{
 "query": "carvedilol",
 "ingredient": "carvedilol",
 "slug": "carvedilol",
 "rxcui": "20352",
 "brands": [
  "Coreg"
 ],
 "names": [
  "carvedilol",
  "carvedilol phosphate"
 ],
 "classes": [
  {
   "id": "C07AG",
   "name": "Alpha and beta blocking agents"
  }
 ],
 "alternatives": [
  "labetalol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 120
  },
  "boxed_warning": "",
  "indications_and_usage": "is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension. ( 1.3 ) 1.1 Heart Failure COREG CR is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) , Clinical Studies (14.1) ] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction COREG CR is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies (14.2) ] . 1.3 Hypertension COREG CR is \u0131ndicated for the management of essential hypertension [see Clinical Studies (14.3 , 14.4) ] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7....",
  "contraindications": "is contraindicated in the following conditions: Bronchial asthma or related bronchospastic conditions. Deaths from status asthmaticus have been reported following single doses of immediate-release carvedilol. Second- or third-degree AV block. Sick sinus syndrome. Severe bradycardia (unless a permanent pacemaker is in place). Patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. Such patients should first be weaned from intravenous therapy before initiating COREG CR. Patients with severe hepatic impairment. Patients with a history of a serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic reaction, angioedema) to carvedilol or any of the components of COREG CR. Bronchial asthma or related bronchospastic conditions. ( 4 ) Second- or third-degree AV block. ( 4 ) Sick sinus syndrome. ( 4 ) Severe bradycardia (unless permanent pacemaker in place). ( 4 ) Patients in cardiogenic shock or decompensated heart failure requiring the use of IV inotropic therapy. ( 4 ) Severe hepatic impairment. ( 2.4 , 4 ) History of serious hypersensitivity reaction (e.g., Stevens-Johnson syndrome, anaphylactic rea...",
  "warnings_and_cautions": "In clinical trials of COREG CR in subjects with hypertension (338 subjects) and in subjects with left ventricular dysfunction following a myocardial infarction or heart failure (187 subjects), the profile of adverse events observed with carvedilol phosphate was generally similar to that observed with the administration of immediate-release carvedilol. Therefore, the information included within this section is based on data from controlled clinical trials with COREG CR as well as immediate-release carvedilol. Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. ( 5.1 ) Bradycardia, hypotension, worsening heart failure/fluid retention may occur. Reduce the dose as needed. ( 5.2 , 5.3 , 5.4 ) Non-allergic bronchospasm (e.g., chronic bronchitis and emphysema): Avoid \u03b2-blockers. ( 4 ) However, if deemed necessary, use with caution and at lowest effective dose. ( 5.5 ) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor.( 5.6 ) 5.1 Cessation of Therapy Patients with coronary artery disease, who are being treated with COREG CR, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angi...",
  "warnings": "",
  "adverse_reactions": "The safety profile of COREG CR was similar to that observed for immediate-release carvedilol. Most common adverse events seen with immediate-release carvedilol ( 6.1 ): Heart failure and left ventricular dysfunction following myocardial infarction (\u226510%): Dizziness, fatigue, hypotension, diarrhea, hyperglycemia, asthenia, bradycardia, weight increase. Hypertension (\u22655%): Dizziness. To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics at 1-844-200-7910 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Carvedilol has been evaluated for safety in subjects with heart failure (mild, moderate, and severe), in subjects with left ventricular dysfunction following myocardial infarction, and in hypertensive subjects. The observed adverse event profile was consistent with the pharmacology of the drug and the health status of the subjects in the clinical trials. Adverse events reported fo...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients taking COREG CR should be advised of the following: Patients should not interrupt or discontinue using COREG CR without a phys\u0131cian's advice. Patients with heart failure should consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. Patients may experience a drop in blood pressure when standing, resulting in dizziness and, rarely, fainting. Patients should sit or lie down when these symptoms of lowered blood pressure occur. If experiencing dizziness or fatigue, patients should avoid driving or hazardous tasks. Patients should consult a physician if they experience dizziness or faintness, in case the dosage should be adjusted. Patients should not crush or chew COREG CR. Patients should take COREG CR with food. Inform patients or caregivers that there is a risk of hypoglycemia when Coreg is given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions (5.6) ] . Contact lens wearers may experience decreased lacrim...",
  "spl_medguide": "",
