{
 "query": "phenytoin",
 "ingredient": "phenytoin",
 "slug": "phenytoin",
 "rxcui": "8183",
 "brands": [
  "Dilantin",
  "Phenytek"
 ],
 "names": [
  "phenytoin",
  "phenytoin sodium"
 ],
 "classes": [
  {
   "id": "N03AB",
   "name": "Hydantoin derivatives"
  }
 ],
 "alternatives": [
  "ethotoin",
  "fosphenytoin",
  "mephenytoin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 40,
   "INTRAMUSCULAR": 9,
   "INTRAVENOUS": 9
  },
  "boxed_warning": "",
  "indications_and_usage": "Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. Phenytoin oral suspension is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. ( 1 )",
  "contraindications": "Phenytoin oral suspension is contraindicated in patients with: A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5) ]. Reactions have included angioedema. A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8) ]. Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Hypersensitivity to phenytoin, its ingredients, or other hydantoins ( 4 , 5.5 ) A history of prior acute hepatotoxicity attributable to phenytoin ( 4 , 5.8 ) Coadministration with delavirdine ( 4 )",
  "warnings_and_cautions": "Withdrawal Precipitated Seizure: May precipitate status epilepticus. Dose reductions or discontinuation should be done gradually. ( 5.1 ) Suicidal Behavior and Ideation: Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. ( 5.2 ) Serious Dermatologic Reactions: Discontinue phenytoin oral suspension at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. ( 5.3 ) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: If signs or symptoms of hypersensitivity are present, evaluate the patient immediately. Discontinue if an alternative etiology cannot be established. ( 5.4 ) Cardiac Effects: Bradycardia and cardiac arrest have been reported. ( 5.6 ) Angioedema: Discontinue immediately if symptoms of angioedema such as facial, perioral, or upper airway swelling occur. ( 5.7 ) Hepatic Injury: Cases of acute hepatotoxicity have been reported with phenytoin oral suspension. If this occurs, immediately discontinue. ( 4 , 5.8 ) He...",
  "warnings": "",
  "adverse_reactions": "The following serious adverse reactions are described elsewhere in the labeling: Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.4) ] Hypersensitivity [see Warnings and Precautions (5.5) ] Cardiac Effects [see Warnings and Precautions (5.6) ] Angioedema [see Warnings and Precautions (5.7) ] Hepatic Injury [see Warnings and Precautions (5.8) ] Hematopoietic Complications [see Warnings and Precautions (5.9) ] Effects on Vitamin D and Bone [see Warnings and Precautions (5.10) ] Exacerbation of Porphyria [see Warnings and Precautions (5.12) ] Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.13) ] Hyperglycemia [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of phenytoin were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions ( 5.3 ) 2/2021",
  "information_for_patients": "Advise patients to read the FDA-approved patient labeling (Medication Guide). Administration Information Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage regimen, and of informing the physician of any clinical condition in which it is not possible to take the drug orally as prescribed, e.g., surgery, etc. Instruct patients to use an accurately calibrated measuring device when using this medication to ensure accurate dosing. Withdrawal of Antiepileptic Drugs Advise patients not to discontinue use of phenytoin without consulting with their healthcare provider. Phenytoin should normally be gradually withdrawn to reduce the potential for increased seizure frequency and status epilepticus [see Warnings and Precautions (5.1) ] . Suicidal Ideation and Behavior Counsel patients, their caregivers, and families that AEDs, including phenytoin, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be rep...",
  "spl_medguide": "This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: July 2021 Dispense with Medication Guide available at: https://www.taro.com/usa-medication-guides MEDICATION GUIDE Phenytoin (fen' i toin) Oral Suspension, USP What is the most important information I should know about phenytoin oral suspension? Do not stop taking phenytoin oral suspension without first talking to your healthcare provider. Stopping phenytoin oral suspension suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause you to have seizures more often or seizures that will not stop (status epilepticus). Like other antiepileptic drugs, phenytoin oral suspension may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: Thoughts about suicide or dying Attempts to commit suicide New or worse depression New or worse anxiety Feeling agitated or restless Panic attacks Trouble sleeping (insomnia) New or worse irritability Acting aggressive, being angry, or violent Acting on dangerous impulses An extreme increase in...",
  "clinical_studies": "",
  "brand_name": "Phenytoin",
  "manufacturer": "ATLANTIC BIOLOGICALS CORP.",
  "application_number": "ANDA040521",
  "pharm_class_epc": [
   "Anti-epileptic Agent [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250528",
  "set_id": "09daf485-3355-44cb-92af-072dd281e129",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 24654,
  "serious": 19924,
  "death": 2582,
  "hospitalization": 9087,
  "primary_suspect": 24347,
  "top_reactions": [
   [
    "Drug Ineffective",
    3640
   ],
   [
    "Seizure",
    3335
   ],
   [
    "Off Label Use",
    1668
   ],
   [
    "Drug Interaction",
    1551
   ],
   [
    "Toxicity To Various Agents",
    1507
   ],
   [
    "Drug Hypersensitivity",
    984
   ],
   [
    "Fall",
    896
   ],
   [
    "Dizziness",
    826
   ],
   [
    "Status Epilepticus",
    820
   ],
   [
    "Fatigue",
    778
   ],
   [
    "Headache",
    724
   ],
   [
