{
 "query": "propranolol",
 "ingredient": "propranolol",
 "slug": "propranolol",
 "rxcui": "8787",
 "brands": [
  "Hemangeol",
  "Inderal",
  "InnoPran"
 ],
 "names": [
  "propranolol",
  "propranolol hydrochloride"
 ],
 "classes": [
  {
   "id": "C07AA",
   "name": "Beta blocking agents, non-selective"
  }
 ],
 "alternatives": [
  "alprenolol",
  "bopindolol",
  "bupranolol",
  "carteolol",
  "mepindolol",
  "nadolol",
  "oxprenolol",
  "penbutolol",
  "pindolol",
  "sotalol",
  "tertatolol",
  "timolol"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 127,
   "INTRAVENOUS": 7
  },
  "boxed_warning": "",
  "indications_and_usage": "oral solution contains the beta-adrenergic blocker propranolol hydrochloride and is indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. HEMANGEOL oral solution is a beta-adrenergic blocker indicated for the treatment of proliferating infantile hemangioma requiring systemic therapy. ( 1 )",
  "contraindications": "is contraindicated in the following conditions: Premature infants with corrected age < 5 weeks Infants weighing less than 2 kg Known hypersensitivity to propranolol or any of the excipients [see Description (11) ] Asthma or history of bronchospasm Heart rate <80 beats per minute, greater than first degree heart block, or decompensated heart failure Blood pressure <50/30 mmHg Pheochromocytoma Premature infants with corrected age <5 weeks ( 4 ) Infants weighing less than 2 kg ( 4 ) Known hypersensitivity to propranolol or excipients ( 4 ) Asthma or history of bronchospasm ( 4 , 5.3 , 6 , 10 , 17 ) Bradycardia (<80 beats per minute), greater than first degree heart block, decompensated heart failure ( 4 , 5.2 , 5.4 , 10 , 17 ) Blood pressure <50/30 mmHg ( 4 , 5.2 , 10 , 17 ) Pheochromocytoma ( 4 )",
  "warnings_and_cautions": "Hypoglycemia: Administer during or after feeding. Do not use in patients who are not able to feed or are vomiting ( 4 , 5.1 , 6 , 10, 17 ) \u2022 Bradycardia and hypotension ( 4 , 5.2 , 17 ) \u2022 Bronchospasm: Avoid use in patients with asthma or lower respiratory infection ( 4 , 5.3 , 6 , 10 , 17 ) \u2022 Increased risk of stroke in PHACE syndrome ( 5.5 ) 5.1 Hypoglycemia HEMANGEOL prevents the response of endogenous catecholamines to correct hypoglycemia and masks the adrenergic warning signs of hypoglycemia, particularly tachycardia, palpitations and sweating. HEMANGEOL can cause hypoglycemia at any time during treatment. Risk is increased during a fasting period (e.g., poor oral food intake, infection, vomiting) or when glucose demands are increased (e.g., cold, stress, infections). Withhold the dose under these conditions. Hypoglycemia may present in the form of seizures, lethargy, or coma. Discontinue HEMANGEOL if hypoglycemia develops and treat appropriately Concomitant treatment with corticosteroids may increase the risk of hypoglycemia [ see Drug Interactions (7) ] . 5.2 Bradycardia and Hypotension HEMANGEOL may cause or worsen bradycardia or hypotension. In the studies of HEMANGEOL fo...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Hypoglycemia and related events, like hypoglycemic seizure [see Warnings and Precautions (5.1) ]. Bronchospasm [see Warnings and Precautions (5.3) ]. The most common adverse reactions to HEMANGEOL (occurring \u2265 10% of patients) were sleep disorders, aggravated respiratory tract infections, diarrhea, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pierre Fabre Pharmaceuticals, Inc. at 1-855-PFPHARM (737-4276) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION and Medication Guide 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 may not reflect the rates observed in clinical practice. Clinical Trials Experience with HEMANGEOL in Infants with proliferating infantile hemangioma In clinical trials for proliferating infantile hemangioma, the most frequently reported adverse reactions (>10%) in infants treated with HEMANGEOL were sleep disorders, aggravated respiratory tract infections such as bronchitis and ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-approved