{
 "query": "metoprolol",
 "ingredient": "metoprolol",
 "slug": "metoprolol",
 "rxcui": "6918",
 "brands": [
  "Lopressor",
  "Kapspargo",
  "Toprol"
 ],
 "names": [
  "metoprolol",
  "metoprolol fumarate",
  "metoprolol succinate",
  "metoprolol tartrate"
 ],
 "classes": [
  {
   "id": "C07AB",
   "name": "Beta blocking agents, selective"
  }
 ],
 "alternatives": [
  "acebutolol",
  "atenolol",
  "betaxolol",
  "bisoprolol",
  "celiprolol",
  "esmolol",
  "landiolol",
  "nebivolol",
  "practolol",
  "talinolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 324,
   "INTRAVENOUS": 22
  },
  "boxed_warning": "WARNING: ISCHEMIC HEART DISEASE Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. When discontinuing chronically administered TOPROL-XL, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of 1 - 2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, TOPROL-XL administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Warn patients against interruption or discontinuation of therapy without the physician\u2019s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue TOPROL-XL therapy abruptly even in patients treated only for hypertension (5.1). WARNING: ISCHEMIC HEART DISEASE See full prescribing information for complete boxed warning. Following abrupt cessation of therapy with beta-blocking agents, exacerbations of angina pectoris and myocardial infarction have occurred. Warn patients against interruption...",
  "indications_and_usage": "TOPROL-XL, metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. TOPROL-XL is indicated for the treatment of: \u2022 Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) \u2022 Angina Pectoris. (1.2) \u2022 Heart Failure - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3) 1.1 Hypertension TOPROL-XL is indicated for the treatment of hypertension, 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 including metoprolol. 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 advic...",
  "contraindications": "is contraindicated in severe bradycardia, second or third degree heart block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product. \u2022 Known hypersensitivity to product components. (4) \u2022 Severe bradycardia. (4) \u2022 Heart block greater than first degree. (4) \u2022 Cardiogenic shock. (4) \u2022 Decompensated cardiac failure. (4) \u2022 Sick sinus syndrome without a pacemaker. (4)",
  "warnings_and_cautions": "\u2022 Heart Failure: Worsening cardiac failure may occur. (5.2) \u2022 Bronchospastic Disease: Avoid beta blockers. (5.3) \u2022 Pheochromocytoma: If required, first initiate therapy with an alpha blocker. (5.4) \u2022 Major Surgery: Avoid initiation of high-dose extended-release metoprolol in patients undergoing non-cardiac surgery because it has been associated with bradycardia, hypotension, stroke and death. Do not routinely withdraw chronic beta blocker therapy prior to surgery. ( 5.5 , 6.1 ) \u2022 Diabetes and Hypoglycemia: May mask tachycardia occurring with hypoglycemia. (5.6) \u2022 Patients with Hepatic Impairment: (5.7) \u2022 Thyrotoxicosis: Abrupt withdrawal in patients with thyrotoxicosis might precipitate a thyroid storm. (5.8) \u2022 Anaphylactic Reactions: Patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction. (5.9) \u2022 Peripheral Vascular Disease: Can aggravate symptoms of arterial insufficiency. (5.10) \u2022 Calcium Channel Blockers: Because of significant inotropic and chronotropic effects in patients treated with beta-blockers and calcium channel blockers of the verapamil and diltiazem type, caution should be exercised in patients treated with these agents concomit...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are described elsewhere in labeling: \u2022 Worsening angina or myocardial infarction [see Warnings and Precautions (5) ]. \u2022 Worsening heart failure [see Warnings and Precautions (5) ]. \u2022 Worsening AV block [see Contraindications (4) ]. Most common adverse reactions: tiredness, dizziness, depression, shortness of breath, bradycardia, hypotension, diarrhea, pruritus, rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aralez Pharmaceuticals US Inc. at 1-866-207-6592 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Hypertension and Angina: Most adverse reactions have been mild and transient. The most common (>2%) adverse reactions are tiredness, dizziness, depression, diarrhea...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise patients to take TOPROL-XL regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue TOPROL-XL without consulting the physician. Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient\u2019s response to therapy with TOPROL-XL has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking TOPROL-XL. Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. TOPROL-XL and PLENDIL are trademarks of the AstraZeneca group of companies. Manufactured for: Aralez Pharmaceuticals US Inc. 400 Alexander Park Drive Princeton, NJ 08540-6539 \u00a9 Aralez Pharmaceuticals US Inc. 2016",
  "spl_medguide": "",
  "clinical_studies": "In five controlled studies in normal healthy subjects, the same daily doses of TOPROL-XL and immediate-release metoprolol were compared in terms of the extent and duration of beta 1 - blockade produced. Both formulations were given in a dose range equivalent to 100-400 mg of immediate-release metoprolol per day. In these studies, TOPROL-XL was administered once a day and immediate-release metoprolol was administered once to four times a day. A sixth controlled study compared the beta 1 -blocking effects of a 50 mg daily dose of the two formulations. In each study, beta 1 -blockade was expressed as the percent change from baseline in exercise heart rate following standardized submaximal exercise tolerance tests at steady state. TOPROL-XL administered once a day, and immediate-release metoprolol administered once to four times a day, provided comparable total beta 1 -blockade over 24 hours (area under the beta 1 -blockade versus time curve) in the dose range 100-400 mg. At a dosage of 50 mg once daily, TOPROL-XL produced significantly higher total beta 1 -blockade over 24 hours than immediate-release metoprolol. For TOPROL-XL, the percent reduction in exercise heart rate was relative...",
