{
 "query": "bisoprolol",
 "ingredient": "bisoprolol",
 "slug": "bisoprolol",
 "rxcui": "19484",
 "brands": [],
 "names": [
  "bisoprolol",
  "bisoprolol fumarate"
 ],
 "classes": [
  {
   "id": "C07AB",
   "name": "Beta blocking agents, selective"
  }
 ],
 "alternatives": [
  "acebutolol",
  "atenolol",
  "betaxolol",
  "celiprolol",
  "esmolol",
  "landiolol",
  "metoprolol",
  "nebivolol",
  "practolol",
  "talinolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 50
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Bisoprolol fumarate is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.",
  "contraindications": "CONTRAINDICATIONS Bisoprolol fumarate is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in the setting of congestive heart failure, and beta-blockade may result in further depression of myocardial contractility and precipitate more severe failure. In general, beta-blocking agents should be avoided in patients with overt congestive failure. However, in some patients with compensated cardiac failure it may be necessary to utilize them. In such a situation, they must be used cautiously. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blockers can, in some patients, precipitate cardiac failure. At the first signs or symptoms of heart failure, discontinuation of bisoprolol fumarate should be considered. In some cases, beta-blocker therapy can be continued while heart failure is treated with other drugs. Abrupt Cessation of Therapy Exacerbation of angina pectoris, and, in some instances, myocardial infarction or ventricular arrhythmia, have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Such patients should, therefore, be cautioned against interruption or disc...",
  "adverse_reactions": "ADVERSE REACTIONS Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies. In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5 to 20 mg of bisoprolol fumarate; 132 received placebo. Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy. The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5 to 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5 to 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related. Body System/Adverse Experience All Adver...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients, especially those with coronary artery disease, should be warned about discontinuing use of bisoprolol fumarate without a physician's supervision. Patients should also be advised to consult a physician if any difficulty in breathing occurs, or if they develop signs or symptoms of congestive heart failure or excessive bradycardia. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned that beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia, and bisoprolol fumarate should be used with caution. Patients should know how they react to this medicine before they operate automobiles and machinery or engage in other tasks requiring alertness.",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL STUDIES TIn two randomized double-blind placebo-controlled trials conducted in the U.S., reductions in systolic and diastolic blood pressure and heart rate 24 hours after dosing in patients with mild-to-moderate hypertension are shown below. In both studies, mean systolic/diastolic blood pressures at baseline were approximately 150/100 mm Hg, and mean heart rate was 76 bpm. Drug effect is calculated by subtracting the placebo effect from the overall change in blood pressure and heart rate. Sitting Systolic/Diastolic Pressure (BP) and Heart Rate (HR) Mean Decrease (\u0394) After 3 to 4 Weeks a Observed Total change from baseline minus placebo. Study A Bisoprolol Fumarate Placebo 5 mg 10 mg 20 mg n= 61 61 61 61 Total \u0394BP (mm Hg) 5.4/3.2 10.4/8.0 11.2/10.9 12.8/11.9 Drug Effect a - 5.0/4.8 5.8/7.7 7.4/8.7 Total \u0394HR (bpm) 0.5 7.2 8.7 11.3 Drug Effect a - 6.7 8.2 10.8 Study B Bisoprolol Fumarate Placebo 2.5 mg 10 mg n= 56 59 62 Total \u0394BP (mm Hg) 3.0/3.7 7.6/8.1 13.5/11.2 Drug Effect a - 4.6/4.4 10.5/7.5 Total \u0394HR (bpm) 1.6 3.8 10.7 Drug Effect a - 2.2 9.1 Blood pressure responses were seen within one week of treatment and changed little thereafter. They were sustained for 12 weeks a...",
  "brand_name": "Bisoprolol Fumarate",
  "manufacturer": "Rising Pharma Holdings, Inc.",
  "application_number": "ANDA219044",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250516",
  "set_id": "200ab93b-6ad3-46cb-8f57-db056a14de16",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 131798,
  "serious": 127888,
  "death": 14737,
  "hospitalization": 74405,
  "primary_suspect": 130602,
  "top_reactions": [
   [
    "Dyspnoea",
    8934
   ],
   [
    "Acute Kidney Injury",
    8182
   ],
   [
    "Fatigue",
    6710
   ],
   [
    "Diarrhoea",
    6345
   ],
   [
    "Nausea",
    5971
   ],
   [
    "Dizziness",
    5824
   ],
   [
    "Off Label Use",
    5583
   ],
   [
    "Drug Interaction",
    5434
   ],
   [
    "Fall",
    5406
   ],
   [
    "Hypotension",
    5401
   ],
   [
    "Vomiting",
    4801
   ],
   [
    "Asthenia",
    4795
   ],
   [
    "Anaemia",
    4656
   ],
   [
    "Malaise",
    4655
   ],
   [
    "Drug Ineffective",
    4561
   ]
  ],
  "by_year": {
   "2019": 16028,
   "2020": 15595,
   "2021": 12821,
   "2022": 11837,
   "2023": 7169,
   "2024": 5280,
   "2025": 10468,
   "2026": 5108
  },
  "by_year_primary": {
   "2019": 16008,
   "2020": 15561,
   "2021": 12732,
   "2022": 11492,
   "2023": 6990,
   "2024": 5168,
   "2025": 10190,
   "2026": 4991
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20171002",
   "reason": "Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity  was observed during the 18 month stability testing.",
   "firm": "Unichem Pharmaceuticals Usa Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 14,
  "nda": 1,
  "anda": 13,
  "first_approval": "19920731",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 5,
  "labeling_recent": 0,
  "sponsors": [
   "ALEMBIC",
   "AUROBINDO PHARMA",
   "HARMAN FINOCHEM",
   "MICRO LABS",
   "NATCO PHARMA USA",
   "NOVITIUM PHARMA",
   "PRINSTON INC",
   "RUBICON RESEARCH"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/31/1992"
 },
 "trials": {
  "total": 142,
  "completed": 78,
  "terminated": 9,
  "with_results": 24,
  "industry": 33,
  "phase3": 17,
  "results_share": 0.3076923076923077,
  "terminated_share": 0.06338028169014084
 },
 "pubmed": {
  "rct": 214,
  "meta": 7,
  "recent_rct": 22,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "bisoprolol"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1091996,
  "beneficiaries": 285708,
  "spend": 30247354.95,
  "by_brand": [
   {
    "brand": "Bisoprolol Fumarate",
    "claims": 1091996,
    "per_claim": 27.699144457,
    "is_generic": true
   }
  ],
  "per_claim": 27.6991444565731
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "bisoprolol",
  "matched": "bisoprolol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 20349,
  "fills": 1091996,
  "per_million": 18634.68364352983,
  "ratio": 6.729874248537966,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 83,
   "letter": "B",
   "why": [
    "18,635 FDA reports naming it as the suspect drug per million Medicare fills, 6.7x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Serious outcomes are 1.7x the FAERS average share (-2)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "214 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 31% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 13 generic makers (-1)"
   ],
   "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 (13 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dyspnoea, acute kidney injury, fatigue, diarrhoea. How would we recognize and handle those?",
  "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.)"
 ]
}