{
 "query": "mometasone",
 "ingredient": "mometasone",
 "slug": "mometasone",
 "rxcui": "108118",
 "brands": [
  "Asmanex",
  "Nasonex",
  "Propel",
  "Sinuva"
 ],
 "names": [
  "mometasone",
  "mometasone furoate",
  "mometasone furoate monohydrate"
 ],
 "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",
  "fluticasone furoate",
  "halobetasol",
  "halometasone",
  "hydrocortisone aceponate",
  "methylprednisolone aceponate",
  "prednicarbate",
  "prednisolone",
  "tixocortol",
  "triamcinolone"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 32,
   "NASAL": 16,
   "RESPIRATORY (INHALATION)": 3,
   "INTRASINAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older. Mometasone Furoate Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients \u22652 years of age. ( 1 )",
  "contraindications": "Mometasone furoate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Mometasone furoate cream is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. ( 4 )",
  "warnings_and_cautions": "Reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment, Cushing's syndrome, and hyperglycemia may occur due to systemic absorption. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. Modify use should HPA axis suppression develop. ( 5.1 , 8.4 ) Pediatric patients may be more susceptible to systemic toxicity. ( 5.1 , 8.4 ) 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 Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of high-potency ste...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions are: burning, pruritus, and skin atrophy. ( 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 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 controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of mometasone furoate cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of mometasone furoate cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of mometasone furoate cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis. The following adverse reactions were reported to be possibly or probably related to treatme...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions Ophthalmic Adverse Reactions ( 5.2 ) 05/2018",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of the following: Use mometasone furoate cream as directed by the physician. It is for external use only. Avoid contact with the eyes. Advise patients to report any visual symptoms to their healthcare providers. Do not use mometasone furoate cream on the face, underarms, or groin areas unless directed by the physician. Do not use mometasone furoate cream for any disorder other than that for which it was prescribed. Do not bandage or otherwise cover or wrap the treated skin area so as to be occlusive, unless directed by the physician. Report any signs of local adverse reactions to the physician. Advise patients not to use mometasone furoate cream in the treatment of diaper dermatitis. Do not apply mometasone furoate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing. Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, contact the physician. Do not use other corticosteroid-containing products with mometasone furoate cream without first consulting with the physician.",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of mometasone furoate cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total of 366 subjects (12 to 81 years of age), of whom 177 received mometasone furoate cream and 181 subjects received vehicle cream, were evaluated in these trials. Mometasone furoate cream or the vehicle cream were applied once daily for 21 days. The two trials showed mometasone furoate cream is effective in the treatment of psoriasis and atopic dermatitis.",
  "brand_name": "Mometasone Furoate",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA076679",
  "pharm_class_epc": [],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20250908",
  "set_id": "79e13e15-5bd3-48b1-877a-1cd92abbc7c5",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 43497,
  "serious": 25823,
  "death": 1610,
  "hospitalization": 11135,
  "primary_suspect": 43436,
  "top_reactions": [
   [
    "Dyspnoea",
    4131
   ],
   [
    "No Adverse Event",
    3871
   ],
   [
    "Product Quality Issue",
    3586
   ],
   [
    "Drug Ineffective",
    3372
   ],
   [
    "Asthma",
    3092
   ],
   [
    "Headache",
    2943
   ],
   [
    "Cough",
    2881
   ],
   [
    "Fatigue",
    2842
   ],
   [
    "Nausea",
    2283
   ],
   [
    "Drug Dose Omission",
    2257
   ],
   [
    "Poor Quality Device Used",
    2170
   ],
   [
    "Off Label Use",
    2082
   ],
   [
    "Wheezing",
    2068
   ],
   [
    "Pneumonia",
    1993
   ],
   [
    "Pain",
    1832
   ]
  ],
  "by_year": {
   "2019": 4785,
   "2020": 4185,
   "2021": 3727,
   "2022": 3456,
   "2023": 3038,
   "2024": 2636,
   "2025": 2522,
   "2026": 1272
  },
  "by_year_primary": {
   "2019": 4785,
   "2020": 4183,
   "2021": 3724,
   "2022": 3445,
   "2023": 3026,
   "2024": 2623,
   "2025": 2511,
   "2026": 1267
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240528",
   "reason": "Defective Container",
   "firm": "Organon Llc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20240528",
   "reason": "Defective Container",
   "firm": "Organon Llc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20230104",
   "reason": "Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.",
   "firm": "Intersect ENT, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20220616",
   "reason": "Defective Container",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190723",
   "reason": "GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 33,
  "nda": 8,
  "anda": 25,
  "first_approval": "19870430",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 35,
  "labeling_recent": 10,
  "sponsors": [
   "AMNEAL",
   "AMNEAL PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "CHARTWELL MOLECULAR",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "FOUGERA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/30/1987"
 },
 "trials": {
  "total": 351,
  "completed": 241,
  "terminated": 38,
  "with_results": 142,
  "industry": 217,
  "phase3": 107,
  "results_share": 0.5892116182572614,
  "terminated_share": 0.10826210826210826
 },
 "pubmed": {
  "rct": 221,
  "meta": 12,
  "recent_rct": 19,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 337030.42,
  "records": 2729,
  "by_name": [
   [
    "Propel",
    321627.0
   ],
   [
    "Sinuva",
    15403.42
   ]
  ],
  "names_checked": [
   "mometasone",
   "Asmanex",
   "Nasonex",
   "Propel",
   "Sinuva"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1059088,
  "beneficiaries": 545274,
  "spend": 54200640.95,
  "by_brand": [
   {
    "brand": "Mometasone Furoate",
    "claims": 993833,
    "per_claim": 43.869795449,
    "is_generic": true
   },
   {
    "brand": "Asmanex",
    "claims": 35699,
    "per_claim": 182.40821956,
    "is_generic": false
   },
   {
    "brand": "Asmanex HFA",
    "claims": 29556,
    "per_claim": 138.36782718,
    "is_generic": false
   }
  ],
  "per_claim": 51.176711425301775
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "mometasone",
  "matched": "mometasone",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6401,
  "fills": 1059088,
  "per_million": 6043.87926215763,
  "ratio": 2.1827334547635284,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 93,
   "letter": "A",
   "why": [
    "6,044 FDA reports naming it as the suspect drug per million Medicare fills, 2.2x the median drug on this site (-7)",
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "221 randomized trials and 12 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)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 83,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 4 Class III across 25 generic makers (-4)",
    "10 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": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $337,030 tied to this drug last year (-15)",
    "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": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, no adverse event, product quality issue. How would we recognize and handle those?",
  "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.)"
 ]
}