{ "query": "brimonidine", "ingredient": "brimonidine", "slug": "brimonidine", "rxcui": "134615", "brands": [ "Mirvaso", "Alphagan", "Lumify" ], "names": [ "brimonidine", "brimonidine tartrate" ], "classes": [ { "id": "S01EA", "name": "Sympathomimetics in glaucoma therapy" }, { "id": "S01GA", "name": "Sympathomimetics used as decongestants" } ], "alternatives": [ "apraclonidine", "clonidine", "dipivefrin", "epinephrine", "naphazoline", "oxymetazoline", "phenylephrine", "synephrine", "tetrahydrozoline", "xylometazoline" ], "label": { "route_mode": "OPHTHALMIC", "route_counts": { "OPHTHALMIC": 34, "TOPICAL": 2 }, "boxed_warning": "", "indications_and_usage": "Brimonidine tartrate ophthalmic solution, 0.15% is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Brimonidine tartrate ophthalmic solution, 0.15% is an alpha adrenergic agonist indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension ( 1 ).", "contraindications": "\u2022 Neonates and infants (pediatric patients younger than 2 years old) ( 4.1 ). \u2022 Hypersensitivity to any component of this product ( 4.2 ). 4.1 Neonates and Infants (Pediatric Patients Younger than 2 Years Old) Brimonidine tartrate ophthalmic solution, 0.15% is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 ) ]. 4.2 Hypersensitivity Reactions Brimonidine tartrate ophthalmic solution, 0.15% is contraindicated in patients with hypersensitivity to any component of this product [see Adverse Reactions ( 6.1 ) and ( 6.2 )].", "warnings_and_cautions": "\u2022 Potentiation of vascular insufficiency ( 5.1 ) 5.1 Potentiation of Vascular Insufficiency Brimonidine tartrate ophthalmic solution, 0.15% may potentiate syndromes associated with vascular insufficiency. Brimonidine tartrate ophthalmic solution, 0.15% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. 5.2 Severe Cardiovascular Disease Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. 5.3 Contamination of Topical Ophthalmic Products After Use 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 patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.", "warnings": "", "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in the labeling: \u2022 Neonates and Infants (Pediatric Patients Younger than 2 Years Old) [see Contraindications ( 4.1 )] \u2022 Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.1 )] \u2022 Severe Cardiovascular Disease [see Warnings and Precautions ( 5.2 )] \u2022 Contamination of Topical Ophthalmic Products After Use [see Warnings and Precautions ( 5.3 )] Most common adverse reactions are allergic conjunctivitis, conjunctival hyperemia, and eye pruritis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 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. Adverse reactions occurring in approximately 10 to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis. Adverse reactions occurring in approximately 5 to 9% of the subjects included...", "drug_abuse_and_dependence": "", "controlled_substance": "", "recent_major_changes": "\u2022 Contraindications, Neonates and Infants (Pediatric Patients Younger than 2 Years Old) ( 4.1 ) 11/2025 \u2022 Warnings and Precautions, Severe Cardiovascular Disease ( 5.2 ) 11/2025 \u2022 Warnings and Precautions, Contamination of Topical Ophthalmic Products After Use ( 5.3 ) 11/2025", "information_for_patients": "Handling the Container 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 infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions [see Warnings and Precautions ( 5.3 )] . Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle. When to Seek Physician Advice 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. Use with Other Ophthalmic Drugs Advise patients that if more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart. Potential for Decreased Mental Alertness As with other drugs in this class, brimonidine tartrate ophthalmic solution, 0.15% may cause fatigue and/or drowsiness in some patients. Patients who engage in ha...", "spl_medguide": "", "clinical_studies": "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. Adverse reactions occurring in approximately 10 to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis. Adverse reactions occurring in approximately 5 to 9% of the subjects included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. Adverse reactions occurring in approximately 1 to 4% of subjects included: allergic reaction, arthralgia, arthritis, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, chest pain, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, diabetes