Drug · FAERS side-effect profile with label screen
Clobetasol Propionate side effects: what 10,270 FDA adverse event reports show
Drug class
Corticosteroid
FDA label, Indications wording
Who reports
10,270 reports · 47% serious · 434 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Clobetasol propionate shampoo, 0.05% is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older ( 1 ). Limitations of Use: Do not use on the face, axillae or groin. ( 1.2 ) Avoid any contact with the eyes and lips.
FDA label, Indications and Usage
What it is
Clobetasol Propionate Shampoo, 0.05%, contains clobetasol propionate, a synthetic fluorinated corticosteroid, for topical use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents.
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 3Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 29
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. 1,049 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 | 166.7 114.2–243.3ROR 167.2 · χ² 4,259 / p <1e-300 | 140.0 EB05 102.2 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 100% (drug 64%) · 72% consumer | no trial data cached |
| Cushing's syndrome | 50 | 155.7 116.9–207.5ROR 156.5 · χ² 6,991 / p <1e-300 | 137.1 EB05 108.1 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=50 | no trial data cached |
| Hypothalamic pituitary adrenal axis suppression | 16 | 96.4 58.4–159.1ROR 96.5 · χ² 1,351 / p 4e-296 | 83.2 EB05 54.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | no trial data cached |
| Biliary sepsis | 14 | 63.7 37.4–108.4ROR 63.8 · χ² 778 / p 2e-171 | 57.2 EB05 36.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Lichen sclerosus | 18 | 56.1 35.2–89.6ROR 56.2 · χ² 896 / p 5e-197 | 51.8 EB05 34.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Blood cortisol decreased | 13 | 41.7 24.1–72.2ROR 41.8 · χ² 467 / p 7e-104 | 38.8 EB05 24.1 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Skin atrophy | 112 | 40.6 33.7–48.9ROR 41.0 · χ² 4,202 / p <1e-300 | 39.6 EB05 33.8 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=96 | no trial data cached |
| Adrenal suppression | 14 | 34.4 20.3–58.3ROR 34.4 · χ² 414 / p 2e-92 | 32.5 EB05 20.5 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=13 | no trial data cached |
| Human herpesvirus 8 infection | 10 | 34.1 18.3–63.7ROR 34.1 · χ² 284 / p 5e-64 | 31.7 EB05 18.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Skin weeping | 53 | 33.0 25.2–43.3ROR 33.2 · χ² 1,587 / p <1e-300 | 32.2 EB05 25.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Neoplasm skin | 22 | 29.3 19.2–44.5ROR 29.3 · χ² 564 / p 5e-125 | 28.2 EB05 19.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Steroid withdrawal syndrome | 14 | 28.4 16.8–48.1ROR 28.5 · χ² 339 / p 6e-76 | 27.1 EB05 17.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Cushingoid | 42 | 26.9 19.8–36.4ROR 27.0 · χ² 1,007 / p 3e-221 | 26.2 EB05 20.2 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=42 | no trial data cached |
| Skin striae | 19 | 26.3 16.7–41.4ROR 26.4 · χ² 432 / p 3e-96 | 25.4 EB05 17.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Seborrhoeic keratosis | 18 | 25.3 15.9–40.3ROR 25.4 · χ² 392 / p 2e-87 | 24.4 EB05 16.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Beta haemolytic streptococcal infection | 13 | 21.3 12.4–36.8ROR 21.4 · χ² 230 / p 4e-52 | 20.3 EB05 12.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Skin fissures | 177 | 19.3 16.7–22.3ROR 19.6 · χ² 3,025 / p <1e-300 | 19.1 EB05 16.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=42 | no trial data cached |
| Necrotising fasciitis | 33 | 19.3 13.7–27.2ROR 19.3 · χ² 549 / p 1e-121 | 18.9 EB05 14.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=32 | no trial data cached |
| Secondary adrenocortical insufficiency | 13 | 17.9 10.4–30.8ROR 17.9 · χ² 189 / p 3e-43 | 16.9 EB05 9.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Product physical consistency issue | 45 | 16.9 12.6–22.7ROR 17.0 · χ² 653 / p 3e-144 | 16.6 EB05 12.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | 75% consumer | no trial data cached |
| Steroid diabetes | 12 | 16.9 9.6–29.8ROR 16.9 · χ² 163 / p 1e-37 | 15.7 EB05 8.7 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Xerosis | 10 | 16.8 9.0–31.3ROR 16.8 · χ² 132 / p 7e-31 | 15.2 EB05 7.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Radiculopathy | 21 | 16.4 10.7–25.1ROR 16.4 · χ² 285 / p 2e-64 | 15.8 EB05 10.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=21 · 75% consumer | no trial data cached |
| Seborrhoeic dermatitis | 13 | 16.3 9.4–28.1ROR 16.3 · χ² 170 / p 4e-39 | 15.2 EB05 8.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lichen planus | 18 | 16.1 10.1–25.5ROR 16.1 · χ² 237 / p 7e-54 | 15.3 EB05 9.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Squamous cell carcinoma of skin | 47 | 16.0 12.0–21.4ROR 16.1 · χ² 643 / p 4e-142 | 15.8 EB05 12.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 89% (drug 64%) | no trial data cached |
