{"id":"brimonidine-tartrate","rwe":[],"_fda":{"id":"4e5af967-1d35-5b67-e063-6294a90a9296","set_id":"022de945-0b26-40ae-8e88-d3fe2464d106","openfda":{"unii":["4S9CL2DY2H"],"route":["OPHTHALMIC"],"rxcui":["1999016","1999021"],"spl_id":["4e5af967-1d35-5b67-e063-6294a90a9296"],"brand_name":["LUMIFY Redness Reliever Eye Drops"],"spl_set_id":["022de945-0b26-40ae-8e88-d3fe2464d106"],"package_ndc":["24208-537-25","24208-537-08","24208-537-99","24208-537-75","24208-537-10","24208-537-01","24208-537-15","24208-537-05","24208-537-35"],"product_ndc":["24208-537"],"generic_name":["BRIMONIDINE TARTRATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BRIMONIDINE TARTRATE"],"manufacturer_name":["Bausch & Lomb Incorporated"],"application_number":["NDA208144"],"is_original_packager":[true]},"purpose":["Purpose Redness reliever"],"version":"17","warnings":["Warnings For external use only Do not use if solution changes color or becomes cloudy Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye condition worsens or persists for more than 3 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"questions":["Questions or comments? [phone icon] Call: 1-800-553-5340"],"do_not_use":["Do not use if solution changes color or becomes cloudy"],"effective_time":"20260331","active_ingredient":["Active ingredient Brimonidine tartrate (0.025%)"],"inactive_ingredient":["Inactive ingredients benzalkonium chloride, boric acid, calcium chloride dihydrate, glycerin, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH."],"indications_and_usage":["Use relieves redness of the eye due to minor eye irritations"],"ask_doctor_or_pharmacist":["Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye condition worsens or persists for more than 3 days"],"spl_unclassified_section":["Other information store at 15-25°C (59-77°F)"],"dosage_and_administration":["Directions adults and children 5 years of age and over: instill 1 drop in the affected eye(s) every 6-8 hours do not use more than 4 times daily remove contact lenses before use wait at least 10 minutes before re-inserting contact lenses after use if using other ophthalmic products while using this product, wait at least 5 minutes between each product to avoid contamination, do not touch tip of container to any surface replace cap after each use children under 5 years of age: consult a doctor"],"spl_product_data_elements":["LUMIFY Redness Reliever Eye Drops BRIMONIDINE TARTRATE BENZALKONIUM CHLORIDE BORIC ACID CALCIUM CHLORIDE GLYCERIN POTASSIUM CHLORIDE SODIUM BORATE SODIUM CHLORIDE WATER BRIMONIDINE TARTRATE BRIMONIDINE"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 7.5 mL Carton BAUSCH + LOMB LARGE SIZE LUMIFY ® BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.025% REDNESS RELIEVER EYE DROPS WORKS IN 1 MINUTE LASTS UP TO 8 HOURS Sterile 0.25 FL OZ (7.5 mL) AB53708 3911700 carton"]},"tags":[{"label":"alpha-Adrenergic Agonist","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Alpha-2C adrenergic receptor","category":"target"},{"label":"ADRA2C","category":"gene"},{"label":"ADRA2A","category":"gene"},{"label":"ADRA2B","category":"gene"},{"label":"D11AX21","category":"atc"},{"label":"Topical","category":"route"},{"label":"Ophthalmic","category":"route"},{"label":"Gel","category":"form"},{"label":"Solution","category":"form"},{"label":"Solution/ Drops","category":"form"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Ocular hypertension","category":"indication"},{"label":"Open-angle glaucoma","category":"indication"},{"label":"Rosacea","category":"indication"},{"label":"Senju Pharmaceutical Co., Ltd","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-2 Receptor Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-Agonists","category":"pharmacology"},{"label":"Antihypertensive Agents","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"TREATMENT FAILURE","source":"FDA FAERS","actionTaken":"3167 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1920 reports"},{"date":"","signal":"OCULAR HYPERAEMIA","source":"FDA FAERS","actionTaken":"1612 reports"},{"date":"","signal":"EYE IRRITATION","source":"FDA FAERS","actionTaken":"1605 reports"},{"date":"","signal":"EYE PAIN","source":"FDA FAERS","actionTaken":"1400 