{
 "query": "timolol",
 "ingredient": "timolol",
 "slug": "timolol",
 "rxcui": "10600",
 "brands": [
  "Betimol",
  "Istalol",
  "Timoptic"
 ],
 "names": [
  "timolol",
  "timolol anhydrous",
  "timolol hemihydrate",
  "timolol maleate"
 ],
 "classes": [
  {
   "id": "C07AA",
   "name": "Beta blocking agents, non-selective"
  },
  {
   "id": "S01ED",
   "name": "Beta blocking agents"
  }
 ],
 "alternatives": [
  "alprenolol",
  "betaxolol",
  "bopindolol",
  "bupranolol",
  "carteolol",
  "levobunolol",
  "mepindolol",
  "metipranolol",
  "nadolol",
  "oxprenolol",
  "penbutolol",
  "pindolol",
  "propranolol",
  "sotalol",
  "tertatolol"
 ],
 "label": {
  "route_mode": "OPHTHALMIC",
  "route_counts": {
   "OPHTHALMIC": 72,
   "ORAL": 2
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Timolol Maleate Ophthalmic Gel Forming Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
  "contraindications": "CONTRAINDICATIONS Timolol Maleate Ophthalmic Gel Forming Solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS, Obstructive Pulmonary Disease ); (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS, Cardiac Failure ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical ophthalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate ( see CONTRAINDICATIONS ). Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients Without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Timolol Maleate Ophthalmic Gel Forming Solution should be discontinued. Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mil...",
  "adverse_reactions": "ADVERSE REACTIONS In clinical trials, transient blurred vision upon instillation of the drop was reported in approximately one in three patients (lasting from 30 seconds to 5 minutes). Less than 1% of patients discontinued from the studies due to blurred vision. The frequency of patients reporting burning and stinging upon instillation was comparable between Timolol Maleate Ophthalmic Gel Forming Solution and TIMOPTIC (approximately one in eight patients). Adverse experiences reported in 1 to 5% of patients were: Ocular: Pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing; Systemic: Headache, dizziness, and upper respiratory infections. The following additional adverse experiences have been reported with the ocular administration of this or other timolol maleate formulations: BODY AS A WHOLE Asthenia/fatigue, and chest pain. CARDIOVASCULAR Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebrovascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet. DIGESTIVE Nausea, diarrhea...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. Patients should also be instructed 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 infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions (see PRECAUTIONS, General ). Patients should also be advised 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. Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling timolol maleate ophthalmic gel forming solution. Patients with bronchial asthma, a history of bronchial asthma, severe chr...",
  "spl_medguide": "",
  "clinical_studies": "Clinical Studies In controlled, double-masked, multicenter clinical studies, comparing timolol maleate ophthalmic gel forming solution 0.25% to TIMOPTIC 0.25% and timolol maleate ophthalmic gel forming solution 0.5% to TIMOPTIC 0.5%, timolol maleate ophthalmic gel forming solution administered once a day was shown to be equally effective in lowering intraocular pressure as the equivalent concentration of TIMOPTIC administered twice a day. The effect of timolol in lowering intraocular pressure was evident for 24 hours with a single dose of timolol maleate ophthalmic gel forming solution. Repeated observations over a period of six months indicate that the intraocular pressure-lowering effect of timolol maleate ophthalmic gel forming solution was consistent. The results from the largest U.S. and international clinical trials comparing timolol maleate ophthalmic gel forming solution 0.5% to TIMOPTIC 0.5% are shown in Figure 1 . International Study Timolol maleate ophthalmic gel forming solution administered once daily had a safety profile similar to that of an equivalent concentration of TIMOPTIC administered twice daily. Due to the physical characteristics of the formulation, there wa...",
  "brand_name": "Timolol Maleate",
  "manufacturer": "Sagent Pharmaceuticals",
  "application_number": "ANDA214645",
  "pharm_class_epc": [],
  "route": [
   "OPHTHALMIC"
  ],
  "effective_time": "20260109",
  "set_id": "272bb565-f099-4896-b2f6-48ab9180e941",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 18340,
  "serious": 8334,
  "death": 895,
  "hospitalization": 3488,
