{
 "query": "loperamide / simethicone",
 "ingredient": "loperamide / simethicone",
 "slug": "loperamide-simethicone",
 "rxcui": "214681",
 "brands": [
  "Imodium Advanced",
  "Imodium Multi-Symptom Relief"
 ],
 "names": [
  "loperamide / simethicone"
 ],
 "components": [
  {
   "ingredient": "loperamide",
   "slug": "loperamide",
   "grade": "C",
   "total": 63,
   "scores": {
    "safety": "F",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "12/28/1976",
   "first_approval": "19761228"
  },
  {
   "ingredient": "simethicone",
   "slug": "simethicone",
   "grade": "B",
   "total": 82,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "C"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "",
   "first_approval": ""
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19761228",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "loperamide / simethicone",
   "Imodium Advanced",
   "Imodium Multi-Symptom Relief"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 34,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, loperamide (34)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2018 (-16)",
    "17,671 FDA reports naming it as the suspect drug per million Medicare fills, 6.4x 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)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 39,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, simethicone (39)",
    "77 randomized trials and 10 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 24% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 98,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, loperamide (98)",
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III across 30 generic makers (-2)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, loperamide (100)",
    "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": [
    "Graded by its riskiest ingredient, simethicone (70)",
    "Sold over the counter under an FDA monograph: no application to approve, many makers",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 58,
 "grade": "D",
 "questions": [
  "This is a fixed combination of loperamide and simethicone. Why both together, instead of only the one I need?",
  "In 2018 the FDA issued a safety communication about this drug (FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use). Does that risk apply to me?",
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, nausea, fatigue. 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 difenoxin, diphenoxylate, eluxadoline? 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.)",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?"
 ]
}