{
 "query": "betamethasone",
 "ingredient": "betamethasone",
 "slug": "betamethasone",
 "rxcui": "1514",
 "brands": [
  "Celestone Soluspan",
  "Del-Beta",
  "Diprolene",
  "Luxiq",
  "Sernivo"
 ],
 "names": [
  "betamethasone",
  "betamethasone acetate",
  "betamethasone benzoate",
  "betamethasone dipropionate",
  "betamethasone dipropionate, augmented",
  "betamethasone sodium phosphate",
  "betamethasone valerate"
 ],
 "classes": [
  {
   "id": "A07EA",
   "name": "Corticosteroids acting locally"
  },
  {
   "id": "C05AA",
   "name": "Corticosteroids"
  },
  {
   "id": "D07AC",
   "name": "Corticosteroids, potent (group III)"
  },
  {
   "id": "H02AB",
   "name": "Glucocorticoids"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "R03BA",
   "name": "Glucocorticoids"
  },
  {
   "id": "S01BA",
   "name": "Corticosteroids, plain"
  },
  {
   "id": "S02BA",
   "name": "Corticosteroids"
  },
  {
   "id": "S03BA",
   "name": "Corticosteroids"
  }
 ],
 "alternatives": [
  "alclometasone",
  "amcinonide",
  "beclomethasone",
  "budesonide",
  "ciclesonide",
  "clobetasol",
  "clobetasone",
  "cloprednol",
  "cortisone",
  "cortivazol",
  "deflazacort",
  "desonide",
  "desoximetasone",
  "dexamethasone",
  "diflorasone",
  "diflucortolone",
  "difluprednate",
  "fluclorolone",
  "flunisolide",
  "fluocinolone acetonide",
  "fluocinonide",
  "fluocortolone",
  "fluorometholone",
  "flurandrenolide",
  "fluticasone",
  "fluticasone furoate",
  "halobetasol",
  "halometasone",
  "hydrocortisone",
  "hydrocortisone aceponate",
  "loteprednol",
  "medrysone",
  "meprednisone",
  "methylprednisolone",
  "methylprednisolone aceponate",
  "mometasone",
  "paramethasone",
  "prednicarbate",
  "prednisolone",
  "prednisone",
  "prednylidene",
  "rimexolone",
  "tixocortol",
  "triamcinolone",
  "vamorolone"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 105,
   "INTRA-ARTICULAR": 8,
   "INTRALESIONAL": 8,
   "INTRAMUSCULAR": 8,
   "SOFT TISSUE": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. SERNIVO Spray is a corticosteroid indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. ( 1 )",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Spray can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during or after treatment. High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and use in pediatric patients may predispose to HPA axis suppression. Use of topical corticosteroids may require periodic evaluation for HPA axis suppression. Modify use if HPA axis suppression develops. ( 5.1 ) High potency corticosteroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure and young age may predispose to HPA axis suppression. ( 5.1 ) Topical corticosteroids may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist. ( 5.2 ) 5.1 Effects on Endocrine System SERNIVO Spray can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency corticosteroids, large treatment surface areas,...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions (\u22651%) are application site reactions, including pruritus, burning and/or stinging, pain, and atrophy. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Promius Pharma, LLC. at 1-888-966-8766 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 clinical practice. In two randomized, multicenter, prospective vehicle-controlled clinical trials, subjects with moderate plaque psoriasis of the body applied SERNIVO Spray or vehicle spray twice daily for 4 weeks. A total of 352 subjects applied SERNIVO Spray and 180 subjects applied vehicle spray. Adverse reactions that occurred in at least 1% of subjects treated with SERNIVO Spray for up to 28 days are presented in Table 1 . Table 1: Adverse Reactions Occurring in \u22651% of Subjects Treated with SERNIVO Spray for up to Four Weeks SERNIVO Spray b.i.d. (N=352) Vehicle Spray b.i.d. (N=180) Application site pruritus 6.0% 9.4% Appl...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Inform patients of the following: Discontinue therapy when control is achieved, unless directed otherwise by the physician. Do not use for longer than 4 consecutive weeks. Avoid contact with the eyes. Avoid use of SERNIVO Spray on the face, scalp, underarms, groin or other intertriginous areas, unless directed by the physician. Do not occlude the treatment area with bandage or other covering, unless directed by the physician. Local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use, or use of higher potency corticosteroids. Advise a woman to use SERNIVO Spray on the smallest area of skin and for the shortest duration possible while pregnant or breastfeeding. Advise breastfeeding women not to apply SERNIVO Spray directly to the nipple and areola to avoid direct infant exposure. Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215 For Encore Dermatology, Inc. Scottsdale, AZ 85254 Sernivo is a registered trademark of Encore Dermatology, Inc. Revised: 2021-04 Product Insert Item Number SER1325 03/20",
