{
 "query": "olopatadine",
 "ingredient": "olopatadine",
 "slug": "olopatadine",
 "rxcui": "135391",
 "brands": [
  "Pataday",
  "PATANASE"
 ],
 "names": [
  "olopatadine",
  "olopatadine hydrochloride"
 ],
 "classes": [
  {
   "id": "R01AC",
   "name": "Antiallergic agents, excl. corticosteroids"
  }
 ],
 "alternatives": [
  "antazoline",
  "azelastine",
  "cromolyn",
  "levocabastine",
  "nedocromil",
  "thonzylamine"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 104,
   "NASAL": 6
  },
  "boxed_warning": "",
  "indications_and_usage": "Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings For external use only",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "PATADAY ONCE DAILY RELIEF",
  "manufacturer": "Alcon Laboratories, Inc.",
  "application_number": "NDA021545",
  "pharm_class_epc": [],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20260120",
  "set_id": "1c7d2342-ba1c-4244-9814-d92a05725d4e",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 17580,
  "serious": 5765,
  "death": 569,
  "hospitalization": 2620,
  "primary_suspect": 17571,
  "top_reactions": [
   [
    "Treatment Failure",
    4700
   ],
   [
    "Drug Ineffective",
    2055
   ],
   [
    "Eye Irritation",
    761
   ],
   [
    "Headache",
    623
   ],
   [
    "Fatigue",
    559
   ],
   [
    "Nausea",
    533
   ],
   [
    "Vision Blurred",
    508
   ],
   [
    "Diarrhoea",
    481
   ],
   [
    "Eye Pruritus",
    451
   ],
   [
    "Hypersensitivity",
    436
   ],
   [
    "Pruritus",
    432
   ],
   [
    "Dyspnoea",
    427
   ],
   [
    "Off Label Use",
    411
   ],
   [
    "Pain",
    410
   ],
   [
    "Ocular Hyperaemia",
    409
   ]
  ],
  "by_year": {
   "2019": 1164,
   "2020": 5299,
   "2021": 1880,
   "2022": 1153,
   "2023": 881,
   "2024": 890,
   "2025": 958,
   "2026": 645
  },
  "by_year_primary": {
   "2019": 1164,
   "2020": 5299,
   "2021": 1880,
   "2022": 1150,
   "2023": 878,
   "2024": 890,
   "2025": 958,
   "2026": 642
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220629",
   "reason": "CGMP Deviations: products were stored outside the drug label specifications.",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 37,
  "nda": 4,
  "anda": 29,
  "first_approval": "19961218",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 15,
  "labeling_recent": 5,
  "sponsors": [
   "ALCON LABS INC",
   "ALEMBIC",
   "AMNEAL",
   "APOTEX",
   "APOTEX INC",
   "BARR LABS INC",
   "BAUSCH AND LOMB INC",
   "EUGIA PHARMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/18/1996"
 },
 "trials": {
  "total": 65,
  "completed": 58,
  "terminated": 5,
  "with_results": 37,
  "industry": 58,
  "phase3": 22,
  "results_share": 0.6379310344827587,
  "terminated_share": 0.07692307692307693
 },
 "pubmed": {
  "rct": 87,
  "meta": 2,
  "recent_rct": 2,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 52648.9,
  "records": 23,
  "by_name": [
   [
    "Pataday",
    52648.9
   ]
  ],
  "names_checked": [
   "olopatadine",
   "Pataday",
   "PATANASE"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 43298,
  "beneficiaries": 18053,
  "spend": 3958889.22,
  "by_brand": [
   {
    "brand": "Olopatadine HCl",
    "claims": 43298,
    "per_claim": 91.433535498,
    "is_generic": true
   }
  ],
  "per_claim": 91.43353549817544
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.4x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 47,
   "letter": "F",
   "why": [
    "87 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 91,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 29 generic makers (-1)",
    "5 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $52,649 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 (29 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 85,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are treatment failure, eye irritation, headache. How would we recognize and handle those?",
  "Why this one over antazoline, azelastine, cromolyn? 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.)"
 ]
}