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1222 reports"},{"date":"","signal":"VISION BLURRED","source":"FDA FAERS","actionTaken":"1187 reports"},{"date":"","signal":"INTRAOCULAR PRESSURE INCREASED","source":"FDA FAERS","actionTaken":"1061 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1041 reports"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"997 reports"}],"drugInteractions":[{"url":"/drug/phenelzine","drug":"phenelzine","action":"Avoid combination","effect":"May interact with Phenelzine","source":"DrugCentral","drugSlug":"phenelzine"},{"url":"/drug/selegiline","drug":"selegiline","action":"Avoid combination","effect":"May interact with Selegiline","source":"DrugCentral","drugSlug":"selegiline"},{"url":"/drug/tranylcypromine","drug":"tranylcypromine","action":"Avoid combination","effect":"May interact with Tranylcypromine","source":"DrugCentral","drugSlug":"tranylcypromine"}],"commonSideEffects":[{"effect":"Allergic conjunctivitis","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Conjunctival hyperemia","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Eye pruritus","drugRate":"15%","severity":"common","organSystem":""},{"effect":"Burning sensation","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Conjunctival folliculosis","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Hypertension","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Ocular allergic reaction","drugRate":"7%","severity":"common","organSystem":""},{"effect":"Oral 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hemorrhage","drugRate":"2.5%","severity":"common","organSystem":""},{"effect":"Conjunctivitis","drugRate":"2.5%","severity":"common","organSystem":""}],"contraindications":["Acute cerebrovascular insufficiency","Acute disease of cardiovascular system","Anaphylaxis","Bronchospasm","Cardiogenic shock","Cerebrovascular disease","Complete atrioventricular block","Decompensated cardiac failure","Depressive disorder","Diabetes mellitus","General anesthesia","Hyperthyroidism","Hypoglycemic disorder","Myasthenia gravis","Orthostatic hypotension","Partial atrioventricular block","Pregnancy, function","Pulmonary emphysema","Raynaud's phenomenon","Severe chronic obstructive pulmonary disease","Sinus bradycardia","Thromboangiitis obliterans"],"specialPopulations":{"Pregnancy":"Teratogenicity studies have been performed in animals. Brimonidine tartrate was not teratogenic when given orally during gestation days through 15 in rats and days through 18 in rabbits. The highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved AUC exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate/timolol maleate ophthalmic solution, drop in both eyes twice daily.Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on mg/kg basis (MRHOD)] demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1,000 mg/kg/day (83,000 times the MRHOD) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses 8,300 times the MRHOD without apparent maternotoxicity.There are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to limited extent. Because animal reproduction studies are not","Geriatric use":"No overall differences in safety or effectiveness have been observed between elderly and other adult patients.","Paediatric use":"In well-controlled clinical study conducted in pediatric glaucoma patients (ages to years) the most commonly observed adverse events with brimonidine tartrate ophthalmic solution 0.2% dosed three times daily were somnolence (50% 83% in patients ages to years) and decreased alertness. In pediatric patients years of age or older (>20kg), somnolence appears to occur less frequently (25%). The most commonly observed adverse event was somnolence. Approximately 16% of patients on brimo"},"seriousAdverseEvents":[{"effect":"Apnea","drugRate":"","severity":"serious"},{"effect":"Coma","drugRate":"","severity":"serious"},{"effect":"Respiratory depression","drugRate":"","severity":"serious"},{"effect":"Hypotension","drugRate":"2.5%","severity":"serious"},{"effect":"Hypothermia","drugRate":"","severity":"serious"},{"effect":"Syncope","drugRate":"","severity":"serious"},{"effect":"Bradycardia","drugRate":"","severity":"serious"},{"effect":"Tachycardia","drugRate":"","severity":"serious"},{"effect":"Severe