  "brand_name": "TOPROL XL",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "NDA019962",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20180220",
  "set_id": "a07891a5-152e-4a38-8179-e05a90458a7d",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 297984,
  "serious": 202901,
  "death": 31729,
  "hospitalization": 112558,
  "primary_suspect": 296918,
  "top_reactions": [
   [
    "Fatigue",
    20820
   ],
   [
    "Diarrhoea",
    17448
   ],
   [
    "Dyspnoea",
    16849
   ],
   [
    "Nausea",
    16061
   ],
   [
    "Drug Ineffective",
    15051
   ],
   [
    "Off Label Use",
    14374
   ],
   [
    "Dizziness",
    13828
   ],
   [
    "Death",
    12784
   ],
   [
    "Headache",
    11360
   ],
   [
    "Asthenia",
    10959
   ],
   [
    "Fall",
    10931
   ],
   [
    "Pain",
    10378
   ],
   [
    "Pneumonia",
    8692
   ],
   [
    "Acute Kidney Injury",
    8610
   ],
   [
    "Hypotension",
    8192
   ]
  ],
  "by_year": {
   "2019": 30026,
   "2020": 27436,
   "2021": 23457,
   "2022": 21358,
   "2023": 20411,
   "2024": 19770,
   "2025": 20397,
   "2026": 10238
  },
  "by_year_primary": {
   "2019": 30004,
   "2020": 27387,
   "2021": 23330,
   "2022": 21117,
   "2023": 20204,
   "2024": 19615,
   "2025": 20230,
   "2026": 10165
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260129",
   "reason": "Failed Dissolution Specifications",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260129",
   "reason": "Failed Dissolution Specifications",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260129",
   "reason": "Failed Dissolution Specifications",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260129",
   "reason": "Failed Dissolution Specifications",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240506",
   "reason": "Presence of Foreign Substance: metal in tablet",
   "firm": "Rubicon Research Private Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220126",
   "reason": "CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.",
   "firm": "CARDINAL HEALTHCARE",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20211231",
   "reason": "Complaint received of foreign matter (metal) embedded in tablet.",
   "firm": "Rubicon Research Private Limited",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210909",
   "reason": "Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.",
   "firm": "Aurobindo Pharma USA Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20181015",
   "reason": "Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.",
   "firm": "Baxter Healthcare Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180423",
   "reason": "Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140523",
   "reason": "Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131213",
   "reason": "Failed Dissolution Specification; 12-Month stability interval.",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 12,
 "drugsfda": {
  "applications": 68,
  "nda": 7,
  "anda": 60,
  "first_approval": "19780807",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 47,
  "labeling_recent": 8,
  "sponsors": [
   "ACCORD HLTHCARE",
   "ACTAVIS ELIZABETH",
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "ALEMBIC PHARMS LTD",
   "ALICORA",
   "ALKEM LABS LTD",
   "AM REGENT"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/07/1978"
 },
 "trials": {
  "total": 351,
  "completed": 210,
  "terminated": 45,
  "with_results": 84,
  "industry": 123,
  "phase3": 56,
  "results_share": 0.4,
  "terminated_share": 0.1282051282051282
 },
 "pubmed": {
  "rct": 792,
  "meta": 27,
  "recent_rct": 24,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "metoprolol",
   "Lopressor",
   "Kapspargo",
   "Toprol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 48208301,
  "beneficiaries": 11645895,
  "spend": 570935558.56,
  "by_brand": [
   {
    "brand": "Metoprolol Succinate",
    "claims": 32213092,
    "per_claim": 14.15483751,
    "is_generic": true
   },
   {
    "brand": "Metoprolol Tartrate",
    "claims": 15912137,
    "per_claim": 6.7259602579,
    "is_generic": true
   },
   {
    "brand": "Kapspargo Sprinkle",
    "claims": 44309,
    "per_claim": 59.74767993,
    "is_generic": false
   },
   {
    "brand": "Toprol XL",
    "claims": 37862,
    "per_claim": 131.61475305,
    "is_generic": false
   },
   {
    "brand": "Lopressor",
    "claims": 901,
    "per_claim": 343.52584906,
    "is_generic": false
   }
  ],
  "per_claim": 11.843096452621301
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "metoprolol",
  "matched": "metoprolol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 50010,
  "fills": 48208301,
  "per_million": 1037.3732108916263,
  "ratio": 0.37464501097268255,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "1,037 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 (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "792 randomized trials and 27 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 40% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 9 Class II, 1 Class III across 60 generic makers (-6)",
    "8 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "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 (60 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "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, 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 acebutolol, atenolol, betaxolol? 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.)"
 ]
}