{
 "query": "fluticasone",
 "ingredient": "fluticasone",
 "slug": "fluticasone",
 "rxcui": "41126",
 "brands": [
  "Xhance",
  "Aller-Flo",
  "Armonair",
  "Arnuity",
  "Beser",
  "Clarispray",
  "Cutivate",
  "Flonase",
  "Flonase Sensimist",
  "Flovent",
  "Fluticare"
 ],
 "names": [
  "fluticasone",
  "fluticasone furoate",
  "fluticasone propionate"
 ],
 "classes": [
  {
   "id": "D07AC",
   "name": "Corticosteroids, potent (group III)"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "R03BA",
   "name": "Glucocorticoids"
  }
 ],
 "alternatives": [
  "amcinonide",
  "beclomethasone",
  "betamethasone",
  "budesonide",
  "ciclesonide",
  "desoximetasone",
  "dexamethasone",
  "diflorasone",
  "diflucortolone",
  "difluprednate",
  "fluclorolone",
  "flunisolide",
  "fluocinolone acetonide",
  "fluocinonide",
  "fluocortolone",
  "flurandrenolide",
  "fluticasone furoate",
  "halobetasol",
  "halometasone",
  "hydrocortisone aceponate",
  "methylprednisolone aceponate",
  "mometasone",
  "prednicarbate",
  "prednisolone",
  "tixocortol",
  "triamcinolone"
 ],
 "label": {
  "route_mode": "NASAL",
  "route_counts": {
   "NASAL": 103,
   "RESPIRATORY (INHALATION)": 45,
   "TOPICAL": 17
  },
  "boxed_warning": "",
  "indications_and_usage": "is a corticosteroid indicated for the treatment of: Chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. ( 1.1 ) Chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. ( 1.2 ) 1.1 Chronic Rhinosinusitis with Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults. 1.2 Chronic Rhinosinusitis without Nasal Polyps XHANCE is indicated for the treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.",
  "contraindications": "is contraindicated in patients with hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.3 ) and Description ( 11 )] . Hypersensitivity to any ingredient in XHANCE. ( 4 )",
  "warnings_and_cautions": "Local Nasal Adverse Reactions: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma. ( 5.1 ) Glaucoma and Cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term. ( 5.2 ) Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur. ( 5.3 ) Immunosuppression and Risk of Infection: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. ( 5.4 ) Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible ...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Local Nasal Adverse Reactions: [see Warnings and Precautions ( 5.1 )] Glaucoma and Cataracts [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions including Anaphylaxis [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Immunosuppression and Risk of Infection [see Warnings and Precautions ( 5.4 )] Hypercorticism and Adrenal Suppression [see Warnings and Precautions ( 5.5 )] Reduction in Bone Mineral Density [see Warnings and Precautions ( 5.7 )] Effect on Growth [see Warnings and Precautions ( 5.8 )] CRSwNP: The most common adverse reactions (incidence \u2265 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. ( 6.1 ) CRSsNP: The most common adverse reactions (incidence \u2265 3%) are epistaxis, headache, and nasopharyngitis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact OptiNose US, Inc. at 1-833-678-6673 and safety@optinose.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because c...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Indications and Usage ( 1.2 ) 03/2024",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Local Nasal Adverse Reactions Inform patients that treatment with XHANCE may lead to adverse reactions, which include epistaxis, nasal erosions, and nasal ulceration. Candida infection may also occur with treatment with XHANCE. In addition, XHANCE has been associated with nasal septal perforation and impaired wound healing. Patients who have experienced recent nasal ulcerations, nasal surgery, or nasal trauma should not use XHANCE until healing has occurred [see Warnings and Precautions ( 5.1 )] . Glaucoma and Cataracts Inform patients that glaucoma and cataracts are associated with long-term use of nasal and orally inhaled corticosteroids, including fluticasone propionate, and may increase the risk of some eye problems. Consider regular eye exams. Advise patients to notify their healthcare providers if a change in vision is noted while using XHANCE [see Warnings and Precautions ( 5.2 )] . Hypersensitivity Reactions, Including Anaphylaxis Inform patients that hypersensitivity reactions, including anaphylaxis, angioedema, urticaria, contact dermatitis, rash, bronchospasm, a...