{
 "query": "nebivolol",
 "ingredient": "nebivolol",
 "slug": "nebivolol",
 "rxcui": "31555",
 "brands": [
  "Bystolic"
 ],
 "names": [
  "nebivolol",
  "nebivolol hydrochloride"
 ],
 "classes": [
  {
   "id": "C07AB",
   "name": "Beta blocking agents, selective"
  }
 ],
 "alternatives": [
  "acebutolol",
  "atenolol",
  "betaxolol",
  "bisoprolol",
  "celiprolol",
  "esmolol",
  "landiolol",
  "metoprolol",
  "practolol",
  "talinolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 43
  },
  "boxed_warning": "",
  "indications_and_usage": "Nebivolol is a beta-adrenergic blocking agent 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. (1.1) 1.1 Hypertension Nebivolol tablets are indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies (14.1) ]. Nebivolol tablets may be used alone or in combination with other antihypertensive agents [see Drug Interactions (7) ]. 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with nebivolol tablets. 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 one drug to a...",
  "contraindications": "Nebivolol is contraindicated in the following conditions: Severe bradycardia Heart block greater than first degree Patients with cardiogenic shock Decompensated cardiac failure Sick sinus syndrome (unless a permanent pacemaker is in place) Patients with severe hepatic impairment (Child-Pugh greater than B) Patients who are hypersensitive to any component of this product. Severe bradycardia (4) Heart block greater than first degree (4) Patients with cardiogenic shock (4) Decompensated cardiac failure (4) Sick sinus syndrome (unless a permanent pacemaker is in place) (4) Patients with severe hepatic impairment (Child-Pugh greater than B) (4) Hypersensitive to any component of this product (4)",
  "warnings_and_cautions": "Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue. (5.1) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor. (5.5) 5.1 Abrupt Cessation of Therapy Do not abruptly discontinue nebivolol therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with \u03b2-blockers. Myocardial infarction and ventricular arrhythmias may occur with or without preceding exacerbation of the angina pectoris. Caution patients without overt coronary artery disease against interruption or abrupt discontinuation of therapy. As with other \u03b2-blockers, when discontinuation of nebivolol is planned, carefully observe and advise patients to minimize physical activity. Taper nebivolol over 1 to 2 weeks when possible. If the angina worsens or acute coronary insufficiency develops, re-start nebivolol promptly, at least temporarily. 5.2 Angina and Acute Myocardial Infarction Nebivolol was not studied in patients with angina pectoris or who had a recent MI. 5.3 Bronchosp...",
  "warnings": "",
  "adverse_reactions": "Most common adverse reactions (6.1) : Headache, fatigue To report SUSPECTED ADVERSE REACTIONS, Contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Nebivolol has been evaluated for safety in patients with hypertension and in patients with heart failure. The observed adverse reaction profile was consistent with the pharmacology of the drug and the health status of the patients in the clinical trials. Adverse reactions reported for each of these patient populations are provided below. Excluded are adverse reactions considered too general to be informative and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. The data described below reflect worldwide clinical trial exposure to nebivolol in 6,545 patients, including 5,038 patients treated for hypertension and the remaining 1,507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received nebivolol for up to 24 months, with over 1,900 patients treated for at least 6 months, and approximately 1,300 p...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Hypoglycemia (5.5) 6/2023",
  "information_for_patients": "See FDA-approved patient labeling ( Patient Information ). Patient Advice Advise patients to take nebivolol regularly and continuously, as directed. Nebivolol can be taken with or without food. If a dose is missed, take the next scheduled dose only (without doubling it). Do not interrupt or discontinue nebivolol without consulting the physician. Patients should know how they react to this medicine before they operate automobiles, use machinery, or engage in other tasks requiring alertness. Advise patients to consult a physician if any difficulty in breathing occurs, or if they develop signs or symptoms of worsening congestive heart failure such as weight gain or increasing shortness of breath, or excessive bradycardia. Caution patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, that \u03b2-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Inform patients or caregivers that there is a risk of hypoglycemia when nebivolol 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 (5.5) ]. Tr...