{
 "query": "primidone",
 "ingredient": "primidone",
 "slug": "primidone",
 "rxcui": "8691",
 "brands": [
  "Mysoline"
 ],
 "names": [
  "primidone"
 ],
 "classes": [
  {
   "id": "N03AA",
   "name": "Barbiturates and derivatives"
  }
 ],
 "alternatives": [
  "barbexaclone",
  "mephobarbital",
  "metharbital",
  "phenobarbital"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 26
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Primidone, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.",
  "contraindications": "CONTRAINDICATIONS Primidone is contraindicated in: 1) patients with porphyria and 2) patients who are hypersensitive to phenobarbital (see ACTIONS ).",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS The abrupt withdrawal of antiepileptic medication may precipitate status epilepticus. The therapeutic efficacy of a dosage regimen takes several weeks before it can be assessed. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including primidone, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for ...",
  "adverse_reactions": "ADVERSE REACTIONS The most frequently occurring early side effects are ataxia and vertigo. These tend to disappear with continued therapy, or with reduction of initial dosage. Occasionally, the following have been reported: nausea, anorexia, vomiting, fatigue, hyperirritability, emotional disturbances, sexual impotency, diplopia, nystagmus, drowsiness, and morbilliform skin eruptions. Granulocytopenia, agranulocytosis, and red-cell hypoplasia and aplasia, have been reported rarely. These and, occasionally, other persistent or severe side effects may necessitate withdrawal of the drug. Megaloblastic anemia may occur as a rare idiosyncrasy to primidone and to other anticonvulsants. The anemia responds to folic acid without necessity of discontinuing medication.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Suicidal Thinking and Behavior - Patients, their caregivers, and families should be counseled that AEDs, including primidone, may increase the risk of suicidal thoughts and behavior and should be advised 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 reported immediately to healthcare providers. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Usage in Pregnancy section). Please refer to the Primidone Tablets, USP Medication Guide provided with the product for more information.",
  "spl_medguide": "MEDICATION GUIDE Dispense with Medication Guide available at: www.lannett.com/med-guide/primidone Primidone Tablets, USP Read this Medication Guide before you start taking primidone tablets, USP and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. What is the most important information I should know about Primidone Tablets, USP? Do not stop taking primidone tablets, USP without first talking to your healthcare provider. Stopping primidone tablets, USP suddenly can cause serious problems. Primidone tablets, USP can cause serious side effects, including: 1. Like other antiepileptic drugs, primidone tablets, USP 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 viol...",
  "clinical_studies": "",
  "brand_name": "Primidone",
  "manufacturer": "Aphena Pharma Solutions - Tennessee, LLC",
  "application_number": "ANDA084903",
  "pharm_class_epc": [
   "Anti-epileptic Agent [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240109",
  "set_id": "ad8b50e2-e797-4326-a57e-d254da85b6b9",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 7916,
  "serious": 4994,
  "death": 685,
  "hospitalization": 2354,
  "primary_suspect": 7850,
  "top_reactions": [
   [
    "Drug Ineffective",
    681
   ],
   [
    "Fatigue",
    557
   ],
   [
    "Fall",
    511
   ],
   [
    "Off Label Use",
    489
   ],
   [
    "Tremor",
    460
   ],
   [
    "Diarrhoea",
    400
   ],
   [
    "Dizziness",
    358
   ],
   [
    "Nausea",
    356
   ],
   [
    "Drug Interaction",
    338
   ],
   [
    "Seizure",
    289
   ],
   [
    "Somnolence",
    289
   ],
   [
    "Headache",
    281
   ],
   [
    "Death",
    258
   ],
   [
    "Dyspnoea",
    258
   ],
   [
    "Asthenia",
    250
   ]
  ],
  "by_year": {
   "2019": 716,
   "2020": 729,
   "2021": 651,
   "2022": 559,
   "2023": 589,
   "2024": 566,
   "2025": 578,
   "2026": 311
  },
  "by_year_primary": {
   "2019": 716,
   "2020": 727,
   "2021": 651,
   "2022": 541,
   "2023": 573,
   "2024": 560,
   "2025": 572,
   "2026": 297
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260603",
   "reason": "Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.",
   "firm": "Amneal Pharmaceuticals, LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260501",
   "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260501",
   "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260427",
   "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260427",
   "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
   "firm": "Golden State Medical Supply Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260424",
   "reason": "Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.",
   "firm": "Lannett Company Inc.",
   "status": "Ongoing"
  }
 ],
 "recall_total": 6,
 "drugsfda": {
  "applications": 12,
  "nda": 1,
  "anda": 10,
  "first_approval": "19540308",
  "rems": false,
  "rems_last": "20111117",
  "labeling_supplements": 3,
  "labeling_recent": 0,
  "sponsors": [
   "AMNEAL PHARM",
   "CARNEGIE",
   "CHARTWELL RX",
   "HIKMA",
   "IMPAX LABS",
   "LANNETT",
   "OXFORD PHARMS",
   "RUBICON RESEARCH"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/08/1954"
 },
 "trials": {
  "total": 11,
  "completed": 6,
  "terminated": 3,
  "with_results": 4,
  "industry": 4,
  "phase3": 0,
  "results_share": 0.6666666666666666,
  "terminated_share": 0.2727272727272727
 },
 "pubmed": {
  "rct": 8,
  "meta": 1,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "primidone",
   "Mysoline"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1427565,
  "beneficiaries": 300098,
  "spend": 46460577.300000004,
  "by_brand": [
   {
    "brand": "Primidone",
    "claims": 1425514,
    "per_claim": 23.540665998,
    "is_generic": true
   },
   {
    "brand": "Mysoline",
    "claims": 2051,
    "per_claim": 6291.0913457,
    "is_generic": false
   }
  ],
  "per_claim": 32.54533229660296
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1429,
  "fills": 1427565,
  "per_million": 1001.0052081691553,
  "ratio": 0.361510788268682,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,001 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 (1.0x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 21,
   "letter": "F",
   "why": [
    "8 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "'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, 0 Class II, 6 Class III across 10 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 (10 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, fall. 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?",
  "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.)"
 ]
}