{
 "query": "albuterol",
 "ingredient": "albuterol",
 "slug": "albuterol",
 "rxcui": "435",
 "brands": [
  "ProAir",
  "Proventil",
  "Ventolin"
 ],
 "names": [
  "albuterol",
  "albuterol sulfate"
 ],
 "classes": [
  {
   "id": "R03AC",
   "name": "Selective beta-2-adrenoreceptor agonists"
  },
  {
   "id": "R03CC",
   "name": "Selective beta-2-adrenoreceptor agonists"
  }
 ],
 "alternatives": [
  "bambuterol",
  "bitolterol",
  "clenbuterol",
  "fenoterol",
  "formoterol",
  "hexoprenaline",
  "indacaterol",
  "isoetharine",
  "olodaterol",
  "pirbuterol",
  "procaterol",
  "reproterol",
  "rimiterol",
  "salmeterol",
  "terbutaline",
  "tulobuterol"
 ],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 101,
   "ORAL": 18
  },
  "boxed_warning": "FEV 1 as Mean Percent Change from Test-Day Pre-Dose in a 6-Week Clinical Trial Day 1 Day 1 Image Day 43 Day 43 Image",
  "indications_and_usage": "Albuterol Sulfate HFA Inhalation Aerosol is a beta 2 -adrenergic agonist indicated for: \u2022 Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. ( 1.1 ) \u2022 Prevention of exercise-induced bronchospasm in patients 4 years of age and older. ( 1.2 ) 1.1 Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.",
  "contraindications": "Albuterol Sulfate HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol components. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate [see Warnings and Precautions (5.6) ] . Hypersensitivity to albuterol and any other Albuterol Sulfate HFA Inhalation Aerosol Components. ( 4 )",
  "warnings_and_cautions": "\u2022 Life-threatening paradoxical bronchospasm may occur. Discontinue Albuterol Sulfate HFA immediately and treat with alternative therapy. ( 5.1 ) \u2022 Need for more doses of Albuterol Sulfate HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) \u2022 Albuterol Sulfate HFA is not a substitute for corticosteroids. ( 5.3 ) \u2022 Cardiovascular effects may occur. Use with caution in patients sensitive to sympathomimetic drugs and patients with cardiovascular or convulsive disorders. ( 5.4 , 5.7 ) \u2022 Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) \u2022 Immediate hypersensitivity reactions may occur. Discontinue Albuterol Sulfate HFA immediately. ( 5.6 ) \u2022 Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Albuterol Sulfate HFA Inhalation Aerosol can produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, Albuterol Sulfate HFA Inhalation Aerosol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use ...",
  "warnings": "",
  "adverse_reactions": "Use of Albuterol Sulfate HFA may be associated with the following: \u2022 Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] \u2022 Cardiovascular Effects [see Warnings and Precautions (5.4) ] \u2022 Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] \u2022 Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions (\u22653.0% and >placebo) are headache, tachycardia, pain, dizziness, pharyngitis, and rhinitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Respiratory, LLC at 1-888-482-9522 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience A total of 1090 subjects were treated with Albuterol Sulfate HFA Inhalation Aerosol, or with the same formulation of albuterol as in Albuterol Sulfate HFA Inhalation Aerosol, during the worldwide clinical development program. 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. Adult and Adolescents 12 Years of Age and Older: The adverse reaction information presen...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-Approved Patient Labeling (17.9) Patients should be given the following information: 17.1 Frequency of Use The action of Albuterol Sulfate HFA Inhalation Aerosol should last for 4 to 6 hours. Do not use Albuterol Sulfate HFA Inhalation Aerosol more frequently than recommended. Instruct patients to not increase the dose or frequency of doses of Albuterol Sulfate HFA Inhalation Aerosol without consulting the physician. If patients find that treatment with Albuterol Sulfate HFA Inhalation Aerosol becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately. 17.2 Priming and Cleaning Priming : Priming is essential to ensure appropriate albuterol content in each actuation. Instruct patients to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing three sprays into the air, away from the face. Cleaning: To ensure proper dosing and prevent actuator orifice blockage, instruct patients to wash the red plastic actuator mouthpiece and dry thoroughly at least once a week. Instruct patients...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Bronchospasm Associated with Asthma Adult and Adolescent Patients 12 Years of Age and Older: In a 6-week, randomized, double-blind, placebo-controlled trial, Albuterol Sulfate HFA Inhalation Aerosol (58 patients) was compared to a matched placebo HFA inhalation aerosol (58 patients) in asthmatic patients 12 to 76 years of age at a dose of 180 mcg albuterol four times daily. An evaluator-blind marketed active comparator HFA-134a albuterol inhaler arm (56 patients) was included. Serial FEV 1 measurements, shown below as percent change from test-day baseline at Day 1 and at Day 43, demonstrated that two inhalations of Albuterol Sulfate HFA Inhalation Aerosol produced significantly greater improvement in FEV 1 over the pre-treatment value than the matched placebo, as well as a comparable bronchodilator effect to the marketed active comparator HFA-134a albuterol inhaler. FEV 1 as Mean Percent Change from Test-Day Pre-Dose in a 6-Week Clinical Trial Day 1 Day 1 Image Day 43 Day 43 Image In this study, 31 of 58 patients treated with Albuterol Sulfate HFA Inhalation Aerosol achieved a 15% increase in FEV 1 within 30 minutes post-dose on Day 1. In these patients, the median time to ons...",
