{
 "query": "meclizine",
 "ingredient": "meclizine",
 "slug": "meclizine",
 "rxcui": "6676",
 "brands": [
  "Antivert",
  "Bonine",
  "Dramamine Less Drowsy",
  "Dramamine Nausea Relief",
  "Pepto Nausea",
  "Wal-Dram 2"
 ],
 "names": [
  "meclizine",
  "meclizine hydrochloride"
 ],
 "classes": [
  {
   "id": "R06AE",
   "name": "Piperazine derivatives"
  }
 ],
 "alternatives": [
  "buclizine",
  "cetirizine",
  "chlorcyclizine",
  "cyclizine",
  "levocetirizine",
  "oxatomide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 141
  },
  "boxed_warning": "",
  "indications_and_usage": "Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults. Meclizine hydrochloride tablets are indicated for the treatment of vertigo associated with diseases affecting the vestibular system in adults ( 1 ).",
  "contraindications": "Meclizine hydrochloride tablets are contraindicated in patients with a hypersensitivity to meclizine or any of the inactive ingredients [see Adverse Reactions (6) and Description (11) ]. Meclizine hydrochloride tablets are contraindicated in patients with hypersensitivity to meclizine or any of the inactive ingredients ( 4 ).",
  "warnings_and_cautions": "May cause drowsiness: Use caution when driving a car or operating dangerous machinery ( 5.1 ). Potential anticholinergic action: this drug should be prescribed with care to patients with a history of asthma, glaucoma, or enlargement of the prostate gland ( 5.2 ). 5.1 Drowsiness Since drowsiness may occur with use of meclizine hydrochloride tablets, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery. Patients should avoid alcoholic beverages while taking meclizine hydrochloride tablets [see Drug Interactions (7.1) ] . 5.2 Concurrent Medical Conditions Because of its potential anticholinergic action, meclizine hydrochloride tablets should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions associated with the use of meclizine hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported. Common adverse reactions are anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, and vomiting. On rare occasions blurred vision has been reported ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Administration Instructions: Advise patients that the tablets must be swallowed whole, but chewable tablets must be chewed or crushed completely before swallowing [see Dosage and Administration (2.1) ] . Adverse Reactions: Advise patients that meclizine hydrochloride tablets may cause anaphylactic reaction, drowsiness, dry mouth, headache, fatigue, vomiting and, on rare occasions, blurred vision [see Warnings and Precautions (5.1) , Adverse Reactions (6) ] . Inform patients that meclizine hydrochloride tablets may impair their ability to engage in potentially dangerous activities, such as operating machinery or vehicles. Concomitant Drug Interactions: Advise patients regarding medications that should not be taken in combination with meclizine hydrochloride tablets or that may necessitate increased monitoring [see Drug Interactions (7.1 , 7.2) ] . Inform patients that alcohol may increase adverse reactions. Concurrent Medical Conditions: Advise patients to notify their healthcare provider about all of their medical conditions, including if they are pregnant or plan to become pregnant or if they are breastfeeding [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1 ...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "MECLIZINE HYDROCHLORIDE",
  "manufacturer": "Bryant Ranch Prepack",
  "application_number": "ANDA202640",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260608",
  "set_id": "1079db3f-d8ad-4c25-aa91-8ac8054ee4f2",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 15046,
  "serious": 8969,
  "death": 1267,
  "hospitalization": 4186,
  "primary_suspect": 15038,
  "top_reactions": [
   [
    "Dizziness",
    1364
   ],
   [
    "Fatigue",
    1359
   ],
   [
    "Nausea",
    1247
   ],
   [
    "Diarrhoea",
    1008
   ],
   [
    "Headache",
    972
   ],
   [
    "Chronic Kidney Disease",
    940
   ],
   [
    "Fall",
    905
   ],
   [
    "Pain",
    869
   ],
   [
    "Dyspnoea",
    731
   ],
   [
    "Drug Ineffective",
    715
   ],
   [
    "Asthenia",
    673
   ],
   [
    "Off Label Use",
    671
   ],
   [
    "Acute Kidney Injury",
    657
   ],
   [
    "Vomiting",
    638
   ],
   [
    "Renal Failure",
    621
   ]
  ],
  "by_year": {
   "2019": 1776,
   "2020": 1521,
   "2021": 1317,
   "2022": 1117,
   "2023": 982,
   "2024": 1038,
   "2025": 1215,
   "2026": 588
  },
  "by_year_primary": {
   "2019": 1776,
   "2020": 1521,
   "2021": 1317,
   "2022": 1115,
   "2023": 978,
   "2024": 1036,
   "2025": 1215,
   "2026": 588
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260316",
   "reason": "Failed tablet specifications.",
   "firm": "Amerisource Health Services LLC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191001",
   "reason": "Subpotent Drug",
   "firm": "Sato Pharmaceutical Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191001",
   "reason": "Subpotent Drug",
   "firm": "Sato Pharmaceutical Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 4,
 "drugsfda": {
  "applications": 38,
  "nda": 1,
  "anda": 32,
  "first_approval": "19570214",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 2,
  "labeling_recent": 0,
  "sponsors": [
   "ABC HOLDING",
   "AMNEAL PHARMS",
   "ANABOLIC",
   "ANI PHARMS",
   "AUROBINDO PHARMA USA",
   "BUNDY",
   "CASPER PHARMA LLC",
   "CHARTWELL RX"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/14/1957"
 },
 "trials": {
  "total": 11,
  "completed": 7,
  "terminated": 0,
  "with_results": 3,
  "industry": 4,
  "phase3": 1,
  "results_share": 0.42857142857142855,
  "terminated_share": 0.0
 },
 "pubmed": {
  "rct": 10,
  "meta": 0,
  "recent_rct": 0,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "meclizine",
   "Antivert",
   "Bonine",
   "Dramamine Less Drowsy",
   "Dramamine Nausea Relief",
   "Pepto Nausea",
   "Wal-Dram 2"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3025148,
  "beneficiaries": 1416078,
  "spend": 25483698.49,
  "by_brand": [
   {
    "brand": "Meclizine HCl",
    "claims": 3025148,
    "per_claim": 8.4239509902,
    "is_generic": true
   }
  ],
  "per_claim": 8.42395099016643
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2839,
  "fills": 3025148,
  "per_million": 938.4664816399065,
  "ratio": 0.33892506729500277,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "938 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.9x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 24,
   "letter": "F",
   "why": [
    "10 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 2 Class III across 32 generic makers (-4)"
   ],
   "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 (32 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are dizziness, fatigue, nausea, diarrhoea. How would we recognize and handle those?",
  "Why this one over buclizine, cetirizine, chlorcyclizine? 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.)"
 ]
}