{
 "query": "ipratropium",
 "ingredient": "ipratropium",
 "slug": "ipratropium",
 "rxcui": "7213",
 "brands": [
  "Atrovent"
 ],
 "names": [
  "ipratropium",
  "ipratropium bromide",
  "ipratropium bromide anhydrous",
  "ipratropium bromide monohydrate",
  "ipratropium cation"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 33,
   "NASAL": 18
  },
  "boxed_warning": "",
  "indications_and_usage": "Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is an anticholinergic indicated for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema ( 1 )",
  "contraindications": "is contraindicated in the following conditions [ see Warnings and Precautions (5.2) ]. Hypersensitivity to ipratropium bromide or other ATROVENT HFA components Hypersensitivity to atropine or any of its derivatives Hypersensitivity to ipratropium bromide or other ATROVENT HFA components ( 4 ) Hypersensitivity to atropine or any of its derivatives ( 4 )",
  "warnings_and_cautions": "Not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response ( 5.1 ) Hypersensitivity reactions including anaphylaxis: Discontinue ATROVENT HFA at once and consider alternative treatments ( 5.2 ) Paradoxical bronchospasm: Discontinue ATROVENT HFA and consider other treatments if paradoxical bronchospasm occurs ( 5.3 ) Ocular effects: Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if signs or symptoms of narrow-angle glaucoma develop ( 5.4 ) Urinary retention: Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if signs or symptoms of urinary retention develop ( 5.5 ) 5.1 Use for Maintenance Treatment Only ATROVENT HFA is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response. 5.2 Hypersensitivity Reactions, Including Anaphylaxis Hypersensitivity reactions including urticaria, angioedema, rash, bronchospasm,...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described, or described in greater detail, in other sections: Hypersensitivity Reactions, Including Anaphylaxis [ see Contraindications (4) and Warnings and Precautions (5.2) ] Paradoxical Bronchospasm [ see Warnings and Precautions (5.3) ] Ocular Effects [ see Warnings and Precautions (5.4) ] Urinary Retention [ see Warnings and Precautions (5.5) ] 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 patients. Most common adverse reactions (>5% incidence in the 12-week placebo-controlled trials) were bronchitis, COPD exacerbation, dyspnea, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience The adverse reaction information concerning ATROVENT HFA is derived from two 12-week, double-blind, parallel-group studies and one 1-year open-label, parallel group study. These studies compared ATROVENT H...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Appropriate and safe use of ATROVENT HFA includes providing the patient with the information listed below and an understanding of the way it should be administered. Advise patients that ATROVENT HFA is a bronchodilator for the maintenance treatment of bronchospasm associated with COPD and is not indicated for the initial treatment of acute episodes of bronchospasm where rescue therapy is required for rapid response. Hypersensitivity Reactions Inform patients that hypersensitivity reactions, including urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema, may occur after the administration of ATROVENT HFA. Advise patients to immediately discontinue ATROVENT HFA and consult a physician [ see Warnings and Precautions (5.2) ] . Paradoxical Bronchospasm Inform patients that ATROVENT HFA can produce paradoxical bronchospasm that can be life-threatening. If paradoxical bronchospasm occurs, patients should discontinue using ATROVENT HFA. Ocular Effects Caution patients to avoid spraying the aerosol into their eyes and be advised that this may result in precipitation or worsening o...",
  "spl_medguide": "",
  "clinical_studies": "Conclusions regarding the efficacy of ATROVENT HFA were derived from two randomized, double-blind, controlled clinical studies. These studies enrolled males and females ages 40 years and older, with a history of COPD, a smoking history of >10 pack-years, an FEV 1 <65% and an FEV 1 /FVC <70%. One of the studies was a 12-week randomized, double-blind active, and placebo-controlled study in which 505 of the 507 randomized COPD patients were evaluated for the safety and efficacy of 42 mcg (n=124) and 84 mcg (n=126) ATROVENT HFA in comparison to 42 mcg (n=127) ATROVENT CFC and their respective placebos (HFA n=62, CFC n=66). Data for both placebo HFA and placebo CFC were combined in the evaluation. Serial FEV 1 (shown in Figure 1, below, as means adjusted for center and baseline effects on test day 1 and test day 85 (primary endpoint)) demonstrated that 1 dose (2 inhalations/21 mcg each) of ATROVENT HFA produced significantly greater improvement in pulmonary function than placebo. During the six hours immediately post-dose on day 1, the average hourly improvement in adjusted mean FEV 1 was 0.148 liters for ATROVENT HFA (42 mcg) and 0.013 liters for placebo. The mean peak improvement in F...",
