{
 "query": "fexofenadine",
 "ingredient": "fexofenadine",
 "slug": "fexofenadine",
 "rxcui": "87636",
 "brands": [
  "Allegra",
  "Wal-Fex"
 ],
 "names": [
  "fexofenadine",
  "fexofenadine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 223
  },
  "boxed_warning": "",
  "indications_and_usage": "Uses reduces hives and 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 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 Substitue for Epinephrine. If your doctor has prescribed an epinephrine injector for \"anaphylaxis\" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your ...",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Curist Hives Relief",
  "manufacturer": "Little Pharma, Inc.",
  "application_number": "ANDA204507",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260715",
  "set_id": "04c75e93-b1f4-2546-e063-6394a90af0e1",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 58699,
  "serious": 23677,
  "death": 1717,
  "hospitalization": 8721,
  "primary_suspect": 58621,
  "top_reactions": [
   [
    "Drug Ineffective",
    9252
   ],
   [
    "Fatigue",
    2982
   ],
   [
    "Headache",
    2915
   ],
   [
    "Nausea",
    2614
   ],
   [
    "Pruritus",
    2381
   ],
   [
    "Diarrhoea",
    2295
   ],
   [
    "Dizziness",
    2239
   ],
   [
    "Off Label Use",
    2074
   ],
   [
    "Dyspnoea",
    2072
   ],
   [
    "Rash",
    1985
   ],
   [
    "No Adverse Event",
    1745
   ],
   [
    "Pain",
    1739
   ],
   [
    "Somnolence",
    1636
   ],
   [
    "Urticaria",
    1632
   ],
   [
    "Insomnia",
    1594
   ]
  ],
  "by_year": {
   "2019": 4895,
   "2020": 4771,
   "2021": 4214,
   "2022": 4002,
   "2023": 4686,
   "2024": 4610,
   "2025": 4928,
   "2026": 2729
  },
  "by_year_primary": {
   "2019": 4893,
   "2020": 4770,
   "2021": 4209,
   "2022": 3987,
   "2023": 4669,
   "2024": 4600,
   "2025": 4913,
   "2026": 2717
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240118",
   "reason": "CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Completed"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20230209",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "L. Perrigo Company",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 27,
  "nda": 5,
  "anda": 20,
  "first_approval": "19960725",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 21,
  "labeling_recent": 2,
  "sponsors": [
   "AUROBINDO PHARMA LTD",
   "BARR",
   "CHATTEM SANOFI",
   "CONTRACT PHARMACAL",
   "DR REDDYS",
   "DR REDDYS LABS LTD",
   "GRANULES",
   "HETERO LABS LTD V"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/25/1996"
 },
 "trials": {
  "total": 109,
  "completed": 83,
  "terminated": 5,
  "with_results": 17,
  "industry": 70,
  "phase3": 15,
  "results_share": 0.20481927710843373,
  "terminated_share": 0.045871559633027525
 },
 "pubmed": {
  "rct": 143,
  "meta": 4,
  "recent_rct": 7,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fexofenadine",
   "Allegra",
   "Wal-Fex"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fexofenadine",
  "matched": "fexofenadine",
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.3x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 34,
   "letter": "F",
   "why": [
    "143 randomized trials and 4 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 20% 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": 90,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 11 Class II, 0 Class III across 20 generic makers (-6)",
    "2 label changes approved since 2021 (-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": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (20 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, headache, nausea. How would we recognize and handle those?",
  "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.)"
 ]
}