{
 "query": "nitroglycerin",
 "ingredient": "nitroglycerin",
 "slug": "nitroglycerin",
 "rxcui": "4917",
 "brands": [
  "Nitro-Bid",
  "Nitrostat",
  "Rectiv",
  "Nitro-Dur",
  "Nitrolingual",
  "Gonitro",
  "NitroMist"
 ],
 "names": [
  "nitroglycerin"
 ],
 "classes": [
  {
   "id": "C01DA",
   "name": "Organic nitrates"
  },
  {
   "id": "C05AE",
   "name": "Muscle relaxants"
  }
 ],
 "alternatives": [
  "diltiazem",
  "erythrityl tetranitrate",
  "isosorbide dinitrate",
  "isosorbide mononitrate",
  "pentaerythritol tetranitrate"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 83,
   "SUBLINGUAL": 41,
   "INTRAVENOUS": 7,
   "RECTAL": 7,
   "TOPICAL": 3,
   "TRANSDERMAL": 3,
   "NASAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Nitrolingual Pumpspray is a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease ( 1 ).",
  "contraindications": "Use of phosphodiesterase type 5 (PDE-5) Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). ( 4.1 , 7.1 ) Severe anemia. ( 4.2 ) Increased intracranial pressure. ( 4.3 ) Hypersensitivity to Nitrolingual Pumpspray or to other nitrates or nitrites or any excipient. ( 4.4 ) 4.1 P DE-5 - I nhibitors and sGC- S timulators Do not use Nitrolingual Pumpspray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1) ]. Do not use Nitrolingual Pumpspray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. 4.2 Severe Anemia Nitrolingual Pumpspray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). 4.3 Increased I ntracranial P ressure Nitrolingual Pumpspray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracran...",
  "warnings_and_cautions": "Tolerance: Excessive use may lead to tolerance. ( 5.1 ) Hypotension: Severe hypotension may occur. ( 5.2 ) 5.1 Tolerance Excessive use may lead to the development of tolerance. Only the smallest number of doses required for effective relief of the acute angina attack should be used [see Dosage and Administration (2.1) ]. 5. 2 Hypotension Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses. 5.3 Hypertrophic Obstructive Cardiomyopathy Nitrate therapy may aggravate the angina caused by hypertrophic obstructive cardiomyopathy. 5.4 Headache Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persistent but usually subside with continued use.",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions occurring at a frequency greater than 2 % are headache, dizzinesss and paresthesia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Independence Pharmaceuticals, LLC at 1-866-525-0688 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 a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse reactions occurring at a frequency greater than 2 % and greater than placebo included: headache, dizziness, and paresthesia. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Nitrolingual Pumpspray and other nitroglycerin drugs. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure. Neurologic: weakness, drowsiness Dermatologic: cutaneous vasodilation, flushing, drug rash, exfoliative dermatitits Gastrointes...",
  "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) The following trademarks are either registered trademarks or trademarks of Pohl-Boskamp in the United States and/or other countries: Pohl-Boskamp word mark; Pohl-Boskamp logo; Nitrolingual\u00ae word mark; Nitrolingual\u00ae Pumpspray shapes, Nitrolingual\u00ae Pumpspray colors . U.S. Patent No. 7,872,049 Manufactured for: Independence Pharmaceuticals, LLC Mason, OH 45040 USA by G. Pohl-Boskamp GmbH & Co. KG, 25551 Hohenlockstedt, Germany.",
  "spl_medguide": "",
  "clinical_studies": "In a randomized, double-blind single-dose, 5-period cross-over study in 51 patients with exertional angina pectoris significant dose-related increases in exercise tolerance, time to onset of angina and ST-segment depression were seen following doses of 0.2, 0.4, 0.8 and 1.6 mg of nitroglycerin delivered by metered pumpspray as compared to placebo. The drug showed a profile of mild to moderate adverse events.",
  "brand_name": "NITROLINGUAL",
  "manufacturer": "INDEPENDENCE PHARMACEUTICALS, LLC",
  "application_number": "NDA018705",
  "pharm_class_epc": [
   "Nitrate Vasodilator [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240513",
  "set_id": "d19b5f51-ca85-48d6-9ccd-8ae26249cdc3",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 50559,
  "serious": 40652,
