{
 "query": "ramipril",
 "ingredient": "ramipril",
 "slug": "ramipril",
 "rxcui": "35296",
 "brands": [
  "Altace",
  "Vostally"
 ],
 "names": [
  "ramipril"
 ],
 "classes": [
  {
   "id": "C09AA",
   "name": "ACE inhibitors, plain"
  }
 ],
 "alternatives": [
  "benazepril",
  "captopril",
  "cilazapril",
  "enalapril",
  "fosinopril",
  "imidapril",
  "lisinopril",
  "moexipril",
  "perindopril",
  "quinapril",
  "spirapril",
  "trandolapril",
  "zofenopril"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 33
  },
  "boxed_warning": "WARNING: FETAL TOXICITY WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ). When pregnancy is detected, discontinue ramipril as soon as possible ( 5.6 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.6 ).",
  "indications_and_usage": "Ramipril capsules are an angiotensin converting enzyme (ACE) inhibitor 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. It may be used alone or in combination with thiazide diuretics ( 1.1 ). In patients 55 years or older at high risk of developing a major cardiovascular event, ramipril capsules are indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes ( 1.2 ). Ramipril capsules are indicated in stable patients who have demonstrated clinical signs of congestive heart failure post-myocardial infarction ( 1.3 ). 1.1 Hypertension Ramipril capsules are 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 this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, includi...",
  "contraindications": "Ramipril capsules are contraindicated in patients who are hypersensitive to this product or any other ACE inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Ramipril capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril capsules within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.1 )] . Do not co-administer ramipril capsules with aliskiren: in patients with diabetes Angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema ( 4 ). Ramipril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer ramipril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor ( 4 ). Do not co-administer aliskiren with ramipril in patients with diabetes ( 4 ).",
  "warnings_and_cautions": "Angioedema, increased risk in patients with a prior history ( 5.1 ) Hypotension and hyperkalemia ( 5.5 , 5.8 ) Renal impairment: monitor renal function during therapy ( 5.3 ) Avoid concomitant use of an ACE inhibitor and angiotensin blocker ( 5.7 ) Rare cholestatic jaundice and hepatic failure ( 5.2 ) Rare neutropenia and agranulocytosis ( 5.4 ) 5.1 Anaphylactoid and Possibly Related Reactions Presumably because drugs that act directly on the renin-angiotensin-aldosterone system (e.g., ACE inhibitors) affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving these drugs (including ramipril) may be subject to a variety of adverse reactions, some of them serious. Angioedema Angioedema may occur at any time during treatment with ACE inhibitors including ramipril. Head and Neck Angioedema Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor o...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions in patients with hypertension included headache, dizziness, fatigue, and cough ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 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, the 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. Hypertension Ramipril has been evaluated for safety in over 4,000 patients with hypertension; of these, 1,230 patients were studied in U.S. controlled trials, and 1,107 were studied in foreign controlled trials. Almost 700 of these patients were treated for at least one year. The overall incidence of reported adverse events was similar in ramipril and placebo patients. The most frequent clinical side effects (possibly or probably related to study drug) reported by patients receiving ramipril in placebo-controlled trials were: headache (5.4%), dizziness (2.2%), and fatigue or asthenia (2%), but only the last one was more comm...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "RECENT MAJOR CHANGES Warnings and Precautions, Angioedema ( 5.1 ) 2/2026",
  "information_for_patients": "Angioedema Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose of ramipril and in some cases, its onset may be delayed, presenting months or even years after initiation of therapy. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician. Neutropenia Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia. Symptomatic Hypotension Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ramipril if syncope (fainting) occurs, and to follow up with their health care providers. Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ramipril can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope. Pregnancy Tell female patients of childbearing age about the con...