{
 "query": "budesonide",
 "ingredient": "budesonide",
 "slug": "budesonide",
 "rxcui": "19831",
 "brands": [
  "Tarpeyo",
  "Eohilia",
  "Pulmicort",
  "Uceris",
  "Ortikos",
  "Rhinocort"
 ],
 "names": [
  "budesonide",
  "budesonide (11.beta.,16.alpha.(s))"
 ],
 "classes": [
  {
   "id": "A07EA",
   "name": "Corticosteroids acting locally"
  },
  {
   "id": "D07AC",
   "name": "Corticosteroids, potent (group III)"
  },
  {
   "id": "R01AD",
   "name": "Corticosteroids"
  },
  {
   "id": "R03BA",
   "name": "Glucocorticoids"
  }
 ],
 "alternatives": [
  "amcinonide",
  "beclomethasone",
  "betamethasone",
  "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)": 38,
   "ORAL": 20,
   "NASAL": 6,
   "RECTAL": 3
  },
  "boxed_warning": "For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. Do not use with an ultrasonic nebulizer.",
  "indications_and_usage": "Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.",
  "contraindications": "The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to budesonide or any of the ingredients of budesonide inhalation suspension [see Warnings and Precautions (5.3) , Description (11) and Adverse Reactions (6.2) ]. Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ( 4 ) Hypersensitivity to any of the ingredients in budesonide inhalation suspension ( 4 )",
  "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 following inhalation. ( 5.1 ) Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) Hypersensitivity Reactions: Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or 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 ) Transferring Patients from Systemic Corticosteroid Therapy: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension ( 5.5 ) Hypercorticism and Adrenal Suppression: May occur with v...",
  "warnings": "",
  "adverse_reactions": "Systemic and inhaled corticosteroid use may result in the following: Candida albicans Infection [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence of \u22653%) are respiratory infection, rhinitis, coughing, otitis media, viral infection, moniliasis, gastroenteritis, vomiting, diarrhea, abdominal pain, ear infection, epistaxis, conjunctivitis, rash ( 6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varyin...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "17.1 Administration with a Jet Nebulizer Patients should be advised that budesonide inhalation suspension should be administered with a jet nebulizer connected to a compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are not recommended. The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see Dosage and Administration (2) ]. 17.2 Oral Candidiasis Patients should be advised that localized infections with Candida albicans 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 therapy with budesonide inhalation suspension, but at times therapy with budesonide inhalation suspension may need to be temporarily interrupted under close medical supervision. Rinsing the mouth after inhalation is advised [see Warnings and Precautions (5.1...",
  "spl_medguide": "",
  "clinical_studies": "Three double-blind, placebo-controlled, parallel group, randomized U.S. clinical trials of 12-weeks duration each were conducted in 1018 pediatric patients, 6 months to 8 years of age, 657 males and 361 females (798 Caucasians, 140 Blacks, 56 Hispanics, 3 Asians, 21 Others) with persistent asthma of varying disease duration (2 to 107 months) and severity. Doses of 0.25 mg, 0.5 mg, and 1 mg administered either once or twice daily were compared to placebo to provide information about appropriate dosing to cover a range of asthma severity. A Pari-LC-Jet Plus Nebulizer (with a face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to patients in the 3 U.S. controlled clinical trials. The co-primary endpoints were nighttime and daytime asthma symptom scores (0 to 3 scale). Improvements were addressed in terms of the primary efficacy variables of changes from baseline to the double-blind treatment period in nighttime and daytime asthma symptom scores (scale 0 to 3) as recorded in the patient diaries. Baseline was defined as the mean of the last seven days prior to randomization). The double-blind treatment period was defined as...",
  "brand_name": "Budesonide Inhalation",
  "manufacturer": "American Health Packaging",
  "application_number": "ANDA210897",
  "pharm_class_epc": [
   "Corticosteroid [EPC]"
  ],
  "route": [
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20250612",
  "set_id": "45e5f304-1177-42a2-91c9-3ed1a9c9f8e6",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 68157,
  "serious": 48008,
  "death": 3967,
  "hospitalization": 22409,
  "primary_suspect": 68015,
  "top_reactions": [
   [
    "Off Label Use",
    8426
   ],
   [
    "Dyspnoea",
    8323
   ],
   [
    "Drug Ineffective",
    7747
   ],
   [
    "Asthma",
    6821
   ],
   [
    "Fatigue",
    4963
   ],
   [
    "Cough",
    4841
   ],
   [
    "Headache",
    4252
   ],
   [
    "Diarrhoea",
    3936
   ],
   [
    "Condition Aggravated",
    3863
   ],
   [
    "Pneumonia",
    3805
   ],
   [
    "Nausea",
    3747
   ],
   [
    "Wheezing",
    3663
   ],
   [
    "Malaise",
    3175
   ],
   [
    "Weight Decreased",
    3036
   ],
   [
    "Pain",
    2940
   ]
  ],
  "by_year": {
   "2019": 5627,
   "2020": 6419,
   "2021": 6315,
   "2022": 6666,
   "2023": 7218,
   "2024": 7310,
   "2025": 6551,
   "2026": 3588
  },
  "by_year_primary": {
   "2019": 5624,
   "2020": 6410,
   "2021": 6305,
   "2022": 6638,
   "2023": 7189,
   "2024": 7280,
   "2025": 6532,
   "2026": 3576
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260529",