  "clinical_studies": "Support for the use of COREG CR extended-release capsules for the treatment of mild-to-severe heart failure and for patients with left ventricular dysfunction following myocardial infarction is based on the equivalence of pharmacokinetic and pharmacodynamic (\u03b2 1 -blockade) parameters between COREG CR and immediate-release carvedilol [see Clinical Pharmacology (12.2 , 12.3) ] . The clinical trials performed with immediate-release carvedilol in heart failure and left ventricular dysfunction following myocardial infarction are presented below. 14.1 Heart Failure A total of 6,975 subjects with mild-to-severe heart failure were evaluated in placebo-controlled and active-controlled trials of immediate-release carvedilol. Mild-to-Moderate Heart Failure Carvedilol was studied in 5 multicenter, placebo-controlled trials, and in 1 active-controlled trial (COMET trial) involving subjects with mild-to-moderate heart failure. Four U.S. multicenter, double-blind, placebo-controlled trials enrolled 1,094 subjects (696 randomized to carvedilol) with NYHA class II-III heart failure and ejection fraction less than or equal to 0.35. The vast majority were on digitalis, diuretics, and an ACE inhibitor...",
  "brand_name": "Coreg CR",
  "manufacturer": "Waylis Therapeutics LLC",
  "application_number": "NDA022012",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250425",
  "set_id": "d3625d78-6eb6-41fe-8f6f-664965c104c4",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 111245,
  "serious": 78800,
  "death": 13761,
  "hospitalization": 45137,
  "primary_suspect": 110874,
  "top_reactions": [
   [
    "Fatigue",
    7331
   ],
   [
    "Dyspnoea",
    6480
   ],
   [
    "Diarrhoea",
    6036
   ],
   [
    "Death",
    5141
   ],
   [
    "Dizziness",
    5115
   ],
   [
    "Nausea",
    5090
   ],
   [
    "Drug Ineffective",
    4751
   ],
   [
    "Acute Kidney Injury",
    4696
   ],
   [
    "Hypotension",
    4532
   ],
   [
    "Off Label Use",
    4513
   ],
   [
    "Chronic Kidney Disease",
    4176
   ],
   [
    "Asthenia",
    4043
   ],
   [
    "Fall",
    3620
   ],
   [
    "Headache",
    3546
   ],
   [
    "Renal Failure",
    3423
   ]
  ],
  "by_year": {
   "2019": 11351,
   "2020": 9496,
   "2021": 8514,
   "2022": 7215,
   "2023": 7014,
   "2024": 6863,
   "2025": 6733,
   "2026": 3417
  },
  "by_year_primary": {
   "2019": 11344,
   "2020": 9483,
   "2021": 8486,
   "2022": 7132,
   "2023": 6921,
   "2024": 6813,
   "2025": 6674,
   "2026": 3393
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250820",
   "reason": "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm",
   "firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250807",
   "reason": "CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250807",
   "reason": "CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250807",
   "reason": "CGMP Deviations: Presence of a nitrosamine,  N-Nitroso Carvedilol I  Impurity above the current Acceptable Intake Level.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250806",
   "reason": "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250806",
   "reason": "CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250228",
   "reason": "CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250228",
   "reason": "CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250228",
   "reason": "CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250228",
   "reason": "CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250122",
   "reason": "CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  }
 ],
 "recall_total": 17,
 "drugsfda": {
  "applications": 21,
  "nda": 2,
  "anda": 19,
  "first_approval": "19950914",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 29,
  "labeling_recent": 2,
  "sponsors": [
   "AUROBINDO PHARMA",
   "CHARTWELL MOLECULAR",
   "GLENMARK PHARMS LTD",
   "HIKMA",
   "IMPAX LABS INC",
   "LUPIN",
   "MLV",
   "PLIVA HRVATSKA DOO"
  ],
  "unapproved": false,
  "first_approval_fmt": "09/14/1995"
 },
 "trials": {
  "total": 276,
  "completed": 134,
  "terminated": 28,
  "with_results": 49,
  "industry": 79,
  "phase3": 43,
  "results_share": 0.3656716417910448,
  "terminated_share": 0.10144927536231885
 },
 "pubmed": {
  "rct": 409,
  "meta": 36,
  "recent_rct": 22,
  "cochrane": [
   {
    "pmid": "30372514",
    "title": "Carvedilol versus traditional, non-selective beta-blockers for adults with cirrhosis and gastroesophageal varices",
    "year": "2018"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "carvedilol",
   "Coreg"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 15885186,
  "beneficiaries": 3668668,
  "spend": 176876767.71999997,
  "by_brand": [
   {
    "brand": "Carvedilol",
    "claims": 15794645,
    "per_claim": 8.5605508804,
    "is_generic": true
   },
   {
    "brand": "Carvedilol ER",
    "claims": 85750,
    "per_claim": 372.24293598,
    "is_generic": false
   },
   {
    "brand": "Coreg Cr",
    "claims": 4102,
    "per_claim": 2123.2996977,
    "is_generic": false
   },
   {
    "brand": "Coreg",
    "claims": 689,
    "per_claim": 1504.0615965,
    "is_generic": false
   }
  ],
  "per_claim": 11.134699192064856
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "carvedilol",
  "matched": "carvedilol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 16880,
  "fills": 15885186,
  "per_million": 1062.6252660812409,
  "ratio": 0.3837647341294667,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,063 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 71,
   "letter": "C",
   "why": [
    "409 randomized trials and 36 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "1 independent Cochrane review(s) exist",
    "Only 37% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 15 Class II, 2 Class III across 19 generic makers (-7)",
    "2 label changes approved since 2021 (-4)"
   ],
   "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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (19 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, dyspnoea, diarrhoea, death. How would we recognize and handle those?",
  "Why this one over labetalol? 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.)"
 ]
}