{
 "query": "latanoprost",
 "ingredient": "latanoprost",
 "slug": "latanoprost",
 "rxcui": "43611",
 "brands": [
  "Xalatan",
  "Iyuzeh",
  "Xelpros"
 ],
 "names": [
  "latanoprost",
  "latanoprost acid"
 ],
 "classes": [
  {
   "id": "S01EE",
   "name": "Prostaglandin analogues"
  }
 ],
 "alternatives": [
  "bimatoprost",
  "latanoprostene bunod",
  "tafluprost",
  "travoprost",
  "unoprostone"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 19,
   "TOPICAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "\u2122 (latanoprost ophthalmic solution) 0.005% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. IYUZEH is a prostaglandin F2\u03b1 analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )",
  "contraindications": "Known hypersensitivity to latanoprost or any other ingredients in this product. Known hypersensitivity to latanoprost or any other ingredients in this product. ( 4 )",
  "warnings_and_cautions": "Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. ( 5.1 ) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually, reversible. ( 5.2 ) 5.1 Pigmentation Topical latanoprost ophthalmic products, including IYUZEH have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, ...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions have been reported with the use of topical latanoprost products and are discussed in greater detail in other sections of the label: Iris pigmentation changes [see Warnings and Precautions (5.1) ] Eyelid skin darkening [see Warnings and Precautions (5.1) ] Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ] Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ] Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ] Most common adverse reactions (5% to 35%) for IYUZEH are: conjunctival hyperemia, eye irritation, eye pruritus, abnormal sensation in eye, foreign body sensation in eyes, vision blurred and lacrimation increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . See 17 for PATIENT COUNSELING INFORMATION. Revised: 03/2024 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 rates in the cl...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of IYUZEH. Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with latanoprost ophthalmic solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. Handling the Container Advise patients that IYUZEH is a sterile solution that does not contain a preservative. The drops are supplied in single-dose container. The solution from one individual container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual container is opened, the remaining contents should be discarded immediately after administration. Open a new single-dose container every time you use IYUZEH. When to Seek Physician Advice Advise ...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Elevated Baseline IOP In randomized, controlled clinical trials of patients with open angle glaucoma or ocular hypertension with mean baseline IOP of 19 - 24 mmHg, IYUZEH lowered IOP by 3 \u2013 8 mmHg versus 4 \u2013 8 mmHg by latanoprost ophthalmic solution preserved with benzalkonium chloride. Latanoprost ophthalmic solution preserved with benzalkonium chloride was approximately 1 mmHg more effective than IYUZEH.",
  "brand_name": "IYUZEH",
  "manufacturer": "Thea Pharma Inc.",
  "application_number": "NDA216472",
  "pharm_class_epc": [
   "Prostaglandin Analog [EPC]"
  ],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20240730",
  "set_id": "192fc081-cc38-4e83-b779-9592e060b915",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 39593,
  "serious": 19714,
  "death": 2327,
  "hospitalization": 8159,
  "primary_suspect": 39554,
  "top_reactions": [
   [
    "Treatment Failure",
    5927
   ],
   [
    "Drug Ineffective",
    2663
   ],
   [
    "Fatigue",
    2027
   ],
   [
    "Eye Irritation",
    1658
   ],
   [
    "Off Label Use",
    1515
   ],
   [
    "Diarrhoea",
    1448
   ],
   [
    "Headache",
    1441
   ],
   [
    "Death",
    1313
   ],
   [
    "Eye Pain",
    1288
   ],
   [
    "Nausea",
    1266
   ],
   [
    "Dyspnoea",
    1242
   ],
   [
    "Dizziness",
    1236
   ],
   [
    "Vision Blurred",
    1162
   ],
   [
    "Fall",
    1122
   ],
   [
    "Pain",
    1063
   ]
  ],
  "by_year": {
   "2019": 3312,
   "2020": 9223,
   "2021": 2688,
   "2022": 2509,
   "2023": 2619,
   "2024": 2573,
   "2025": 2816,
   "2026": 1431
  },
  "by_year_primary": {
   "2019": 3311,
   "2020": 9222,
   "2021": 2684,
   "2022": 2501,
   "2023": 2610,
   "2024": 2567,
   "2025": 2810,
   "2026": 1427
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20240422",
   "reason": "Failed Release Testing: Out of specification for particulate matter test.",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 16,
  "nda": 3,
  "anda": 12,
  "first_approval": "19960605",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 19,
  "labeling_recent": 3,
  "sponsors": [
   "APOTEX INC",
   "BAUSCH AND LOMB",
   "CARNEGIE",
   "EPIC PHARMA LLC",
   "EUGIA PHARMA",
   "FDC LTD",
   "GLAND",
   "J MOLNER"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/05/1996"
 },
 "trials": {
  "total": 278,
  "completed": 201,
  "terminated": 22,
  "with_results": 71,
  "industry": 192,
  "phase3": 56,
  "results_share": 0.35323383084577115,
  "terminated_share": 0.07913669064748201
 },
 "pubmed": {
  "rct": 380,
  "meta": 26,
  "recent_rct": 37,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 178015.03,
  "records": 3455,
  "by_name": [
   [
    "Iyuzeh",
    173973.01
   ],
   [
    "Xelpros",
    4042.02
   ]
  ],
  "names_checked": [
   "latanoprost",
   "Xalatan",
   "Iyuzeh",
   "Xelpros"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 10894397,
  "beneficiaries": 2568896,
  "spend": 134865338.34,
  "by_brand": [
   {
    "brand": "Latanoprost",
    "claims": 10884075,
    "per_claim": 11.942330761,
    "is_generic": true
   },
   {
    "brand": "Xalatan",
    "claims": 10322,
    "per_claim": 473.17522379,
    "is_generic": false
   }
  ],
  "per_claim": 12.379330250219448
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "latanoprost",
  "matched": "latanoprost",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 6804,
  "fills": 10894397,
  "per_million": 624.5412205925669,
  "ratio": 0.22555166258890277,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "625 FDA reports naming it as the suspect drug per million Medicare fills, 0.2x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "380 randomized trials and 26 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 35% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 1 Class III across 12 generic makers (-0)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 85,
   "letter": "B",
   "why": [
    "Pharma paid doctors $178,015 tied to this drug last year (-15)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (12 applications)",
    "5 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 86,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are treatment failure, fatigue, eye irritation. 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 bimatoprost, latanoprostene bunod, tafluprost? 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.)"
 ]
}