{
 "query": "benazepril",
 "ingredient": "benazepril",
 "slug": "benazepril",
 "rxcui": "18867",
 "brands": [
  "Lotensin"
 ],
 "names": [
  "benazepril",
  "benazepril hydrochloride"
 ],
 "classes": [
  {
   "id": "C09AA",
   "name": "ACE inhibitors, plain"
  }
 ],
 "alternatives": [
  "captopril",
  "cilazapril",
  "enalapril",
  "fosinopril",
  "imidapril",
  "lisinopril",
  "moexipril",
  "perindopril",
  "quinapril",
  "ramipril",
  "spirapril",
  "trandolapril",
  "zofenopril"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 108
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinueLotensin as soon as possible. Drugs thatactdirectlyon the renin-angiotensin system can causeinjury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING-FETAL TOXICITY See full prescribinginformation forcomplete boxed warning. When pregnancyis detected, discontinue Lotensin as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 )",
  "indications_and_usage": "1. INDICATIONS AND USAGE Lotensin \u00ae is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. 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 one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program\u2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, ...",
  "contraindications": "4. CONTRAINDICATIONS Lotensin is contraindicated in patients: who are hypersensitive to benazepril or to any other ACE inhibitor with a history of angioedema with or without previous ACE inhibitor treatment Lotensin is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lotensin within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions (5.2) ]. Do not coadminister aliskiren with angiotensin receptor blockers, ACE inhibitors, including Lotensin in patients with diabetes [see Drug Interactions (7.4) ] . Angioedema or history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Coadministration with aliskiren in patients with diabetes ( 4 )",
  "warnings_and_cautions": "5. WARNINGS AND PRECAUTIONS Angioedema: Discontinue Lotensin and treat appropriately. ( 5.2 ) Monitor renal function periodically. ( 5.3 ) Monitor blood pressure after initiation. ( 5.4 ) Hyperkalemia: Monitor serum potassium periodically. ( 5.5 ) Hepatic toxicity: Monitor for jaundice or signs of liver failure. ( 5.6 ) 5.1 Fetal Toxicity Lotensin 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 Lotensin as soon as possible [see Use in Specific Populations (8.1) ] . 5.2 Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and/or larynx including some fatal reactions, have occured in patients treated with Lotensin. Patients with involvement of the tongue, glottis o...",
  "warnings": "",
  "adverse_reactions": "6 . ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Lotensin has been evaluated for safety in over 6000 patients with hypertension; over 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in Lotensin and placebo patients. The reported side effects were generally mild and transient, and there was no relation between side effects and age, duration of therapy, or total dosage within the range of 2 to 80 mg. Discontinuation of therapy because of a side effect was required in approximately 5% of U.S. patients treated with Lotensin and in 3% of patients treated with placebo. The most common reasons for discontinuation were headache (0.6%) and cough (0.5%). Adverse reactions seen in at least 1% greater frequency in patients treated with Lotensin than placebo were headache (6% vs. 4%), dizziness (4% vs. 2%), somnolence (2% vs. 0%) and postural dizziness (2% vs. 0%). Adverse reactions reporte...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "17. PATIENT COUNSELING INFORMATION Pregnancy: Tell female patients of childbearing age about the consequences of exposure to Lotensin during pregnancy. Discuss treatment options with women planning to become pregnant. Instruct patients to report pregnancies to their physicians as soon as possible. Angioedema: Angioedema, including laryngeal edema, can occur at any time with treatment with ACE inhibitors. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to take no more drugs until they have consulted with the prescribing physician. Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patients to discontinue the drug until they have consulted with the prescribing physician. Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of a reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly. Hyperkalemia: Tell patients not to us...",
