pharmacopeia
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Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.contraindicated

Dosage & administration

Sourced from openFDA

Apply a thin layer of clobetasol propionate ointment to the affected skin areas twice daily and rub in gently and completely. (See INDICATIONS AND USAGE .) Clobetasol propionate ointment are super- high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks , and amounts greater than 50 g per week should not be used . As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Clobetasol propionate ointment should not be used with occlusive dressings . Geriatric Use : In studies where geriatric patients (65 years of age or older, see PRECAUTIONS ) have been treated with clobetasol propionate ointment, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

Adverse reactions

Sourced from openFDA

In controlled clinical trials, the most frequent adverse events reported for clobetasol propionate ointment were burning sensation, irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in specific populations

Sourced from openFDA

Pregnancy: Teratogenic Effects: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Clobetasol propionate has not been tested for teratogenicity when applied topically; however, it is absorbed percutaneously, and when administered subcutaneously it was a significant teratogen in both the rabbit and mouse. Clobetasol propionate has greater teratogenic potential than steroids that are less potent. Teratogenicity studies in mice using the subcutaneous route resulted in fetotoxicity at the highest dose tested (1 mg/kg) and teratogenicity at all dose levels tested down to 0.03 mg/kg. These doses are approximately 1.4 and 0.04 times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate and skeletal abnormalities. In rabbits, clobetasol propionate was teratogenic at doses of 3 and 10 mcg/kg. These doses are approximately 0.02 and 0.05 times, respectively, the human topical dose of clobetasol propionate ointment. Abnormalities seen included cleft palate, cranioschisis, and other skeletal abnormalities. There are no adequate and well-controlled studies of the teratogenic potential of clobetasol propionate in pregnant women.

Overdosage

Sourced from openFDA

Topically applied clobetasol propionate ointment can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

Approval history

Sourced from openFDA
  • Feb 16, 1994ANDAANDA074089Cosette
  • Feb 23, 1996ANDAANDA074407Fougera Pharms
  • Jul 8, 1996ANDAANDA074249Sun Pharma Canada
  • Jul 24, 2003NDANDA021535Galderma Labs Lp
  • Feb 5, 2004NDANDA021644Galderma Labs
  • Oct 27, 2005NDANDA021835Galderma Labs Lp
  • Nov 28, 2017NDANDA209483Primus Pharms
  • Mar 4, 2024NDANDA218158Harrow Eye

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
10,959 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1,18811%
  2. 2Pruritus8798.0%
  3. 3Off Label Use6956.3%
  4. 4Psoriasis6826.2%
  5. 5Rash6405.8%
  6. 6Fatigue5324.9%
  7. 7Headache5204.7%
  8. 8Product Use In Unapproved Indication5064.6%
  9. 9Nausea4944.5%
  10. 10Diarrhoea4744.3%
  11. 11Arthralgia4394.0%
  12. 12Pain4183.8%
  13. 13Skin Exfoliation3743.4%
  14. 14Dry Skin3643.3%
  15. 15Erythema3553.2%

Literature

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Recent PubMed references pinned to Clobetasol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 127 ClinicalTrials.gov registrations naming Clobetasol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Clobetasol work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Clobetasol used for?
According to FDA labeling, Clobetasol carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Clobetasol?
Clobetasol is classified as Corticosteroids, plain, Corticosteroids, very potent (group IV), Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Antipruritic Activity, Decreased Immunologically Active Molecule Activity, Decreased Protein Synthesis, Vasoconstriction.
What are the brand names for Clobetasol?
Clobetasol is marketed under brand names including Byqlovi, Clobex, Clodan, Impeklo, Impoyz, Olux, Temovate, Tovet.
What are the contraindications for Clobetasol?
Clobetasol labeling lists contraindications including: Clobetasol propionate ointment is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.. Always consult the full prescribing information and a clinician.
Note. Data for clobetasol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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