{
 "query": "irbesartan",
 "ingredient": "irbesartan",
 "slug": "irbesartan",
 "rxcui": "83818",
 "brands": [
  "Avapro"
 ],
 "names": [
  "irbesartan"
 ],
 "classes": [
  {
   "id": "C09CA",
   "name": "Angiotensin II receptor blockers (ARBs), plain"
  }
 ],
 "alternatives": [
  "azilsartan medoxomil",
  "candesartan",
  "eprosartan",
  "losartan",
  "olmesartan medoxomil",
  "telmisartan",
  "valsartan"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 62
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue AVAPRO as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue AVAPRO as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 , 8.1 )",
  "indications_and_usage": "AVAPRO is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. ( 1.2 ) 1.1 Hypertension AVAPRO \u00ae is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood P...",
  "contraindications": "AVAPRO is contraindicated in patients who are hypersensitive to any component of this product. Do not coadminister aliskiren with AVAPRO in patients with diabetes. Hypersensitivity to any component of this product. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 )",
  "warnings_and_cautions": "Hypotension: Correct volume or salt depletion prior to administration. ( 5.2 ) Monitor renal function and serum potassium. ( 5.3 ) 5.1 Fetal Toxicity AVAPRO can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue AVAPRO as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initialization of treatment with AVAPRO. Correct volume or salt depletion prior to administration of AVAPRO or use a lower starting dose [see Dosage and Administration (2.4) ] . 5.3 Impaired Renal Function Changes in renal function...",
  "warnings": "",
  "adverse_reactions": "The following important adverse reactions are described elsewhere in the labeling: Hypotension in Volume or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Nephropathy in type 2 diabetic patients: The most common adverse reactions which were more frequent than placebo were hyperkalemia dizziness, orthostatic dizziness, and orthostatic hypotension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension AVAPRO has been evaluated for safety in more than 4300 patients with hypertension and about 5000 subjects overall. This experience in...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Pregnancy Advise female patients of childbearing age about the consequences of exposure to AVAPRO during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible. Potassium Supplements Advise patients receiving AVAPRO not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions (7.1) ] .",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension The antihypertensive effects of AVAPRO were examined in 7 placebo-controlled 8- to 12-week trials in patients with baseline diastolic blood pressures of 95 to 110 mmHg. Doses of 1 to 900 mg were included in these trials in order to fully explore the dose-range of irbesartan. These studies allowed comparison of once or twice-daily regimens at 150 mg/day, comparisons of peak and trough effects, and comparisons of response by sex, age, and race. Two of the seven placebo-controlled trials identified above examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination. The 7 studies of irbesartan monotherapy included a total of 1915 patients randomized to irbesartan (1\u2013900 mg) and 611 patients randomized to placebo. Once-daily doses of 150 mg and 300 mg provided statistically and clinically significant decreases in systolic and diastolic blood pressure with trough (24 hours post-dose) effects after 6 to 12 weeks of treatment compared to placebo, of about 8\u201310/5\u20136 mmHg and 8\u201312/5\u20138 mmHg, respectively. No further increase in effect was seen at dosages greater than 300 mg. The dose-response relationships for effects on systolic and diastolic pr...",
  "brand_name": "Avapro",
  "manufacturer": "Sanofi-Aventis U.S. LLC",
  "application_number": "NDA020757",
  "pharm_class_epc": [
   "Angiotensin 2 Receptor Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260824",
  "set_id": "7885b2a8-be4e-48ab-8113-4e6ab791eb98",
  "has_boxed_warning": true,
  "boxed_labels": "43 of 43",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 36126,
  "serious": 30151,
  "death": 2791,
  "hospitalization": 16686,
  "primary_suspect": 35832,
  "top_reactions": [
   [
    "Acute Kidney Injury",
    2513
   ],
   [
    "Fatigue",
    2154
   ],
   [
    "Diarrhoea",
    1952
   ],
   [
    "Nausea",
    1900
   ],
   [
    "Fall",
    1838
   ],
   [
    "Off Label Use",
    1743
   ],
   [
    "Drug Ineffective",
    1734
   ],
   [
    "Headache",
    1598
   ],
   [
    "Dyspnoea",
    1574
   ],
   [
    "Dizziness",
    1526
   ],
   [
    "Malaise",
    1512
   ],
   [
    "Asthenia",
    1443
   ],
   [
    "Cough",
    1288
   ],
   [
    "Hypotension",
    1267
   ],
   [
    "Pain",
    1259
   ]
  ],
  "by_year": {
   "2019": 4362,
   "2020": 3898,
   "2021": 3038,
   "2022": 2929,
   "2023": 2889,
   "2024": 2634,
   "2025": 2760,
   "2026": 1309
  },
  "by_year_primary": {
   "2019": 4358,
   "2020": 3891,
   "2021": 3030,
   "2022": 2859,
   "2023": 2825,
   "2024": 2586,
   "2025": 2687,
   "2026": 1293
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220718",
   "reason": "Failed Dissolution Specifications",
   "firm": "Jubilant Cadista Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220718",
   "reason": "Failed dissolution specifications.",
   "firm": "Jubilant Cadista Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211012",
   "reason": "CGMP Deviations: impurity N-nitrosoirbesartan detected in API",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211012",
   "reason": "CGMP Deviations: impurity N-nitrosoirbesartan detected in API",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211012",
   "reason": "CGMP Deviations: impurity N-nitrosoirbesartan detected in API",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190118",
   "reason": "CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.",
   "firm": "Prinston Pharmaceutical Inc",
   "status": "Completed"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 24,
  "nda": 1,
  "anda": 23,
  "first_approval": "19970930",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 20,
  "labeling_recent": 4,
  "sponsors": [
   "AJANTA PHARMA LTD",
   "ALEMBIC PHARMS LTD",
   "AMNEAL PHARMS",
   "APOTEX INC",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "HETERO LABS LTD V"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/30/1997"
 },
 "trials": {
  "total": 140,
  "completed": 94,
  "terminated": 11,
  "with_results": 12,
  "industry": 79,
  "phase3": 38,
  "results_share": 0.1276595744680851,
  "terminated_share": 0.07857142857142857
 },
 "pubmed": {
  "rct": 212,
  "meta": 5,
  "recent_rct": 8,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "irbesartan",
   "Avapro"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2565998,
  "beneficiaries": 631260,
  "spend": 57215582.88,
  "by_brand": [
   {
    "brand": "Irbesartan",
    "claims": 2562169,
    "per_claim": 21.434250403,
    "is_generic": true
   },
   {
    "brand": "Avapro",
    "claims": 3829,
    "per_claim": 600.00286237,
    "is_generic": false
   }
  ],
  "per_claim": 22.297594495397114
 },
 "mdl": [
  {
   "number": "2875",
   "title": "Valsartan, Losartan, and Irbesartan Products Liability Litigation",
   "judge": "Bumb, Renee M.",
   "court": "NJ",
   "docket": "1:19-md-2875",
   "actions": "",
   "matched": "irbesartan"
  }
 ],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6566,
  "fills": 2565998,
  "per_million": 2558.848448050232,
  "ratio": 0.9241223841448913,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,559 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "212 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 13% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 6 Class II, 0 Class III across 23 generic makers (-6)",
    "4 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 60,
   "letter": "D",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Named in 1 active federal multidistrict litigation(s) (-40)"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (23 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 68,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are acute kidney injury, fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over azilsartan medoxomil, candesartan, eprosartan? What would make you pick one of those instead?",
  "This drug is in active federal litigation. What is the claim, and does it affect my risk?",
  "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.)"
 ]
}