{
 "query": "tiotropium",
 "ingredient": "tiotropium",
 "slug": "tiotropium",
 "rxcui": "69120",
 "brands": [
  "Spiriva"
 ],
 "names": [
  "tiotropium",
  "tiotropium bromide",
  "tiotropium bromide mono",
  "tiotropium bromide monohydrate",
  "tiotropium bromide, anhydrous"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "RESPIRATORY (INHALATION)",
  "route_counts": {
   "RESPIRATORY (INHALATION)": 5,
   "ORAL": 4
  },
  "boxed_warning": "",
  "indications_and_usage": "(tiotropium bromide inhalation powder) is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. SPIRIVA HANDIHALER is indicated to reduce exacerbations in COPD patients. SPIRIVA HANDIHALER is an anticholinergic indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), and for reducing COPD exacerbations ( 1 )",
  "contraindications": "is contraindicated in patients with a hypersensitivity to tiotropium, ipratropium, or any components of this product [see Warnings and Precautions (5.2) ] . In clinical trials and postmarketing experience with SPIRIVA HANDIHALER, immediate hypersensitivity reactions, including angioedema (including swelling of the lips, tongue, or throat), itching, or rash have been reported [see Warnings and Precautions (5.2) ]. Hypersensitivity to tiotropium, ipratropium, or any components of SPIRIVA capsules ( 4 )",
  "warnings_and_cautions": "Not for acute use: Not a rescue medication ( 5.1 ) Immediate hypersensitivity reactions: Discontinue SPIRIVA HANDIHALER at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, urticaria, rash, bronchospasm, or anaphylaxis, occur. Use with caution in patients with severe hypersensitivity to milk proteins. ( 5.2 ) Paradoxical bronchospasm: Discontinue SPIRIVA HANDIHALER and consider other treatments if paradoxical bronchospasm occurs ( 5.3 ) Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. ( 5.4 ) Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs. ( 5.5 ) 5.1 Not for Acute Use SPIRIVA HANDIHALER is intended as a once-daily maintenance treatment for COPD and should not be used for relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. 5.2 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions, including urtica...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described, or described in greater detail, in other sections: Immediate hypersensitivity reactions [see Warnings and Precautions (5.2) ] Paradoxical bronchospasm [see Warnings and Precautions (5.3) ] Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.4) ] Worsening of urinary retention [see Warnings and Precautions (5.5) ] The most common adverse reactions (>5% incidence in the 1-year placebo-controlled trials) were upper respiratory tract infection, dry mouth, sinusitis, pharyngitis, non-specific chest pain, urinary tract infection, dyspepsia, and rhinitis ( 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 Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice. 6-Month to 1-Year Trials The data described below reflect exposure to SPIRIVA HANDIHALER in 2,6...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Not for Acute Use: Instruct patients that SPIRIVA HANDIHALER is a once-daily maintenance bronchodilator and should not be used for immediate relief of breathing problems (i.e., as a rescue medication). Immediate Hypersensitivity Reactions: Inform patients that anaphylaxis, angioedema (including swelling of the lips, tongue, or throat), urticaria, rash, bronchospasm, or itching, may occur after administration of SPIRIVA HANDIHALER. Advise patient to immediately discontinue treatment and consult a physician should any of these signs or symptoms develop. Paradoxical Bronchospasm: Inform patients that SPIRIVA HANDIHALER can produce paradoxical bronchospasm. Advise patients that if paradoxical bronchospasm occurs, patients should discontinue SPIRIVA HANDIHALER. Worsening of Narrow-Angle Glaucoma: Instruct patients to be alert for signs and symptoms of narrow-angle glaucoma (e.g., eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema). Instruct patients to consult a physician immediately s...",
  "spl_medguide": "",
  "clinical_studies": "The SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) clinical development program consisted of six Phase 3 studies in 2,663 patients with COPD (1,308 receiving SPIRIVA HANDIHALER): two 1-year, placebo-controlled studies, two 6-month, placebo-controlled studies and two 1-year, ipratropium-controlled studies. These studies enrolled patients who had a clinical diagnosis of COPD, were 40 years of age or older, had a history of smoking greater than 10 pack-years, had a forced expiratory volume in one second (FEV 1 ) less than or equal to 60% or 65% of predicted, and a ratio of FEV 1 /FVC of less than or equal to 0.7. In these studies, SPIRIVA HANDIHALER, administered once-daily in the morning, provided improvement in lung function (FEV 1 ), with peak effect occurring within 3 hours following the first dose. Two additional trials evaluated exacerbations: a 6-month, randomized, double-blind, placebo-controlled, multicenter clinical trial of 1,829 COPD patients in a US Veterans Affairs setting and a 4-year, randomized, double-blind, placebo-controlled, multicenter, clinical trial of 5,992 COPD patients. Long-term effects on lung function and other outcomes, were also evaluated in ...",
  "brand_name": "Spiriva HandiHaler",
  "manufacturer": "Boehringer Ingelheim Pharmaceuticals, Inc.",
  "application_number": "NDA021395",
  "pharm_class_epc": [],
  "route": [
   "ORAL",
   "RESPIRATORY (INHALATION)"
  ],
  "effective_time": "20251110",
  "set_id": "820839ef-e53d-47e8-a3b9-d911ff92e6a9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 100517,
  "serious": 61498,
  "death": 7636,
  "hospitalization": 35155,
  "primary_suspect": 100341,
  "top_reactions": [
   [
    "Dyspnoea",
    19284
   ],
   [
