{
 "query": "cetirizine",
 "ingredient": "cetirizine",
 "slug": "cetirizine",
 "rxcui": "20610",
 "brands": [
  "Zerviate",
  "Quzyttir",
  "Aller-Tec",
  "Wal Zyr 24 Hour Allergy",
  "Wal-Zyr",
  "Zyrtec"
 ],
 "names": [
  "cetirizine",
  "cetirizine hydrochloride"
 ],
 "classes": [
  {
   "id": "R06AE",
   "name": "Piperazine derivatives"
  }
 ],
 "alternatives": [
  "buclizine",
  "chlorcyclizine",
  "cyclizine",
  "levocetirizine",
  "meclizine",
  "oxatomide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 403,
   "INTRAVENOUS": 1,
   "OPHTHALMIC": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Perennial Allergic Rhinitis Cetirizine hydrochloride oral solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria Cetirizine hydrochloride oral solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.",
  "contraindications": "CONTRAINDICATIONS Cetirizine hydrochloride oral solution, USP is contraindicated in those patients with a known hypersensitivity to it or any of its ingredients or hydroxyzine.",
  "warnings_and_cautions": "",
  "warnings": "",
  "adverse_reactions": "ADVERSE REACTIONS Pediatric studies were conducted with cetirizine hydrochloride. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with cetirizine hydrochloride at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid). The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with cetirizine hydrochloride were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of cetirizine hydrochloride was uncommon (0.4% on cetirizine hydrochloride vs. 1.0% on placebo...",
  "drug_abuse_and_dependence": "DRUG ABUSE AND DEPENDENCE There is no information to indicate that abuse or dependency occurs with cetirizine hydrochloride.",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "Clinical Studies Multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients 12 years and older with perennial allergic rhinitis were conducted in the United States. Two of these showed significant reductions in symptoms of perennial allergic rhinitis for up to 8 weeks in duration. Two 4-week multicenter, randomized, double-blind, clinical trials comparing cetirizine 5 to 20 mg to placebo in patients with chronic idiopathic urticaria were also conducted and showed significant improvement in symptoms of chronic idiopathic urticaria. In general, the 10 mg dose was more effective than the 5 mg dose and the 20 mg dose gave no added effect. Some of these trials included pediatric patients aged 12 to 16 years. In addition, four multicenter, randomized, placebo-controlled, double-blind 2 to 4 week trials in 534 pediatric patients aged 6 to 11 years with seasonal allergic rhinitis were conducted in the United States at doses up to 10 mg.",
  "brand_name": "CETIRIZINE HYDROCHLORIDE",
  "manufacturer": "BAJAJ MEDICAL, LLC",
  "application_number": "ANDA090191",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20251016",
  "set_id": "05324e41-ee3f-0e4b-e063-6294a90a102c",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 157611,
  "serious": 86731,
  "death": 10350,
  "hospitalization": 35954,
  "primary_suspect": 157337,
  "top_reactions": [
   [
    "Drug Ineffective",
    21540
   ],
   [
    "Fatigue",
    19536
   ],
   [
    "Pain",
    16024
   ],
   [
    "Off Label Use",
    14537
   ],
   [
    "Rash",
    13592
   ],
   [
    "Pruritus",
    12774
   ],
   [
    "Headache",
    12692
   ],
   [
    "Nausea",
    11476
   ],
   [
    "Abdominal Discomfort",
    11176
   ],
   [
    "Alopecia",
    11135
   ],
   [
    "Dyspnoea",
    10969
   ],
   [
    "Arthralgia",
    10319
   ],
   [
    "Hypersensitivity",
    9939
   ],
   [
    "Diarrhoea",
    9924
   ],
   [
    "Rheumatoid Arthritis",
    9680
   ]
  ],
  "by_year": {
   "2019": 13363,
   "2020": 14295,
   "2021": 15074,
   "2022": 14174,
   "2023": 13400,
   "2024": 15169,
   "2025": 15828,
   "2026": 7606
  },
  "by_year_primary": {
   "2019": 13356,
   "2020": 14290,
   "2021": 15049,
   "2022": 14109,
   "2023": 13346,
   "2024": 15123,
   "2025": 15795,
   "2026": 7582
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20260624",
   "reason": "Cross Contamination with Other Products: Customer complaints for appearance of  discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.",
   "firm": "JB Chemicals and Pharmaceuticals Ltd",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20250912",
   "reason": "Tablet/Capsules Imprinted with Wrong ID",
   "firm": "JB Chemicals and Pharmaceuticals Ltd",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20250912",
   "reason": "Tablet/Capsules Imprinted with Wrong ID",
   "firm": "JB Chemicals and Pharmaceuticals Ltd",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250313",
   "reason": "CGMP Deviations",
   "firm": "Glenmark Pharmaceuticals Inc., USA",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20211005",
   "reason": "Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.",
   "firm": "A-S Medication Solutions LLC.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20181019",
   "reason": "Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150928",
   "reason": "Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester",
   "firm": "Perrigo Company PLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20120920",
   "reason": "Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)",
   "firm": "Sandoz Incorporated",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 72,
  "nda": 8,
  "anda": 63,
  "first_approval": "19951208",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 38,
  "labeling_recent": 16,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "AIPING PHARM INC",
   "AMNEAL PHARMS",
   "AMNEAL PHARMS NY",
   "APOTEX",
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/08/1995"
 },
 "trials": {
  "total": 141,
  "completed": 102,
  "terminated": 15,
  "with_results": 37,
  "industry": 89,
  "phase3": 35,
  "results_share": 0.3627450980392157,
  "terminated_share": 0.10638297872340426
 },
 "pubmed": {
  "rct": 272,
  "meta": 5,
  "recent_rct": 7,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 21987.11,
  "records": 660,
  "by_name": [
   [
    "Quzyttir",
    21908.45
   ],
   [
    "Zerviate",
    78.66
   ]
  ],
  "names_checked": [
   "cetirizine",
   "Zerviate",
   "Quzyttir",
   "Aller-Tec",
   "Wal Zyr 24 Hour Allergy",
   "Wal-Zyr",
   "Zyrtec"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 26642,
  "beneficiaries": 10088,
  "spend": 4705547.7700000005,
  "by_brand": [
   {
    "brand": "Cetirizine HCl",
    "claims": 16308,
    "per_claim": 13.138543046,
    "is_generic": true
   },
   {
    "brand": "Zerviate",
    "claims": 10118,
    "per_claim": 380.78921131,
    "is_generic": false
   },
   {
    "brand": "Quzyttir",
    "claims": 216,
    "per_claim": 2955.8294907,
    "is_generic": false
   }
  ],
  "per_claim": 176.6214161849711
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20250516",
   "title": "FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)",
   "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines",
   "kind": "drug",
   "matched": "zyrtec"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "cetirizine",
  "matched": "cetirizine",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 77,
   "letter": "B",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2025 (-8)",
    "Death share in reports is near or below the FAERS average (0.7x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "272 randomized trials and 5 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 36% of completed registered trials posted results (-8)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 68,
   "letter": "C",
   "why": [
    "Recalls since 2016: 1 Class I, 2 Class II, 3 Class III across 63 generic makers (-24)",
    "16 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $21,987 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 (63 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 74,
 "grade": "C",
 "questions": [
  "In 2025 the FDA issued a safety communication about this drug (FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines ceti). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are fatigue, pain. 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 buclizine, chlorcyclizine, cyclizine? 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.)"
 ]
}