mellitus, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterol...", "brand_name": "Brimonidine Tartrate", "manufacturer": "Sandoz Inc", "application_number": "NDA021764", "pharm_class_epc": [], "route": [ "OPHTHALMIC" ], "effective_time": "20251124", "set_id": "b1e7ebd4-d0d2-40a5-aa11-5f68bc5972bd", "has_boxed_warning": false, "controlled": false, "mentions_rems": false }, "faers": { "total": 20651, "serious": 7025, "death": 678, "hospitalization": 2710, "primary_suspect": 20634, "top_reactions": [ [ "Treatment Failure", 2885 ], [ "Drug Ineffective", 1863 ], [ "Eye Irritation", 1260 ], [ "Ocular Hyperaemia", 1197 ], [ "Eye Pain", 1044 ], [ "Headache", 883 ], [ "Vision Blurred", 855 ], [ "Hypersensitivity", 719 ], [ "Erythema", 706 ], [ "Off Label Use", 696 ], [ "Fatigue", 687 ], [ "Dry Eye", 667 ], [ "Condition Aggravated", 613 ], [ "Intraocular Pressure Increased", 588 ], [ "Dizziness", 573 ] ], "by_year": { "2019": 2350, "2020": 4900, "2021": 1356, "2022": 1277, "2023": 1488, "2024": 1334, "2025": 1422, "2026": 885 }, "by_year_primary": { "2019": 2350, "2020": 4900, "2021": 1354, "2022": 1276, "2023": 1484, "2024": 1329, "2025": 1420, "2026": 883 } }, "faers_base": { "total": 20692304, "serious_share": 0.5742697381596559, "death_share": 0.09102355155810585 }, "recalls": [ { "class": "Class III", "date": "20200604", "reason": "Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.", "firm": "SOMERSET THERAPEUTICS LLC", "status": "Terminated" }, { "class": "Class III", "date": "20200604", "reason": "Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.", "firm": "SOMERSET THERAPEUTICS LLC", "status": "Terminated" }, { "class": "Class III", "date": "20200604", "reason": "Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.", "firm": "SOMERSET THERAPEUTICS LLC", "status": "Terminated" } ], "recall_total": 3, "drugsfda": { "applications": 30, "nda": 8, "anda": 22, "first_approval": "19960906", "rems": false, "rems_last": "", "labeling_supplements": 21, "labeling_recent": 6, "sponsors": [ "ABBVIE", "ALEMBIC", "ALLERGAN", "APOTEX", "BAUSCH AND LOMB INC", "DR REDDYS LABS SA", "GALDERMA LABS LP", "GLAND" ], "unapproved": false, "first_approval_fmt": "09/06/1996" }, "trials": { "total": 213, "completed": 146, "terminated": 22, "with_results": 85, "industry": 115, "phase3": 45, "results_share": 0.5821917808219178, "terminated_share": 0.10328638497652583 }, "pubmed": { "rct": 212, "meta": 7, "recent_rct": 21, "cochrane": [] }, "payments": { "year": "2024", "usd": 0.0, "records": 0, "by_name": [], "names_checked": [ "brimonidine", "Mirvaso", "Alphagan", "Lumify" ], "source": "bulk-index" }, "partd": { "year": "2024", "claims": 2692766, "beneficiaries": 729741, "spend": 190677291.01, "by_brand": [ { "brand": "Brimonidine Tartrate", "claims": 2435341, "per_claim": 40.084918178, "is_generic": true }, { "brand": "Alphagan P", "claims": 256839, "per_claim": 360.77727308, "is_generic": false }, { "brand": "Mirvaso", "claims": 586, "per_claim": 674.35537543, "is_generic": false } ], "per_claim": 70.81093975859766 }, "mdl": [], "dsc": [], "settlements": [], "prescrire": null, "eml": { "listed": false, "status": "", "name": "", "matched": null, "stewardship": [] }, "exposure": { "years": [ "2024", "2025", "2026" ], "reports_recent": 3632, "fills": 2692766, "per_million": 1348.7989673072225, "ratio": 0.48711572518094237, "median": 2768.949753790441 }, "scores": { "safety": { "score": 100, "letter": "A", "why": [ "1,349 FDA reports naming it as the suspect drug per million Medicare fills, 0.5x the median drug on this site", "Death share in reports is near or below the FAERS average (0.4x)" ], "weight": 0.35 }, "evidence": { "score": 60, "letter": "D", "why": [ "212 randomized trials and 7 systematic reviews/meta-analyses indexed in PubMed", "No Cochrane review found (-5)" ], "weight": 0.25 }, "regulatory": { "score": 86, "letter": "B", "why": [ "Recalls since 2016: 0 Class I, 0 Class II, 3 Class III across 22 generic makers (-1)", "6 label changes approved since 2021: the safety story is still moving (-8)", "Label lists recent major changes to warnings or indications (-5)" ], "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 (22 applications)", "10 same-class alternatives exist" ], "weight": 0.1 } }, "total": 88, "grade": "A", "questions": [ "The most-reported problems in FDA's adverse event data are treatment failure, eye irritation, ocular hyperaemia. How would we recognize and handle those?", "Why this one over apraclonidine, clonidine, dipivefrin? 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.)" ] }