  "brand_name": "Albuterol Sulfate HFA",
  "manufacturer": "Proficient Rx LP",
  "application_number": "NDA021457",
  "pharm_class_epc": [],
  "route": [
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20231001",
  "set_id": "d617e361-5c03-45ac-9bbe-0fa418edb19f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 342562,
  "serious": 200236,
  "death": 20615,
  "hospitalization": 99839,
  "primary_suspect": 342095,
  "top_reactions": [
   [
    "Dyspnoea",
    48958
   ],
   [
    "Asthma",
    31886
   ],
   [
    "Drug Ineffective",
    24626
   ],
   [
    "Cough",
    23308
   ],
   [
    "Wrong Technique In Product Usage Process",
    20168
   ],
   [
    "Fatigue",
    19717
   ],
   [
    "Pneumonia",
    18884
   ],
   [
    "Wheezing",
    17558
   ],
   [
    "Headache",
    17484
   ],
   [
    "Off Label Use",
    16009
   ],
   [
    "Nausea",
    15999
   ],
   [
    "Pain",
    13968
   ],
   [
    "Diarrhoea",
    13894
   ],
   [
    "Malaise",
    13380
   ],
   [
    "Dizziness",
    11829
   ]
  ],
  "by_year": {
   "2019": 33095,
   "2020": 35082,
   "2021": 31456,
   "2022": 25028,
   "2023": 26777,
   "2024": 29608,
   "2025": 30008,
   "2026": 14220
  },
  "by_year_primary": {
   "2019": 33084,
   "2020": 35071,
   "2021": 31389,
   "2022": 24945,
   "2023": 26694,
   "2024": 29535,
   "2025": 29925,
   "2026": 14181
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20250724",
   "reason": "Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.",
   "firm": "Cipla USA, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class I",
   "date": "20230627",
   "reason": "Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).",
   "firm": "Cipla USA, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "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": "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": "20200916",
   "reason": "Defective Delivery System: Sustained trend of failure to dispense complaints.",
   "firm": "Perrigo Company PLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170516",
   "reason": "Defective Delivery System: Elevated number of units with out of specification results for leak rate",
   "firm": "GlaxoSmithKline, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20170322",
   "reason": "Defective Delivery System: Elevated number of units with out of specification results for leak rate.",
   "firm": "GlaxoSmithKline, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20151203",
   "reason": "Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.",
   "firm": "GlaxoSmithKline, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20120726",
   "reason": "Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.",
   "firm": "GlaxoSmithKline Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 99,
  "nda": 17,
  "anda": 71,
  "first_approval": "19810501",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 77,
  "labeling_recent": 4,
  "sponsors": [
   "ACERTIS PHARMS",
   "ACTAVIS MID ATLANTIC",
   "ADAPTIS",
   "AIZANT",
   "AM THERAP",
   "AMNEAL IRELAND LTD",
   "AMNEAL PHARMS",
   "AMNEAL PHARMS CO"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/01/1981"
 },
 "trials": {
  "total": 951,
  "completed": 695,
  "terminated": 107,
  "with_results": 349,
  "industry": 554,
  "phase3": 244,
  "results_share": 0.5021582733812949,
  "terminated_share": 0.11251314405888538
 },
 "pubmed": {
  "rct": 336,
  "meta": 4,
  "recent_rct": 12,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "albuterol",
   "ProAir",
   "Proventil",
   "Ventolin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 21226306,
  "beneficiaries": 7709981,
  "spend": 720370133.3800001,
  "by_brand": [
   {
    "brand": "Albuterol Sulfate HFA",
    "claims": 18591605,
    "per_claim": 29.724982126,
    "is_generic": false
   },
   {
    "brand": "Ventolin HFA",
    "claims": 2272575,
    "per_claim": 67.261299368,
    "is_generic": false
   },
   {
    "brand": "Albuterol Sulfate",
    "claims": 301760,
    "per_claim": 32.733245891,
    "is_generic": true
   },
   {
    "brand": "Proair Respiclick",
    "claims": 55802,
    "per_claim": 81.47261263,
    "is_generic": false
   },
   {
    "brand": "Proair Digihaler",
    "claims": 3914,
    "per_claim": 103.60713848,
    "is_generic": false
   },
   {
    "brand": "Proair HFA",
    "claims": 549,
    "per_claim": 76.665482696,
    "is_generic": false
   },
   {
    "brand": "Proventil HFA",
    "claims": 101,
    "per_claim": 70.623267327,
    "is_generic": false
   }
  ],
  "per_claim": 33.93761181903248
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 73641,
  "fills": 21226306,
  "per_million": 3469.327164133034,
  "ratio": 1.2529397326130025,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 88,
   "letter": "A",
   "why": [
    "3,469 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "336 randomized trials and 4 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 68,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 7 Class II, 1 Class III across 71 generic makers (-28)",
    "4 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 (71 applications)",
    "16 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 81,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, cough. How would we recognize and handle those?",
  "Why this one over bambuterol, bitolterol, clenbuterol? 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.)"
 ]
}