{
 "query": "levocetirizine",
 "ingredient": "levocetirizine",
 "slug": "levocetirizine",
 "rxcui": "356887",
 "brands": [
  "Xyzal"
 ],
 "names": [
  "levocetirizine",
  "levocetirizine dihydrochloride"
 ],
 "classes": [
  {
   "id": "R06AE",
   "name": "Piperazine derivatives"
  }
 ],
 "alternatives": [
  "buclizine",
  "cetirizine",
  "chlorcyclizine",
  "cyclizine",
  "meclizine",
  "oxatomide"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 74
  },
  "boxed_warning": "",
  "indications_and_usage": "Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.",
  "contraindications": "The use of levocetirizine dihydrochloride is contraindicated in: Patients with a known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets or to cetirizine ( 4.1 ) Patients with end-stage renal disease at less than 10 mL/min creatinine clearance or patients undergoing hemodialysis ( 4.2 ) Children 6 months to 11 years of age with renal impairment ( 4.3 ) 4.1 Patients with Known Hypersensitivity Patients with known hypersensitivity to levocetirizine or any of the ingredients of levocetirizine dihydrochloride tablets, or to cetirizine. Observed reactions range from urticaria to anaphylaxis [see Adverse Reactions (6.2) ]. 4.2 Patients with End-Stage Renal Disease Patients with end-stage renal disease (CL CR <10 mL/min) and patients undergoing hemodialysis 4.3 Pediatric Patients with Impaired Renal Function Children 6 months to 11 years of age with impaired renal function",
  "warnings_and_cautions": "Somnolence: Somnolence, fatigue, and asthenia have been reported with use of levocetirizine dihydrochloride tablets in some patients in clinical trials. Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking levocetirizine dihydrochloride tablets. Avoid concurrent use of alcohol or other central nervous system depressants with levocetirizine dihydrochloride tablets. ( 5.1 ) Urinary Retention: Urinary retention has been reported with use of levocetirizine dihydrochloride tablets. Use with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia). Discontinue levocetirizine dihydrochloride tablets if urinary retention occurs. ( 5.2 ) Risk of New Onset Pruritus After Discontinuation of Levocetirizine dihydrochloride tablets: New onset pruritus within a few days after discontinuation of Levocetirizine dihydrochloride tablets has been reported, usually after long-term use (e.g., few months to years) of Levocetirizine dihydrochloride tablets. Symptoms may improve with restarting or tapering Levocetirizine dihydrochloride tablets ( 5.3 ). 5.1 Somnolence In clin...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: Somnolence [see Warnings and Precautions (5.1) ] Urinary Retention [see Warnings and Precautions (5.2) ] Risk of New Onset Pruritus After Discontinuation of Levocetirizine dihydrochloride tablets [see Warnings and Precautions (5.3) ] The most common adverse reactions (rate \u22652% and > placebo) were somnolence, nasopharyngitis, fatigue, dry mouth, and pharyngitis in subjects 12 years of age and older, and pyrexia, somnolence, cough, and epistaxis in children 6 to 12 years of age. In subjects 1 to 5 years of age, the most common adverse reactions (rate \u22652% and > placebo) were pyrexia, diarrhea, vomiting, and otitis media. In subjects 6 to 11 months of age, the most common adverse reactions (rate \u22653% and > placebo) were diarrhea and constipation. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Warnings and Precautions, Risk of New Onset Pruritus After Discontinuation of Levocetirizine dihydrochloride tablets ( 5.3 ) 07/2025",
  "information_for_patients": "Somnolence Caution patients against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of levocetirizine dihydrochloride [see Warnings and Precautions (5.1) ] . Concomitant Use of Alcohol and other Central Nervous System Depressants Instruct patients to avoid concurrent use of levocetirizine dihydrochloride with alcohol or other central nervous system depressants because additional reduction in mental alertness may occur [see Warnings and Precautions (5.1) ] . Risk of New Onset Pruritus After Discontinuation of Levocetirizine Dihydrochloride Tablets Inform patients pruritus has occurred within a few days of discontinuing levocetirizine dihydrochloride tablets among patients who used levocetirizine dihydrochloride tablets long-term (e.g., few months to years). Pruritus may improve with restarting or tapering levocetirizine dihydrochloride tablets [see Warnings and Precautions (5.3) ] . Advise patient to seek medical advice if pruritus occurs. Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 USA Rev. 8/2025 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA",