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Chronic Rhinosinusitis with Nasal Polyps The efficacy of XHANCE was evaluated in two randomized, double-blind, parallel\u2011group, multicenter, placebo-controlled, dose-ranging trials in adults 18 years and older with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and associated moderate to severe nasal congestion (Trial 1 [NCT01622569], Trial 2 [NCT01624662]). The two trials included a total of 646 patients [348 (53.9%) males and 298 (46.1%) females] with a mean age of 45.5 years. Patients were randomized 1:1:1:1 to receive 93 mcg, 186 mcg, or 372 mcg twice daily or placebo for a period of 16 weeks. At baseline 35.7%, 79.0%, and 18.3% had polyps graded as mild, moderate, or severe, respectively. In addition, 90.6% of patients reported previous use of a topical steroid nasal spray for the treatment of CRSwNP and 53.6% reported previous sinus surgery or polypectomy. The co-primary efficacy endpoints were 1) change from baseline to Week 4 in nasal congestion / obstruction averaged over the preceding 7 days of treatment and 2) change from baseline to Week 16 in bilateral polyp grade. Nasal congestion was rated by the patient on a 0 to 3 categorical severity scale (0 = none, 1 = mi...",
  "brand_name": "XHANCE",
  "manufacturer": "OptiNose US, Inc.",
  "application_number": "NDA209022",
  "pharm_class_epc": [],
  "route": [
   "NASAL"
  ],
  "effective_time": "20260112",
  "set_id": "c79bbb9f-e483-4093-8c92-ea978e7bf278",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 145397,
  "serious": 73815,
  "death": 6948,
  "hospitalization": 33188,
  "primary_suspect": 145152,
  "top_reactions": [
   [
    "Drug Ineffective",
    13031
   ],
   [
    "Dyspnoea",
    11559
   ],
   [
    "Fatigue",
    9393
   ],
   [
    "Headache",
    9081
   ],
   [
    "Off Label Use",
    8566
   ],
   [
    "Nausea",
    7844
   ],
   [
    "Asthma",
    7843
   ],
   [
    "Cough",
    7770
   ],
   [
    "Pain",
    7023
   ],
   [
    "Diarrhoea",
    6834
   ],
   [
    "Pneumonia",
    6146
   ],
   [
    "Dizziness",
    5656
   ],
   [
    "Malaise",
    5133
   ],
   [
    "Product Dose Omission Issue",
    4926
   ],
   [
    "Vomiting",
    4826
   ]
  ],
  "by_year": {
   "2019": 14848,
   "2020": 14509,
   "2021": 13003,
   "2022": 11036,
   "2023": 11237,
   "2024": 12235,
   "2025": 12167,
   "2026": 5917
  },
  "by_year_primary": {
   "2019": 14837,
   "2020": 14500,
   "2021": 12993,
   "2022": 11003,
   "2023": 11158,
   "2024": 12196,
   "2025": 12133,
   "2026": 5897
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 38,
  "nda": 13,
  "anda": 25,
  "first_approval": "19901214",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 82,
  "labeling_recent": 17,
  "sponsors": [
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "BRIGHT",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "FOUGERA",
   "FOUGERA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/14/1990"
 },
 "trials": {
  "total": 838,
  "completed": 658,
  "terminated": 77,
  "with_results": 337,
  "industry": 623,
  "phase3": 243,
  "results_share": 0.5121580547112462,
  "terminated_share": 0.09188544152744631
 },
 "pubmed": {
  "rct": 929,
  "meta": 74,
  "recent_rct": 43,
  "cochrane": [
   {
    "pmid": "27582089",
    "title": "Vilanterol and fluticasone furoate for asthma",
    "year": "2016"
   },
   {
    "pmid": "22161385",
    "title": "Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children",
    "year": "2011"
   },
   {
    "pmid": "18843646",
    "title": "Fluticasone at different doses for chronic asthma in adults and children",
    "year": "2008"
   },
   {
    "pmid": "18843640",
    "title": "Fluticasone versus placebo for chronic asthma in adults and children",
    "year": "2008"
   },
   {
    "pmid": "18646100",
    "title": "Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children",
    "year": "2008"
   },
   {
    "pmid": "17943772",
    "title": "Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and children",
    "year": "2007"