    "Drug Reaction With Eosinophilia And Systemic Symptoms",
    694
   ],
   [
    "Nausea",
    686
   ],
   [
    "Pyrexia",
    657
   ],
   [
    "Rash",
    635
   ]
  ],
  "by_year": {
   "2019": 2604,
   "2020": 2593,
   "2021": 2051,
   "2022": 1634,
   "2023": 1488,
   "2024": 1293,
   "2025": 1218,
   "2026": 406
  },
  "by_year_primary": {
   "2019": 2600,
   "2020": 2579,
   "2021": 2034,
   "2022": 1569,
   "2023": 1414,
   "2024": 1251,
   "2025": 1164,
   "2026": 385
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20231027",
   "reason": "Failed Dissolution Specifications",
   "firm": "Amneal Pharmaceuticals of New York, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230530",
   "reason": "Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)",
   "firm": "Amneal Pharmaceuticals of New York, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20221114",
   "reason": "Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.",
   "firm": "Acella Pharmaceuticals, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20221114",
   "reason": "Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.",
   "firm": "Acella Pharmaceuticals, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class I",
   "date": "20200207",
   "reason": "Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20130817",
   "reason": "Failed dissolution specifications; 18 month CRT",
   "firm": "Amneal Pharmaceuticals of New York, LLC.",
   "status": "Terminated"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 43,
  "nda": 2,
  "anda": 35,
  "first_approval": "19530106",
  "rems": false,
  "rems_last": "20110527",
  "labeling_supplements": 55,
  "labeling_recent": 2,
  "sponsors": [
   "ACELLA",
   "ACTAVIS MID ATLANTIC",
   "AM REGENT",
   "AMNEAL PHARMS NY",
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "CHARTWELL MOLECULAR",
   "EPIC PHARMA LLC"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/06/1953"
 },
 "trials": {
  "total": 130,
  "completed": 80,
  "terminated": 25,
  "with_results": 28,
  "industry": 46,
  "phase3": 17,
  "results_share": 0.35,
  "terminated_share": 0.19230769230769232
 },
 "pubmed": {
  "rct": 243,
  "meta": 57,
  "recent_rct": 8,
  "cochrane": [
   {
    "pmid": "31425629",
    "title": "Phenobarbitone versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2019"
   },
   {
    "pmid": "31318037",
    "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2019"
   },
   {
    "pmid": "30350354",
    "title": "Oxcarbazepine versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2018"
   },
   {
    "pmid": "30091458",
    "title": "Sodium valproate versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2018"
   },
   {
    "pmid": "28240353",
    "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2017"
   },
   {
    "pmid": "28225152",
    "title": "Topical phenytoin for treating pressure ulcers",
    "year": "2017"
   },
   {
    "pmid": "27123830",
    "title": "Phenytoin versus valproate monotherapy for partial onset seizures and generalised onset tonic-clonic seizures: an individual participant data review",
    "year": "2016"
   },
   {
    "pmid": "26275105",
    "title": "Carbamazepine versus phenytoin monotherapy for epilepsy: an individual participant data review",
    "year": "2015"
   },
   {
    "pmid": "23970302",
    "title": "Phenytoin versus valproate monotherapy for partial onset seizures and generalised onset tonic-clonic seizures",
    "year": "2013"
   },
   {
    "pmid": "23728645",
    "title": "Oxcarbazepine versus phenytoin monotherapy for epilepsy",
    "year": "2013"
   },
   {
    "pmid": "23440786",
    "title": "Phenobarbitone versus phenytoin monotherapy for partial onset seizures and generalised onset tonic-clonic seizures",
    "year": "2013"
   },
   {
    "pmid": "22592741",
    "title": "Phenytoin for neuropathic pain and fibromyalgia in adults",
    "year": "2012"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "phenytoin",
   "Dilantin",
   "Phenytek"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 109247,
  "beneficiaries": 14772,
  "spend": 5107176.73,
  "by_brand": [
   {
    "brand": "Phenytoin",
    "claims": 101306,
    "per_claim": 34.722393442,
    "is_generic": true
   },
   {
    "brand": "Dilantin",
    "claims": 7472,
    "per_claim": 192.11568121,
    "is_generic": false
   },
   {
    "brand": "Dilantin-125",
    "claims": 428,
    "per_claim": 352.79123832,
    "is_generic": false
   },
   {
    "brand": "Phenytoin Sodium",
    "claims": 41,
    "per_claim": 75.778536585,
    "is_generic": true
   }
  ],
  "per_claim": 46.74889681181177
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "phenytoin",
  "matched": "phenytoin",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2800,
  "fills": 109247,
  "per_million": 25629.994416322646,
  "ratio": 9.256215061771169,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 70,
   "letter": "C",
   "why": [
    "25,630 FDA reports naming it as the suspect drug per million Medicare fills, 9.3x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (1.2x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 65,
   "letter": "C",
   "why": [
    "243 randomized trials and 57 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "12 independent Cochrane review(s) exist",
    "Only 35% 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": 68,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 2 Class II, 2 Class III across 35 generic makers (-23)",
    "2 label changes approved since 2021 (-4)",
    "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 (35 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "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 ethotoin, fosphenytoin, mephenytoin? 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.)"
 ]
}