–32.6ROR 19.5 · χ² 205 / p 9e-47	18.2 EB05 10.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Skin discolouration	21	17.6 11.6–26.8ROR 18.3 · χ² 313 / p 2e-70	17.2 EB05 11.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 56.2	no trial data cached
Inappropriate schedule of drug administration	31	16.6 11.8–23.3ROR 17.5 · χ² 439 / p 8e-98	16.3 EB05 11.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · 90% consumer	no trial data cached
Dry skin	52	15.2 11.8–19.7ROR 16.7 · χ² 682 / p 1e-150	15.1 EB05 11.9 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	88% consumer	no trial data cached
Incorrect drug administration duration	10	13.5 7.3–25.0ROR 13.7 · χ² 104 / p 1e-24	11.6 EB05 5.8 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug effect decreased	13	9.2 5.4–15.7ROR 9.4 · χ² 87 / p 6e-21	7.6 EB05 4.5 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product storage error	19	8.5 5.4–13.2ROR 8.7 · χ² 118 / p 8e-28	7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 31.9	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
Erythema (skin redness)	161	30.3 26.6–34.4ROR 42.6 · χ² 4,566 / p <1e-300	30.1 EB05 26.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2 · 89% consumer	no trial data cached
Skin burning sensation	91	49.4 40.9–59.6ROR 59.1 · χ² 4,273 / p <1e-300	48.8 EB05 41.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 55.8 · 89% consumer	no trial data cached
Skin exfoliation	69	32.0 25.7–39.9ROR 36.5 · χ² 2,050 / p <1e-300	31.8 EB05 25.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 27.5 · 90% consumer	no trial data cached
Dry skin	52	15.2 11.8–19.7ROR 16.7 · χ² 682 / p 1e-150	15.1 EB05 11.9 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	88% consumer	no trial data cached
Intentional product use issue	50	21.9 16.8–28.6ROR 24.0 · χ² 981 / p 1e-215	21.8 EB05 17.1 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	88% consumer	no trial data cached
Skin irritation	50	42.0 32.3–54.8ROR 46.2 · χ² 1,964 / p <1e-300	41.4 EB05 32.6 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 84% consumer	no trial data cached
Intentional product misuse	48	21.3 16.3–27.9ROR 23.3 · χ² 912 / p 1e-200	21.1 EB05 16.6 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	92% consumer	no trial data cached
Drug ineffective for unapproved indication	43	29.8 22.3–39.6ROR 32.2 · χ² 1,169 / p 2e-256	29.4 EB05 22.7 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.3 · 98% consumer	no trial data cached
Incorrect product storage	43	124.7 93.6–166.3ROR 135.4 · χ² 5,142 / p <1e-300	117.9 EB05 91.2 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=1 · 93% consumer	no trial data cached
Inappropriate schedule of drug administration	31	16.6 11.8–23.3ROR 17.5 · χ² 439 / p 8e-98	16.3 EB05 11.9 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious PRR 12.4 · 90% consumer	no trial data cached
Pain of skin	29	41.4 29.1–59.1ROR 43.7 · χ² 1,105 / p 2e-242	40.4 EB05 29.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 93% consumer	no trial data cached
Skin discolouration	21	17.6 11.6–26.8ROR 18.3 · χ² 313 / p 2e-70	17.2 EB05 11.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 56.2	no trial data cached
Rash papular	21	36.1 23.7–54.9ROR 37.5 · χ² 681 / p 2e-150	35.0 EB05 24.1 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	95% consumer	no trial data cached
Product storage error	19	8.5 5.4–13.2ROR 8.7 · χ² 118 / p 8e-28	7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 31.9	no trial data cached
Drug effect decreased	13	9.2 5.4–15.7ROR 9.4 · χ² 87 / p 6e-21	7.6 EB05 4.5 · IC025 +1.9 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.

Skin burning sensation — n=91, PRR 49.4
Pain of skin — n=29, PRR 41.4
Rash papular — n=21, PRR 36.1
Skin exfoliation — n=69, PRR 32.0
Erythema — n=161, PRR 30.3
Skin discolouration — n=21, PRR 17.6

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 Fluocinolone Acetonide?

In FDA FAERS, the most frequently co-reported reaction terms for Fluocinolone Acetonide are erythema, skin burning sensation, skin exfoliation, dry skin, skin irritation, pain of skin. 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 Fluocinolone Acetonide have an FDA boxed warning?

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

Do FAERS signals prove that Fluocinolone Acetonide 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 09284ede-6be9-4192-b178-567b3c6265bb, effective 20260508; matched on openfda.generic_name.exact:"FLUOCINOLONE ACETONIDE")
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, 26 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.