{
 "query": "enalapril",
 "ingredient": "enalapril",
 "slug": "enalapril",
 "rxcui": "3827",
 "brands": [
  "Vasotec",
  "Epaned"
 ],
 "names": [
  "enalapril",
  "enalapril maleate"
 ],
 "classes": [
  {
   "id": "C09AA",
   "name": "ACE inhibitors, plain"
  }
 ],
 "alternatives": [
  "benazepril",
  "captopril",
  "cilazapril",
  "fosinopril",
  "imidapril",
  "lisinopril",
  "moexipril",
  "perindopril",
  "quinapril",
  "ramipril",
  "spirapril",
  "trandolapril",
  "zofenopril"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 69
  },
  "boxed_warning": "WARNING: FETAL TOXICITY \u2022 When pregnancy is detected, discontinue ENALAPRIL MALEATE as soon as possible. [See Warnings and Precautions ( 5.1 )] \u2022 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. \u2022 When pregnancy is detected, discontinue ENALAPRIL MALEATE as soon as possible ( 5.1 ). \u2022 Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).",
  "indications_and_usage": "Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: treatment of hypertension in adults and children older than one month, 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 symptomatic heart failure ( 1.2 ). treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure ( 1.3 ). 1.1 Hypertension Enalapril maleate is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Use ( 8.4 ) and Clinical Studies ( 14 )]. 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smo...",
  "contraindications": "Enalapril maleate is contraindicated in patients with: \u2022a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor [see Warnings and Precautions ( 5.2 )]. \u2022hereditary or idiopathic angioedema [see Warnings and Precautions ( 5.2 )] . Do not co-administer aliskiren with enalapril maleate in patients with diabetes [see Drug Interactions ( 7.2 )] . Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2 )] . Hypersensitivity related to previous treatment with an ACEI ( 4 ). Hereditary or idiopathic angioedema ( 4 ). Do not co-administer aliskiren in patients with diabetes ( 4 ). In combination with a neprilysin inhibitor ( 4 ).",
  "warnings_and_cautions": "Angioedema and Anaphylactoid Reactions ( 5.2 ). Impaired Renal Function: Assess renal function ( 5.5 ). Hyperkalemia ( 5.6 ). 5.1 Fetal Toxicity 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 enalapril maleate 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 occurred in patients treated with angiotensin converting enzyme inhibitors, including enalapril maleate, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Enalapril maleate should be promptly discontinued and appr...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described elsewhere: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Hepatic failure [see Warnings and Precautions ( 5.4 )] Renal impairment [see Warnings and Precautions ( 5.5 )] Hyperkalemia [see Warnings and Precautions ( 5.6 )] The most common adverse reaction for patients treated for hypertension (\u22653%) was fatigue ( 6.1 ). The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 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 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. Enalapril has been evaluated for safety in more than 10,000 patients, including over 1,000 patients treated for one year or more. In clinical trials, discontinuation of therapy for clinical adverse experiences was re...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "\u2022Pregnancy Tell female patients of childbearing age about the consequences of exposure to enalapril maleate 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. \u2022Angioedema Angioedema, including laryngeal edema, may occur at any time during treatment with angiotensin-converting enzyme inhibitors, including enalapril. Advise patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, or tongue, or difficulty in swallowing or breathing) and to consult with the prescribing physician before taking more drug. \u2022Hypotension Caution patients to report lightheadedness, especially during the first few days of therapy. If actual syncope occurs, tell 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 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 to consult with the...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Heart Failure, Mortality Trials In a multicenter, placebo-controlled clinical trial, 2,569 patients with all degrees of symptomatic heart failure and ejection fraction \u226435 percent were randomized to placebo or enalapril and followed for up to 55 months (SOLVD-Treatment). Use of enalapril was associated with an 11 percent reduction in all-cause mortality and a 30 percent reduction in hospitalization for heart failure. Diseases that excluded patients from enrollment in the study included severe stable angina (>2 attacks/day), hemodynamically significant valvular or outflow tract obstruction, renal failure (creatinine >2.5 mg/dL), cerebral vascular disease (e.g., significant carotid artery disease), advanced pulmonary disease, malignancies, active myocarditis and constrictive pericarditis. The mortality benefit associated with enalapril does not appear to depend upon digitalis being present. A second multicenter trial used the SOLVD protocol for study of asymptomatic or minimally symptomatic patients. SOLVD-Prevention patients, who had left ventricular ejection fraction \u226435% and no history of symptomatic heart failure, were randomized to placebo (n = 2117) or enalapril (n = 2111)...",