patient labeling (Medication Guide and Instructions for Use). Patient advice Advise parents or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instructions for using oral dosing syringe Instruct parents or caregivers on use of the oral dosing syringe. Risk of hypoglycemia Inform parents or caregivers that there is a risk of hypoglycemia while on HEMANGEOL. Hypoglycemia can occur at any time during treatment. Instruct caregivers to skip dosing in patients who are fasting (e.g., poor oral food intake, infection, vomiting), or when glucose demands are increased (e.g., cold, stress, infections). Instruct parents or caregivers how to recognize the signs of hypoglycemia. Tell them to discontinue HEMANGEOL if hypoglycemia develops and call their health care provider immediately or take the child to the emergency room. [see Warnings and Precautions 5.1] Cardiovascular risks Advise parents or caregivers that there is a potential risk for bradycardia, aggravation of pre-existing conduction disorders, and hypotension associated with the use of HEMANGEOL. Instruct them to contact their healthcare provider in case of fatigue, pa...",
  "spl_medguide": "MEDICATION GUIDE HEMANGEOL \u00ae (he-man je-ohl) (propranolol hydrochloride oral solution) What is the most important information I should know about HEMANGEOL? HEMANGEOL can cause serious side effects, including: Low blood sugar (hypoglycemia) , especially if your child is not taking feedings, or is vomiting. HEMANGEOL may make it more difficult to recognize the signs and symptoms of low blood sugar in your child. To help reduce the risk of low blood sugar with HEMANGEOL: Give HEMANGEOL during or shortly after feeding your child. Feed your child regularly during treatment. Tell your doctor if your child has a poor appetite. If your child is not taking feedings, for example, due to an illness or vomiting, do not give HEMANGEOL until your child is taking feedings normally again. If your child has any of the signs or symptoms of low blood sugar listed below during treatment with HEMANGEOL, stop giving your child HEMANGEOL, call your healthcare provider immediately or go to the emergency room. If the child is conscious, give him/her a drink of liquid containing sugar. Signs or symptoms of low blood sugar include: pale, blue or purple skin color, sweating, irritability, crying for no appar...",
  "clinical_studies": "randomized, double-blind study in 460 infants, aged 35 days to 5 months at inclusion, with proliferating infantile hemangiomas (IH) requiring systemic therapy (excluding life-threatening IH, function-threatening IH, and ulcerated IH with pain and lack of response to simple wound care measures) compared four regimens of HEMANGEOL (1.2 or 3.4 mg/kg/day in twice daily divided doses for 3 or 6 months; N=99-103 per group) to placebo (N=55). Clinical efficacy was evaluated by counting complete or nearly complete resolution of the target hemangioma, which was evaluated by blinded centralized independent assessments of photographs at Week 24 compared to baseline. Demographic patient characteristics and hemangioma characteristics were similar among the five regimens. For the whole population, 29% were male, 37% were in the lower age group (35-90 days), and 72% were Caucasian. Overall, 70% had a target hemangioma on the head, most commonly cheek (13%) and forehead (11%). The main reason for treatment discontinuation was the treatment inefficacy, which happened in 58% of patients randomized to placebo, 25-30% of patients randomized to HEMANGEOL for 3 months (mainly after the switch to placebo...",
  "brand_name": "HEMANGEOL",
  "manufacturer": "Pierre Fabre Pharmaceuticals, Inc.",
  "application_number": "NDA205410",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260625",
  "set_id": "b6f9dd2a-632b-87eb-70f0-b2064d7ed48a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 58609,
  "serious": 39699,
  "death": 5745,
  "hospitalization": 17137,
  "primary_suspect": 58295,
  "top_reactions": [
   [
    "Off Label Use",
    7921
   ],
   [
