{
 "query": "beclomethasone",
 "ingredient": "beclomethasone",
 "slug": "beclomethasone",
 "rxcui": "1347",
 "brands": [
  "Qnasl",
  "Beconase",
  "Qvar"
 ],
 "names": [
  "beclomethasone",
  "beclomethasone 17-monopropionate",
  "beclomethasone dipropionate",
  "beclomethasone dipropionate monohydrate"
 ],
 "classes": [
  {
   "id": "A07EA",
   "name": "Corticosteroids acting locally"
  },
  {
   "id": "D07AC",
   "name": "Corticosteroids, potent (group III)"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "R03BA",
   "name": "Glucocorticoids"
  }
 ],
 "alternatives": [
  "amcinonide",
  "betamethasone",
  "budesonide",
  "ciclesonide",
  "desoximetasone",
  "dexamethasone",
  "diflorasone",
  "diflucortolone",
  "difluprednate",
  "fluclorolone",
  "flunisolide",
  "fluocinolone acetonide",
  "fluocinonide",
  "fluocortolone",
  "flurandrenolide",
  "fluticasone",
  "fluticasone furoate",
  "halobetasol",
  "halometasone",
  "hydrocortisone",
  "hydrocortisone aceponate",
  "methylprednisolone aceponate",
  "mometasone",
  "prednicarbate",
  "prednisolone",
  "prednisone",
  "tixocortol",
  "triamcinolone"
 ],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 4
  },
  "boxed_warning": "",
  "indications_and_usage": "Beclomethasone dipropionate HFA inhalation aerosol is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. Important Limitations of Use: Beclomethasone dipropionate HFA inhalation aerosol is NOT indicated for the relief of acute bronchospasm. Beclomethasone dipropionate HFA inhalation aerosol is a corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. (1) Important Limitations: Not indicated for the relief of acute bronchospasm. (1)",
  "contraindications": "Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Hypersensitivity to any of the ingredients of beclomethasone dipropionate HFA inhalation aerosol. (4) 4.1 Status Asthmaticus Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. 4.2 Hypersensitivity Beclomethasone dipropionate HFA inhalation aerosol is contraindicated in patients with known hypersensitivity to beclomethasone dipropionate or any of the ingredients in beclomethasone dipropionate HFA inhalation aerosol [see Warnings and Precautions (5.6) ] .",
  "warnings_and_cautions": "Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth with water without swallowing after inhalation. (5.1) Deterioration of asthma and acute episodes: Do not use beclomethasone dipropionate HFA inhalation aerosol for relief of acute symptoms. Patients require immediate re-evaluation during rapidly deteriorating asthma. (5.2) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to beclomethasone dipropionate HFA inhalation aerosol. (5.3) Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Use with caution in patients with these infections because of the potential for worsening of these infections. (5.4) Paradoxical Bronchospasm: Bronchospasm, with an immediate increase in wheezing, may occur after dosing. Treat b...",
  "warnings": "",
  "adverse_reactions": "Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.1) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.7) ] Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Eye Disorders [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence \u22653% and > placebo) include headache, pharyngitis, oral symptoms (inhalation route), and sinusitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 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. The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Risks Associated with Corticosteroid Therapy Local Effects : Advise patients that localized infections with Candida albicans have occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, it should be treated with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing with beclomethasone dipropionate HFA inhalation aerosol therapy, but at times therapy with beclomethasone dipropionate HFA inhalation aerosol may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised [see Warnings and Precautions (5.1) ] . Immunosuppression : Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physician without delay. Inform patients of potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex [see Warnings and Precautions (5.4) ] . Hypercorticism and Adrenal Suppression : Advise patients ...",
  "spl_medguide": "",
  "clinical_studies": "Blinded, randomized, parallel, placebo-controlled and active-controlled clinical studies were conducted in 940 adult asthma patients to assess the efficacy and safety of beclomethasone dipropionate HFA inhalation aerosol in the treatment of asthma. Fixed doses ranging from 40 mcg to 160 mcg twice daily were compared to placebo, and doses ranging from 40 mcg to 320 mcg twice daily were compared with doses of 42 mcg to 336 mcg twice daily of an active CFC-BDP comparator. These studies provided information about appropriate dosing through a range of asthma severity. A blinded, randomized, parallel, placebo-controlled study was conducted in 353 pediatric patients (age 5 to 12 years) to assess the efficacy and safety of HFA beclomethasone dipropionate in the treatment of asthma. Fixed doses of 40 mcg and 80 mcg twice daily were compared with placebo in this study. In these adult and pediatric efficacy trials, at the doses studied, measures of pulmonary function [forced expiratory volume in 1 second (FEV 1 ) and morning peak expiratory flow (AM PEF)] and asthma symptoms were significantly improved with beclomethasone dipropionate HFA inhalation aerosol treatment when compared to placebo....",
