{
 "query": "fluocinonide",
 "ingredient": "fluocinonide",
 "slug": "fluocinonide",
 "rxcui": "4462",
 "brands": [
  "Vanos"
 ],
 "names": [
  "fluocinonide"
 ],
 "classes": [
  {
   "id": "C05AA",
   "name": "Corticosteroids"
  },
  {
   "id": "D07AC",
   "name": "Corticosteroids, potent (group III)"
  }
 ],
 "alternatives": [
  "amcinonide",
  "beclomethasone",
  "betamethasone",
  "budesonide",
  "desoximetasone",
  "dexamethasone",
  "diflorasone",
  "diflucortolone",
  "difluprednate",
  "fluclorolone",
  "fluocinolone acetonide",
  "fluocortolone",
  "fluorometholone",
  "flurandrenolide",
  "fluticasone",
  "halobetasol",
  "halometasone",
  "hydrocortisone",
  "hydrocortisone aceponate",
  "methylprednisolone aceponate",
  "mometasone",
  "prednicarbate",
  "prednisolone",
  "triamcinolone"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 47
  },
  "boxed_warning": "Important: For skin use only. Do not get Fluocinonide Cream USP, 0.1% in your eyes, mouth, or vagina. Not for use on the face, groin, or underarms.",
  "indications_and_usage": "Fluocinonide cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) Avoid use on the face, groin, or axillae. ( 1.2 ) Avoid use in perioral dermatitis or rosacea. 1.1 Indication Fluocinonide cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ]. 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of fluocinonide cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is see...",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Fluocinonide cream USP, 0.1% has been shown to suppress the HPA axis. Systemic absorption of fluocinonide cream USP, 0.1% may produce reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, Cushing's syndrome, hyperglycemia and unmask latent diabetes ( 5.1 ) Systemic absorption may require evaluation for HPA axis suppression ( 5.1 ) Modify use should HPA axis suppression develop ( 5.1 ) Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ( 5.3 ) Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation and allergic contact dermatitis and may be more likely to occur with occlusive use or more potent corticosteroids ( 5.3 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. ( 5.1 , 8.4 ) 5.1 Effect on Endocrine System Systemic absorption of topical corticosteroids, including fluocinonide cream USP, 0.1%, can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topica...",
  "warnings": "",
  "adverse_reactions": "The most commonly reported adverse reactions (\u22651%) were headache, application site burning, nasopharyngitis, and nasal congestion. ( 6 ) 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 studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream USP, 0.1% for 2 weeks. The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (\u22651%) in Adult Clinical Trials Adverse Reaction Fluocinonide Cream USP, 0.1%, once daily (n=216) Fluocinonide Cream USP, 0.1%, twice daily (n=227) Vehicle Cream, once or twice daily (n=211) Headache 8 (3.7%) 9 (4.0%) 6 (2.8%) Application Site Burning 5 (2.3%) 4 (1.8%) 14 (6.6%) Nasopharyngitis...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "[See FDA-approved patient labeling (Patient Information) ] Patients using fluocinonide cream USP, 0.1% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or unintended effects: Fluocinonide cream USP, 0.1% is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. It should not be used on the face, groin, and underarms. Fluocinonide cream USP, 0.1% should not be used for any disorder other than that for which it was prescribed. The treated skin area should not be bandaged or otherwise covered or wrapped, so as to be occlusive unless directed by the physician. Patients should report to their physician any signs of local adverse reactions. Other corticosteroid-containing products should not be used with fluocinonide cream USP, 0.1% without first talking to the physician. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen in 2 weeks, the patient should be instructed to contact a physician. The safety of the use of fluocinonide cream USP, 0.1%...",
  "spl_medguide": "",
