{
 "query": "dorzolamide",
 "ingredient": "dorzolamide",
 "slug": "dorzolamide",
 "rxcui": "60207",
 "brands": [],
 "names": [
  "dorzolamide",
  "dorzolamide hydrochloride"
 ],
 "classes": [
  {
   "id": "S01EC",
   "name": "Carbonic anhydrase inhibitors"
  }
 ],
 "alternatives": [
  "acetazolamide",
  "brinzolamide",
  "dichlorphenamide",
  "methazolamide"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 35
  },
  "boxed_warning": "",
  "indications_and_usage": "Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. ( 1 )",
  "contraindications": "Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product [see Warnings and Precautions ( 5.1 )]. Dorzolamide Hydrochloride Ophthalmic Solution is contraindicated in patients who are hypersensitive to any component of this product. ( 4 , 5.1 )",
  "warnings_and_cautions": "Sulfonamide Hypersensitivity ( 5.1 ) Bacterial Keratitis ( 5.2 ) Corneal Endothelium ( 5.3 ) Allergic Reactions ( 5.4 ) Acute Angle-Closure Glaucoma ( 5.5 ) 5.1 Sulfonamide Hypersensitivity Dorzolamide Hydrochloride Ophthalmic Solution contains dorzolamide, a sulfonamide; and although administered topically, it is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of Dorzolamide Hydrochloride Ophthalmic Solution. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation [see Contraindications ( 4 )]. 5.2 Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patien...",
  "warnings": "",
  "adverse_reactions": "The most frequently reported adverse reactions associated with Dorzolamide Hydrochloride Ophthalmic Solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a bitter taste following administration. Superficial punctate keratitis occurred in 10 to 15% of patients and signs and symptoms of ocular allergic reaction in approximately 10%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals at 1-866-625-1618 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Controlled clinical trials : The most frequent adverse reactions associated with Dorzolamide Hydrochloride Ophthalmic Solution were ocular burning, stinging, or discomfort immediately following ocular administration (approximately one-third of patients). Approximately one-quarter of patients noted a...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Sulfonamide Reactions Dorzolamide Hydrochloride Ophthalmic Solution is a sulfonamide and although administered topically is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. Advise patients that if serious or unusual reactions including severe skin reactions or signs of hypersensitivity occur, they should discontinue the use of the product [see Warnings and Precautions ( 5.1 )]. Intercurrent Ocular Conditions Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container. Handling Ophthalmic Solutions Instruct patients to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular inf...",
  "spl_medguide": "",
  "clinical_studies": "The efficacy of Dorzolamide Hydrochloride Ophthalmic Solution was demonstrated in clinical studies in the treatment of elevated intraocular pressure in patients with glaucoma or ocular hypertension (baseline IOP \u2265 23 mmHg). The IOP-lowering effect of Dorzolamide Hydrochloride Ophthalmic Solution was approximately 3 to 5 mmHg throughout the day and this was consistent in clinical studies of up to one year duration. The efficacy of Dorzolamide Hydrochloride Ophthalmic Solution when dosed less frequently than three times a day (alone or in combination with other products) has not been established. In a one year clinical study, the effect of Dorzolamide Hydrochloride Ophthalmic Solution 2% three times daily on the corneal endothelium was compared to that of betaxolol ophthalmic solution twice daily and timolol maleate ophthalmic solution 0.5% twice daily. There were no statistically significant differences between groups in corneal endothelial cell counts or in corneal thickness measurements. There was a mean loss of approximately 4% in the endothelial cell counts for each group over the one year period.",
  "brand_name": "Dorzolamide Hydrochloride",
  "manufacturer": "Sagent Pharmaceuticals",
  "application_number": "ANDA215660",
  "pharm_class_epc": [],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20260109",
  "set_id": "0246463c-6c24-4611-8e22-2d5254ace66a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 9798,
  "serious": 4342,
  "death": 490,
  "hospitalization": 1739,
  "primary_suspect": 9794,
  "top_reactions": [
   [
    "Treatment Failure",
    1897
   ],
   [
    "Drug Ineffective",
    851
   ],
   [
    "Off Label Use",
    592
   ],
   [
    "Fatigue",
    533
   ],
   [
    "Eye Irritation",
    427
   ],
   [
    "Headache",
    413
   ],
   [
    "Eye Pain",
    377
   ],
   [
    "Hypersensitivity",
    366
   ],
   [
    "Pain",
    358
   ],
   [
    "Vision Blurred",
    299
   ],
   [
    "Weight Decreased",
    299
   ],
   [
    "Diarrhoea",
    296
   ],
   [
    "Rash",
    295
   ],
   [
    "Dizziness",
    294
   ],
   [
    "Pain In Extremity",
    284
   ]
  ],
  "by_year": {
   "2019": 823,
   "2020": 2614,
   "2021": 552,
   "2022": 612,
   "2023": 737,
   "2024": 734,
   "2025": 785,
   "2026": 380
  },
  "by_year_primary": {
   "2019": 823,
   "2020": 2614,
   "2021": 551,
   "2022": 610,
   "2023": 737,
   "2024": 734,
   "2025": 784,
   "2026": 380
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 15,
  "nda": 1,
  "anda": 14,
  "first_approval": "19941209",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 17,
  "labeling_recent": 0,
  "sponsors": [
   "ALEMBIC",
   "AM REGENT",
   "BAUSCH AND LOMB",
   "FDC LTD",
   "GLAND",
   "HIKMA",
   "MICRO LABS",
   "MSD SUB MERCK"
  ],
  "unapproved": false,
  "first_approval_fmt": "12/09/1994"
 },
 "trials": {
  "total": 90,
  "completed": 65,
  "terminated": 10,
  "with_results": 28,
  "industry": 47,
  "phase3": 19,
  "results_share": 0.4307692307692308,
  "terminated_share": 0.1111111111111111
 },
 "pubmed": {
  "rct": 199,
  "meta": 7,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "dorzolamide"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1050631,
  "beneficiaries": 303348,
  "spend": 21527147.69,
  "by_brand": [
   {
    "brand": "Dorzolamide HCl",
    "claims": 1050631,
    "per_claim": 20.489732066,
    "is_generic": true
   }
  ],
  "per_claim": 20.489732065777616
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 1898,
  "fills": 1050631,
  "per_million": 1806.5334070668007,
  "ratio": 0.6524254925875128,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "1,807 FDA reports naming it as the suspect drug per million Medicare fills, 0.7x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 51,
   "letter": "D",
   "why": [
    "199 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 43% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "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 (14 applications)",
    "4 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. 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 acetazolamide, brinzolamide, dichlorphenamide? 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.)"
 ]
}