  "primary_suspect": 18308,
  "top_reactions": [
   [
    "Treatment Failure",
    3739
   ],
   [
    "Drug Ineffective",
    1276
   ],
   [
    "Fatigue",
    862
   ],
   [
    "Eye Pain",
    744
   ],
   [
    "Eye Irritation",
    741
   ],
   [
    "Off Label Use",
    669
   ],
   [
    "Dizziness",
    629
   ],
   [
    "Hypersensitivity",
    625
   ],
   [
    "Diarrhoea",
    617
   ],
   [
    "Nausea",
    544
   ],
   [
    "Dyspnoea",
    533
   ],
   [
    "Vision Blurred",
    521
   ],
   [
    "Fall",
    494
   ],
   [
    "Headache",
    492
   ],
   [
    "Ocular Hyperaemia",
    461
   ]
  ],
  "by_year": {
   "2019": 1562,
   "2020": 5232,
   "2021": 1169,
   "2022": 1029,
   "2023": 1099,
   "2024": 913,
   "2025": 1184,
   "2026": 572
  },
  "by_year_primary": {
   "2019": 1561,
   "2020": 5231,
   "2021": 1161,
   "2022": 1020,
   "2023": 1091,
   "2024": 912,
   "2025": 1182,
   "2026": 570
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20250705",
   "reason": "Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250418",
   "reason": "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20250123",
   "reason": "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241205",
   "reason": "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20241029",
   "reason": "Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240812",
   "reason": "Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240718",
   "reason": "Defective container; yellow colored spike from cap lodged in the nozzle",
   "firm": "FDC Limited",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240425",
   "reason": "Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.",
   "firm": "FDC Limited",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20240305",
   "reason": "Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.",
   "firm": "Thea Pharma, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191115",
   "reason": "Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic so",
   "firm": "Rising Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20191115",
   "reason": "Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic so",
   "firm": "Rising Pharmaceuticals, Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 11,
 "drugsfda": {
  "applications": 63,
  "nda": 7,
  "anda": 46,
  "first_approval": "19780817",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 83,
  "labeling_recent": 3,
  "sponsors": [
   "ABBVIE",
   "AKORN INC",
   "ALEMBIC",
   "AMNEAL",
   "ANI PHARMS",
   "APOTEX",
   "APOTEX INC",
   "BAUSCH AND LOMB"
  ],
  "unapproved": false,
  "first_approval_fmt": "08/17/1978"
 },
 "trials": {
  "total": 335,
  "completed": 249,
  "terminated": 35,
  "with_results": 107,
  "industry": 214,
  "phase3": 99,
  "results_share": 0.42971887550200805,
  "terminated_share": 0.1044776119402985
 },
 "pubmed": {
  "rct": 716,
  "meta": 31,
  "recent_rct": 38,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "timolol",
   "Betimol",
   "Istalol",
   "Timoptic"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2973686,
  "beneficiaries": 842485,
  "spend": 55507463.24,
  "by_brand": [
   {
    "brand": "Timolol Maleate",
    "claims": 2958063,
    "per_claim": 17.327068805,
    "is_generic": true
   },
   {
    "brand": "Betimol",
    "claims": 14344,
    "per_claim": 251.03382111,
    "is_generic": false
   },
   {
    "brand": "Istalol",
    "claims": 1279,
    "per_claim": 509.83032056,
    "is_generic": false
   }
  ],
  "per_claim": 18.66621534351643
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "timolol",
  "matched": "timolol",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2664,
  "fills": 2973686,
  "per_million": 895.8578679793361,
  "ratio": 0.3235370619322319,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "896 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.5x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 69,
   "letter": "C",
   "why": [
    "716 randomized trials and 31 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 43% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 89,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 9 Class II, 2 Class III across 46 generic makers (-7)",
    "3 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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (46 applications)",
    "15 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 91,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are treatment failure, fatigue, eye pain. 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 alprenolol, betaxolol, bopindolol? 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.)"
 ]
}