Drug · FAERS side-effect profile with label screen
Fluocinolone Acetonide side effects: what 3,734 FDA adverse event reports show
Who reports
3,734 reports · 40% serious · 69 with death outcome · 61% 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 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 2Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 26
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.
- 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. 100 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 |
|---|---|---|---|---|---|---|
| Intraocular pressure increased (raised eye pressure) | 203 | 90.2 78.8–103.2ROR 95.3 · χ² 17,534 / p <1e-300 | 88.0 EB05 78.3 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 132.8 · 94% clinician | no trial data cached |
| Device failure | 151 | 56.4 48.2–66.0ROR 58.8 · χ² 8,088 / p <1e-300 | 55.5 EB05 48.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · 99% clinician | no trial data cached |
| Circumstance or information capable of leading to medication error | 141 | 23.7 20.1–27.9ROR 24.6 · χ² 3,033 / p <1e-300 | 23.5 EB05 20.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=5 · 99% clinician | no trial data cached |
| Device dislocation | 157 | 20.4 17.5–23.8ROR 21.2 · χ² 2,868 / p <1e-300 | 20.3 EB05 17.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 91% clinician | no trial data cached |
| Product administration error | 70 | 19.8 15.7–24.9ROR 20.1 · χ² 1,224 / p 2e-268 | 19.6 EB05 16.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 96% clinician | no trial data cached |
| Needle issue | 97 | 19.1 15.7–23.2ROR 19.6 · χ² 1,642 / p <1e-300 | 19.0 EB05 16.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=12 · 97% clinician | no trial data cached |
| Glaucoma | 59 | 17.2 13.4–22.2ROR 17.5 · χ² 884 / p 1e-194 | 17.1 EB05 13.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.0 · ♀ 40% (drug 61%) · 91% clinician | no trial data cached |
| Vitreous floaters | 26 | 15.0 10.2–22.0ROR 15.1 · χ² 326 / p 4e-73 | 14.6 EB05 10.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Retinal detachment | 22 | 13.5 8.9–20.4ROR 13.5 · χ² 241 / p 1e-54 | 12.8 EB05 8.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 18.5 | no trial data cached |
| Sleep disorder due to a general medical condition | 36 | 12.5 9.0–17.3ROR 12.6 · χ² 370 / p 1e-82 | 12.1 EB05 8.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Eye inflammation | 20 | 11.9 7.7–18.5ROR 12.0 · χ² 189 / p 3e-43 | 11.0 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Scratch | 19 | 10.3 6.6–16.2ROR 10.4 · χ² 150 / p 7e-35 | 9.2 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Complication of device insertion | 32 | 9.7 6.9–13.7ROR 9.8 · χ² 241 / p 1e-54 | 9.0 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=2 · 93% clinician | no trial data cached |
| Dermatitis atopic | 86 | 9.7 7.9–11.9ROR 9.9 · χ² 661 / p 5e-146 | 9.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Visual acuity reduced | 40 | 6.7 4.9–9.1ROR 6.8 · χ² 189 / p 3e-43 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Blindness | 46 | 6.3 4.8–8.5ROR 6.4 · χ² 202 / p 4e-46 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Dermatitis | 23 | 6.2 4.1–9.4ROR 6.3 · χ² 96 / p 6e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Eczema | 55 | 6.1 4.7–8.0ROR 6.2 · χ² 232 / p 1e-52 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | no trial data cached |
| Scab | 12 | 5.9 3.4–10.5ROR 6.0 · χ² 45 / p 1e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Uveitis | 14 | 5.8 3.5–9.8ROR 5.8 · χ² 51 / p 4e-13 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Psoriasis | 133 | 5.7 4.8–6.8ROR 5.9 · χ² 515 / p 2e-114 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.5 | no trial data cached |
| Skin haemorrhage | 14 | 5.4 3.2–9.2ROR 5.5 · χ² 46 / p 5e-12 | 4.7 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Skin fissures | 18 | 5.4 3.4–8.5ROR 5.4 · χ² 59 / p 6e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Skin exfoliation | 77 | 5.2 4.2–6.5ROR 5.3 · χ² 258 / p 2e-58 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Conjunctivitis | 16 | 4.9 3.0–8.0ROR 4.9 · χ² 46 / p 7e-12 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Cataract | 51 | 4.8 3.7–6.3ROR 4.9 · χ² 151 / p 4e-35 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Discomfort | 52 | 4.8 3.7–6.3ROR 4.9 · χ² 154 / p 1e-35 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Blindness unilateral | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 7e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Seasonal allergy | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 7e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Eye pain | 46 | 4.7 3.5–6.2ROR 4.7 · χ² 130 / p 3e-30 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Eye haemorrhage | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Skin discolouration | 35 | 4.3 3.1–5.9ROR 4.3 · χ² 85 / p 2e-20 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| No adverse event | 132 | 4.2 3.5–4.9ROR 4.3 · χ² 319 / p 1e-71 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 92% clinician | no trial data cached |
