{
 "query": "viloxazine",
 "ingredient": "viloxazine",
 "slug": "viloxazine",
 "rxcui": "11196",
 "brands": [
  "Qelbree"
 ],
 "names": [
  "viloxazine",
  "viloxazine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": {
  "total": 1319,
  "serious": 427,
  "death": 11,
  "hospitalization": 113,
  "primary_suspect": 1318,
  "top_reactions": [
   [
    "Headache",
    146
   ],
   [
    "Vomiting",
    132
   ],
   [
    "Migraine",
    124
   ],
   [
    "Nausea",
    122
   ],
   [
    "Insomnia",
    105
   ],
   [
    "Fatigue",
    103
   ],
   [
    "Drug Ineffective",
    89
   ],
   [
    "Suicidal Ideation",
    83
   ],
   [
    "Somnolence",
    82
   ],
   [
    "Withdrawal Syndrome",
    59
   ],
   [
    "Anxiety",
    58
   ],
   [
    "Product Dose Omission Issue",
    47
   ],
   [
    "Depression",
    46
   ],
   [
    "Irritability",
    45
   ],
   [
    "Anger",
    44
   ]
  ],
  "by_year": {
   "2005": 1,
   "2020": 3,
   "2021": 63,
   "2022": 219,
   "2023": 205,
   "2024": 194,
   "2025": 303,
   "2026": 331
  },
  "by_year_primary": {
   "2005": 1,
   "2020": 3,
   "2021": 63,
   "2022": 218,
   "2023": 205,
   "2024": 194,
   "2025": 303,
   "2026": 331
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 3,
  "nda": 1,
  "anda": 0,
  "first_approval": "20210402",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 1,
  "labeling_recent": 1,
  "sponsors": [
   "APPCO PHARMA LLC",
   "SUPERNUS PHARMS",
   "ZENARA PHARMA PRIVATE LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/02/2021"
 },
 "trials": {
  "total": 16,
  "completed": 12,
  "terminated": 0,
  "with_results": 11,
  "industry": 16,
  "phase3": 8,
  "results_share": 0.9166666666666666,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 32,
  "meta": 1,
  "recent_rct": 12,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 4364969.14,
  "records": 61140,
  "by_name": [
   [
    "Qelbree",
    4364969.14
   ]
  ],
  "names_checked": [
   "viloxazine",
   "Qelbree"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 11851,
  "beneficiaries": 3232,
  "spend": 6796780.57,
  "by_brand": [
   {
    "brand": "Qelbree",
    "claims": 11851,
    "per_claim": 573.51958231,
    "is_generic": false
   }
  ],
  "per_claim": 573.5195823137288
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 37,
   "letter": "F",
   "why": [
    "32 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 90,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "Approved within the last 5 years: long-term safety is not yet known (-10)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $4,364,969 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are headache, vomiting, migraine, nausea. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}