Drug · FAERS side-effect profile with label screen
Clobetasol Propionate Ointment and 0.05% side effects: what 10,228 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Clobetasol Propionate Ointment Usp, 0.05% (Clobetasol Propionate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
10,228 reports · 47% serious · 433 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis.
FDA label, Indications and Usage
What it is
DESCRIPTION Clobetasol propionate ointment USP contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.
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 1Lab value / disease marker 1No label text to screen 38
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.
- 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.
- 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. 1,048 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 |
|---|---|---|---|---|---|---|
| Topical steroid withdrawal reaction | 29 | 167.4 114.7–244.3ROR 167.8 · χ² 4,277 / p <1e-300 | 140.5 EB05 102.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 100% (drug 64%) · 72% consumer | no trial data cached |
| Cushing's syndrome | 50 | 156.3 117.3–208.3ROR 157.1 · χ² 7,020 / p <1e-300 | 137.7 EB05 108.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=50 | no trial data cached |
| Hypothalamic pituitary adrenal axis suppression | 16 | 96.8 58.6–159.7ROR 96.9 · χ² 1,357 / p 2e-297 | 83.5 EB05 54.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Biliary sepsis | 14 | 64.0 37.6–108.9ROR 64.1 · χ² 781 / p 3e-172 | 57.4 EB05 36.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Lichen sclerosus | 18 | 56.4 35.3–90.0ROR 56.5 · χ² 899 / p 7e-198 | 52.0 EB05 34.8 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Blood cortisol decreased | 13 | 41.9 24.2–72.5ROR 41.9 · χ² 469 / p 3e-104 | 38.9 EB05 24.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Skin atrophy | 112 | 40.8 33.8–49.1ROR 41.2 · χ² 4,221 / p <1e-300 | 39.7 EB05 33.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=95 | no trial data cached |
| Adrenal suppression | 14 | 34.5 20.4–58.5ROR 34.6 · χ² 416 / p 1e-92 | 32.6 EB05 20.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Human herpesvirus 8 infection | 10 | 34.2 18.3–63.9ROR 34.3 · χ² 285 / p 2e-64 | 31.8 EB05 18.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Skin weeping | 53 | 33.1 25.3–43.5ROR 33.3 · χ² 1,594 / p <1e-300 | 32.3 EB05 25.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | no trial data cached |
| Steroid withdrawal syndrome | 16 | 32.7 19.9–53.5ROR 32.7 · χ² 453 / p 9e-101 | 31.1 EB05 20.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Neoplasm skin | 22 | 29.4 19.3–44.7ROR 29.4 · χ² 567 / p 1e-125 | 28.3 EB05 19.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 100% clinician | no trial data cached |
| Cushingoid | 43 | 27.6 20.5–37.3ROR 27.7 · χ² 1,062 / p 3e-233 | 27.0 EB05 20.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=43 | no trial data cached |
| Skin striae | 19 | 26.4 16.8–41.5ROR 26.5 · χ² 434 / p 1e-96 | 25.5 EB05 17.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Seborrhoeic keratosis | 18 | 25.4 16.0–40.5ROR 25.5 · χ² 394 / p 7e-88 | 24.5 EB05 16.4 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Beta haemolytic streptococcal infection | 13 | 21.4 12.4–37.0ROR 21.4 · χ² 231 / p 2e-52 | 20.4 EB05 12.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Necrotising fasciitis | 33 | 19.4 13.7–27.3ROR 19.4 · χ² 551 / p 3e-122 | 19.0 EB05 14.1 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 | no trial data cached |
| Skin fissures | 173 | 18.9 16.3–22.0ROR 19.2 · χ² 2,896 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=42 | no trial data cached |
| Secondary adrenocortical insufficiency | 13 | 17.9 10.4–31.0ROR 18.0 · χ² 190 / p 2e-43 | 16.9 EB05 9.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Lichen planus | 20 | 17.9 11.6–27.8ROR 18.0 · χ² 300 / p 1e-67 | 17.4 EB05 11.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Seborrhoeic dermatitis | 14 | 17.6 10.4–29.8ROR 17.6 · χ² 201 / p 6e-46 | 16.7 EB05 10.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Steroid diabetes | 12 | 17.0 9.6–30.0ROR 17.0 · χ² 163 / p 1e-37 | 15.8 EB05 8.7 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Xerosis | 10 | 16.9 9.1–31.4ROR 16.9 · χ² 133 / p 5e-31 | 15.3 EB05 7.7 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Product physical consistency issue | 44 | 16.6 12.3–22.3ROR 16.7 · χ² 625 / p 4e-138 | 16.3 EB05 12.6 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | 74% consumer | no trial data cached |
| Radiculopathy | 21 | 16.4 10.7–25.2ROR 16.5 · χ² 287 / p 1e-64 | 15.9 EB05 10.6 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 75% consumer | no trial data cached |
| Squamous cell carcinoma of skin | 47 | 16.1 12.1–21.5ROR 16.2 · χ² 646 / p 8e-143 | 15.8 EB05 12.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=46 · ♀ 89% (drug 64%) | no trial data cached |