  "death": 5713,
  "hospitalization": 23058,
  "primary_suspect": 50409,
  "top_reactions": [
   [
    "Dyspnoea",
    3707
   ],
   [
    "Fatigue",
    3363
   ],
   [
    "Fall",
    2888
   ],
   [
    "Nausea",
    2874
   ],
   [
    "Drug Ineffective",
    2819
   ],
   [
    "Dizziness",
    2711
   ],
   [
    "Diarrhoea",
    2602
   ],
   [
    "Pain",
    2561
   ],
   [
    "Headache",
    2463
   ],
   [
    "Myocardial Infarction",
    2430
   ],
   [
    "Off Label Use",
    2390
   ],
   [
    "Acute Kidney Injury",
    2297
   ],
   [
    "Hypotension",
    2243
   ],
   [
    "Malaise",
    2237
   ],
   [
    "Chest Pain",
    2221
   ]
  ],
  "by_year": {
   "2019": 5291,
   "2020": 4525,
   "2021": 3589,
   "2022": 3373,
   "2023": 3309,
   "2024": 3209,
   "2025": 3133,
   "2026": 1342
  },
  "by_year_primary": {
   "2019": 5285,
   "2020": 4518,
   "2021": 3578,
   "2022": 3339,
   "2023": 3276,
   "2024": 3185,
   "2025": 3114,
   "2026": 1337
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260724",
   "reason": "Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde",
   "firm": "American Regent, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20211227",
   "reason": "Defective Delivery System",
   "firm": "Padagis US LLC",
   "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 I",
   "date": "20131118",
   "reason": "Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and EPDM rubber from the vial stopper.",
   "firm": "Baxter Healthcare Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 66,
  "nda": 14,
  "anda": 40,
  "first_approval": "19810528",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 61,
  "labeling_recent": 2,
  "sponsors": [
   "ABBVIE",
   "ABRAXIS PHARM",
   "ACTAVIS LABS FL INC",
   "AM REGENT",
   "AMVIKA",
   "AUROBINDO PHARMA",
   "BAUSCH",
   "BAXTER HLTHCARE"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/28/1981"
 },
 "trials": {
  "total": 335,
  "completed": 198,
  "terminated": 25,
  "with_results": 51,
  "industry": 45,
  "phase3": 47,
  "results_share": 0.25757575757575757,
  "terminated_share": 0.07462686567164178
 },
 "pubmed": {
  "rct": 551,
  "meta": 26,
  "recent_rct": 31,
  "cochrane": [
   {
    "pmid": "26558329",
    "title": "Nitroglycerin for management of retained placenta",
    "year": "2015"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nitroglycerin",
   "Nitro-Bid",
   "Nitrostat",
   "Rectiv",
   "Nitro-Dur",
   "Nitrolingual",
   "Gonitro",
   "NitroMist"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2543848,
  "beneficiaries": 1446815,
  "spend": 47969015.89,
  "by_brand": [
   {
    "brand": "Nitroglycerin",
    "claims": 2342965,
    "per_claim": 14.842065882,
    "is_generic": true
   },
   {
    "brand": "Nitroglycerin Patch",
    "claims": 170164,
    "per_claim": 41.003211549,
    "is_generic": false
   },
   {
    "brand": "Nitro-Bid",
    "claims": 22885,
    "per_claim": 48.550196198,
    "is_generic": false
   },
   {
    "brand": "Nitrostat",
    "claims": 3269,
    "per_claim": 53.686121138,
    "is_generic": false
   },
   {
    "brand": "Rectiv",
    "claims": 3218,
    "per_claim": 671.06683033,
    "is_generic": false
   },
   {
    "brand": "Nitro-Dur",
    "claims": 1298,
    "per_claim": 2113.8877042,
    "is_generic": false
   },
   {
    "brand": "Nitrolingual",
    "claims": 49,
    "per_claim": 559.47020408,
    "is_generic": false
   }
  ],
  "per_claim": 18.85687190822722
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7636,
  "fills": 2543848,
  "per_million": 3001.75167698699,
  "ratio": 1.0840758929907863,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 90,
   "letter": "A",
   "why": [
    "3,002 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 (1.2x)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 64,
   "letter": "C",
   "why": [
    "551 randomized trials and 26 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 26% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 0 Class III across 40 generic makers (-6)",
    "2 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 (40 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, fall, nausea. How would we recognize and handle those?",
  "Why this one over diltiazem, erythrityl tetranitrate, isosorbide dinitrate? 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.)"
 ]
}