{
 "query": "diphenhydramine",
 "ingredient": "diphenhydramine",
 "slug": "diphenhydramine",
 "rxcui": "3498",
 "brands": [
  "Banophen",
  "Benadryl",
  "Calagel Reformulated Jun 2019",
  "Dermamycin",
  "Diphedryl",
  "Diphenhist",
  "Dormin",
  "Genahist",
  "Nytol",
  "Pediaclear Cough",
  "Siladryl",
  "Simply Sleep",
  "Sleepinal",
  "Sominex",
  "The Itch Eraser",
  "Twilite",
  "Unisom Sleep",
  "Vanamine",
  "Wal-Dryl Allergy",
  "Wal-Dryl Childrens",
  "Wal-Sleep Z",
  "Wal-Som",
  "Wal-Som Maximum Strength",
  "Z-Sleep",
  "Zzzquil"
 ],
 "names": [
  "diphenhydramine",
  "diphenhydramine citrate",
  "diphenhydramine diacefyllinate",
  "diphenhydramine hydrochloride",
  "diphenhydramine tannate"
 ],
 "classes": [
  {
   "id": "D04AA",
   "name": "Antihistamines for topical use"
  },
  {
   "id": "R06AA",
   "name": "Aminoalkyl ethers"
  }
 ],
 "alternatives": [
  "bamipine",
  "bromodiphenhydramine",
  "carbinoxamine",
  "chloropyramine",
  "chlorphenoxamine",
  "clemastine",
  "dimenhydrinate",
  "dimethindene",
  "diphenylpyraline",
  "doxylamine",
  "isothipendyl",
  "pheniramine",
  "promethazine",
  "pyrilamine",
  "thonzylamine",
  "trimethobenzamide",
  "tripelennamine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 869,
   "TOPICAL": 97,
   "INTRAMUSCULAR": 26,
   "INTRAVENOUS": 26,
   "CUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "Uses for the relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings Do not use for children under 12 years of age with any other product containing diphenhydramine, even one used on skin",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OF",
  "manufacturer": "The Procter & Gamble Manufacturing Company",
  "application_number": "M010",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260908",
  "set_id": "01906eed-78ee-f2a1-e063-6294a90a809b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 140596,
  "serious": 97872,
  "death": 17704,
  "hospitalization": 39804,
  "primary_suspect": 140401,
  "top_reactions": [
   [
    "Off Label Use",
    17655
   ],
   [
    "Fatigue",
    14706
   ],
   [
    "Headache",
    12549
   ],
   [
    "Nausea",
    12464
   ],
   [
    "Drug Ineffective",
    10629
   ],
   [
    "Pain",
    10582
   ],
   [
    "Pruritus",
    9117
   ],
   [
    "Dyspnoea",
    8974
   ],
   [
    "Infusion Related Reaction",
    8638
   ],
   [
    "Arthralgia",
    8517
   ],
   [
    "Rash",
    7928
   ],
   [
    "Diarrhoea",
    7817
   ],
   [
    "Pyrexia",
    7295
   ],
   [
    "Malaise",
    7101
   ],
   [
    "Cough",
    6942
   ]
  ],
  "by_year": {
   "2019": 12190,
   "2020": 18116,
   "2021": 13689,
   "2022": 13376,
   "2023": 12014,
   "2024": 10508,
   "2025": 10821,
   "2026": 5165
  },
  "by_year_primary": {
   "2019": 12188,
   "2020": 18112,
   "2021": 13675,
   "2022": 13329,
   "2023": 11944,
   "2024": 10486,
   "2025": 10796,
   "2026": 5158
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 93,
  "nda": 4,
  "anda": 53,
  "first_approval": "19460304",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 15,
  "labeling_recent": 0,
  "sponsors": [
   "ABRAXIS PHARM",
   "ALPHARMA US PHARMS",
   "ALRA",
   "ANABOLIC",
   "ANNORA PHARMA",
   "APP PHARMS",
   "AVET LIFESCIENCES",
   "BEL MAR"
  ],
  "unapproved": false,
  "first_approval_fmt": "03/04/1946"
 },
 "trials": {
  "total": 1259,
  "completed": 796,
  "terminated": 155,
  "with_results": 328,
  "industry": 595,
  "phase3": 246,
  "results_share": 0.4120603015075377,
  "terminated_share": 0.12311358220810167
 },
 "pubmed": {
  "rct": 131,
  "meta": 5,
  "recent_rct": 12,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "diphenhydramine",
   "Banophen",
   "Benadryl",
   "Calagel Reformulated Jun 2019",
   "Dermamycin",
   "Diphedryl",
   "Diphenhist",
   "Dormin",
   "Genahist",
   "Nytol",
   "Pediaclear Cough",
   "Siladryl",
   "Simply Sleep",
   "Sleepinal",
   "Sominex",
   "The Itch Eraser",
   "Twilite",
   "Unisom Sleep",
   "Vanamine",
   "Wal-Dryl Allergy",
   "Wal-Dryl Childrens",
   "Wal-Sleep Z",
   "Wal-Som",
   "Wal-Som Maximum Strength",
   "Z-Sleep",
   "Zzzquil"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 61123,
  "beneficiaries": 23077,
  "spend": 1343066.21,
  "by_brand": [
   {
    "brand": "Diphenhydramine HCl",
    "claims": 61123,
    "per_claim": 21.973172292,
    "is_generic": true
   }
  ],
  "per_claim": 21.97317229193593
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (1.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "131 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 41% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 53 generic makers (-3)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (53 applications)",
    "17 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 84,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, headache, nausea. 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 bamipine, bromodiphenhydramine, carbinoxamine? 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.)"
 ]
}