| Enthesopathy | 12 | 15.7 8.9–27.7ROR 15.7 · χ² 150 / p 1e-34 | 14.4 EB05 7.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Skin haemorrhage | 107 | 15.3 12.7–18.5ROR 15.4 · χ² 1,405 / p <1e-300 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 | no trial data cached |
| Pemphigoid | 53 | 14.7 11.3–19.3ROR 14.8 · χ² 661 / p 5e-146 | 14.5 EB05 11.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 · 100% clinician | no trial data cached |
| Eye allergy | 11 | 14.7 8.2–26.7ROR 14.8 · χ² 127 / p 1e-29 | 13.1 EB05 6.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Skin swelling | 55 | 13.3 10.2–17.3ROR 13.4 · χ² 611 / p 4e-135 | 13.0 EB05 10.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Infusion site discharge | 11 | 13.2 7.3–24.0ROR 13.3 · χ² 112 / p 2e-26 | 11.5 EB05 6.0 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Rebound atopic dermatitis | 13 | 13.1 7.6–22.7ROR 13.2 · χ² 133 / p 4e-31 | 11.7 EB05 6.5 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Tenosynovitis | 16 | 11.9 7.3–19.5ROR 11.9 · χ² 148 / p 2e-34 | 10.7 EB05 6.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Skin hypertrophy | 16 | 11.8 7.2–19.2ROR 11.8 · χ² 146 / p 6e-34 | 10.5 EB05 6.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Skin hypopigmentation | 10 | 11.7 6.3–21.8ROR 11.7 · χ² 87 / p 5e-21 | 9.6 EB05 4.9 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Dermatitis atopic | 282 | 11.6 10.4–13.0ROR 11.9 · χ² 2,718 / p <1e-300 | 11.5 EB05 10.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=37 | no trial data cached |
| Dermatitis bullous | 40 | 11.4 8.4–15.6ROR 11.5 · χ² 369 / p 2e-82 | 11.0 EB05 8.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.3 | no trial data cached |
| Macule | 15 | 11.1 6.7–18.5ROR 11.1 · χ² 128 / p 7e-30 | 9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Hypertrichosis | 10 | 11.0 5.9–20.5ROR 11.0 · χ² 81 / p 1e-19 | 8.9 EB05 4.6 · 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 |
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) | 1,050 | 1.6 1.5–1.7ROR 1.7 · χ² 275 / p 6e-62 | 1.6 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Pruritus (itching) | 907 | 4.9 4.6–5.2ROR 5.3 · χ² 2,878 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Off label use (used outside approved label) | 682 | 1.6 1.5–1.7ROR 1.7 · χ² 164 / p 9e-38 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Rash | 653 | 3.1 2.9–3.3ROR 3.2 · χ² 937 / p 3e-206 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Psoriasis | 538 | 8.5 7.8–9.2ROR 8.9 · χ² 3,538 / p <1e-300 | 8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 | no trial data cached |
| Product use in unapproved indication | 528 | 4.4 4.1–4.8ROR 4.6 · χ² 1,414 / p <1e-300 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Fatigue (tiredness) | 509 | 1.3 1.2–1.5ROR 1.4 · χ² 46 / p 7e-12 | 1.3 EB05 1.2 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Headache | 488 | 1.6 1.5–1.7ROR 1.6 · χ² 111 / p 2e-26 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Diarrhoea (diarrhea) | 434 | 1.4 1.3–1.5ROR 1.4 · χ² 47 / p 4e-12 | 1.4 EB05 1.3 · IC025 +0.3 | No label text to screen label has no adverse-reaction text | serious PRR 1.6 | no trial data cached |
| Nausea | 431 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.009 | 1.1 EB05 1.0 · IC025 +0.0 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial data cached |
| Arthralgia (joint pain) | 412 | 2.0 1.9–2.2ROR 2.1 · χ² 221 / p 3e-50 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial data cached |
| Pain | 393 | 1.3 1.2–1.4ROR 1.3 · χ² 29 / p 3e-8 | 1.3 EB05 1.2 · IC025 +0.2 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial data cached |
| Dry skin | 387 | 6.0 5.5–6.7ROR 6.2 · χ² 1,628 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Skin exfoliation | 373 | 9.2 8.4–10.2ROR 9.5 · χ² 2,727 / p <1e-300 | 9.1 EB05 8.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.1 | no trial data cached |
| Erythema (skin redness) | 338 | 3.4 3.0–3.7ROR 3.5 · χ² 567 / p 1e-125 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | 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 Clobetasol Propionate Ointment and 0.05%?
In FDA FAERS, the most frequently co-reported reaction terms for Clobetasol Propionate Ointment and 0.05% are pruritus, rash, psoriasis, fatigue, headache, diarrhoea. 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 Clobetasol Propionate Ointment and 0.05% have an FDA boxed warning?
No. The FDA label retrieved for Clobetasol Propionate Ointment and 0.05% has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clobetasol Propionate Ointment 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 032f1f4e-1f1c-409a-8fac-6449ee543caa, effective 20260807; matched on
openfda.generic_name.exact:"CLOBETASOL PROPIONATE OINTMENT 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, 1,088 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.