  "spl_medguide": "",
  "clinical_studies": "Two multi-center, randomized, double-blind, vehicle-controlled clinical trials were conducted in subjects aged 18 years and older with moderate plaque psoriasis. In both trials, randomized subjects applied SERNIVO Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20%, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-grade reduction from baseline). Table 3 presents the efficacy results at Day 15 and Day 29. Table 3: Proportion of Subjects with Plaque Psoriasis with Treatment Success a after 14 Days and 28 Days of Treatment a Treatment success is defined as an IGA of 0 or 1 (clear or almost clear) and at least a 2-grade reduction from baseline. Study 1 Study 2 SERNIVO Spray b.i.d. (N=182) Vehicle Spray b.i.d. (N=95) SERNIVO Spray b.i.d. (N=174) Vehicle Spray b.i.d. (N=87) Treatment Success at Day 15 21.5% 7.4% 19.0% 2.3% Treatment Success at Day 29 42.7% 11.7% 34.5% 13.6%",
  "brand_name": "Sernivo",
  "manufacturer": "Primus Pharmaceuticals, Inc.",
  "application_number": "NDA208079",
  "pharm_class_epc": [],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20260422",
  "set_id": "b1b3d1b0-da9b-11eb-ad76-0800200c9a66",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 29202,
  "serious": 23498,
  "death": 2985,
  "hospitalization": 10075,
  "primary_suspect": 29170,
  "top_reactions": [
   [
    "Drug Ineffective",
    4115
   ],
   [
    "Off Label Use",
    2558
   ],
   [
    "Nausea",
    1839
   ],
   [
    "Rash",
    1818
   ],
   [
    "Pain",
    1725
   ],
   [
    "Pruritus",
    1688
   ],
   [
    "Foetal Exposure During Pregnancy",
    1648
   ],
   [
    "Fatigue",
    1551
   ],
   [
    "Psoriasis",
    1533
   ],
   [
    "Pyrexia",
    1529
   ],
   [
    "Headache",
    1492
   ],
   [
    "Condition Aggravated",
    1481
   ],
   [
    "Dyspnoea",
    1461
   ],
   [
    "Maternal Exposure During Pregnancy",
    1461
   ],
   [
    "Product Use In Unapproved Indication",
    1457
   ]
  ],
  "by_year": {
   "2019": 2705,
   "2020": 2747,
   "2021": 3049,
   "2022": 2867,
   "2023": 3386,
   "2024": 2143,
   "2025": 2734,
   "2026": 1230
  },
  "by_year_primary": {
   "2019": 2705,
   "2020": 2746,
   "2021": 3045,
   "2022": 2862,
   "2023": 3373,
   "2024": 2143,
   "2025": 2726,
   "2026": 1229
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 102,
  "nda": 38,
  "anda": 57,
  "first_approval": "19610417",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 85,
  "labeling_recent": 0,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "ALEMBIC",
   "ALPHARMA US PHARMS",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL MOLECULAR",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "FOUGERA"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/17/1961"
 },
 "trials": {
  "total": 518,
  "completed": 301,
  "terminated": 47,
  "with_results": 93,
  "industry": 173,
  "phase3": 96,
  "results_share": 0.3089700996677741,
  "terminated_share": 0.09073359073359073
 },
 "pubmed": {
  "rct": 460,
  "meta": 13,
  "recent_rct": 63,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "betamethasone",
   "Celestone Soluspan",
   "Del-Beta",
   "Diprolene",
   "Luxiq",
   "Sernivo"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1052712,
  "beneficiaries": 585428,
  "spend": 42491136.47,
  "by_brand": [
   {
    "brand": "Betamethasone Dipropionate",
    "claims": 766652,
    "per_claim": 43.072159546,
    "is_generic": true
   },
   {
    "brand": "Betamethasone Valerate",
    "claims": 279579,
    "per_claim": 31.996737631,
    "is_generic": true
   },
   {
    "brand": "Betamethasone Diprop Augmented",
    "claims": 6481,
    "per_claim": 80.876917142,
    "is_generic": false
   }
  ],
  "per_claim": 40.36349587541512
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "betamethasone",
  "matched": "betamethasone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6098,
  "fills": 1052712,
  "per_million": 5792.6574409715095,
  "ratio": 2.092005256881923,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 89,
   "letter": "A",
   "why": [
    "5,793 FDA reports naming it as the suspect drug per million Medicare fills, 2.1x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 49,
   "letter": "F",
   "why": [
    "460 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 31% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 57 generic makers (-1)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (57 applications)",
    "45 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, 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, amcinonide, beclomethasone? 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.)"
 ]
}