{
 "query": "sucralfate",
 "ingredient": "sucralfate",
 "slug": "sucralfate",
 "rxcui": "10156",
 "brands": [
  "Carafate"
 ],
 "names": [
  "sucralfate",
  "sucralfate malate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 67
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Sucralfate Oral Suspension is indicated in the short-term (up to 8 weeks) treatment of active duodenal ulcer.",
  "contraindications": "CONTRAINDICATIONS Sucralfate Oral Suspension is contraindicated for patients with known hypersensitivity reactions to the active substance or to any of the excipients.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Fatal complications, including pulmonary and cerebral emboli have occurred with inappropriate intravenous administration of Sucralfate Oral Suspension. Administer Sucralfate Oral Suspension only by the oral route. Do not administer intravenously.",
  "adverse_reactions": "ADVERSE REACTIONS Adverse reactions to sucralfate tablets in clinical trials were minor and only rarely led to discontinuation of the drug. In studies involving over 2700 patients treated with sucralfate, adverse effects were reported in 129 (4.7%). Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of the patients are listed below by body system: Gastrointestinal: diarrhea, dry mouth, flatulence, gastric discomfort, indigestion, nausea, vomiting Dermatological: pruritus, rash Nervous System: dizziness, insomnia, sleepiness, vertigo Other: back pain, headache Post-marketing cases of hypersensitivity have been reported with the use of Sucralfate Oral Suspension, including anaphylactic reactions, dyspnea, lip swelling, edema of the mouth, pharyngeal edema, pruritus, rash, swelling of the face and urticaria. Cases of bronchospasm, laryngeal edema and respiratory tract edema have been reported with an unknown oral formulation of sucralfate. Cases of hyperglycemia have been reported with sucralfate. Bezoars have been reported in patients treated with sucralfate. The majority of patients had underlying medical conditions that may predispos...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Sucralfate",
  "manufacturer": "Precision Dose, Inc.",
  "application_number": "ANDA209356",
  "pharm_class_epc": [
   "Aluminum Complex [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250128",
  "set_id": "0dc592e9-541c-4fac-8ab5-829d43521c01",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 19907,
  "serious": 13347,
  "death": 1840,
  "hospitalization": 7326,
  "primary_suspect": 19878,
  "top_reactions": [
   [
    "Nausea",
    1931
   ],
   [
    "Fatigue",
    1523
   ],
   [
    "Diarrhoea",
    1477
   ],
   [
    "Off Label Use",
    1336
   ],
   [
    "Headache",
    1264
   ],
   [
    "Pain",
    1183
   ],
   [
    "Drug Ineffective",
    1161
   ],
   [
    "Dyspnoea",
    1102
   ],
   [
    "Vomiting",
    1073
   ],
   [
    "Chronic Kidney Disease",
    987
   ],
   [
    "Weight Decreased",
    873
   ],
   [
    "Malaise",
    867
   ],
   [
    "Dizziness",
    839
   ],
   [
    "Death",
    827
   ],
   [
    "Constipation",
    805
   ]
  ],
  "by_year": {
   "2019": 2214,
   "2020": 1981,
   "2021": 1524,
   "2022": 1344,
   "2023": 1404,
   "2024": 1337,
   "2025": 1506,
   "2026": 697
  },
  "by_year_primary": {
   "2019": 2214,
   "2020": 1981,
   "2021": 1522,
   "2022": 1340,
   "2023": 1395,
   "2024": 1329,
   "2025": 1501,
   "2026": 697
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20231018",
   "reason": "Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.",
   "firm": "VistaPharm LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230830",
   "reason": "Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results",
   "firm": "VistaPharm LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 17,
  "nda": 2,
  "anda": 15,
  "first_approval": "19811030",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 18,
  "labeling_recent": 1,
  "sponsors": [
   "ABBVIE",
   "ABON PHARMS LLC",
   "AMNEAL",
   "AMNEAL PHARMS",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "GLENMARK PHARMS LTD",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/30/1981"
 },
 "trials": {
  "total": 30,
  "completed": 16,
  "terminated": 3,
  "with_results": 2,
  "industry": 4,
  "phase3": 4,
  "results_share": 0.125,
  "terminated_share": 0.1
 },
 "pubmed": {
  "rct": 292,
  "meta": 12,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "sucralfate",
   "Carafate"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2358705,
  "beneficiaries": 851256,
  "spend": 129780785.27,
  "by_brand": [
   {
    "brand": "Sucralfate",
    "claims": 2355764,
    "per_claim": 54.556769706,
    "is_generic": true
   },
   {
    "brand": "Carafate",
    "claims": 2941,
    "per_claim": 427.71548453,
    "is_generic": false
   }
  ],
  "per_claim": 55.02205034966221
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3527,
  "fills": 2358705,
  "per_million": 1495.3120462287568,
  "ratio": 0.5400285953841562,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 85,
   "letter": "B",
   "why": [
    "1,495 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x 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)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 50,
   "letter": "D",
   "why": [
    "292 randomized trials and 12 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 12% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 82,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 1 Class II, 0 Class III across 15 generic makers (-18)"
   ],
   "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": [
    "Generic versions approved (15 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 77,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are nausea, fatigue, diarrhoea. 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?",
  "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.)"
 ]
}