{
 "query": "dexmethylphenidate / serdexmethylphenidate",
 "ingredient": "dexmethylphenidate / serdexmethylphenidate",
 "slug": "dexmethylphenidate-serdexmethylphenidate",
 "rxcui": "2562192",
 "brands": [
  "Azstarys"
 ],
 "names": [
  "dexmethylphenidate / serdexmethylphenidate"
 ],
 "components": [
  {
   "ingredient": "dexmethylphenidate",
   "slug": "dexmethylphenidate",
   "grade": "C",
   "total": 65,
   "scores": {
    "safety": "D",
    "evidence": "F",
    "regulatory": "B",
    "conflict": "A",
    "options": "A"
   },
   "boxed": true,
   "controlled": true,
   "first_approval_fmt": "11/13/2001",
   "first_approval": "20011113"
  },
  {
   "ingredient": "serdexmethylphenidate",
   "slug": "serdexmethylphenidate",
   "grade": "D",
   "total": 58,
   "scores": {
    "safety": "D",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "F"
   },
   "boxed": true,
   "controlled": true,
   "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": "20011113",
  "first_approval_fmt": "",
  "anda": 0,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 1667199.17,
  "records": 76309,
  "by_name": [
   [
    "Azstarys",
    1667199.17
   ]
  ],
  "names_checked": [
   "dexmethylphenidate / serdexmethylphenidate",
   "Azstarys"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 60,
   "letter": "D",
   "why": [
    "Graded by its riskiest ingredient, dexmethylphenidate (60)",
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Federally controlled substance: dependence and misuse risk (-10)",
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 16,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, serdexmethylphenidate (16)",
    "3 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 87,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, dexmethylphenidate (87)",
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 21 generic makers (-0)",
    "7 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": 70,
   "letter": "C",
   "why": [
    "Graded by its riskiest ingredient, dexmethylphenidate (100)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL",
    "For the combination product itself:",
    "Pharma paid doctors $1,667,199 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, serdexmethylphenidate (40)",
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 53,
 "grade": "D",
 "questions": [
  "This is a fixed combination of dexmethylphenidate and serdexmethylphenidate. 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?",
  "This is a controlled substance. What is the plan for how long I take it and how I stop?",
  "The most-reported problems in FDA's adverse event data are anxiety, nausea, headache. How would we recognize and handle those?",
  "Why this one over amphetamine, armodafinil, atomoxetine? 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?"
 ]
}