{
 "query": "phenobarbital",
 "ingredient": "phenobarbital",
 "slug": "phenobarbital",
 "rxcui": "8134",
 "brands": [
  "Sezaby"
 ],
 "names": [
  "phenobarbital",
  "phenobarbital sodium"
 ],
 "classes": [
  {
   "id": "N03AA",
   "name": "Barbiturates and derivatives"
  }
 ],
 "alternatives": [
  "barbexaclone",
  "mephobarbital",
  "metharbital",
  "primidone"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 76,
   "INTRAMUSCULAR": 13,
   "INTRAVENOUS": 4
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Sedative Anticonvulsant- For the treatment of generalized and partial seizures.",
  "contraindications": "CONTRAINDICATIONS Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS 1. Habit-Forming Phenobarbital may be habit-forming. Tolerance and psychological and physical dependence may occur with continued use ( see Drug Abuse and Dependence and Pharmacokinetics under Clinical Pharmacology ). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. Abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time ( see Drug Abuse and Dependence ). 2. Acute or Chronic Pain Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could...",
  "adverse_reactions": "ADVERSE REACTIONS The following adverse reactions have been reported: CNS Depression- Residual sedation or \"hangover,\" drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children. Like other nonanalgesic hypnotic drugs, barbiturates such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs. Symptoms may last for days after the drug is discontinued. Respiratory/Circulatory- Respiratory depression, apnea, circulatory collapse. Allergic- Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticar...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE Controlled Substance Phenobarbital is a Schedule IV drug. Dependence Barbiturates may be habit-forming. Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. Daily administration in excess of 400 mg of pentobarbital or secobarbital for approximately 90 days is likely to produce some degree of physical dependence. A dosage of 600 to 800 mg taken for at least 35 days is sufficient to produce withdrawal seizures. The average daily dose for the barbiturate addict is usually about 1.5 g. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than twofold. As this occurs, the margin between intoxicating dosage and fatal dosage becomes smaller. Symptoms of acute intoxication with barbiturates include unsteady gait, slurred speech, and sustained nystagmus. Mental signs of chronic intoxication include confusion, poor judgment, irritability, insomnia, and somatic complaints. Symptoms of barbiturate dependence are similar to those of chronic alcoholism. If an individual ...",
  "controlled_substance": "Controlled Substance Phenobarbital is a Schedule IV drug.",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients The following information and instructions should be given to patients receiving barbiturates. The use of barbiturates carries with it an associated risk of psychological and/or physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician. Barbiturates may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly. Alcohol should not be consumed while taking barbiturates. The concurrent use of the barbiturates with other CNS depressants (eg, alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS-depressant effects.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Phenobarbital",
  "manufacturer": "Pharmaceutical Associates, Inc.",
  "application_number": "",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20220105",
  "set_id": "037c7532-7688-44fd-8c76-d25e8adf5fb5",
  "has_boxed_warning": false,
  "controlled": true,
  "mentions_rems": false
 },
 "faers": {
  "total": 14643,
  "serious": 12675,
  "death": 1764,
  "hospitalization": 6016,
  "primary_suspect": 14544,
  "top_reactions": [
   [
    "Drug Ineffective",
    2482
   ],
   [
    "Seizure",
    1920
   ],
   [
    "Off Label Use",
    1610
   ],
   [
    "Drug Interaction",
    650
   ],
   [
    "Toxicity To Various Agents",
    610
   ],
   [
    "Status Epilepticus",
    541
   ],
   [
    "Epilepsy",
    510
   ],
   [
    "Multiple-Drug Resistance",
    490
   ],
   [
    "Somnolence",
    476
   ],
   [
    "Condition Aggravated",
    445
   ],
   [
    "Fall",
    427
   ],
   [
    "Product Use In Unapproved Indication",
    421
   ],
   [
    "Pyrexia",
    409
   ],
   [
    "Hypotension",
    387
   ],
   [
    "Product Use Issue",
    367
   ]
  ],
  "by_year": {
   "2019": 1344,
   "2020": 1283,
   "2021": 1337,
   "2022": 1172,
   "2023": 1311,
   "2024": 1171,
   "2025": 1004,
   "2026": 406
  },
  "by_year_primary": {
   "2019": 1344,
   "2020": 1282,
   "2021": 1328,
   "2022": 1153,
   "2023": 1290,
   "2024": 1149,
   "2025": 987,
   "2026": 399
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220314",
   "reason": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.",
   "firm": "Vitae Enim Vitae Scientific, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20220314",
   "reason": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.",
   "firm": "Vitae Enim Vitae Scientific, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161003",
   "reason": "Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point",
   "firm": "West-Ward Pharmaceuticals Corp.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 1,
  "nda": 1,
  "anda": 0,
  "first_approval": "20221117",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "SUN PHARM INDS INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "11/17/2022"
 },
 "trials": {
  "total": 67,
  "completed": 35,
  "terminated": 19,
  "with_results": 20,
  "industry": 16,
  "phase3": 15,
  "results_share": 0.5714285714285714,
  "terminated_share": 0.2835820895522388
 },
 "pubmed": {
  "rct": 114,
  "meta": 26,
  "recent_rct": 9,
  "cochrane": [
   {
    "pmid": "36924438",
    "title": "Postnatal phenobarbital for the prevention of intraventricular haemorrhage in preterm infants",
    "year": "2023"
   },
   {
    "pmid": "23943189",
    "title": "Postnatal phenobarbital for the prevention of intraventricular haemorrhage in preterm infants",
    "year": "2013"
   },
   {
    "pmid": "20091502",
    "title": "Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage",
    "year": "2010"
   },
   {
    "pmid": "17943755",
    "title": "Postnatal phenobarbital for the prevention of intraventricular hemorrhage in preterm infants",
    "year": "2007"
   },
   {
    "pmid": "17443599",
    "title": "Antenatal phenobarbital for reducing neonatal jaundice after red cell isoimmunization",
    "year": "2007"
   },
   {
    "pmid": "12917885",
    "title": "Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage",
    "year": "2003"
   },
   {
    "pmid": "11405952",
    "title": "Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage",
    "year": "2001"
   },
   {
    "pmid": "10796164",
    "title": "Phenobarbital prior to preterm birth for preventing neonatal periventricular haemorrhage",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "phenobarbital",
   "Sezaby"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 399060,
  "beneficiaries": 51334,
  "spend": 11814207.6,
  "by_brand": [
   {
    "brand": "Phenobarbital",
    "claims": 398979,
    "per_claim": 29.373000885,
    "is_generic": true
   },
   {
    "brand": "Phenobarbital Sodium",
    "claims": 81,
    "per_claim": 1172.8034568,
    "is_generic": true
   }
  ],
  "per_claim": 29.605090963764848
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "phenobarbital",
  "matched": "phenobarbital",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2535,
  "fills": 399060,
  "per_million": 6352.428206284769,
  "ratio": 2.2941652146590497,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 78,
   "letter": "B",
   "why": [
    "6,352 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 54,
   "letter": "D",
   "why": [
    "114 randomized trials and 26 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "8 independent Cochrane review(s) exist",
    "28% of registered trials were terminated, withdrawn, or suspended (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 3 Class II, 0 Class III (-9)",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "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": 70,
   "letter": "C",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "C",
 "questions": [
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are seizure, drug interaction. 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 barbexaclone, mephobarbital, metharbital? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}