  "brand_name": "Enalapril maleate",
  "manufacturer": "Wilshire Pharmaceuticals, Inc.",
  "application_number": "NDA208686",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251216",
  "set_id": "c7934b45-eb6b-44c1-bd2c-ef0fa10850c1",
  "has_boxed_warning": true,
  "boxed_labels": "56 of 66",
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 41177,
  "serious": 34572,
  "death": 4153,
  "hospitalization": 19861,
  "primary_suspect": 40774,
  "top_reactions": [
   [
    "Acute Kidney Injury",
    2411
   ],
   [
    "Diarrhoea",
    2215
   ],
   [
    "Drug Ineffective",
    2057
   ],
   [
    "Dyspnoea",
    1866
   ],
   [
    "Fatigue",
    1862
   ],
   [
    "Nausea",
    1837
   ],
   [
    "Drug Interaction",
    1785
   ],
   [
    "Off Label Use",
    1756
   ],
   [
    "Dizziness",
    1562
   ],
   [
    "Headache",
    1415
   ],
   [
    "Vomiting",
    1380
   ],
   [
    "Malaise",
    1341
   ],
   [
    "Pain",
    1296
   ],
   [
    "Hypertension",
    1286
   ],
   [
    "Asthenia",
    1259
   ]
  ],
  "by_year": {
   "2019": 4497,
   "2020": 3760,
   "2021": 3017,
   "2022": 2391,
   "2023": 2441,
   "2024": 2037,
   "2025": 1850,
   "2026": 895
  },
  "by_year_primary": {
   "2019": 4472,
   "2020": 3743,
   "2021": 2985,
   "2022": 2331,
   "2023": 2361,
   "2024": 1962,
   "2025": 1800,
   "2026": 849
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260423",
   "reason": "Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test",
   "firm": "JB Chemicals and Pharmaceuticals Ltd",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220316",
   "reason": "CGMP Deviations",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220316",
   "reason": "CGMP Deviations",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220316",
   "reason": "CGMP Deviations",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220316",
   "reason": "CGMP Deviations",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20140521",
   "reason": "Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.",
   "firm": "Valeant Pharmaceuticals North America LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 26,
  "nda": 3,
  "anda": 23,
  "first_approval": "19851224",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 39,
  "labeling_recent": 0,
  "sponsors": [
   "AIPING PHARM INC",
   "ALKEM LABS LTD",
   "AMNEAL",
   "ANNORA PHARMA",
   "APOTHECON",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA USA",
   "AZURITY"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/24/1985"
 },
 "trials": {
  "total": 177,
  "completed": 108,
  "terminated": 19,
  "with_results": 37,
  "industry": 48,
  "phase3": 43,
  "results_share": 0.3425925925925926,
  "terminated_share": 0.10734463276836158
 },
 "pubmed": {
  "rct": 817,
  "meta": 7,
  "recent_rct": 17,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "enalapril",
   "Vasotec",
   "Epaned"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2002117,
  "beneficiaries": 465867,
  "spend": 38200530.81999999,
  "by_brand": [
   {
    "brand": "Enalapril Maleate",
    "claims": 2000801,
    "per_claim": 17.415102596,
    "is_generic": true
   },
   {
    "brand": "Vasotec",
    "claims": 1253,
    "per_claim": 2608.6877574,
    "is_generic": false
   },
   {
    "brand": "Epaned",
    "claims": 63,
    "per_claim": 1391.9106349,
    "is_generic": false
   }
  ],
  "per_claim": 19.080069156797528
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "enalapril",
  "matched": "enalapril",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4611,
  "fills": 2002117,
  "per_million": 2303.0622086521416,
  "ratio": 0.8317457568521995,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "2,303 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "A boxed warning caps the overall grade at C (score 77 shown as 74)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 55,
   "letter": "D",
   "why": [
    "817 randomized trials and 7 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 34% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 0 Class III across 23 generic makers (-6)"
   ],
   "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 (23 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "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, diarrhoea, dyspnoea. How would we recognize and handle those?",
  "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.)"
 ]
}