| Product dose omission issue | 209 | 4.1 3.6–4.7ROR 4.3 · χ² 498 / p 2e-110 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Ear pain | 14 | 4.0 2.4–6.8ROR 4.1 · χ² 29 / p 3e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Skin disorder | 23 | 3.9 2.6–5.8ROR 3.9 · χ² 46 / p 5e-12 | 3.6 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Off label use (used outside approved label) | 598 | 3.9 3.6–4.2ROR 4.4 · χ² 1,324 / p 4e-290 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 90% clinician | no trial data cached |
| Sleep disorder | 48 | 3.9 2.9–5.1ROR 3.9 · χ² 99 / p 1e-23 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Photophobia (light sensitivity) | 12 | 3.6 2.1–6.4ROR 3.6 · χ² 20 / p 4e-6 | 3.2 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Visual impairment | 79 | 3.6 2.9–4.5ROR 3.7 · χ² 147 / p 4e-34 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 598 | 3.9 3.6–4.2ROR 4.4 · χ² 1,324 / p 4e-290 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 90% clinician | no trial data cached |
| Pruritus (itching) | 216 | 3.2 2.8–3.7ROR 3.3 · χ² 332 / p 2e-74 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Product dose omission issue | 209 | 4.1 3.6–4.7ROR 4.3 · χ² 498 / p 2e-110 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 203 | 90.2 78.8–103.2ROR 95.3 · χ² 17,534 / p <1e-300 | 88.0 EB05 78.3 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 132.8 · 94% clinician | no trial data cached |
| Device dislocation | 157 | 20.4 17.5–23.8ROR 21.2 · χ² 2,868 / p <1e-300 | 20.3 EB05 17.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · 91% clinician | no trial data cached |
| Device failure | 151 | 56.4 48.2–66.0ROR 58.8 · χ² 8,088 / p <1e-300 | 55.5 EB05 48.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · 99% clinician | no trial data cached |
| Circumstance or information capable of leading to medication error | 141 | 23.7 20.1–27.9ROR 24.6 · χ² 3,033 / p <1e-300 | 23.5 EB05 20.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=5 · 99% clinician | no trial data cached |
| Psoriasis | 133 | 5.7 4.8–6.8ROR 5.9 · χ² 515 / p 2e-114 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.5 | no trial data cached |
| No adverse event | 132 | 4.2 3.5–4.9ROR 4.3 · χ² 319 / p 1e-71 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 92% clinician | no trial data cached |
| Needle issue | 97 | 19.1 15.7–23.2ROR 19.6 · χ² 1,642 / p <1e-300 | 19.0 EB05 16.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=12 · 97% clinician | no trial data cached |
| Dermatitis atopic | 86 | 9.7 7.9–11.9ROR 9.9 · χ² 661 / p 5e-146 | 9.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Visual impairment | 79 | 3.6 2.9–4.5ROR 3.7 · χ² 147 / p 4e-34 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Skin exfoliation | 77 | 5.2 4.2–6.5ROR 5.3 · χ² 258 / p 2e-58 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Dry skin | 76 | 3.2 2.6–4.1ROR 3.3 · χ² 116 / p 2e-27 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Product administration error | 70 | 19.8 15.7–24.9ROR 20.1 · χ² 1,224 / p 2e-268 | 19.6 EB05 16.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.9 · 96% 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.
- Circumstance or information capable of leading to medication error — n=141, PRR 23.7
- Needle issue — n=97, PRR 19.1
- Vitreous floaters — n=26, PRR 15.0
- Retinal detachment — n=22, PRR 13.5
- Sleep disorder due to a general medical condition — n=36, PRR 12.5
- Eye inflammation — n=20, PRR 11.9
- Complication of device insertion — n=32, PRR 9.7
- Visual acuity reduced — n=40, PRR 6.7
- Blindness — n=46, PRR 6.3
- Skin exfoliation — n=77, PRR 5.2
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 pruritus, intraocular pressure increased, circumstance or information capable of leading to medication error, psoriasis, needle issue, 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 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, fieldpatient.drug.openfda.generic_name.exact, 140 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.