    "Drug Ineffective",
    5092
   ],
   [
    "Nausea",
    3710
   ],
   [
    "Fatigue",
    3392
   ],
   [
    "Headache",
    3303
   ],
   [
    "Product Use In Unapproved Indication",
    3242
   ],
   [
    "Diarrhoea",
    2789
   ],
   [
    "Product Use Issue",
    2633
   ],
   [
    "Dizziness",
    2550
   ],
   [
    "Vomiting",
    2224
   ],
   [
    "Toxicity To Various Agents",
    2135
   ],
   [
    "Dyspnoea",
    2053
   ],
   [
    "Pain",
    1933
   ],
   [
    "Fall",
    1789
   ],
   [
    "Insomnia",
    1779
   ]
  ],
  "by_year": {
   "2019": 5820,
   "2020": 5690,
   "2021": 4837,
   "2022": 5489,
   "2023": 5846,
   "2024": 6688,
   "2025": 5903,
   "2026": 3234
  },
  "by_year_primary": {
   "2019": 5818,
   "2020": 5685,
   "2021": 4807,
   "2022": 5417,
   "2023": 5794,
   "2024": 6634,
   "2025": 5861,
   "2026": 3192
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "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": "20140813",
   "reason": "CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 131,
  "nda": 6,
  "anda": 77,
  "first_approval": "19671113",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 49,
  "labeling_recent": 5,
  "sponsors": [
   "ACTAVIS ELIZABETH",
   "ADARE PHARMS INC",
   "AIPING PHARM INC",
   "AMTA",
   "ANDA REPOSITORY",
   "ANI PHARMS",
   "BAXTER HLTHCARE CORP",
   "CHARTWELL INJECTABLE"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/13/1967"
 },
 "trials": {
  "total": 437,
  "completed": 202,
  "terminated": 62,
  "with_results": 71,
  "industry": 45,
  "phase3": 65,
  "results_share": 0.35148514851485146,
  "terminated_share": 0.14187643020594964
 },
 "pubmed": {
  "rct": 1185,
  "meta": 64,
  "recent_rct": 47,
  "cochrane": [
   {
    "pmid": "28212466",
    "title": "WITHDRAWN: Propranolol for migraine prophylaxis",
    "year": "2017"
   },
   {
    "pmid": "15106196",
    "title": "Propranolol for migraine prophylaxis",
    "year": "2004"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 53229.53,
  "records": 159,
  "by_name": [
   [
    "Hemangeol",
    53229.53
   ]
  ],
  "names_checked": [
   "propranolol",
   "Hemangeol",
   "Inderal",
   "InnoPran"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4164278,
  "beneficiaries": 999700,
  "spend": 112120124.46000001,
  "by_brand": [
   {
    "brand": "Propranolol HCl",
    "claims": 3038695,
    "per_claim": 17.498075881,
    "is_generic": true
   },
   {
    "brand": "Propranolol HCl ER",
    "claims": 1123421,
    "per_claim": 42.655295192,
    "is_generic": false
   },
   {
    "brand": "Inderal La",
    "claims": 1324,
    "per_claim": 5459.2927115,
    "is_generic": false
   },
   {
    "brand": "Innopran XL",
    "claims": 584,
    "per_claim": 4658.8392295,
    "is_generic": false
   },
   {
    "brand": "Inderal XL",
    "claims": 254,
    "per_claim": 4252.3178346,
    "is_generic": false
   }
  ],
  "per_claim": 26.924265013046682
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "propranolol",
  "matched": "propranolol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15687,
  "fills": 4164278,
  "per_million": 3767.0395684437976,
  "ratio": 1.3604579004321269,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "3,767 FDA reports naming it as the suspect drug per million Medicare fills, 1.4x the median drug on this site (-3)",
    "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": 81,
   "letter": "B",
   "why": [
    "1185 randomized trials and 64 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "2 independent Cochrane review(s) exist",
    "Only 35% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 77 generic makers (-1)",
    "5 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $53,230 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 (77 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 91,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, fatigue. 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 alprenolol, bopindolol, bupranolol? 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.)"
 ]
}