{
 "query": "isosorbide",
 "ingredient": "isosorbide",
 "slug": "isosorbide",
 "rxcui": "6057",
 "brands": [],
 "names": [
  "isosorbide",
  "isosorbide mononitrate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 37
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Isosorbide Mononitrate Tablets are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.",
  "contraindications": "CONTRAINDICATIONS Isosorbide mononitrate is contraindicated in patients who are allergic to it. Do not use isosorbide mononitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide mononitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Amplification of the vasodilatory effects of isosorbide mononitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The benefits of isosorbide mononitrate in patients with acute myocardial infarction or congestive heart failure have not been established. Because the effects of isosorbide mononitrate are difficult to terminate rapidly, this drug is not recommended in these settings. If isosorbide mononitrate is used in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.",
  "adverse_reactions": "ADVERSE REACTIONS Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy. The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment. Frequency of Adverse Reactions (Discontinuations) Some individuals discontinued for multiple reasons. 6 Placebo-Controlled Studies Dose Placebo 5 mg 10 mg 20 mg Patients 160 54 52 159 Headache 6% (0%) 17% (0%) 13% (0%) 35% (5%) Fatigue 2% (0%) 0% (0%) 4% (0%) 1% (0%) Upper Respiratory Infection <1% (0%) 0% (0%) 4% (0%) 1% (0%) Pain <1% (0%) 4% (0%) 0% (0%) <1% (0%) Dizziness 1% (0%) 0% (0%) 0% (0%) 4% (0%) Nausea <1% (0%) 0% (0%) 0% (0%) 3% (2%) Increased Cough <1% (0%) 0% (0%) 2% (0%) <1% (0%) Rash 0% (0%) 2% (2%) 0% (0%) <1% (0%) Abdominal Pain <1% (0%) 0% (0%) 2% (0%) 0% (0%) Allergic Reaction 0% (0%) 0% (0%) 2% (0%) 0% (0%) Cardiovascular Disorder 0% (0%)...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be told that the antianginal efficacy of Isosorbide Mononitrate Tablets can be maintained by carefully following the prescribed schedule of dosing (two doses taken seven hours apart). For most patients, this can be accomplished by taking the first dose on awakening and the second dose 7 hours later. As with other nitrates, daily headaches sometimes accompany treatment with isosorbide mononitrate. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with isosorbide mononitrate, since loss of headache may be associated with simultaneous loss of antianginal efficacy. Aspirin and/or acetaminophen, on the other hand, often successfully relieve isosorbide mononitrate-induced headaches with no deleterious effect on isosorbide mononitrate's antianginal efficacy. Treatment with isosorbide mononitrate may be associated with light-headedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol.",
  "spl_medguide": "",
  "clinical_studies": "Clinical Trials The acute and chronic antianginal efficacy of isosorbide mononitrate has been confirmed in clinical trials. The clinical efficacy of isosorbide mononitrate was studied in 21 stable angina pectoris patients. After single dose administration of Isosorbide Mononitrate Tablets, 20 mg, the exercise capacity was increased by 42.7% after one hour, 29.6% after 6 hours, and by 25% after eight hours when compared to placebo. Controlled trials of single doses of Isosorbide Mononitrate Tablets have demonstrated that antianginal activity is present about 1 hour after dosing, with peak effect seen from 1-4 hours after dosing. In one multicenter placebo-controlled trial, isosorbide mononitrate was found to be safe and effective during acute and chronic (3 weeks) treatment of angina pectoris. Two hundred fourteen (214) patients were enrolled in the trial; 54 patients were randomized to receive placebo and 106 patients were randomized to receive 10 or 20 mg of Isosorbide Mononitrate Tablets twice daily seven hours apart. The largest effect of isosorbide mononitrate, compared to placebo, was on day one - dose one. Although 14 hours after the first dose of day 14, the increase in exer...",
  "brand_name": "isosorbide mononitrate",
  "manufacturer": "Proficient Rx LP",
  "application_number": "NDA020215",
  "pharm_class_epc": [
   "Nitrate Vasodilator [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20191101",
  "set_id": "f871dfa7-219f-4704-8e4d-215caeb7408d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 31582,
  "serious": 24638,
  "death": 3739,
  "hospitalization": 14208,
  "primary_suspect": 31452,
  "top_reactions": [
   [
    "Dyspnoea",
    2244
   ],
   [
    "Fatigue",
    1963
   ],
   [
    "Diarrhoea",
    1864
   ],
   [
    "Dizziness",
    1848
   ],
   [
    "Nausea",
    1734
   ],
   [
    "Acute Kidney Injury",
    1692
   ],
   [
    "Myocardial Infarction",
    1643
   ],
   [
    "Chest Pain",
    1518
   ],
   [
    "Off Label Use",
    1467
   ],
   [
    "Headache",
    1457
   ],
   [
    "Death",
    1303
   ],
   [
    "Chronic Kidney Disease",
    1284
   ],
   [
    "Vomiting",
    1250
   ],
   [
    "Pain",
    1228
   ],
   [
    "Malaise",
    1208
   ]
  ],
  "by_year": {
   "2019": 3265,
   "2020": 2641,
   "2021": 1916,
   "2022": 1871,
   "2023": 2138,
   "2024": 1687,
   "2025": 1784,
   "2026": 822
  },
  "by_year_primary": {
   "2019": 3265,
   "2020": 2640,
   "2021": 1911,
   "2022": 1835,
   "2023": 2112,
   "2024": 1666,
   "2025": 1755,
   "2026": 817
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 24,
  "nda": 4,
  "anda": 20,
  "first_approval": "19740130",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 14,
  "labeling_recent": 0,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ALCON",
   "ALKERMES GAINESVILLE",
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "CHARTWELL MOLECULAR",
   "DEXCEL LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/30/1974"
 },
 "trials": {
  "total": 113,
  "completed": 67,
  "terminated": 12,
  "with_results": 17,
  "industry": 30,
  "phase3": 19,
  "results_share": 0.2537313432835821,
  "terminated_share": 0.10619469026548672
 },
 "pubmed": {
  "rct": 487,
  "meta": 10,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "isosorbide"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4862596,
  "beneficiaries": 1169964,
  "spend": 62826606.24,
  "by_brand": [
   {
    "brand": "Isosorbide Mononitrate ER",
    "claims": 4766057,
    "per_claim": 12.612347053,
    "is_generic": false
   },
   {
    "brand": "Isosorbide Mononitrate",
    "claims": 96539,
    "per_claim": 28.127920115,
    "is_generic": true
   }
  ],
  "per_claim": 12.920383729184987
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4238,
  "fills": 4862596,
  "per_million": 871.5509164240665,
  "ratio": 0.3147586608355722,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "872 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 53,
   "letter": "D",
   "why": [
    "487 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 25% 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 (20 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, fatigue, diarrhoea, dizziness. 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.)"
 ]
}