{
 "query": "clobetasol",
 "ingredient": "clobetasol",
 "slug": "clobetasol",
 "rxcui": "2590",
 "brands": [
  "Clobex",
  "Clodan",
  "Byqlovi",
  "Impoyz",
  "Olux",
  "Temovate",
  "Tovet"
 ],
 "names": [
  "clobetasol",
  "clobetasol propionate"
 ],
 "classes": [
  {
   "id": "D07AD",
   "name": "Corticosteroids, very potent (group IV)"
  },
  {
   "id": "S01BA",
   "name": "Corticosteroids, plain"
  }
 ],
 "alternatives": [
  "alclometasone",
  "betamethasone",
  "clobetasone",
  "cortisone",
  "desonide",
  "dexamethasone",
  "difluprednate",
  "fluocinolone acetonide",
  "fluorometholone",
  "halcinonide",
  "hydrocortisone",
  "loteprednol",
  "medrysone",
  "prednisolone",
  "rimexolone",
  "triamcinolone"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 104,
   "OPHTHALMIC": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "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. ( 1.2 ) 1.1 Indication Clobetasol propionate shampoo, 0.05%, is a super-high potent topical corticosteroid formulation indicated for the treatment of moderate to severe forms of scalp psoriasis in subjects 18 years of age and older. Treatment should be limited to 4 consecutive weeks. The total dosage should not exceed 50 g (50 mL or 1.75 fl. oz.) per week. Patients should be instructed to use clobetasol propionate shampoo, 0.05%, for the minimum time period necessary to achieve the desired results [see Dosage and Administration (2) ] . Use in patients younger than 18 years of age is not recommended due to numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4) ] . 1.2 Limitations of Use Clobetasol propionate shampoo, 0.05%, should not be used on the face, groin or axillae. Avoid any contact of the drug product ...",
  "contraindications": "None None ( 4 )",
  "warnings_and_cautions": "Clobetasol propionate is a highly potent topical corticosteroid that has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis at the lowest doses tested. ( 5.1 ) Cushing's syndrome, hyperglycemia and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. ( 5.1 ) Systemic absorption may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. ( 5.1 ) Children may be more susceptible to systemic toxicity from use of topical corticosteroids. ( 5.1 , 8.4 ) If irritation develops in the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, use of clobetasol propionate shampoo should be discontinued until the infection has been adequately controlled. ( 5.3 ) Local adverse reactions with topical corticosteroids may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions include: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, s...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions are burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals, U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials with clobetasol propionate shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia. Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis. Table 1: Summary of Selected Adverse Events \u2265 1% by Body System Body System Clobetasol Propionate Shampoo, 0.05% N=558 Vehicle Shampoo N=127 Skin and Appendages 49 (8...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling ( Patient Information ) Information for Patients Inform the patient using topical corticosteroids to adhere to following instructions: This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. Clobetasol propionate shampoo, 0.05%, is for external use only. It should not be used on the face, underarms or groin areas. Avoid contact with the eyes and lips. This medication should not be used for any disorder other than that for which it was prescribed. The scalp area should not be covered while the medication is on the scalp (e.g., shower cap, bathing cap) so as to be occlusive unless directed by the physician. Patients should report any signs of local or systemic adverse reactions to their physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician. Patients should wash their hands after applying the medication. Patients should inform their physician(s) that they are using clobetasol propionate shampoo, 0.05%, if surgery is contemplated. Do not use other corticosteroid-containing product...",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of clobetasol propionate shampoo, 0.05%, have been evaluated in two clinical trials involving 290 subjects with moderate to severe scalp psoriasis. In both trials, subjects were treated with either clobetasol propionate shampoo or the corresponding vehicle applied once daily for 15 minutes before lathering and rinsing for a period of 4 weeks. Efficacy results are presented in Table 2 below. Table 2: Efficacy Results Clobetasol Propionate Shampoo, 0.05% N (%) Shampoo, Vehicle N (%) Study A Study B Study A Study B Total Number of Subjects 95 99 47 49 Success Rate Success rate defined as the proportion of subjects with a-0 (clear) or 1 (minimal) on a 0 to 5 point physician's Global Severity Scale for scalp psoriasis. at Endpoint At four (4) weeks or last observation recorded for a subject during the treatment period (baseline if no post-baseline data were available). 40 (42.1%) 28 (28.3%) 1 (2.1%) 5 (10.2%) Subjects with Scalp Psoriasis Parameter Clear (None) at Endpoint Erythema Subjects with 0 (clear) on a 0 to 3 point scalp psoriasis parameter scale. 17 (17.9%) 12 (12.1%) 3 (6.4%) 1 (2.0%) Scaling 21 (22.1%) 15 (15.2%) 0 (0%) 2 (4.1%) Plaque Thickening 35 (3...",