   "reason": "Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250630",
   "reason": "Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.",
   "firm": "Cipla USA, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220915",
   "reason": "Lack of Assurance of Sterility",
   "firm": "CIPLA",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130111",
   "reason": "Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.",
   "firm": "AstraZeneca LP",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130111",
   "reason": "Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.",
   "firm": "AstraZeneca LP",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 32,
  "nda": 11,
  "anda": 21,
  "first_approval": "19940214",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 48,
  "labeling_recent": 8,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "AMNEAL PHARMS",
   "APOTEX",
   "ASTRAZENECA",
   "AUROBINDO PHARMA USA",
   "BARR LABS DIV TEVA",
   "CALLIDITAS",
   "CHEPLAPHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/14/1994"
 },
 "trials": {
  "total": 709,
  "completed": 467,
  "terminated": 67,
  "with_results": 179,
  "industry": 410,
  "phase3": 213,
  "results_share": 0.38329764453961457,
  "terminated_share": 0.09449929478138223
 },
 "pubmed": {
  "rct": 1021,
  "meta": 98,
  "recent_rct": 95,
  "cochrane": [
   {
    "pmid": "26497719",
    "title": "Oral budesonide for induction of remission in ulcerative colitis",
    "year": "2015"
   },
   {
    "pmid": "26039678",
    "title": "Budesonide for induction of remission in Crohn's disease",
    "year": "2015"
   },
   {
    "pmid": "25141071",
    "title": "Budesonide for maintenance of remission in Crohn's disease",
    "year": "2014"
   },
   {
    "pmid": "24343671",
    "title": "Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children",
    "year": "2013"
   },
   {
    "pmid": "23633340",
    "title": "Combination formoterol and budesonide as maintenance and reliever therapy versus current best practice (including inhaled steroid maintenance), for chronic asthma in adults and children",
    "year": "2013"
   },
   {
    "pmid": "22161385",
    "title": "Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children",
    "year": "2011"
   },
   {
    "pmid": "20927762",
    "title": "Oral budesonide for induction of remission in ulcerative colitis",
    "year": "2010"
   },
   {
    "pmid": "19370682",
    "title": "Combination formoterol and budesonide as maintenance and reliever therapy versus inhaled steroid maintenance for chronic asthma in adults and children",
    "year": "2009"
   },
   {
    "pmid": "19160212",
    "title": "Budesonide for maintenance of remission in Crohn's disease",
    "year": "2009"
   },
   {
    "pmid": "18646100",
    "title": "Combination fluticasone and salmeterol versus fixed dose combination budesonide and formoterol for chronic asthma in adults and children",
    "year": "2008"
   },
   {
    "pmid": "18646064",
    "title": "Budesonide for induction of remission in Crohn's disease",
    "year": "2008"
   },
   {
    "pmid": "17943772",
    "title": "Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and children",
    "year": "2007"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 3797090.26,
  "records": 23720,
  "by_name": [
   [
    "Tarpeyo",
    1986661.46
   ],
   [
    "Eohilia",
    1810428.8
   ]
  ],
  "names_checked": [
   "budesonide",
   "Tarpeyo",
   "Eohilia",
   "Pulmicort",
   "Uceris",
   "Ortikos",
   "Rhinocort"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 640774,
  "beneficiaries": 214569,
  "spend": 197399963.7,
  "by_brand": [
   {
    "brand": "Budesonide Dr",
    "claims": 207194,
    "per_claim": 128.02229582,
    "is_generic": false
   },
   {
    "brand": "Budesonide",
    "claims": 173739,
    "per_claim": 181.22090676,
    "is_generic": true
   },
   {
    "brand": "Pulmicort Flexhaler",
    "claims": 121500,
    "per_claim": 319.77786626,
    "is_generic": false
   },
   {
    "brand": "Budesonide EC",
    "claims": 106512,
    "per_claim": 213.2024893,
    "is_generic": false
   },
   {
    "brand": "Budesonide ER",
    "claims": 27485,
    "per_claim": 1336.1998661,
    "is_generic": false
   },
   {
    "brand": "Tarpeyo",
    "claims": 2385,
    "per_claim": 16039.32735,
    "is_generic": false
   },
   {
    "brand": "Eohilia",
    "claims": 776,
    "per_claim": 2001.8588015,
    "is_generic": false
   },
   {
    "brand": "Pulmicort",
    "claims": 638,
    "per_claim": 440.01910658,
    "is_generic": false
   },
   {
    "brand": "Uceris",
    "claims": 545,
    "per_claim": 1861.1285505,
    "is_generic": false
   }
  ],
  "per_claim": 308.06487732024084
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "budesonide",
  "matched": "budesonide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 17388,
  "fills": 640774,
  "per_million": 27135.932481655,
  "ratio": 9.800081220147954,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 80,
   "letter": "B",
   "why": [
    "27,136 FDA reports naming it as the suspect drug per million Medicare fills, 9.8x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 84,
   "letter": "B",
   "why": [
    "1021 randomized trials and 98 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",
    "Only 38% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 88,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III across 21 generic makers (-4)",
    "8 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $3,797,090 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 (21 applications)",
    "28 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma. 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.)"
 ]
}