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension Ramipril has been compared with other ACE inhibitors, beta-blockers, and thiazide diuretics as monotherapy for hypertension. It was approximately as effective as other ACE inhibitors and as atenolol. Administration of ramipril to patients with mild to moderate hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is infrequent, although it can occur in patients who are salt- and/or volume-depleted [see Warnings and Precautions ( 5.5 )] . Use of ramipril in combination with thiazide diuretics gives a blood pressure lowering effect greater than that seen with either agent alone. In single-dose studies, doses of 5 mg to 20 mg of ramipril lowered blood pressure within 1 to 2 hours, with peak reductions achieved 3 to 6 hours after dosing. The antihypertensive effect of a single dose persisted for 24 hours. In longer term (4 to 12 weeks) controlled studies, once-daily doses of 2.5 mg to 10 mg were similar in their effect, lowering supine or standing systolic and diastolic blood pressures 24 hours after dosing by about 6/4 mmHg more than placebo. In compar...",
  "brand_name": "Ramipril",
  "manufacturer": "Zydus Pharmaceuticals USA Inc.",
  "application_number": "ANDA078832",
  "pharm_class_epc": [
   "Angiotensin Converting Enzyme Inhibitor [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260605",
  "set_id": "055bb582-67cd-425a-8823-d543c14305ce",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 112485,
  "serious": 105202,
  "death": 11970,
  "hospitalization": 58930,
  "primary_suspect": 111700,
  "top_reactions": [
   [
    "Fatigue",
    8159
   ],
   [
    "Dyspnoea",
    7759
   ],
   [
    "Nausea",
    7340
   ],
   [
    "Off Label Use",
    7072
   ],
   [
    "Diarrhoea",
    6934
   ],
   [
    "Drug Ineffective",
    6654
   ],
   [
    "Dizziness",
    6422
   ],
   [
    "Acute Kidney Injury",
    6208
   ],
   [
    "Vomiting",
    5988
   ],
   [
    "Pain",
    5862
   ],
   [
    "Headache",
    5561
   ],
   [
    "Asthenia",
    5198
   ],
   [
    "Arthralgia",
    5172
   ],
   [
    "General Physical Health Deterioration",
    5096
   ],
   [
    "Malaise",
    4986
   ]
  ],
  "by_year": {
   "2019": 12511,
   "2020": 11974,
   "2021": 9466,
   "2022": 8748,
   "2023": 7629,
   "2024": 8519,
   "2025": 8826,
   "2026": 3511
  },
  "by_year_primary": {
   "2019": 12504,
   "2020": 11954,
   "2021": 9413,
   "2022": 8519,
   "2023": 7510,
   "2024": 8363,
   "2025": 8699,
   "2026": 3463
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260824",
   "reason": "Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).",
   "firm": "Hikma Pharmaceuticals USA INC.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241023",
   "reason": "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20241023",
   "reason": "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20241023",
   "reason": "CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor",
   "firm": "Lupin Pharmaceuticals Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 20,
  "nda": 3,
  "anda": 17,
  "first_approval": "19910128",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 31,
  "labeling_recent": 1,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL MOLECULAR",
   "CHARTWELL RX",
   "CIPLA",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/28/1991"
 },
 "trials": {
  "total": 204,
  "completed": 136,
  "terminated": 21,
  "with_results": 47,
  "industry": 88,
  "phase3": 54,
  "results_share": 0.34558823529411764,
  "terminated_share": 0.10294117647058823
 },
 "pubmed": {
  "rct": 281,
  "meta": 2,
  "recent_rct": 15,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "ramipril",
   "Altace",
   "Vostally"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1541164,
  "beneficiaries": 378413,
  "spend": 18445468.380000003,
  "by_brand": [
   {
    "brand": "Ramipril",
    "claims": 1539276,
    "per_claim": 11.178824928,
    "is_generic": true
   },
   {
    "brand": "Altace",
    "claims": 1888,
    "per_claim": 655.81115466,
    "is_generic": false
   }
  ],
  "per_claim": 11.968530526277542
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "acetylsalicylic acid + atorvastatin + ramipril",
  "matched": "ramipril",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 20525,
  "fills": 1541164,
  "per_million": 13317.85585440615,
  "ratio": 4.8097138043676,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 51,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "13,318 FDA reports naming it as the suspect drug per million Medicare fills, 4.8x the median drug on this site (-14)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 41,
   "letter": "F",
   "why": [
    "281 randomized trials and 2 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 35% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 4 Class II, 0 Class III across 17 generic makers (-6)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (17 applications)",
    "13 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "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, dyspnoea, 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.)"
 ]
}