  "brand_name": "Clobetasol Propionate",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA214867",
  "pharm_class_epc": [],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20250707",
  "set_id": "04d7d65b-d7ed-4223-abab-5d0aed36a155",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 35357,
  "serious": 15765,
  "death": 1196,
  "hospitalization": 6162,
  "primary_suspect": 35328,
  "top_reactions": [
   [
    "Drug Ineffective",
    5463
   ],
   [
    "Psoriasis",
    3770
   ],
   [
    "Pruritus",
    2840
   ],
   [
    "Rash",
    2372
   ],
   [
    "Off Label Use",
    2086
   ],
   [
    "Diarrhoea",
    1815
   ],
   [
    "Nausea",
    1698
   ],
   [
    "Fatigue",
    1647
   ],
   [
    "Headache",
    1587
   ],
   [
    "Product Use In Unapproved Indication",
    1570
   ],
   [
    "Pain",
    1567
   ],
   [
    "Arthralgia",
    1563
   ],
   [
    "Skin Exfoliation",
    1237
   ],
   [
    "Product Dose Omission Issue",
    1170
   ],
   [
    "Dermatitis Atopic",
    1152
   ]
  ],
  "by_year": {
   "2019": 2708,
   "2020": 2859,
   "2021": 2622,
   "2022": 2991,
   "2023": 6315,
   "2024": 3242,
   "2025": 3459,
   "2026": 2054
  },
  "by_year_primary": {
   "2019": 2707,
   "2020": 2859,
   "2021": 2621,
   "2022": 2987,
   "2023": 6308,
   "2024": 3239,
   "2025": 3452,
   "2026": 2053
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260803",
   "reason": "Failed content uniformity specifications.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20230120",
   "reason": "Subpotent Drug: Low assay result observed during long-term stability testing.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20211215",
   "reason": "Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191115",
   "reason": "Defective delivery system; product is not foaming or is coming out as liquid.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191115",
   "reason": "Defective delivery system; product is not foaming or is coming out as liquid.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20190111",
   "reason": "Defective Container; complaints of leakage.",
   "firm": "Oxalis Labs",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20171221",
   "reason": "Failed Content Uniformity Specifications",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170602",
   "reason": "Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.",
   "firm": "G & W  Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 100,
  "nda": 13,
  "anda": 87,
  "first_approval": "19851227",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 31,
  "labeling_recent": 1,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "ALEMBIC",
   "AMNEAL",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA USA",
   "BEACH PRODS",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/27/1985"
 },
 "trials": {
  "total": 131,
  "completed": 89,
  "terminated": 11,
  "with_results": 34,
  "industry": 56,
  "phase3": 23,
  "results_share": 0.38202247191011235,
  "terminated_share": 0.08396946564885496
 },
 "pubmed": {
  "rct": 153,
  "meta": 4,
  "recent_rct": 25,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 343.51,
  "records": 17,
  "by_name": [
   [
    "Clodan",
    343.51
   ]
  ],
  "names_checked": [
   "clobetasol",
   "Clobex",
   "Clodan",
   "Byqlovi",
   "Impoyz",
   "Olux",
   "Temovate",
   "Tovet"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2761530,
  "beneficiaries": 1472451,
  "spend": 126925951.96999998,
  "by_brand": [
   {
    "brand": "Clobetasol Propionate",
    "claims": 2761450,
    "per_claim": 45.945848525,
    "is_generic": true
   },
   {
    "brand": "Clobex",
    "claims": 46,
    "per_claim": 1007.6597826,
    "is_generic": false
   },
   {
    "brand": "Clodan",
    "claims": 34,
    "per_claim": 71.653235294,
    "is_generic": false
   }
  ],
  "per_claim": 45.9621847200646
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 8744,
  "fills": 2761530,
  "per_million": 3166.3606768711547,
  "ratio": 1.1435240645073803,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "3,166 FDA reports naming it as the suspect drug per million Medicare fills, 1.1x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "153 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 38% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 79,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 1 Class II, 6 Class III across 87 generic makers (-21)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $344 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (87 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are psoriasis, pruritus, rash. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over alclometasone, betamethasone, clobetasone? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}