{
 "query": "loratadine",
 "ingredient": "loratadine",
 "slug": "loratadine",
 "rxcui": "28889",
 "brands": [
  "Alavert",
  "Claritin",
  "Cleartime Indoor & Outdoor Allergies",
  "Loradamed",
  "Tavist Non-Sedating",
  "Wal-itin",
  "Wal-vert"
 ],
 "names": [
  "loratadine"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 396
  },
  "boxed_warning": "",
  "indications_and_usage": "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat Uses relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings Do not use if you have ever had allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away. Warnings Severe Allergy Warning : Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately . Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribe...",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Loratadine",
  "manufacturer": "Lannett Company, Inc.",
  "application_number": "ANDA077421",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250619",
  "set_id": "069c4e75-1f9f-4ab5-9570-3d93d12c2a23",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 89305,
  "serious": 39801,
  "death": 3640,
  "hospitalization": 18133,
  "primary_suspect": 89212,
  "top_reactions": [
   [
    "Drug Ineffective",
    10958
   ],
   [
    "Fatigue",
    5844
   ],
   [
    "Nausea",
    4697
   ],
   [
    "Headache",
    4440
   ],
   [
    "Off Label Use",
    4329
   ],
   [
    "Diarrhoea",
    4177
   ],
   [
    "Dyspnoea",
    3826
   ],
   [
    "Dizziness",
    3473
   ],
   [
    "Pain",
    3193
   ],
   [
    "Pruritus",
    2881
   ],
   [
    "Rash",
    2862
   ],
   [
    "Cough",
    2631
   ],
   [
    "Somnolence",
    2576
   ],
   [
    "Arthralgia",
    2423
   ],
   [
    "Vomiting",
    2382
   ]
  ],
  "by_year": {
   "2019": 8504,
   "2020": 7665,
   "2021": 6819,
   "2022": 6239,
   "2023": 5606,
   "2024": 6159,
   "2025": 6113,
   "2026": 3037
  },
  "by_year_primary": {
   "2019": 8500,
   "2020": 7664,
   "2021": 6809,
   "2022": 6212,
   "2023": 5593,
   "2024": 6143,
   "2025": 6104,
   "2026": 3027
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210315",
   "reason": "CGMP Deviations: Intermittent exposure to temperature excursion during storage.",
   "firm": "Cardinal Health Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20150728",
   "reason": "Superpotent Drug: Out Of Specification (OOS) result for Assay.",
   "firm": "Ohm Laboratories, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 47,
  "nda": 9,
  "anda": 38,
  "first_approval": "19930412",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 66,
  "labeling_recent": 11,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ADAPTIS",
   "APOTEX",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "BAYER HEALTHCARE LLC",
   "BIONPHARMA",
   "CATALENT PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/12/1993"
 },
 "trials": {
  "total": 101,
  "completed": 75,
  "terminated": 7,
  "with_results": 30,
  "industry": 67,
  "phase3": 28,
  "results_share": 0.4,
  "terminated_share": 0.06930693069306931
 },
 "pubmed": {
  "rct": 189,
  "meta": 6,
  "recent_rct": 4,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "loratadine",
   "Alavert",
   "Claritin",
   "Cleartime Indoor & Outdoor Allergies",
   "Loradamed",
   "Tavist Non-Sedating",
   "Wal-itin",
   "Wal-vert"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [
  {
   "year": 2004,
   "company": "Schering-Plough",
   "amount_usd": 345000000.0,
   "amount_text": "$345 million",
   "violations": "Medicare fraud, kickbacks",
   "products": "Claritin",
   "laws": "False Claims Act, Anti-Kickback Statute",
   "urls": [
    "https://www.justice.gov/opa/pr/2004/July/04_civ_523.htm"
   ],
   "matched": "claritin"
  },
  {
   "year": 2002,
   "company": "Schering-Plough",
   "amount_usd": 500000000.0,
   "amount_text": "$500 million",
   "violations": "Poor manufacturing practices",
   "products": "Claritin",
   "laws": "FDA Current Good Manufacturing Practices",
   "urls": [
    "http://articles.philly.com/2002-05-18/business/25345918_1_schering-plough-clarinex-schering-stock"
   ],
   "matched": "claritin"
  }
 ],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "loratadine",
  "matched": "loratadine",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.4x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 45,
   "letter": "F",
   "why": [
    "189 randomized trials and 6 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 40% 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": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 38 generic makers (-1)",
    "11 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Maker paid $500 million in 2002 to settle federal allegations naming this drug (Poor manufacturing practices) (-15)",
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (38 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 78,
 "grade": "B",
 "questions": [
  "The maker paid $500 million in 2002 to settle federal allegations about how this drug was marketed. Is my use one of the uses that was promoted improperly?",
  "The most-reported problems in FDA's adverse event data are fatigue, nausea, headache. 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?",
  "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.)"
 ]
}