  "brand_name": "Beclomethasone Dipropionate",
  "manufacturer": "Amneal Pharmaceuticals NY LLC",
  "application_number": "ANDA213811",
  "pharm_class_epc": [],
  "route": [
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20200731",
  "set_id": "d853c96f-21a3-4def-931d-4d47d16acd62",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 25868,
  "serious": 18648,
  "death": 1303,
  "hospitalization": 6859,
  "primary_suspect": 25805,
  "top_reactions": [
   [
    "Dyspnoea",
    3237
   ],
   [
    "Asthma",
    2652
   ],
   [
    "Cough",
    1816
   ],
   [
    "Vomiting",
    1696
   ],
   [
    "Pneumonia",
    1685
   ],
   [
    "Malaise",
    1658
   ],
   [
    "Wheezing",
    1600
   ],
   [
    "Drug Ineffective",
    1576
   ],
   [
    "Headache",
    1305
   ],
   [
    "Fatigue",
    1268
   ],
   [
    "Pain",
    1262
   ],
   [
    "Nausea",
    1248
   ],
   [
    "Drug Hypersensitivity",
    1194
   ],
   [
    "Dizziness",
    1089
   ],
   [
    "Off Label Use",
    948
   ]
  ],
  "by_year": {
   "2019": 2957,
   "2020": 2532,
   "2021": 1818,
   "2022": 1658,
   "2023": 1596,
   "2024": 1794,
   "2025": 1661,
   "2026": 697
  },
  "by_year_primary": {
   "2019": 2954,
   "2020": 2529,
   "2021": 1814,
   "2022": 1647,
   "2023": 1587,
   "2024": 1780,
   "2025": 1648,
   "2026": 692
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 13,
  "nda": 11,
  "anda": 2,
  "first_approval": "19760512",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 61,
  "labeling_recent": 2,
  "sponsors": [
   "AMNEAL IRELAND LTD",
   "AUROLIFE PHARMA LLC",
   "GLAXOSMITHKLINE",
   "NORTON WATERFORD",
   "SCHERING",
   "TEVA BRANDED PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/12/1976"
 },
 "trials": {
  "total": 255,
  "completed": 188,
  "terminated": 26,
  "with_results": 58,
  "industry": 159,
  "phase3": 83,
  "results_share": 0.30851063829787234,
  "terminated_share": 0.10196078431372549
 },
 "pubmed": {
  "rct": 491,
  "meta": 19,
  "recent_rct": 11,
  "cochrane": [
   {
    "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": "15846637",
    "title": "Inhaled fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma in adults and children",
    "year": "2005"
   },
   {
    "pmid": "15674896",
    "title": "Inhaled beclomethasone versus placebo for chronic asthma",
    "year": "2005"
   },
   {
    "pmid": "15106173",
    "title": "Inhaled fluticasone versus inhaled beclomethasone or inhaled budesonide for chronic asthma",
    "year": "2004"
   },
   {
    "pmid": "11869673",
    "title": "Inhaled beclomethasone versus budesonide for chronic asthma",
    "year": "2002"
   },
   {
    "pmid": "11869636",
    "title": "Fluticasone versus beclomethasone or budesonide for chronic asthma",
    "year": "2002"
   },
   {
    "pmid": "11279769",
    "title": "Beclomethasone at different doses for chronic asthma (review)",
    "year": "2001"
   },
   {
    "pmid": "11034752",
    "title": "Inhaled beclomethasone versus placebo for chronic asthma",
    "year": "2000"
   },
   {
    "pmid": "10796632",
    "title": "Beclomethasone for asthma in children: effects on linear growth",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "beclomethasone",
   "Qnasl",
   "Beconase",
   "Qvar"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 234101,
  "beneficiaries": 86699,
  "spend": 77333886.99,
  "by_brand": [
   {
    "brand": "Qvar Redihaler",
    "claims": 222782,
    "per_claim": 325.48784413,
    "is_generic": false
   },
   {
    "brand": "Qnasl",
    "claims": 10598,
    "per_claim": 427.20021608,
    "is_generic": false
   },
   {
    "brand": "Qnasl Children",
    "claims": 372,
    "per_claim": 439.79153226,
    "is_generic": false
   },
   {
    "brand": "Beconase Aq",
    "claims": 349,
    "per_claim": 372.44630372,
    "is_generic": false
   }
  ],
  "per_claim": 330.34411211400203
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4120,
  "fills": 234101,
  "per_million": 17599.241353091187,
  "ratio": 6.355926585160827,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "17,599 FDA reports naming it as the suspect drug per million Medicare fills, 6.4x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.6x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 62,
   "letter": "D",
   "why": [
    "491 randomized trials and 19 systematic reviews/meta-analyses indexed in PubMed",
    "11 independent Cochrane review(s) exist",
    "Only 31% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)"
   ],
   "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 (2 applications)",
    "28 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, cough, vomiting. How would we recognize and handle those?",
  "Why this one over amcinonide, betamethasone, budesonide? 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.)"
 ]
}