{
 "query": "lisinopril",
 "ingredient": "lisinopril",
 "slug": "lisinopril",
 "rxcui": "29046",
 "brands": [
  "Zestril",
  "Qbrelis",
  "Prinivil"
 ],
 "names": [
  "lisinopril",
  "lisinopril anhydrous"
 ],
 "classes": [
  {
   "id": "C09AA",
   "name": "ACE inhibitors, plain"
  }
 ],
 "alternatives": [
  "benazepril",
  "captopril",
  "cilazapril",
  "enalapril",
  "fosinopril",
  "imidapril",
  "moexipril",
  "perindopril",
  "quinapril",
  "ramipril",
  "spirapril",
  "trandolapril",
  "zofenopril"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 219
  },
  "boxed_warning": "WARNING: FETAL TOXICITY When pregnancy is detected, discontinue ZESTRIL as soon as possible [see Warnings and Precautions ( 5.1 )]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Zestril 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": "Zestril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 Hypertension Zestril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. 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 Pressure Education Program\u2019s Joint National Committee on Prevention, Detection, Evaluation, and T...",
  "contraindications": "Zestril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Zestril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [ see Warnings and Precautions (5.2)] . Zestril is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema Do not co-administer aliskiren with ZESTRIL in patients with diabetes [see Drug Interactions (7.4) ] . Angioedema or a history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Co-administration of aliskiren with Zestril in patients with diabetes ( 4 , 7.4 )",
  "warnings_and_cautions": "Angioedema: Discontinue Zestril, provide appropriate therapy and monitor until resolved ( 5.2 ) Renal impairment: Monitor renal function periodically ( 5.3 ) Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation ( 5.4 ) Hyperkalemia: Monitor serum potassium periodically ( 5.5 ) Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure ( 5.6 ) 5.1 Fetal Toxicity Zestril 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 Zestril as soon as possible [see Use in specific Populations (8.1) ] . 5.2 Angioedema and Anaphylactoid Reactions Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may ...",
  "warnings": "",
  "adverse_reactions": "Common adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ) Heart Failure: hypotension and chest pain ( 6.1 ) Acute Myocardial Infarction: hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 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. Hypertension In clinical trials in patients with hypertension treated with Zestril, 5.7% of patients on Zestril discontinued with adverse reactions. The following adverse reactions (events 2% greater on Zestril than on placebo) were observed with Zestril alone: headache (by 3.8%), dizziness (by 3.5%), cough (by 2.5%). Heart Failure In patients with systolic heart failure treated with Zestril for up to four years, 11% discontinued therapy with adverse reactions. In controlled studies in patients with heart failure, therapy was disconti...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Pregnancy: Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including Zestril. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician. Lactation: Advise women not to breastfeed during treatment with Zestril [see Use in Specific Populations (8.2) ] Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the presc...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension Two dose-response studies utilizing a once-daily regimen were conducted in 438 mild to moderate hypertensive patients not on a diuretic. Blood pressure was measured 24 hours after dosing. An antihypertensive effect of Zestril was seen with 5 mg of Zestril in some patients. However, in both studies blood pressure reduction occurred sooner and was greater in patients treated with 10 mg, 20 mg or 80 mg of Zestril than patients treated with 5 mg of Zestril. In controlled clinical studies of patients with mild to moderate hypertension, patients were treated with Zestril 20 mg to 80 mg daily, hydrochlorothiazide 12.5 mg to 50 mg daily or atenolol 50 mg to 200 mg daily; and in other studies of patients with moderate to severe hypertension, patients were treated with Zestril 20 mg to 80 mg daily or metoprolol 100 mg to 200 mg daily. Zestril demonstrated superior reductions of systolic and diastolic compared to hydrochlorothiazide in a population that was 75% Caucasian. Zestril was approximately equivalent to atenolol and metoprolol in reducing diastolic blood pressure, and had somewhat greater effects on systolic blood pressure. Zestril had similar blood pressure reductio...",
  "brand_name": "Zestril",
  "manufacturer": "Upsher-Smith Laboratories, LLC",
  "application_number": "NDA019777",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250102",
  "set_id": "838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 232389,
  "serious": 138537,
  "death": 19345,
  "hospitalization": 71111,
  "primary_suspect": 231939,
  "top_reactions": [
   [
    "Fatigue",
    16263
   ],
   [
    "Diarrhoea",
    13915
   ],
   [
    "Drug Ineffective",
    13763
   ],
   [
    "Nausea",
    13557
   ],
   [
    "Off Label Use",
    10355
   ],
   [
    "Headache",
    10215
   ],
   [
    "Pain",
    10087
   ],
   [
    "Acute Kidney Injury",
    9901
   ],
   [
    "Dyspnoea",
    9740
   ],
   [
    "Dizziness",
    9632
   ],
   [
    "Chronic Kidney Disease",
    9246
   ],
   [
    "Vomiting",
    8167
   ],
   [
    "Asthenia",
    7824
   ],
   [
    "Arthralgia",
    7550
   ],
   [
    "Death",
    7056
   ]
  ],
  "by_year": {
   "2019": 24170,
   "2020": 20078,
   "2021": 16886,
   "2022": 15442,
   "2023": 13188,
   "2024": 12674,
   "2025": 13664,
   "2026": 6152
  },
  "by_year_primary": {
   "2019": 24163,
   "2020": 20066,
   "2021": 16850,
   "2022": 15335,
   "2023": 13128,
   "2024": 12614,
   "2025": 13574,
   "2026": 6080
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20241115",
   "reason": "Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.",
   "firm": "Evaric Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20231027",
   "reason": "Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots",
   "firm": "NCS Healthcare of Kentucky Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220913",
   "reason": "Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200528",
   "reason": "Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20200401",
   "reason": "Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180813",
   "reason": "Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20160406",
   "reason": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20160406",
   "reason": "CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20130409",
   "reason": "Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 9,
 "drugsfda": {
  "applications": 23,
  "nda": 3,
  "anda": 20,
  "first_approval": "19871229",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 77,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ANNORA PHARMA",
   "AUROBINDO",
   "AZURITY",
   "CHARTWELL RX",
   "HERITAGE",
   "HERITAGE PHARMA",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/29/1987"
 },
 "trials": {
  "total": 160,
  "completed": 101,
  "terminated": 27,
  "with_results": 48,
  "industry": 62,
  "phase3": 25,
  "results_share": 0.4752475247524752,
  "terminated_share": 0.16875
 },
 "pubmed": {
  "rct": 305,
  "meta": 1,
  "recent_rct": 7,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "lisinopril",
   "Zestril",
   "Qbrelis",
   "Prinivil"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 36251385,
  "beneficiaries": 8759436,
  "spend": 258155257.9,
  "by_brand": [
   {
    "brand": "Lisinopril",
    "claims": 36247459,
    "per_claim": 6.9763111232,
    "is_generic": true
   },
   {
    "brand": "Zestril",
    "claims": 2794,
    "per_claim": 1111.8253257,
    "is_generic": false
   },
   {
    "brand": "Qbrelis",
    "claims": 1132,
    "per_claim": 1921.6135424,
    "is_generic": false
   }
  ],
  "per_claim": 7.121252274913083
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "lisinopril + amlodipine",
  "matched": "lisinopril",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 32268,
  "fills": 36251385,
  "per_million": 890.117715502456,
  "ratio": 0.32146401872549896,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 65,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "890 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 (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "305 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 48% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 3 Class III across 20 generic makers (-7)"
   ],
   "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 (20 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, 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 benazepril, captopril, cilazapril? 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.)"
 ]
}