| Enthesopathy | 12 | 15.6 8.9–27.6ROR 15.6 · χ² 149 / p 2e-34 | 14.3 EB05 7.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Skin haemorrhage | 107 | 15.2 12.6–18.4ROR 15.4 · χ² 1,399 / p <1e-300 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=32 | no trial data cached |
| Eye allergy | 11 | 14.7 8.1–26.6ROR 14.7 · χ² 126 / p 2e-29 | 13.1 EB05 6.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pemphigoid | 53 | 14.7 11.2–19.2ROR 14.8 · χ² 658 / p 2e-145 | 14.4 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 · 100% clinician | no trial data cached |
| Infusion site discharge | 11 | 13.2 7.3–23.9ROR 13.2 · χ² 111 / p 2e-26 | 11.4 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Rebound atopic dermatitis | 13 | 13.1 7.6–22.6ROR 13.1 · χ² 132 / p 6e-31 | 11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Skin swelling | 54 | 13.0 10.0–17.0ROR 13.1 · χ² 584 / p 3e-129 | 12.7 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Skin wound | 10 | 12.3 6.6–22.9ROR 12.3 · χ² 92 / p 3e-22 | 10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Tenosynovitis | 16 | 11.9 7.3–19.4ROR 11.9 · χ² 148 / p 3e-34 | 10.6 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Dermatitis atopic | 286 | 11.7 10.5–13.2ROR 12.0 · χ² 2,789 / p <1e-300 | 11.6 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=37 | no trial data cached |
| Skin hypertrophy | 16 | 11.7 7.2–19.1ROR 11.7 · χ² 145 / p 9e-34 | 10.5 EB05 6.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pustule | 13 | 11.6 6.7–20.0ROR 11.6 · χ² 115 / p 5e-27 | 10.0 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Dermatitis bullous | 40 | 11.4 8.4–15.5ROR 11.4 · χ² 367 / p 4e-82 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 | no trial data cached |
| Macule | 15 | 11.1 6.7–18.4ROR 11.1 · χ² 127 / p 1e-29 | 9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=6 | 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) | 1,069 | 1.7 1.6–1.8ROR 1.7 · χ² 296 / p 1e-66 | 1.7 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Pruritus (itching) | 909 | 4.9 4.6–5.2ROR 5.3 · χ² 2,876 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Off label use (used outside approved label) | 674 | 1.6 1.5–1.7ROR 1.6 · χ² 151 / p 6e-35 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Rash | 656 | 3.1 2.9–3.3ROR 3.2 · χ² 943 / p 3e-207 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Psoriasis | 548 | 8.6 7.9–9.3ROR 9.0 · χ² 3,670 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.2 | no trial data cached |
| Product use in unapproved indication | 527 | 4.4 4.1–4.8ROR 4.6 · χ² 1,398 / 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) | 512 | 1.3 1.2–1.5ROR 1.4 · χ² 47 / p 4e-12 | 1.3 EB05 1.2 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Headache | 490 | 1.6 1.5–1.7ROR 1.6 · χ² 112 / p 2e-26 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Diarrhoea (diarrhea) | 439 | 1.4 1.3–1.5ROR 1.4 · χ² 50 / p 9e-13 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Nausea | 437 | 1.1 1.0–1.2ROR 1.1 · χ² 7 / p 0.005 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Arthralgia (joint pain) | 412 | 2.0 1.8–2.2ROR 2.1 · χ² 218 / p 1e-49 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Pain | 397 | 1.3 1.2–1.4ROR 1.3 · χ² 31 / p 1e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Dry skin | 387 | 6.0 5.5–6.6ROR 6.2 · χ² 1,619 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Skin exfoliation | 378 | 9.3 8.4–10.3ROR 9.6 · χ² 2,796 / p <1e-300 | 9.2 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 | no trial data cached |
| Erythema (skin redness) | 339 | 3.4 3.0–3.7ROR 3.5 · χ² 568 / p 8e-126 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | 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 weeping — n=53, PRR 33.0
- Neoplasm skin — n=22, PRR 29.3
- Skin fissures — n=177, PRR 19.3
- Necrotising fasciitis — n=33, PRR 19.3
- Radiculopathy — n=21, PRR 16.4
- Squamous cell carcinoma of skin — n=47, PRR 16.0
- Skin haemorrhage — n=107, PRR 15.2
- Pemphigoid — n=53, PRR 14.7
- Skin swelling — n=54, PRR 13.0
- Dermatitis atopic — n=286, PRR 11.7
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?
In FDA FAERS, the most frequently co-reported reaction terms for Clobetasol Propionate 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 have an FDA boxed warning?
No. The FDA label retrieved for Clobetasol Propionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Clobetasol 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 04d7d65b-d7ed-4223-abab-5d0aed36a155, effective 20250707; matched on
openfda.generic_name.exact:"CLOBETASOL 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, fieldpatient.drug.openfda.generic_name.exact, 1,089 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.