{
 "query": "atenolol",
 "ingredient": "atenolol",
 "slug": "atenolol",
 "rxcui": "1202",
 "brands": [
  "Tenormin"
 ],
 "names": [
  "atenolol"
 ],
 "classes": [
  {
   "id": "C07AB",
   "name": "Beta blocking agents, selective"
  }
 ],
 "alternatives": [
  "acebutolol",
  "betaxolol",
  "bisoprolol",
  "celiprolol",
  "esmolol",
  "landiolol",
  "metoprolol",
  "nebivolol",
  "practolol",
  "talinolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 100
  },
  "boxed_warning": "Cessation of Therapy With Atenolol Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension (see DOSAGE AND ADMINISTRATION ).",
  "indications_and_usage": "INDICATIONS AND USAGE Hypertension Atenolol tablets are 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 atenolol. 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 advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program\u2019s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded t...",
  "contraindications": "CONTRAINDICATIONS Atenolol tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure (see WARNINGS ). Atenolol tablets are contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product\u2019s components.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients with acute myocardial infarction, cardiac failure which is not promptly and effectively controlled by 80 mg of intravenous furosemide or equivalent therapy is a contraindication to beta-blocker treatment. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, atenolol should be withdrawn (see DOSAGE AND ADMINISTRATION ). Cessation of Therapy With Atenolol Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarc...",
  "adverse_reactions": "ADVERSE REACTIONS Most adverse effects have been mild and transient. The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (U.S. studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol and placebo is similar, causal relationship to atenolol is uncertain. Volunteered (U.S. Studies) Total - Volunteered and Elicited (Foreign + U.S. Studies) Atenolol (n = 164) Placebo (n = 206) Atenolol (n = 399) Placebo (n = 407) % % % % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2 0.2 Light-headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fatigue 3 1 6 5 Lethargy 1 0 3 0.7 Drowsiness 0.6 0 2 0.5 Depression 0.6 0.5 12 9 Dreaming 0 0 3 1 GASTROINTESTINAL Diarrhea 2 0 3 2 Nausea 4 1 3 1 RESPIRATORY (see WARNINGS ) Wheeziness 0 0 3 3 Dyspnea 0.6 1 6 4 Ac...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Atenolol",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA074056",
  "pharm_class_epc": [
   "beta-Adrenergic Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241022",
  "set_id": "23e96396-85d3-0d8e-e063-6394a90a614d",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 78071,
  "serious": 54053,
  "death": 6478,
  "hospitalization": 27073,
  "primary_suspect": 77792,
  "top_reactions": [
   [
    "Drug Ineffective",
    5214
   ],
   [
    "Fatigue",
    5109
   ],
   [
    "Diarrhoea",
    4598
   ],
   [
    "Nausea",
    4538
   ],
   [
    "Headache",
    3675
   ],
   [
    "Dyspnoea",
    3622
   ],
   [
    "Off Label Use",
    3517
   ],
   [
    "Pain",
    3420
   ],
   [
    "Dizziness",
    3387
   ],
   [
    "Arthralgia",
    3058
   ],
   [
    "Fall",
    2836
   ],
   [
    "Asthenia",
    2778
   ],
   [
    "Malaise",
    2674
   ],
   [
    "Acute Kidney Injury",
    2618
   ],
   [
    "Hypertension",
    2303
   ]
  ],
  "by_year": {
   "2019": 7832,
   "2020": 6490,
   "2021": 5028,
   "2022": 4201,
   "2023": 3572,
   "2024": 3312,
   "2025": 3206,
   "2026": 1453
  },
  "by_year_primary": {
   "2019": 7822,
   "2020": 6486,
   "2021": 5004,
   "2022": 4140,
   "2023": 3524,
   "2024": 3267,
   "2025": 3157,
   "2026": 1424
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20170306",
   "reason": "Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140805",
   "reason": "Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets  were noticeably thicker in appearance.",
   "firm": "Zydus Pharmaceuticals USA Inc",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 32,
  "nda": 2,
  "anda": 28,
  "first_approval": "19810819",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 34,
  "labeling_recent": 1,
  "sponsors": [
   "ABLE",
   "AIPING PHARM INC",
   "APOTHECON",
   "ASTRAZENECA",
   "AUROBINDO PHARMA",
   "CHARTWELL RX",
   "IPCA LABS LTD",
   "MYLAN"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/19/1981"
 },
 "trials": {
  "total": 135,
  "completed": 92,
  "terminated": 18,
  "with_results": 34,
  "industry": 45,
  "phase3": 31,
  "results_share": 0.3695652173913043,
  "terminated_share": 0.13333333333333333
 },
 "pubmed": {
  "rct": 833,
  "meta": 12,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "atenolol",
   "Tenormin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6461960,
  "beneficiaries": 1567617,
  "spend": 52821845.05,
  "by_brand": [
   {
    "brand": "Atenolol",
    "claims": 6459376,
    "per_claim": 7.7010822052,
    "is_generic": true
   },
   {
    "brand": "Tenormin",
    "claims": 2584,
    "per_claim": 1191.0446904,
    "is_generic": false
   }
  ],
  "per_claim": 8.174276078774861
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "atenolol",
  "matched": "atenolol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 7848,
  "fills": 6461960,
  "per_million": 1214.4921974137878,
  "ratio": 0.43861113613609576,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,214 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 (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 60,
   "letter": "D",
   "why": [
    "833 randomized trials and 12 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 37% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 99,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 28 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 (28 applications)",
    "10 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, nausea. How would we recognize and handle those?",
  "Why this one over acebutolol, betaxolol, bisoprolol? 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.)"
 ]
}