{
 "query": "ethinyl estradiol / norelgestromin",
 "ingredient": "ethinyl estradiol / norelgestromin",
 "slug": "ethinyl-estradiol-norelgestromin",
 "rxcui": "352377",
 "brands": [
  "Gwyn Lo",
  "Xulane",
  "Zafemy"
 ],
 "names": [
  "ethinyl estradiol / norelgestromin"
 ],
 "components": [
  {
   "ingredient": "ethinyl estradiol",
   "slug": "ethinyl-estradiol",
   "grade": "C",
   "total": 66,
   "scores": {
    "safety": "D",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "C"
   },
   "boxed": true,
   "controlled": false,
   "first_approval_fmt": "06/25/1943",
   "first_approval": "19430625"
  },
  {
   "ingredient": "norelgestromin",
   "slug": "norelgestromin",
   "grade": "D",
   "total": 59,
   "scores": {
    "safety": "C",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": true,
   "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": "19430625",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 3857.0,
  "records": 2,
  "by_name": [
   [
    "Xulane",
    3857.0
   ]
  ],
  "names_checked": [
   "ethinyl estradiol / norelgestromin",
   "Gwyn Lo",
   "Xulane",
   "Zafemy"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 58,
   "letter": "D",
   "why": [
    "Graded by its riskiest ingredient, ethinyl estradiol (58)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Death appears in 2.6x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 5,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, norelgestromin (5)",
    "6 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 15% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, ethinyl estradiol (95)",
    "No recalls on record since 2016",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, ethinyl estradiol (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, norelgestromin (40)",
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 55,
 "grade": "D",
 "questions": [
  "This is a fixed combination of ethinyl estradiol and norelgestromin. Why both together, instead of only the one I need?",
  "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, lower respiratory tract infection, pruritus, rash. How would we recognize and handle those?",
  "Why this one over chlorotrianisene, diethylstilbestrol, estetrol? What would make you pick one of those instead?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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 cholecystitis, obesity, peritoneal adhesions. 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?"
 ]
}