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Hypertension The antihypertensive effectiveness of nebivolol as monotherapy has been demonstrated in three randomized, double-blind, multi-center, placebo-controlled trials at doses ranging from 1.25 to 40 mg for 12 weeks (Studies 1, 2, and 3). A fourth placebo-controlled trial demonstrated additional antihypertensive effects of nebivolol at doses ranging from 5 to 20 mg when administered concomitantly with up to two other antihypertensive agents (ACE inhibitors, angiotensin II receptor antagonists, and thiazide diuretics) in patients with inadequate blood pressure control. The three monotherapy trials included a total of 2,016 patients (1,811 nebivolol, 205 placebo) with mild to moderate hypertension who had baseline diastolic blood pressures (DBP) of 95 to 109 mmHg. Patients received either nebivolol or placebo once daily for twelve weeks. Two of these monotherapy trials (Studies 1 and 2) studied 1,716 patients in the general hypertensive population with a mean age of 54 years, 55% males, 26% non-Caucasians, 7% diabetics and 6% genotyped as PMs. The third monotherapy trial (Study 3) studied 300 Black patients with a mean age of 51 years, 45% males, 14% diabetics, and 3% as P...",
  "brand_name": "Nebivolol",
  "manufacturer": "American Health Packaging",
  "application_number": "ANDA203828",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250516",
  "set_id": "5418f2b2-3e23-4e7a-b4df-36a1515c9a12",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 32423,
  "serious": 24856,
  "death": 2548,
  "hospitalization": 14008,
  "primary_suspect": 32167,
  "top_reactions": [
   [
    "Diarrhoea",
    1735
   ],
   [
    "Fatigue",
    1684
   ],
   [
    "Dyspnoea",
    1583
   ],
   [
    "Acute Kidney Injury",
    1550
   ],
   [
    "Nausea",
    1512
   ],
   [
    "Drug Ineffective",
    1490
   ],
   [
    "Off Label Use",
    1350
   ],
   [
    "Headache",
    1268
   ],
   [
    "Dizziness",
    1201
   ],
   [
    "Asthenia",
    1094
   ],
   [
    "Fall",
    1062
   ],
   [
    "Hypotension",
    985
   ],
   [
    "Hypertension",
    910
   ],
   [
    "Malaise",
    905
   ],
   [
    "Anaemia",
    900
   ]
  ],
  "by_year": {
   "2019": 3548,
   "2020": 2940,
   "2021": 2209,
   "2022": 2350,
   "2023": 2144,
   "2024": 2104,
   "2025": 1872,
   "2026": 1042
  },
  "by_year_primary": {
   "2019": 3546,
   "2020": 2930,
   "2021": 2190,
   "2022": 2277,
   "2023": 2119,
   "2024": 2045,
   "2025": 1830,
   "2026": 1019
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20251118",
   "reason": "Cross Contamination with Other Products",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241206",
   "reason": "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.",
   "firm": "Aurobindo Pharma USA Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20140512",
   "reason": "Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.",
   "firm": "Forest Pharmaceuticals Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 20,
  "nda": 1,
  "anda": 18,
  "first_approval": "20071217",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 3,
  "labeling_recent": 1,
  "sponsors": [
   "ALKEM LABS LTD",
   "ALLERGAN",
   "ANI PHARMS",
   "APOTEX",
   "AUROBINDO PHARMA LTD",
   "CADILA PHARMS LTD",
   "CHARTWELL RX",
   "GLENMARK PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/17/2007"
 },
 "trials": {
  "total": 128,
  "completed": 86,
  "terminated": 13,
  "with_results": 52,
  "industry": 70,
  "phase3": 24,
  "results_share": 0.6046511627906976,
  "terminated_share": 0.1015625
 },
 "pubmed": {
  "rct": 175,
  "meta": 13,
  "recent_rct": 7,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nebivolol",
   "Bystolic"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1428343,
  "beneficiaries": 357845,
  "spend": 96831734.61999999,
  "by_brand": [
   {
    "brand": "Nebivolol HCl",
    "claims": 1387136,
    "per_claim": 57.939234401,
    "is_generic": true
   },
   {
    "brand": "Bystolic",
    "claims": 41207,
    "per_claim": 399.49855049,
    "is_generic": false
   }
  ],
  "per_claim": 67.7930543433895
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4894,
  "fills": 1428343,
  "per_million": 3426.3478730248967,
  "ratio": 1.2374178579205122,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 98,
   "letter": "A",
   "why": [
    "3,426 FDA reports naming it as the suspect drug per million Medicare fills, 1.2x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 61,
   "letter": "D",
   "why": [
    "175 randomized trials and 13 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 18 generic makers (-2)",
    "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 (18 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 88,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, fatigue, dyspnoea, acute kidney injury. 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.)"
 ]
}