  "spl_medguide": "",
  "clinical_studies": "14.1 Perennial Allergic Rhinitis Adults and Adolescents 12 Years of Age and Older The efficacy of levocetirizine dihydrochloride was evaluated in four randomized, placebo-controlled, double-blind clinical trials in adult and adolescent patients 12 years and older with symptoms of perennial allergic rhinitis. The four clinical trials include two dose-ranging trials of 4 weeks duration and two efficacy trials (one 6-week and one 6-month) in patients with perennial allergic rhinitis. These trials included a total of 1,729 patients (752 males and 977 females) of whom 227 were adolescents 12 to 17 years of age. Efficacy was assessed using a total symptom score from patient recording of 4 symptoms (sneezing, rhinorrhea, nasal pruritus, and ocular pruritus) in three studies and 5 symptoms (sneezing, rhinorrhea, nasal pruritus, ocular pruritus, and nasal congestion) in one study. Patients recorded symptoms using a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe) once daily in the evening reflective of the 24 hour treatment period. The primary endpoint was the mean total symptom score averaged over the first week and over 4 weeks for perennial allergic rhin...",
  "brand_name": "levocetirizine dihydrochloride",
  "manufacturer": "Golden State Medical Supply, Inc.",
  "application_number": "ANDA203646",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260813",
  "set_id": "163dcce7-4535-a596-e063-6394a90a634f",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 28762,
  "serious": 12487,
  "death": 1271,
  "hospitalization": 5295,
  "primary_suspect": 28717,
  "top_reactions": [
   [
    "Drug Ineffective",
    3535
   ],
   [
    "Somnolence",
    2269
   ],
   [
    "Fatigue",
    2087
   ],
   [
    "Headache",
    1577
   ],
   [
    "Pruritus",
    1546
   ],
   [
    "Nausea",
    1429
   ],
   [
    "Diarrhoea",
    1364
   ],
   [
    "Dyspnoea",
    1325
   ],
   [
    "Off Label Use",
    1160
   ],
   [
    "Dizziness",
    1125
   ],
   [
    "Cough",
    1013
   ],
   [
    "Arthralgia",
    983
   ],
   [
    "Pain",
    952
   ],
   [
    "Rash",
    951
   ],
   [
    "Vomiting",
    892
   ]
  ],
  "by_year": {
   "2019": 2921,
   "2020": 2559,
   "2021": 3296,
   "2022": 2571,
   "2023": 2562,
   "2024": 2651,
   "2025": 2622,
   "2026": 1316
  },
  "by_year_primary": {
   "2019": 2921,
   "2020": 2558,
   "2021": 3295,
   "2022": 2565,
   "2023": 2543,
   "2024": 2643,
   "2025": 2615,
   "2026": 1313
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 29,
  "nda": 4,
  "anda": 24,
  "first_approval": "20070525",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 32,
  "labeling_recent": 6,
  "sponsors": [
   "APOTEX",
   "APOTEX INC",
   "CHARTWELL MOLECULAR",
   "CHATTEM SANOFI",
   "DR REDDYS",
   "DR REDDYS LABS LTD",
   "GLENMARK PHARMS LTD",
   "GRANULES"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/25/2007"
 },
 "trials": {
  "total": 84,
  "completed": 69,
  "terminated": 3,
  "with_results": 20,
  "industry": 58,
  "phase3": 23,
  "results_share": 0.2898550724637681,
  "terminated_share": 0.03571428571428571
 },
 "pubmed": {
  "rct": 90,
  "meta": 7,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "levocetirizine",
   "Xyzal"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2327230,
  "beneficiaries": 712089,
  "spend": 28361728.22,
  "by_brand": [
   {
    "brand": "Levocetirizine Dihydrochloride",
    "claims": 2327230,
    "per_claim": 12.186903838,
    "is_generic": true
   }
  ],
  "per_claim": 12.18690383846891
 },
 "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": "xyzal"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6571,
  "fills": 2327230,
  "per_million": 2823.528400716732,
  "ratio": 1.0197109560589093,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 92,
   "letter": "A",
   "why": [
    "FDA issued 1 Drug Safety Communication(s) naming this drug since 2010, most recently 2025 (-8)",
    "2,824 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 33,
   "letter": "F",
   "why": [
    "90 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 29% 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": 87,
   "letter": "B",
   "why": [
    "No recalls on record since 2016",
    "6 label changes approved since 2021: the safety story is still moving (-8)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "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 (24 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "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 somnolence, fatigue, headache. 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.)"
 ]
}