  "spl_medguide": "",
  "clinical_studies": "14 . CLINICAL STUDIES Hypertension Adult Patients In single-dose studies, Lotensin lowered blood pressure within 1 hour, with peak reductions achieved between 2 and 4 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. In multiple-dose studies, once-daily doses of between 20 mg and 80 mg decreased seated pressure 24 hours after dosing by about 6 to 12 mm Hg systolic and 4 to 7 mm Hg diastolic. The trough values represent reductions of about 50% of that seen at peak. Four dose-response studies using once-daily dosing were conducted in 470 mild-to-moderate hypertensive patients not using diuretics. The minimal effective once-daily dose of Lotensin was 10 mg; but further falls in blood pressure, especially at morning trough, were seen with higher doses in the studied dosing range (10 to 80 mg). In studies comparing the same daily dose of Lotensin given as a single morning dose or as a twice-daily dose, blood pressure reductions at the time of morning trough blood levels were greater with the divided regimen. The antihypertensive effects of Lotensin were not appreciably different in patients receiving high- or low-sodium diets. In normal human volun...",
  "brand_name": "Lotensin",
  "manufacturer": "Validus Pharmaceuticals LLC",
  "application_number": "NDA019851",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250930",
  "set_id": "2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11586,
  "serious": 6636,
  "death": 913,
  "hospitalization": 3350,
  "primary_suspect": 11566,
  "top_reactions": [
   [
    "Fatigue",
    781
   ],
   [
    "Drug Ineffective",
    685
   ],
   [
    "Chronic Kidney Disease",
    622
   ],
   [
    "Diarrhoea",
    621
   ],
   [
    "Acute Kidney Injury",
    572
   ],
   [
    "Nausea",
    543
   ],
   [
    "Dizziness",
    488
   ],
   [
    "Headache",
    477
   ],
   [
    "Pain",
    418
   ],
   [
    "Dyspnoea",
    409
   ],
   [
    "Off Label Use",
    400
   ],
   [
    "Death",
    389
   ],
   [
    "Renal Failure",
    379
   ],
   [
    "Fall",
    368
   ],
   [
    "Arthralgia",
    351
   ]
  ],
  "by_year": {
   "2019": 1241,
   "2020": 920,
   "2021": 849,
   "2022": 679,
   "2023": 558,
   "2024": 535,
   "2025": 509,
   "2026": 364
  },
  "by_year_primary": {
   "2019": 1241,
   "2020": 920,
   "2021": 848,
   "2022": 669,
   "2023": 558,
   "2024": 528,
   "2025": 509,
   "2026": 363
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20190924",
   "reason": "Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle",
   "firm": "Amneal Pharmaceuticals, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 13,
  "nda": 1,
  "anda": 12,
  "first_approval": "19910625",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 23,
  "labeling_recent": 0,
  "sponsors": [
   "AMNEAL PHARMS",
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "GENPHARM",
   "HERITAGE PHARMA",
   "MACLEODS PHARMS",
   "PRINSTON INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/25/1991"
 },
 "trials": {
  "total": 57,
  "completed": 39,
  "terminated": 8,
  "with_results": 9,
  "industry": 26,
  "phase3": 7,
  "results_share": 0.23076923076923078,
  "terminated_share": 0.14035087719298245
 },
 "pubmed": {
  "rct": 117,
  "meta": 2,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "benazepril",
   "Lotensin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2142239,
  "beneficiaries": 523161,
  "spend": 22289752.29,
  "by_brand": [
   {
    "brand": "Benazepril HCl",
    "claims": 2142239,
    "per_claim": 10.404885865,
    "is_generic": true
   }
  ],
  "per_claim": 10.404885864742448
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1400,
  "fills": 2142239,
  "per_million": 653.5218526037478,
  "ratio": 0.2360179529112566,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "654 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 34,
   "letter": "F",
   "why": [
    "117 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 23% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 12 generic makers (-0)"
   ],
   "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 (12 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 73,
 "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 fatigue, chronic kidney disease, diarrhoea. How would we recognize and handle those?",
  "Why this one over captopril, cilazapril, enalapril? 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.)"
 ]
}