{
 "query": "hydroxyzine",
 "ingredient": "hydroxyzine",
 "slug": "hydroxyzine",
 "rxcui": "5553",
 "brands": [
  "Vistaril"
 ],
 "names": [
  "hydroxyzine",
  "hydroxyzine hydrochloride",
  "hydroxyzine pamoate"
 ],
 "classes": [
  {
   "id": "N05BB",
   "name": "Diphenylmethane derivatives"
  }
 ],
 "alternatives": [
  "captodiamine"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 89
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia, hydroxyzine may potentiate meperidine (Demerol \u00ae ) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
  "contraindications": "CONTRAINDICATIONS Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy. Hydroxyzine is contraindicated in patients with a prolonged QT interval. Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication. Hydroxyzine is contraindicated in patients with known hypersensitivity to hydroxyzine products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.",
  "adverse_reactions": "ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine pamoate are usually mild and transitory in nature. Skin and Appendages Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in post-marketing reports. Anticholinergic Dry mouth. Central Nervous System Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System QT prolongation, Torsade de Pointes. In post-marketing experience, the following additional undesirable effects have been reported: Body as a Whole Allergic reaction Nervous System Headache Psychiatric Hallucination Skin and Appendages Pruritus, rash, urticaria",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "hydroxyzine pamoate",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA087479",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241216",
  "set_id": "02616eee-a1a4-4afc-b84e-69fd28755138",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 57076,
  "serious": 37024,
  "death": 6750,
  "hospitalization": 18190,
  "primary_suspect": 56833,
  "top_reactions": [
   [
    "Pruritus",
    3940
   ],
   [
    "Drug Ineffective",
    3797
   ],
   [
    "Fatigue",
    3457
   ],
   [
    "Nausea",
    3448
   ],
   [
    "Off Label Use",
    3199
   ],
   [
    "Headache",
    2754
   ],
   [
    "Pain",
    2733
   ],
   [
    "Toxicity To Various Agents",
    2517
   ],
   [
    "Rash",
    2489
   ],
   [
    "Diarrhoea",
    2400
   ],
   [
    "Anxiety",
    2335
   ],
   [
    "Dyspnoea",
    2216
   ],
   [
    "Vomiting",
    2119
   ],
   [
    "Completed Suicide",
    2005
   ],
   [
    "Dizziness",
    1998
   ]
  ],
  "by_year": {
   "2019": 6000,
   "2020": 5606,
   "2021": 5029,
   "2022": 5380,
   "2023": 5717,
   "2024": 5609,
   "2025": 6368,
   "2026": 3320
  },
  "by_year_primary": {
   "2019": 5996,
   "2020": 5599,
   "2021": 5011,
   "2022": 5338,
   "2023": 5675,
   "2024": 5565,
   "2025": 6323,
   "2026": 3286
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260602",
   "reason": "Presence of foreign substance",
   "firm": "ANI Pharmaceuticals, Inc.",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181011",
   "reason": "CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.",
   "firm": "Lannett Company, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140124",
   "reason": "CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140124",
   "reason": "CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.",
   "firm": "Teva Pharmaceuticals USA",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131211",
   "reason": "Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.",
   "firm": "KVK-Tech, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131211",
   "reason": "Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.",
   "firm": "KVK-Tech, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20131211",
   "reason": "Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.",
   "firm": "KVK-Tech, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 147,
  "nda": 5,
  "anda": 101,
  "first_approval": "19560412",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 24,
  "labeling_recent": 0,
  "sponsors": [
   "ABLE",
   "ACTAVIS ELIZABETH",
   "ALPHARMA US PHARMS",
   "ALTANA",
   "AM REGENT",
   "AMNEAL PHARM",
   "AUROBINDO PHARMA LTD",
   "BARR"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/12/1956"
 },
 "trials": {
  "total": 130,
  "completed": 92,
  "terminated": 19,
  "with_results": 34,
  "industry": 64,
  "phase3": 27,
  "results_share": 0.3695652173913043,
  "terminated_share": 0.14615384615384616
 },
 "pubmed": {
  "rct": 96,
  "meta": 2,
  "recent_rct": 4,
  "cochrane": [
   {
    "pmid": "21154375",
    "title": "Hydroxyzine for generalised anxiety disorder",
    "year": "2010"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "hydroxyzine",
   "Vistaril"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 6281237,
  "beneficiaries": 1890638,
  "spend": 92961912.78,
  "by_brand": [
   {
    "brand": "Hydroxyzine HCl",
    "claims": 4702557,
    "per_claim": 15.713608766,
    "is_generic": true
   },
   {
    "brand": "Hydroxyzine Pamoate",
    "claims": 1578610,
    "per_claim": 12.078225147,
    "is_generic": true
   },
   {
    "brand": "Vistaril",
    "claims": 70,
    "per_claim": 13.784,
    "is_generic": false
   }
  ],
  "per_claim": 14.799937142954485
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 15174,
  "fills": 6281237,
  "per_million": 2415.76619382456,
  "ratio": 0.8724485485941359,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,416 FDA reports naming it as the suspect drug per million Medicare fills, 0.9x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.3x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 44,
   "letter": "F",
   "why": [
    "96 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 37% 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, 1 Class III across 101 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": 90,
   "letter": "A",
   "why": [
    "Generic versions approved (101 applications)",
    "1 same-class alternative(s) (-10)"
   ],
   "weight": 0.1
  }
 },
 "total": 83,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are pruritus, fatigue, 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 captodiamine? 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.)"
 ]
}