{
 "query": "levalbuterol",
 "ingredient": "levalbuterol",
 "slug": "levalbuterol",
 "rxcui": "237159",
 "brands": [
  "Xopenex"
 ],
 "names": [
  "levalbuterol",
  "levalbuterol hydrochloride",
  "levalbuterol tartrate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 17,
   "ORAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol Inhalation Solution, USP is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. ( 1 )",
  "contraindications": "Levalbuterol Inhalation Solution, USP is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see Warnings and Precautions (5.6) ]. Hypersensitivity to levalbuterol or racemic albuterol. ( 4 )",
  "warnings_and_cautions": "Life-threatening paradoxical bronchospasm may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately and treat with alternative therapy. ( 5.1 ) Need for more doses of Levalbuterol Inhalation Solution, USP than usual may be a sign of deterioration of asthma and requires reevaluation of treatment. ( 5.2 ) Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. ( 5.3 ) Cardiovascular effects may occur. Consider discontinuation of Levalbuterol Inhalation Solution, USP if these effects occur. Use with caution in patients with underlying cardiovascular disorders. ( 5.4 ) Excessive use may be fatal. Do not exceed recommended dose. ( 5.5 ) Immediate hypersensitivity reactions may occur. Discontinue Levalbuterol Inhalation Solution, USP immediately. ( 5.6 ) Hypokalemia and changes in blood glucose may occur. ( 5.7 , 5.8 ) 5.1 Paradoxical Bronchospasm Levalbuterol Inhalation Solution, USP can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol Inhalation Solution, USP should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, w...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described below and elsewhere in the labeling: Paradoxical bronchospasm [see Warnings and Precautions (5.1) ] Cardiovascular effects [see Warnings and Precautions (5.4) ] Immediate hypersensitivity reactions [see Warnings and Precautions (5.6) ] Hypokalemia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Ritedose Pharmaceuticals, LLC at 1-855-806-3300 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 the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults and Adolescents 12 Years of Age and Older Adverse reaction information concerning Levalbuterol Inhalation Solution, USP in adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 y...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Recent Major Changes to the Dosage and Administration Section Levalbuterol Inhalation Solution, USP is for oral inhalation only. Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose. (Added the word \"with\" to read \"Administer by nebulization using with a standard jet nebulizer...\") 2. Dosage and Administration Updated February 2020",
  "information_for_patients": "See FDA-approved patient labeling (Patient Information Leaflet and Instructions for Using Levalbuterol Inhalation Solution, USP ). Patients should be given the following information: Hypersensitivity Query patients about previously experienced hypersensitivity to levalbuterol or racemic albuterol and counsel patients to report any hypersensitivity reactions to their physician. Frequency of Use Inform patients not to increase the dose or use Levalbuterol Inhalation Solution, USP more frequently than recommended without consulting their physician. If patients find that treatment with Levalbuterol Inhalation Solution, USP becomes less effective for symptomatic relief, symptoms become worse, or they need to use the product more frequently than usual, they should seek medical attention immediately. Paradoxical Bronchospasm Inform patients that Levalbuterol Inhalation Solution, USP can produce paradoxical bronchospasm. Instruct patients to discontinue Levalbuterol Inhalation Solution, USP if paradoxical bronchospasm occurs. Concomitant Drug Use Inform patients using Levalbuterol Inhalation Solution, USP, that other inhaled drugs and asthma medications should be taken only as directed by ...",
  "spl_medguide": "",