Cardiovascular Disease","drugRate":"","severity":"serious"},{"effect":"Potentiation of Vascular Insufficiency","drugRate":"","severity":"serious"}]},"trials":[],"aliases":[],"company":"Senju Pharmaceutical Co., Ltd","patents":[{"applNo":"N218424","source":"FDA Orange Book","status":"Active","expires":"Jul 27, 2029","useCode":"U-2222","territory":"US","drugProduct":false,"patentNumber":"11596600","drugSubstance":false},{"applNo":"N218424","source":"FDA Orange Book","status":"Active","expires":"Jul 14, 2030","useCode":"U-2222","territory":"US","drugProduct":false,"patentNumber":"9259425","drugSubstance":false},{"applNo":"N218424","source":"FDA Orange Book","status":"Active","expires":"Jul 14, 2030","useCode":"U-2222","territory":"US","drugProduct":false,"patentNumber":"8293742","drugSubstance":false},{"type":"Formulation","number":"8053427","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-06-13"},{"type":"Formulation","number":"8513247","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-03-25"},{"type":"Formulation","number":"8513249","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-03-25"},{"type":"Method of Use","number":"9861631","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-03-25"},{"type":"Method of Use","number":"9861632","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-03-25"},{"type":"Method of Use","number":"11833245","applicant":"BAUSCH AND LOMB INC","territory":"US","tradeName":"LUMIFY","expiryDate":"2029-07-27"},{"type":"Formulation","number":"8163725","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-06-13"},{"type":"Formulation","number":"10201517","applicant":"GALDERMA LABORATORIES LP","territory":"US","tradeName":"MIRVASO","expiryDate":"2031-06-13"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$30.2128/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$10,877","description":"BRIMONIDINE TARTRATE 0.1% DROP","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BRIMONIDINE TARTRATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:26:49.026733+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:26:49.026643+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:26:54.886755+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T00:26:49.099783+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:26:47.921598+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BRIMONIDINE TARTRATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:26:55.169420+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:26:45.717041+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:26:45.717072+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:26:56.767176+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Adrenergic receptor alpha-2 agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:26:56.312676+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200389/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:26:55.955854+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA208144","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:26:45.717075+00:00"}},"allNames":"alphagan","offLabel":[],"synonyms":["UK 14,304","mirvaso","brimonidine","brimonidine tartrate","bromoxidine"],"timeline":[{"date":"1996-09-06","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1997-03-13","type":"positive","source":"FDA Orange Book","milestone":"Alphagan approved — 0.5%"},{"date":"2001-03-16","type":"positive","source":"FDA Orange Book","milestone":"Alphagan P approved — 0.15%"},{"date":"2005-08-19","type":"positive","source":"FDA Orange Book","milestone":"Alphagan P approved — 0.1%"},{"date":"2006-05-22","type":"positive","source":"FDA Orange Book","milestone":"Qoliana approved — 0.15%"},{"date":"2013-08-23","type":"positive","source":"FDA Orange Book","milestone":"Mirvaso approved — EQ 0.33% BASE"},{"date":"2014-02-20","type":"positive","source":"DrugCentral","milestone":"EMA approval (Galderma International)"},{"date":"2017-12-22","type":"positive","source":"FDA Orange Book","milestone":"Lumify approved — 0.025%"},{"date":"2020-03-25","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Senju Pharmaceutical