  "clinical_studies": "Two adequate and well-controlled efficacy and safety studies of fluocinonide cream USP, 0.1% have been completed, one in adult subjects with plaque-type psoriasis (Table 2), and one in adult subjects with atopic dermatitis (Table 3). In each of these studies, subjects with between 2% and 10% body surface area involvement at baseline treated all affected areas either once daily or twice daily with fluocinonide cream USP, 0.1% for 14 consecutive days. The primary measure of efficacy was the proportion of subjects whose condition was cleared or almost cleared at the end of treatment. The results of these studies are presented in the tables below as percent and number of patients achieving treatment success at Week 2. Table 2: Plaque-type Psoriasis in Adults Fluocinonide Cream USP, 0.1%, once daily (n=107) Vehicle, once daily (n=54) Fluocinonide Cream USP, 0.1%, twice daily (n=107) Vehicle, twice daily (n=55) Subjects cleared 0 (0) 0 (0) 6 (6%) 0 (0) Subjects achieving treatment success Cleared or almost cleared 19 (18%) 4 (7%) 33 (31%) 3 (5%) Table 3: Atopic Dermatitis in Adults Fluocinonide Cream USP, 0.1%, once daily (n=109) Vehicle, once daily (n=50) Fluocinonide Cream USP, 0.1%, t...",
  "brand_name": "Fluocinonide",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA200734",
  "pharm_class_epc": [
   "Corticosteroid [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20250703",
  "set_id": "16c7d142-e695-4e33-986f-78cb37f7b387",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 5751,
  "serious": 2417,
  "death": 260,
  "hospitalization": 1001,
  "primary_suspect": 5746,
  "top_reactions": [
   [
    "Drug Ineffective",
    807
   ],
   [
    "Psoriasis",
    556
   ],
   [
    "Rash",
    444
   ],
   [
    "Pruritus",
    439
   ],
   [
    "Off Label Use",
    311
   ],
   [
    "Diarrhoea",
    294
   ],
   [
    "Fatigue",
    284
   ],
   [
    "Nausea",
    276
   ],
   [
    "Pain",
    272
   ],
   [
    "Headache",
    265
   ],
   [
    "Product Use In Unapproved Indication",
    229
   ],
   [
    "Arthralgia",
    209
   ],
   [
    "Dermatitis Atopic",
    194
   ],
   [
    "Product Dose Omission Issue",
    194
   ],
   [
    "Chronic Kidney Disease",
    185
   ]
  ],
  "by_year": {
   "2019": 525,
   "2020": 516,
   "2021": 386,
   "2022": 400,
   "2023": 923,
   "2024": 439,
   "2025": 427,
   "2026": 220
  },
  "by_year_primary": {
   "2019": 525,
   "2020": 516,
   "2021": 384,
   "2022": 399,
   "2023": 922,
   "2024": 439,
   "2025": 427,
   "2026": 219
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260325",
   "reason": "Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260325",
   "reason": "Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260325",
   "reason": "Failed Viscosity Specifications:  Out of Specification results, above the specification limit, in viscosity, noted during stability testing.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20170920",
   "reason": "Cross contamination with other products: traces of Dapsone were found in the finished product.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20170317",
   "reason": "Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 47,
  "nda": 6,
  "anda": 40,
  "first_approval": "19710630",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 30,
  "labeling_recent": 0,
  "sponsors": [
   "ALVOGEN",
   "AMNEAL",
   "BAUSCH",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "ENCUBE ETHICALS",
   "FOUGERA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/30/1971"
 },
 "trials": {
  "total": 14,
  "completed": 9,
  "terminated": 2,
  "with_results": 7,
  "industry": 6,
  "phase3": 0,
  "results_share": 0.7777777777777778,
  "terminated_share": 0.14285714285714285
 },
 "pubmed": {
  "rct": 29,
  "meta": 0,
  "recent_rct": 1,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fluocinonide",
   "Vanos"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 733992,
  "beneficiaries": 400723,
  "spend": 31546659.060000002,
  "by_brand": [
   {
    "brand": "Fluocinonide",
    "claims": 733978,
    "per_claim": 42.933405402,
    "is_generic": true
   },
   {
    "brand": "Vanos",
    "claims": 14,
    "per_claim": 2463.145,
    "is_generic": false
   }
  ],
  "per_claim": 42.979567978942555
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1085,
  "fills": 733992,
  "per_million": 1478.2177462424659,
  "ratio": 0.5338550272423398,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,478 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 27,
   "letter": "F",
   "why": [
    "29 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 2 Class III across 40 generic makers (-5)"
   ],
   "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 (40 applications)",
    "24 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are psoriasis, rash, pruritus. 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 amcinonide, beclomethasone, betamethasone? 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.)"
 ]
}