    "Asthma",
    12471
   ],
   [
    "Incorrect Route Of Drug Administration",
    9099
   ],
   [
    "Cough",
    8265
   ],
   [
    "Pneumonia",
    7810
   ],
   [
    "Wheezing",
    7511
   ],
   [
    "Drug Ineffective",
    7016
   ],
   [
    "Chronic Obstructive Pulmonary Disease",
    5408
   ],
   [
    "Fatigue",
    5153
   ],
   [
    "Off Label Use",
    4719
   ],
   [
    "Therapeutic Product Effect Incomplete",
    4675
   ],
   [
    "Product Quality Issue",
    4443
   ],
   [
    "Malaise",
    4401
   ],
   [
    "Loss Of Personal Independence In Daily Activities",
    3890
   ],
   [
    "Productive Cough",
    3873
   ]
  ],
  "by_year": {
   "2019": 9031,
   "2020": 8893,
   "2021": 8396,
   "2022": 5913,
   "2023": 4865,
   "2024": 4858,
   "2025": 4178,
   "2026": 1982
  },
  "by_year_primary": {
   "2019": 9029,
   "2020": 8889,
   "2021": 8374,
   "2022": 5878,
   "2023": 4836,
   "2024": 4823,
   "2025": 4145,
   "2026": 1974
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "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": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20171214",
   "reason": "Failed Stability Specifications",
   "firm": "Boehringer Ingelheim Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20140327",
   "reason": "Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130830",
   "reason": "Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic foreign particles in the API used to manufacture SPIRIVA Handihaler",
   "firm": "Boehringer Ingelheim Roxane Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 5,
 "drugsfda": {
  "applications": 4,
  "nda": 3,
  "anda": 1,
  "first_approval": "20040130",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 17,
  "labeling_recent": 2,
  "sponsors": [
   "BOEHRINGER INGELHEIM",
   "LUPIN"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/30/2004"
 },
 "trials": {
  "total": 429,
  "completed": 372,
  "terminated": 26,
  "with_results": 217,
  "industry": 358,
  "phase3": 129,
  "results_share": 0.5833333333333334,
  "terminated_share": 0.06060606060606061
 },
 "pubmed": {
  "rct": 302,
  "meta": 57,
  "recent_rct": 15,
  "cochrane": [
   {
    "pmid": "27271056",
    "title": "Combination inhaled steroid and long-acting beta\u2082-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease",
    "year": "2016"
   },
   {
    "pmid": "26490945",
    "title": "Long-acting beta2-agonist in addition to tiotropium versus either tiotropium or long-acting beta2-agonist alone for chronic obstructive pulmonary disease",
    "year": "2015"
   },
   {
    "pmid": "26391969",
    "title": "Tiotropium versus ipratropium bromide for chronic obstructive pulmonary disease",
    "year": "2015"
   },
   {
    "pmid": "25046211",
    "title": "Tiotropium versus placebo for chronic obstructive pulmonary disease",
    "year": "2014"
   },
   {
    "pmid": "24043433",
    "title": "Tiotropium versus ipratropium bromide for chronic obstructive pulmonary disease",
    "year": "2013"
   },
   {
    "pmid": "23728670",
    "title": "Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease",
    "year": "2013"
   },
   {
    "pmid": "22972134",
    "title": "Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary disease",
    "year": "2012"
   },
   {
    "pmid": "22786525",
    "title": "Tiotropium versus placebo for chronic obstructive pulmonary disease",
    "year": "2012"
   },
   {
    "pmid": "22513969",
    "title": "Long-acting beta(2)-agonist in addition to tiotropium versus either tiotropium or long-acting beta(2)-agonist alone for chronic obstructive pulmonary disease",
    "year": "2012"
   },
   {
    "pmid": "21901729",
    "title": "The effect of adding inhaled corticosteroids to tiotropium and long-acting beta(2)-agonists for chronic obstructive pulmonary disease",
    "year": "2011"
   },
   {
    "pmid": "21412920",
    "title": "Combination inhaled steroid and long-acting beta(2)-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease",
    "year": "2011"
   },
   {
    "pmid": "20464758",
    "title": "Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary disease",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 2483.85,
  "records": 105,
  "by_name": [
   [
    "Spiriva",
    2483.85
   ]
  ],
  "names_checked": [
   "tiotropium",
   "Spiriva"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2067762,
  "beneficiaries": 551079,
  "spend": 1460510350.92,
  "by_brand": [
   {
    "brand": "Spiriva Respimat",
    "claims": 1276042,
    "per_claim": 687.44450895,
    "is_generic": false
   },
   {
    "brand": "Spiriva Handihaler",
    "claims": 619477,
    "per_claim": 784.95436441,
    "is_generic": false
   },
   {
    "brand": "Tiotropium Bromide",
    "claims": 172243,
    "per_claim": 563.39653879,
    "is_generic": true
   }
  ],
  "per_claim": 706.3242050680882
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "tiotropium bromide",
  "matched": "tiotropium bromide",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10942,
  "fills": 2067762,
  "per_million": 5291.7115219256375,
  "ratio": 1.911089760542518,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 94,
   "letter": "A",
   "why": [
    "5,292 FDA reports naming it as the suspect drug per million Medicare fills, 1.9x the median drug on this site (-6)",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 79,
   "letter": "B",
   "why": [
    "302 randomized trials and 57 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"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III (-9)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $2,484 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 (1 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, asthma, incorrect route of drug administration, cough. 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.)"
 ]
}