  "brand_name": "Atrovent HFA",
  "manufacturer": "Boehringer Ingelheim Pharmaceuticals, Inc.",
  "application_number": "NDA021527",
  "pharm_class_epc": [],
  "route": [
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20251105",
  "set_id": "170e98ef-5560-4068-be7d-e649068eb884",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 33940,
  "serious": 25386,
  "death": 4098,
  "hospitalization": 14709,
  "primary_suspect": 33869,
  "top_reactions": [
   [
    "Dyspnoea",
    5659
   ],
   [
    "Asthma",
    4075
   ],
   [
    "Cough",
    3088
   ],
   [
    "Pneumonia",
    3021
   ],
   [
    "Wheezing",
    2660
   ],
   [
    "Drug Ineffective",
    2483
   ],
   [
    "Fatigue",
    2271
   ],
   [
    "Off Label Use",
    2118
   ],
   [
    "Nausea",
    1804
   ],
   [
    "Malaise",
    1661
   ],
   [
    "Diarrhoea",
    1651
   ],
   [
    "Headache",
    1570
   ],
   [
    "Chronic Obstructive Pulmonary Disease",
    1566
   ],
   [
    "Vomiting",
    1481
   ],
   [
    "Death",
    1463
   ]
  ],
  "by_year": {
   "2019": 3608,
   "2020": 3958,
   "2021": 3515,
   "2022": 2685,
   "2023": 1871,
   "2024": 2252,
   "2025": 2960,
   "2026": 1624
  },
  "by_year_primary": {
   "2019": 3603,
   "2020": 3956,
   "2021": 3509,
   "2022": 2663,
   "2023": 1860,
   "2024": 2245,
   "2025": 2947,
   "2026": 1620
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 33,
  "nda": 5,
  "anda": 28,
  "first_approval": "19861229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 22,
  "labeling_recent": 1,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "AMNEAL",
   "APOTEX INC",
   "ARMSTRONG PHARMS",
   "AUROBINDO PHARMA USA",
   "BAUSCH",
   "BOEHRINGER INGELHEIM",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1986"
 },
 "trials": {
  "total": 173,
  "completed": 123,
  "terminated": 19,
  "with_results": 35,
  "industry": 91,
  "phase3": 37,
  "results_share": 0.2845528455284553,
  "terminated_share": 0.10982658959537572
 },
 "pubmed": {
  "rct": 324,
  "meta": 16,
  "recent_rct": 4,
  "cochrane": [
   {
    "pmid": "26391969",
    "title": "Tiotropium versus ipratropium bromide for chronic obstructive pulmonary disease",
    "year": "2015"
   },
   {
    "pmid": "24043433",
    "title": "Tiotropium versus ipratropium bromide for chronic obstructive pulmonary disease",
    "year": "2013"
   },
   {
    "pmid": "23784858",
    "title": "Intranasal ipratropium bromide for the common cold",
    "year": "2013"
   },
   {
    "pmid": "21735425",
    "title": "Intranasal ipratropium bromide for the common cold",
    "year": "2011"
   },
   {
    "pmid": "16856113",
    "title": "Ipratropium bromide versus long-acting beta-2 agonists for stable chronic obstructive pulmonary disease",
    "year": "2006"
   },
   {
    "pmid": "16625543",
    "title": "Ipratropium bromide versus short acting beta-2 agonists for stable chronic obstructive pulmonary disease",
    "year": "2006"
   },
   {
    "pmid": "11406052",
    "title": "Inhaled short-acting beta2-agonists versus ipratropium for acute exacerbations of chronic obstructive pulmonary disease",
    "year": "2001"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ipratropium",
   "Atrovent"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2293792,
  "beneficiaries": 927811,
  "spend": 179693371.37,
  "by_brand": [
   {
    "brand": "Ipratropium Bromide",
    "claims": 2093538,
    "per_claim": 30.755316593,
    "is_generic": true
   },
   {
    "brand": "Atrovent HFA",
    "claims": 200254,
    "per_claim": 575.79847284,
    "is_generic": false
   }
  ],
  "per_claim": 78.3389999485568
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "ipratropium bromide",
  "matched": "ipratropium",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6812,
  "fills": 2293792,
  "per_million": 2969.754886232056,
  "ratio": 1.0725203236955567,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "2,970 FDA reports naming it as the suspect drug per million Medicare fills, 1.1x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 57,
   "letter": "D",
   "why": [
    "324 randomized trials and 16 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "7 independent Cochrane review(s) exist",
    "Only 28% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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 (28 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, cough, pneumonia. 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.)"
 ]
}