   },
   {
    "pmid": "16625634",
    "title": "Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children",
    "year": "2006"
   },
   {
    "pmid": "16235400",
    "title": "Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children",
    "year": "2005"
   },
   {
    "pmid": "16235315",
    "title": "Fluticasone versus placebo for chronic asthma in adults and children",
    "year": "2005"
   },
   {
    "pmid": "16034902",
    "title": "Inhaled fluticasone at different doses for chronic asthma in adults and children",
    "year": "2005"
   },
   {
    "pmid": "15846649",
    "title": "Inhaled fluticasone versus placebo for chronic asthma in adults and children",
    "year": "2005"
   },
   {
    "pmid": "15846637",
    "title": "Inhaled fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma in adults and children",
    "year": "2005"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 1294172.65,
  "records": 14036,
  "by_name": [
   [
    "Xhance",
    1294172.65
   ]
  ],
  "names_checked": [
   "fluticasone",
   "Xhance",
   "Aller-Flo",
   "Armonair",
   "Arnuity",
   "Beser",
   "Clarispray",
   "Cutivate",
   "Flonase",
   "Flonase Sensimist",
   "Flovent",
   "Fluticare"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 13881088,
  "beneficiaries": 5506994,
  "spend": 514877048.98,
  "by_brand": [
   {
    "brand": "Fluticasone Propionate",
    "claims": 12849868,
    "per_claim": 14.85044197,
    "is_generic": true
   },
   {
    "brand": "Arnuity Ellipta",
    "claims": 659581,
    "per_claim": 303.00466896,
    "is_generic": false
   },
   {
    "brand": "Fluticasone Propionate HFA",
    "claims": 312596,
    "per_claim": 298.82131755,
    "is_generic": false
   },
   {
    "brand": "Flovent HFA",
    "claims": 27166,
    "per_claim": 332.89890083,
    "is_generic": false
   },
   {
    "brand": "Xhance",
    "claims": 25053,
    "per_claim": 796.23848162,
    "is_generic": false
   },
   {
    "brand": "Flovent Diskus",
    "claims": 5772,
    "per_claim": 252.39317394,
    "is_generic": false
   },
   {
    "brand": "Armonair Digihaler",
    "claims": 1052,
    "per_claim": 319.2501616,
    "is_generic": false
   }
  ],
  "per_claim": 37.09198075683981
 },
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2012,
   "company": "GlaxoSmithKline",
   "amount_usd": 3000000000.0,
   "amount_text": "$3 billion ($1B criminal, $2B civil)",
   "violations": "Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to physicians, making false and misleading statements concerning the safety of Avandia, reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program",
   "products": "Avandia (not providing safety data), Wellbutrin, Paxil (promotion of paediatric use), Advair, Lamictal, Zofran, Imitrex, Lotronex, Flovent, Valtrex",
   "laws": "False Claims Act, FDCA",
   "urls": [
    "https://www.justice.gov/opa/pr/2012/July/12-civ-842.html",
    "https://web.archive.org/web/20240714112314/https://www.justice.gov/opa/pr/glaxosmithkline-plead-guilty-and-pay-3-billion-resolve-fraud-allegations-and-failure-report"
   ],
   "matched": "flovent"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fluticasone",
  "matched": "fluticasone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 30226,
  "fills": 13881088,
  "per_million": 2177.49502056323,
  "ratio": 0.7863974481958139,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,177 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x 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": 85,
   "letter": "B",
   "why": [
    "929 randomized trials and 74 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 25 generic makers (-1)",
    "17 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 35,
   "letter": "F",
   "why": [
    "Maker paid $3 billion ($1B criminal, $2B civil) in 2012 to settle federal allegations naming this drug (Criminal: Off-label promotion, failure to disclose safety data. Civil: paying kickbacks to) (-35)",
    "Pharma paid doctors $1,294,173 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (25 applications)",
    "26 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The maker paid $3 billion in 2012 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, headache. 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}