  "clinical_studies": "Adults and Adolescents \u2265 12 Years Old The safety and efficacy of Levalbuterol Inhalation Solution, USP were evaluated in a 4-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 362 adult and adolescent patients 12 years of age and older, with mild-to-moderate asthma (mean baseline FEV 1 60% of predicted). Approximately half of the patients were also receiving inhaled corticosteroids. Patients were randomized to receive Levalbuterol Inhalation Solution, USP 0.63 mg, Levalbuterol Inhalation Solution, USP 1.25 mg, racemic albuterol sulfate 1.25 mg, racemic albuterol sulfate 2.5 mg, or placebo three times a day administered via a PARI LC Plus\u2122 nebulizer and a Dura-Neb \u00ae portable compressor. Racemic albuterol delivered by a chlorofluorocarbon (CFC) metered-dose inhaler (MDI) was used on an as-needed basis as the rescue medication. Efficacy, as measured by the mean percent change from baseline FEV 1 , was demonstrated for all active treatment regimens compared with placebo on day 1 and day 29. On both day 1 (see Figure 1 ) and day 29 (see Figure 2 ), 1.25 mg of Levalbuterol Inhalation Solution, USP demonstrated the largest mean percent change from bas...",
  "brand_name": "Levalbuterol",
  "manufacturer": "Redpharm Drug",
  "application_number": "ANDA203653",
  "pharm_class_epc": [],
  "route": [
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20260717",
  "set_id": "56cb1f4b-ddf4-0661-e063-6394a90a9c45",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 12375,
  "serious": 6506,
  "death": 742,
  "hospitalization": 3546,
  "primary_suspect": 12366,
  "top_reactions": [
   [
    "Dyspnoea",
    1365
   ],
   [
    "Pneumonia",
    783
   ],
   [
    "Headache",
    755
   ],
   [
    "Fatigue",
    740
   ],
   [
    "Asthma",
    715
   ],
   [
    "Cough",
    714
   ],
   [
    "Off Label Use",
    676
   ],
   [
    "Nausea",
    666
   ],
   [
    "Drug Ineffective",
    658
   ],
   [
    "Device Delivery System Issue",
    620
   ],
   [
    "No Adverse Event",
    550
   ],
   [
    "Drug Dose Omission By Device",
    532
   ],
   [
    "Diarrhoea",
    519
   ],
   [
    "Sinusitis",
    483
   ],
   [
    "Pain",
    480
   ]
  ],
  "by_year": {
   "2019": 1215,
   "2020": 1200,
   "2021": 665,
   "2022": 725,
   "2023": 821,
   "2024": 1053,
   "2025": 1110,
   "2026": 605
  },
  "by_year_primary": {
   "2019": 1215,
   "2020": 1199,
   "2021": 665,
   "2022": 725,
   "2023": 816,
   "2024": 1051,
   "2025": 1110,
   "2026": 604
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 14,
  "nda": 2,
  "anda": 12,
  "first_approval": "19990325",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 12,
  "labeling_recent": 0,
  "sponsors": [
   "CIPLA",
   "HIKMA",
   "IMPAX LABS INC",
   "LUOXIN AUROVITAS",
   "LUPIN",
   "MANKIND PHARMA",
   "MYLAN SPECIALITY LP",
   "NEPHRON"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/25/1999"
 },
 "trials": {
  "total": 951,
  "completed": 695,
  "terminated": 107,
  "with_results": 349,
  "industry": 554,
  "phase3": 244,
  "results_share": 0.5021582733812949,
  "terminated_share": 0.11251314405888538
 },
 "pubmed": {
  "rct": 29,
  "meta": 1,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "levalbuterol",
   "Xopenex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 288881,
  "beneficiaries": 114606,
  "spend": 19639931.18,
  "by_brand": [
   {
    "brand": "Levalbuterol Tartrate HFA",
    "claims": 251600,
    "per_claim": 64.971845628,
    "is_generic": false
   },
   {
    "brand": "Levalbuterol HCl",
    "claims": 21694,
    "per_claim": 80.540707569,
    "is_generic": true
   },
   {
    "brand": "Xopenex HFA",
    "claims": 15310,
    "per_claim": 97.762106466,
    "is_generic": false
   },
   {
    "brand": "Levalbuterol Concentrate",
    "claims": 277,
    "per_claim": 176.99227437,
    "is_generic": false
   }
  ],
  "per_claim": 67.98623370868974
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2765,
  "fills": 288881,
  "per_million": 9571.415219415607,
  "ratio": 3.456695162602069,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 89,
   "letter": "A",
   "why": [
    "9,571 FDA reports naming it as the suspect drug per million Medicare fills, 3.5x the median drug on this site (-11)",
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 36,
   "letter": "F",
   "why": [
    "29 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 12 generic makers (-3)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (12 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, pneumonia, headache, fatigue. How would we recognize and handle those?",
  "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.)"
 ]
}