Halobetasol Propionate side effects: what 1,336 FDA adverse event reports show

Halobetasol Propionate · 48 reaction terms · 899 drug–reaction co-reports · data 2026-09-14

Drug class

Corticosteroid

FDA label, Indications wording

Who reports

1,336 reports · 35% serious · 28 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Halobetasol Propionate Topical Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Halobetasol Propionate Topical Foam is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve (12) years of age and older. ( 1 )

FDA label, Indications and Usage

What it is

Halobetasol Propionate Topical Foam is a hydroethanolic aerosol foam that contains a corticosteroid, halobetasol propionate.

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 21 strongest signals

Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 3Not in label — unassessed 12

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.
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. 27 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
Psoriasis	183	22.0 19.2–25.2ROR 25.3 · χ² 3,665 / p <1e-300	21.9 EB05 19.4 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 36.8	no trial data cached
Dermatitis atopic	63	19.8 15.6–25.2ROR 20.7 · χ² 1,108 / p 3e-243	19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Skin haemorrhage	17	18.5 11.5–29.7ROR 18.7 · χ² 264 / p 1e-59	18.0 EB05 11.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Skin fissures	22	18.3 12.1–27.7ROR 18.6 · χ² 343 / p 8e-77	17.9 EB05 12.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Skin lesion	26	15.0 10.3–22.0ROR 15.3 · χ² 326 / p 4e-73	14.6 EB05 10.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.6	no trial data cached
Psoriatic arthropathy	38	14.8 10.8–20.3ROR 15.2 · χ² 477 / p 4e-106	14.6 EB05 11.0 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 28.3	no trial data cached
Drug eruption	14	12.5 7.4–21.0ROR 12.6 · χ² 137 / p 8e-32	11.2 EB05 6.4 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 20.2	no trial data cached
Seasonal allergy	11	12.2 6.8–22.0ROR 12.3 · χ² 103 / p 2e-24	10.4 EB05 5.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Eczema	37	11.6 8.4–15.9ROR 11.9 · χ² 347 / p 1e-77	11.1 EB05 8.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Sciatica	10	9.9 5.3–18.4ROR 10.0 · χ² 71 / p 1e-17	7.8 EB05 4.2 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.7	no trial data cached
Skin exfoliation	51	9.6 7.4–12.6ROR 10.0 · χ² 388 / p 1e-86	9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Therapeutic product effect incomplete	39	8.7 6.4–11.8ROR 8.9 · χ² 257 / p 3e-58	8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9 · 92% clinician	no trial data cached
Eye pruritus	15	7.1 4.3–11.8ROR 7.2 · χ² 73 / p 6e-18	6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	no trial data cached
Dry skin	53	6.3 4.9–8.2ROR 6.5 · χ² 234 / p 5e-53	6.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.1	no trial data cached
Multiple sclerosis	19	6.2 4.0–9.7ROR 6.3 · χ² 78 / p 5e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Treatment failure	31	5.9 4.2–8.4ROR 6.0 · χ² 123 / p 9e-29	5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7	no trial data cached
Therapeutic response shortened	10	4.9 2.7–9.1ROR 5.0 · χ² 28 / p 8e-8	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 4.8	no trial data cached
Skin irritation	12	4.1 2.3–7.2ROR 4.1 · χ² 25 / p 3e-7	3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Multiple sclerosis relapse	11	2.5 1.4–4.5ROR 2.5 · χ² 8 / p 0.002	2.3 EB05 1.4 · IC025 +0.2	Not in label — unassessed	serious PRR 5.7	no trial data cached
Injection site swelling	12	2.5 1.4–4.4ROR 2.5 · χ² 9 / p 0.001	2.3 EB05 1.5 · IC025 +0.3	Not in label — unassessed	serious PRR 2.2	no trial data cached
Injection site pain (pain where injected)	47	2.4 1.8–3.2ROR 2.5 · χ² 39 / p 2e-10	2.4 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 7.1	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
Psoriasis	183	22.0 19.2–25.2ROR 25.3 · χ² 3,665 / p <1e-300	21.9 EB05 19.4 · IC025 +4.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 36.8	no trial data cached
Dermatitis atopic	63	19.8 15.6–25.2ROR 20.7 · χ² 1,108 / p 3e-243	19.7 EB05 15.9 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=8	no trial data cached
Dry skin	53	6.3 4.9–8.2ROR 6.5 · χ² 234 / p 5e-53	6.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.1	no trial data cached
Skin exfoliation	51	9.6 7.4–12.6ROR 10.0 · χ² 388 / p 1e-86	9.2 EB05 7.2 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 18.4	no trial data cached
Injection site pain (pain where injected)	47	2.4 1.8–3.2ROR 2.5 · χ² 39 / p 2e-10	2.4 EB05 1.9 · IC025 +0.8	Labeled (related wording) related wording	serious PRR 7.1	no trial data cached
Therapeutic product effect incomplete	39	8.7 6.4–11.8ROR 8.9 · χ² 257 / p 3e-58	8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 6.9 · 92% clinician	no trial data cached
Psoriatic arthropathy	38	14.8 10.8–20.3ROR 15.2 · χ² 477 / p 4e-106	14.6 EB05 11.0 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 28.3	no trial data cached
Eczema	37	11.6 8.4–15.9ROR 11.9 · χ² 347 / p 1e-77	11.1 EB05 8.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Treatment failure	31	5.9 4.2–8.4ROR 6.0 · χ² 123 / p 9e-29	5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 6.7	no trial data cached
Skin lesion	26	15.0 10.3–22.0ROR 15.3 · χ² 326 / p 4e-73	14.6 EB05 10.2 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.6	no trial data cached
Skin fissures	22	18.3 12.1–27.7ROR 18.6 · χ² 343 / p 8e-77	17.9 EB05 12.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Multiple sclerosis	19	6.2 4.0–9.7ROR 6.3 · χ² 78 / p 5e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.3	no trial data cached
Skin haemorrhage	17	18.5 11.5–29.7ROR 18.7 · χ² 264 / p 1e-59	18.0 EB05 11.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Injection site erythema (redness where injected)	15	1.9 1.2–3.2ROR 1.9 · χ² 6 / p 0.009	1.9 EB05 1.2 · IC025 +0.0	Not in label — unassessed	serious PRR 1.3	no trial data cached
Eye pruritus	15	7.1 4.3–11.8ROR 7.2 · χ² 73 / p 6e-18	6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 2.9	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.

Dermatitis atopic — n=63, PRR 19.8
Skin fissures — n=22, PRR 18.3
Skin lesion — n=26, PRR 15.0
Eczema — n=37, PRR 11.6
Skin exfoliation — n=51, PRR 9.6

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 Halobetasol Propionate?

In FDA FAERS, the most frequently co-reported reaction terms for Halobetasol Propionate are psoriasis, dermatitis atopic, dry skin, skin exfoliation, injection site pain, psoriatic arthropathy. 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 Halobetasol Propionate have an FDA boxed warning?

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

Do FAERS signals prove that Halobetasol Propionate 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 24c41e6d-a314-4984-b45f-e5aa1fffa9b6, effective 20231130; matched on openfda.generic_name.exact:"HALOBETASOL PROPIONATE")
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, 48 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.