{
 "query": "thiamine",
 "ingredient": "thiamine",
 "slug": "thiamine",
 "rxcui": "10454",
 "brands": [],
 "names": [
  "thiamine",
  "thiamine disulfide",
  "thiamine hydrochloride",
  "thiamine mononitrate",
  "thiamine pyrophosphate"
 ],
 "classes": [
  {
   "id": "A11DA",
   "name": "Vitamin B1, plain"
  }
 ],
 "alternatives": [
  "benphothiamine",
  "sulbutiamine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 127,
   "INTRAVENOUS": 23,
   "INTRAMUSCULAR": 21,
   "SUBLINGUAL": 2,
   "CUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke\u2019s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.",
  "contraindications": "CONTRAINDICATIONS A history of sensitivity to thiamine or to any of the ingredients in this drug is a contraindication. (See WARNINGS for further information.)",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Serious hypersensitivity/anaphylactic reactions can occur, especially after repeated administration. Deaths have resulted from IV or IM administration of thiamine (see ADVERSE REACTIONS ). Routine testing for hypersensitivity, in many cases, may not detect hypersensitivity. Nevertheless, a skin test should be performed on patients who are suspected of drug allergies or previous reactions to thiamine, and any positive responders should not receive thiamine by injection. If hypersensitivity to thiamine is suspected (based on histo...",
  "adverse_reactions": "ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. An occasional individual may develop a hypersensitivity or life-threatening anaphylactic reaction to thiamine, especially after repeated injections. Collapse and death have been reported. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness, tightness of the throat, angioneurotic edema, cyanosis, pulmonary edema, and hemorrhage into the gastrointestinal tract have also been reported. Some tenderness and induration may follow IM use (see WARNINGS ).",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Thiamine Hydrochloride",
  "manufacturer": "REMEDYREPACK INC.",
  "application_number": "ANDA080575",
  "pharm_class_epc": [],
  "route": [
   "INTRAMUSCULAR",
   "INTRAVENOUS"
  ],
  "effective_time": "20260831",
  "set_id": "0f38c4ba-cebf-49f4-b0a6-8a5d3ebf618c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 16549,
  "serious": 13801,
  "death": 2324,
  "hospitalization": 8222,
  "primary_suspect": 16463,
  "top_reactions": [
   [
    "Off Label Use",
    1295
   ],
   [
    "Drug Ineffective",
    1127
   ],
   [
    "Fatigue",
    1119
   ],
   [
    "Nausea",
    1084
   ],
   [
    "Diarrhoea",
    1015
   ],
   [
    "Dyspnoea",
    966
   ],
   [
    "Pain",
    918
   ],
   [
    "Headache",
    775
   ],
   [
    "Fall",
    767
   ],
   [
    "Dizziness",
    750
   ],
   [
    "Vomiting",
    741
   ],
   [
    "Malaise",
    701
   ],
   [
    "Condition Aggravated",
    699
   ],
   [
    "Confusional State",
    694
   ],
   [
    "Asthenia",
    662
   ]
  ],
  "by_year": {
   "2019": 1642,
   "2020": 1746,
   "2021": 1493,
   "2022": 1413,
   "2023": 1542,
   "2024": 1484,
   "2025": 1536,
   "2026": 785
  },
  "by_year_primary": {
   "2019": 1642,
   "2020": 1746,
   "2021": 1480,
   "2022": 1391,
   "2023": 1530,
   "2024": 1468,
   "2025": 1530,
   "2026": 769
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20210503",
   "reason": "Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.",
   "firm": "Mylan Institutional LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 23,
  "nda": 0,
  "anda": 18,
  "first_approval": "19720620",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [
   "ABRAXIS PHARM",
   "ASPIRO",
   "BEL MAR",
   "CAPLIN",
   "DELL LABS",
   "DR REDDYS",
   "EPIC PHARMA LLC",
   "EUGIA PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/20/1972"
 },
 "trials": {
  "total": 268,
  "completed": 166,
  "terminated": 19,
  "with_results": 27,
  "industry": 45,
  "phase3": 46,
  "results_share": 0.16265060240963855,
  "terminated_share": 0.0708955223880597
 },
 "pubmed": {
  "rct": 86,
  "meta": 33,
  "recent_rct": 30,
  "cochrane": [
   {
    "pmid": "23818100",
    "title": "Thiamine for prevention and treatment of Wernicke-Korsakoff Syndrome in people who abuse alcohol",
    "year": "2013"
   },
   {
    "pmid": "14974055",
    "title": "Thiamine for Wernicke-Korsakoff Syndrome in people at risk from alcohol abuse",
    "year": "2004"
   },
   {
    "pmid": "11405995",
    "title": "Thiamine for Alzheimer's disease",
    "year": "2001"
   },
   {
    "pmid": "10796655",
    "title": "Thiamine for Alzheimer's disease",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "thiamine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 273,
  "beneficiaries": 100,
  "spend": 3170.23,
  "by_brand": [
   {
    "brand": "Vitamin B-1",
    "claims": 273,
    "per_claim": 11.612564103,
    "is_generic": false
   }
  ],
  "per_claim": 11.612564102564102
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "thiamine",
  "matched": "thiamine",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "86 randomized trials and 33 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 16% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 18 generic makers (-0)"
   ],
   "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 (18 applications)",
    "2 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, nausea. 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 benphothiamine, sulbutiamine? 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.)"
 ]
}