Co., Ltd)"},{"date":"2023-08-01","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 9 manufacturers approved"}],"aiSummary":"Alphagan (Brimonidine Tartrate) is a small molecule alpha-Adrenergic Agonist that targets the Alpha-2C adrenergic receptor. It was originally developed by Senju Pharmaceutical Co., Ltd and is currently owned by Bausch And Lomb Inc. Alphagan is FDA approved for the treatment of ocular hypertension, open-angle glaucoma, and rosacea. The drug is available as a generic medication, with 14 generic manufacturers. Alphagan's commercial status is off-patent, allowing for generic competition.","brandName":"Alphagan","ecosystem":[{"indication":"Ocular hypertension","otherDrugs":[{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"bimatoprost","slug":"bimatoprost","company":""},{"name":"brinzolamide","slug":"brinzolamide","company":"Alcon Pharms Ltd"},{"name":"carteolol","slug":"carteolol","company":""}],"globalPrevalence":1280000000},{"indication":"Open-angle glaucoma","otherDrugs":[{"name":"acetazolamide","slug":"acetazolamide","company":"Teva Branded Pharm"},{"name":"apraclonidine","slug":"apraclonidine","company":"Alcon"},{"name":"betaxolol","slug":"betaxolol","company":"Alcon"},{"name":"bimatoprost","slug":"bimatoprost","company":""}],"globalPrevalence":null},{"indication":"Rosacea","otherDrugs":[{"name":"azelaic acid","slug":"azelaic-acid","company":"Allergan"},{"name":"cortisone acetate","slug":"cortisone-acetate","company":""},{"name":"dexamethasone","slug":"dexamethasone","company":""},{"name":"fluorometholone","slug":"fluorometholone","company":"Allergan"}],"globalPrevalence":434000000}],"mechanism":{"target":"Alpha-2C adrenergic receptor","novelty":"Follow-on","targets":[{"gene":"ADRA2C","source":"DrugCentral","target":"Alpha-2C adrenergic receptor","protein":"Alpha-2C adrenergic receptor"},{"gene":"ADRA2A","source":"DrugCentral","target":"Alpha-2A adrenergic receptor","protein":"Alpha-2A adrenergic receptor"},{"gene":"ADRA2B","source":"DrugCentral","target":"Alpha-2B adrenergic receptor","protein":"Alpha-2B adrenergic receptor"},{"gene":"ADRA1D","source":"DrugCentral","target":"Alpha-1D adrenergic receptor","protein":"Alpha-1D adrenergic receptor"},{"gene":"HTR1A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1A","protein":"5-hydroxytryptamine receptor 1A"},{"gene":"ADRA1A","source":"DrugCentral","target":"Alpha-1A adrenergic receptor","protein":"Alpha-1A adrenergic receptor"},{"gene":"ADRA1B","source":"DrugCentral","target":"Alpha-1B adrenergic receptor","protein":"Alpha-1B adrenergic receptor"}],"moaClass":"Adrenergic alpha-Agonists","modality":"Small Molecule","drugClass":"alpha-Adrenergic Agonist","explanation":"","oneSentence":"","technicalDetail":"Alphagan exerts its effects by activating the alpha-2C adrenergic receptor, which leads to a decrease in aqueous humor production and an increase in uveoscleral outflow, resulting in a reduction in intraocular pressure."},"commercial":{"launchDate":"1996","_launchSource":"DrugCentral (FDA 1996-09-06, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/395","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BRIMONIDINE%20TARTRATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BRIMONIDINE TARTRATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T02:44:00.482437","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:26:58.039324+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"minoxidil","drugSlug":"minoxidil","fdaApproval":"1979-10-18","genericCount":22,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"calcium gluconate","drugSlug":"calcium-gluconate","fdaApproval":"","patentExpiry":"Jul 25, 2037","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"magnesium sulfate","drugSlug":"magnesium-sulfate","fdaApproval":"1981-10-06","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"mequinol","drugSlug":"mequinol","fdaApproval":"1999-12-10","relationship":"same-class"},{"drugName":"finasteride","drugSlug":"finasteride","fdaApproval":"1992-06-19","genericCount":17,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"hydroquinone","drugSlug":"hydroquinone","fdaApproval":"2002-01-18","relationship":"same-class"},{"drugName":"pyrithione 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