{
 "query": "labetalol",
 "ingredient": "labetalol",
 "slug": "labetalol",
 "rxcui": "6185",
 "brands": [
  "Trandate"
 ],
 "names": [
  "labetalol",
  "labetalol hydrochloride"
 ],
 "classes": [
  {
   "id": "C07AG",
   "name": "Alpha and beta blocking agents"
  }
 ],
 "alternatives": [
  "carvedilol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 65,
   "INTRAVENOUS": 18
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Labetalol hydrochloride tablets, USP are indicated in the management of hypertension. Labetalol hydrochloride tablets, USP may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.",
  "contraindications": "CONTRAINDICATIONS Labetalol hydrochloride is contraindicated in bronchial asthma, overt cardiac failure, greater-than-first- degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product [see Warnings ] . Beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Hepatic Injury Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy. The hepatic injury is usually reversible, but hepatic necrosis and death have been reported. Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology. Similar hepatic events have been reported with a related research compound, dilevalol HCl, including two deaths. Dilevalol HCl is one of the four isomers of labetalol hydrochloride. Thus, for patients taking labetalol, periodic determination of suitable hepatic laboratory tests would be appropriate. Appropriate laboratory testing should be done at the first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, persistent anorexia, jaundice, right upper quadrant tenderness, or unexplained \u201cflu-like\u201d symptoms). If the patient has laboratory evidence of liver injury or jaundice, labetalol should be stopped and not restarted. Cardiac Failure Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure. Beta-blockade carries a potential hazard of further depressing myocardial contra...",
  "adverse_reactions": "ADVERSE REACTIONS Most adverse effects are mild and transient and occur early in the course of treatment. In controlled clinical trials of 3 to 4 months\u2019 duration, discontinuation of labetalol hydrochloride due to one or more adverse effects was required in 7% of all patients. In these same trials, other agents with solely beta- blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients. The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol hydrochloride and placebo is similar, causal relationship is uncertain. The rates are based on adverse reactions considered probably drug related by the investigator. If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%; nausea, 14%; fatigue, 11%), but the overall conclusions are unchanged. Labetalol Hydrochloride (N=227) % Placebo (N=98) % Propranolol (N=84) % Metop...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients As with all drugs with beta-blocking activity, certain advice to patients being treated with labetalol hydrochloride is warranted. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. While no incident of the abrupt withdrawal phenomenon (exacerbation of angina pectoris) has been reported with labetalol hydrochloride, dosing with labetalol hydrochloride should not be interrupted or discontinued without a physician\u2019s advice. Patients being treated with labetalol hydrochloride should consult a physician at any signs or symptoms of impending cardiac failure or hepatic dysfunction [see Warnings ] . Also, transient scalp tingling may occur, usually when treatment with labetalol hydrochloride is initiated [see Adverse Reactions ] .",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Labetalol Hydrochloride",
  "manufacturer": "Marlex Pharmaceuticals Inc",
  "application_number": "ANDA075215",
  "pharm_class_epc": [
   "beta-Adrenergic Blocker [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241007",
  "set_id": "28c91727-e5a8-48b3-a4df-d7bec8feda40",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4808,
  "serious": 3541,
  "death": 468,
  "hospitalization": 1659,
  "primary_suspect": 4797,
  "top_reactions": [
   [
    "Maternal Exposure During Pregnancy",
    454
   ],
   [
    "Drug Ineffective",
    371
   ],
   [
    "Off Label Use",
    330
   ],
   [
    "Foetal Exposure During Pregnancy",
    313
   ],
   [
    "Fatigue",
    271
   ],
   [
    "Premature Baby",
    249
   ],
   [
    "Exposure During Pregnancy",
    239
   ],
   [
    "Hypertension",
    239
   ],
   [
    "Diarrhoea",
    224
   ],
   [
    "Nausea",
    216
   ],
   [
    "Headache",
    210
   ],
   [
    "Premature Delivery",
    182
   ],
   [
    "Dyspnoea",
    173
   ],
   [
    "Blood Pressure Increased",
    166
   ],
   [
    "Low Birth Weight Baby",
    150
   ]
  ],
  "by_year": {
   "2019": 361,
   "2020": 341,
   "2021": 299,
   "2022": 313,
   "2023": 293,
   "2024": 435,
   "2025": 915,
   "2026": 543
  },
  "by_year_primary": {
   "2019": 361,
   "2020": 341,
   "2021": 299,
   "2022": 313,
   "2023": 292,
   "2024": 431,
   "2025": 910,
   "2026": 542
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240520",
   "reason": "Lack of Assurance of Sterility-The potential for incomplete crimp seals.",
   "firm": "Pfizer Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20180220",
   "reason": "Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.",
   "firm": "Hospira Inc. A Pfizer Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140516",
   "reason": "Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution",
   "firm": "Hospira Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 32,
  "nda": 5,
  "anda": 26,
  "first_approval": "19840801",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 49,
  "labeling_recent": 2,
  "sponsors": [
   "ADAPTIS",
   "AIPING PHARM INC",
   "ALVOGEN",
   "AMNEAL",
   "APOTHECON",
   "APPCO",
   "BAXTER HLTHCARE CORP",
   "CADILA PHARMS LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/01/1984"
 },
 "trials": {
  "total": 98,
  "completed": 50,
  "terminated": 12,
  "with_results": 14,
  "industry": 8,
  "phase3": 12,
  "results_share": 0.28,
  "terminated_share": 0.12244897959183673
 },
 "pubmed": {
  "rct": 211,
  "meta": 12,
  "recent_rct": 11,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "labetalol",
   "Trandate"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1035716,
  "beneficiaries": 240640,
  "spend": 30466480.45,
  "by_brand": [
   {
    "brand": "Labetalol HCl",
    "claims": 1035716,
    "per_claim": 29.41586347,
    "is_generic": true
   }
  ],
  "per_claim": 29.415863470294944
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1883,
  "fills": 1035716,
  "per_million": 1818.065956304624,
  "ratio": 0.6565904469071195,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,818 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "211 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 28% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 93,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 26 generic makers (-3)",
    "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 (26 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are maternal exposure during pregnancy, foetal exposure during pregnancy. 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 carvedilol? 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.)"
 ]
}