{
 "query": "loratadine / pseudoephedrine",
 "ingredient": "loratadine / pseudoephedrine",
 "slug": "loratadine-pseudoephedrine",
 "rxcui": "214682",
 "brands": [
  "Alavert D",
  "Allerclear",
  "Claritin-D",
  "Wal-itin D"
 ],
 "names": [
  "loratadine / pseudoephedrine"
 ],
 "components": [
  {
   "ingredient": "loratadine",
   "slug": "loratadine",
   "grade": "B",
   "total": 78,
   "scores": {
    "safety": "A",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "B",
    "options": "C"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "04/12/1993",
   "first_approval": "19930412"
  },
  {
   "ingredient": "pseudoephedrine",
   "slug": "pseudoephedrine",
   "grade": "C",
   "total": 72,
   "scores": {
    "safety": "B",
    "evidence": "F",
    "regulatory": "A",
    "conflict": "A",
    "options": "A"
   },
   "boxed": false,
   "controlled": false,
   "first_approval_fmt": "08/29/1975",
   "first_approval": "19750829"
  }
 ],
 "classes": [],
 "alternatives": [],
 "label": {},
 "faers": null,
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "first_approval": "19750829",
  "first_approval_fmt": "",
  "anda": 5,
  "nda": 0,
  "rems": false,
  "labeling_recent": 0
 },
 "trials": null,
 "pubmed": null,
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "loratadine / pseudoephedrine",
   "Alavert D",
   "Allerclear",
   "Claritin-D",
   "Wal-itin D"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": null,
 "exposure": null,
 "scores": {
  "safety": {
   "score": 78,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, pseudoephedrine (78)",
    "Listed by the independent review Prescrire as a drug to avoid (2026 edition) (-10)",
    "Death appears in 2.6x the share of reports seen across all of FAERS (-12)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 22,
   "letter": "F",
   "why": [
    "Graded by its riskiest ingredient, pseudoephedrine (22)",
    "130 randomized trials and 3 systematic reviews/meta-analyses indexed in PubMed",
    "Prescrire's independent reviewers find its harm-benefit balance unfavourable versus alternatives (-10)",
    "No Cochrane review found (-5)",
    "Only 11% 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": 91,
   "letter": "A",
   "why": [
    "Graded by its riskiest ingredient, loratadine (91)",
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 38 generic makers (-1)",
    "11 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Graded by its riskiest ingredient, loratadine (85)",
    "Maker paid $500 million in 2002 to settle federal allegations naming this drug (Poor manufacturing practices) (-15)",
    "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, loratadine (70)",
    "Generic versions approved (38 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 66,
 "grade": "C",
 "questions": [
  "This is a fixed combination of loratadine and pseudoephedrine. Why both together, instead of only the one I need?",
  "The maker paid $500 million in 2002 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. 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?",
  "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.)",
  "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?",
  "The most-reported problems in FDA's adverse event data are pain, systemic lupus erythematosus, rheumatoid arthritis. How would we recognize and handle those?",
  "Why this one over phenylephrine, phenylpropanolamine? What would make you pick one of those instead?"
 ]
}