{
 "query": "linaclotide",
 "ingredient": "linaclotide",
 "slug": "linaclotide",
 "rxcui": "1307404",
 "brands": [
  "Linzess"
 ],
 "names": [
  "linaclotide"
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": {
  "total": 26128,
  "serious": 9524,
  "death": 1105,
  "hospitalization": 4002,
  "primary_suspect": 26091,
  "top_reactions": [
   [
    "Diarrhoea",
    4451
   ],
   [
    "Drug Ineffective",
    4403
   ],
   [
    "Off Label Use",
    3379
   ],
   [
    "Constipation",
    1992
   ],
   [
    "Nausea",
    1437
   ],
   [
    "Fatigue",
    1199
   ],
   [
    "Abdominal Distension",
    1120
   ],
   [
    "Headache",
    1053
   ],
   [
    "Abdominal Pain",
    1015
   ],
   [
    "Pain",
    994
   ],
   [
    "Abdominal Pain Upper",
    917
   ],
   [
    "Dizziness",
    854
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    779
   ],
   [
    "Fall",
    720
   ],
   [
    "Malaise",
    699
   ]
  ],
  "by_year": {
   "2019": 2498,
   "2020": 2301,
   "2021": 1978,
   "2022": 1877,
   "2023": 1989,
   "2024": 2042,
   "2025": 2462,
   "2026": 1451
  },
  "by_year_primary": {
   "2019": 2498,
   "2020": 2300,
   "2021": 1976,
   "2022": 1870,
   "2023": 1983,
   "2024": 2037,
   "2025": 2455,
   "2026": 1443
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 4,
  "nda": 1,
  "anda": 3,
  "first_approval": "20120830",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 8,
  "labeling_recent": 2,
  "sponsors": [
   "ABBVIE",
   "ACTAVIS LABS FL",
   "AUROBINDO PHARMA",
   "MYLAN"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/30/2012"
 },
 "trials": {
  "total": 60,
  "completed": 41,
  "terminated": 6,
  "with_results": 24,
  "industry": 38,
  "phase3": 16,
  "results_share": 0.5853658536585366,
  "terminated_share": 0.1
 },
 "pubmed": {
  "rct": 41,
  "meta": 14,
  "recent_rct": 19,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 1771864.82,
  "records": 67810,
  "by_name": [
   [
    "Linzess",
    1771864.82
   ]
  ],
  "names_checked": [
   "linaclotide",
   "Linzess"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2506531,
  "beneficiaries": 632063,
  "spend": 1981958629.2,
  "by_brand": [
   {
    "brand": "Linzess",
    "claims": 2506531,
    "per_claim": 790.71778054,
    "is_generic": false
   }
  ],
  "per_claim": 790.717780550091
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 5935,
  "fills": 2506531,
  "per_million": 2367.814321865558,
  "ratio": 0.8551308374679734,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,368 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "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": [
    "41 randomized trials and 14 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $1,771,865 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (3 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are diarrhoea, constipation. 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?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}