{
 "query": "diclofenac / misoprostol",
 "ingredient": "diclofenac / misoprostol",
 "slug": "diclofenac-misoprostol",
 "rxcui": "214502",
 "brands": [
  "Arthrotec"
 ],
 "names": [
  "diclofenac / misoprostol"
 ],
 "components": [
  {
   "ingredient": "diclofenac",
   "slug": "diclofenac",
   "grade": "C",
   "total": 74,
   "scores": {
    "safety": "C",
    "evidence": "C",
    "regulatory": "B",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "07/28/1988",
   "first_approval": "19880728"
  },
  {
   "ingredient": "misoprostol",
   "slug": "misoprostol",
   "grade": "C",
   "total": 74,
   "scores": {
    "safety": "C",
    "evidence": "B",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "12/27/1988",
   "first_approval": "19881227"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19880728",
  "first_approval_fmt": "",
  "anda": 4,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "diclofenac / misoprostol",
   "Arthrotec"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 37476,
  "beneficiaries": 11536,
  "spend": 6580149.21,
  "by_brand": [
   {
    "brand": "Diclofenac Sodium-Misoprostol",
    "claims": 36705,
    "per_claim": 161.87608963,
    "is_generic": false
   },
   {
    "brand": "Arthrotec 75",
    "claims": 578,
    "per_claim": 851.02771626,
    "is_generic": false
   },
   {
    "brand": "Arthrotec 50",
    "claims": 193,
    "per_claim": 759.55088083,
    "is_generic": false
   }
  ],
  "per_claim": 175.58301873198846
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 63,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, diclofenac (63)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Prescrire lists one form only (oral diclofenac) as a drug to avoid; shown for context, no score effect",
    "3,543 FDA reports naming it as the suspect drug per million Medicare fills, 1.3x the median drug on this site (-2)",
    "Death share in reports is near or below the FAERS average (0.9x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "A boxed warning caps the overall grade at C (score 76 shown as 74)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 67,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, diclofenac (67)",
    "1070 randomized trials and 43 systematic reviews/meta-analyses indexed in PubMed",
    "10 independent Cochrane review(s) exist",
    "Only 24% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 81,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, diclofenac (81)",
    "Recalls since 2016: 0 Class I, 4 Class II, 1 Class III across 76 generic makers (-6)",
    "27 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, diclofenac (100)",
    "Pharma paid doctors $35,100 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, diclofenac (100)",
    "Generic versions approved (76 applications)",
    "34 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "This is a fixed combination of diclofenac and misoprostol. Why both together, instead of only the one I need?",
  "An independent reviewer (Prescrire) lists this as a drug to avoid because the harms outweigh the benefits versus alternatives. What is your view on that?",
  "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 pain, product use in unapproved indication. 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 aceclofenac, acemetacin, benzydamine? 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.)",
  "The most-reported problems in FDA's adverse event data are foetal exposure during pregnancy, haemorrhage, abortion incomplete. How would we recognize and handle those?",
  "Why this one over carboprost, dinoprost, dinoprostone? What would make you pick one of those instead?"
 ]
}