Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Brimonidine
Drug ID BADD_D00294
Description Brimonidine is an alpha-adrenergic agonist and 2-imidazoline derivative that was first introduced in 1996.[A178951] It is considered to be a third generation alpha-2 aadrenergic receptor agonist, since it displays preferential binding at alpha-2 adrenoceptors over alpha-1 receptors.[A179002] Brimonidine displays a higher selectivity toward the alpha-2 adrenergic receptors than [clonidine] or [apraclonidine], which are also alpha-2 adrenergic agonists.[A178969] Alpha-2 adrenergic agonists are members of the ocular hypotensive agent drug class that are used in the chronic treatment of glaucoma. Early treatment and management of glaucoma, which predominantly involves the lowering of intraocular pressure, is critical since glaucoma is considered to be a common cause of blindness worldwide.[A178948,A178969] Ophthalmically, brimonidine is used to lower intraocular pressure by reducing aqueous humor production and increasing uveoscleral outflow. Because it is oxidately stable, brimonidine is associated with fewer reports of ocular allergic reactions compared to other alpha-2 adrenergic agonists.[A178969] The ophthalmic solution of brimonidine was first approved by the FDA in 1996 as Alphagan [label] and brimonidine is the only selective alpha-adrenergic receptor agonist approved for chronic treatment in glaucoma.[A36674] Brimonidine is also found in ophthalmic solutions in combination with [brinzolamide] under the market name Simbrinza for the reduction in intraocular pressure. Unlike nonselective beta-blockers used in ocular hypertension, brimonidine is not associated with significantly adverse cardiopulmonary side effects.[A178945] Thus brimonidine is an effective and safe alternative to beta-blockers, in patients with, or at high risk for, cardiopulmonary disease.[A178948] The topical form of brimonidine was approved by the FDA in August 2013 for the symptomatic treatment of persistent facial erythema of rosacea in adults. It is marketed under the brand name Mirvaso.[L6535] Brimonidine is the first topical treatment approved for facial erythema of rosacea.[A178978]
Indications and Usage **Opthalmic** Indicated for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension [label] as monotherapy or combination product with [brinzolamide]. **Topical** Indicated for the treatment of persistent (non-transient) facial erythema of rosacea in adults 18 years of age or older.[L6535]
Marketing Status approved
ATC Code D11AX21; S01EA05; S01GA07
DrugBank ID DB00484
KEGG ID D07540
MeSH ID D000068438
PubChem ID 2435
TTD Drug ID D0AE3X
NDC Product Code 63629-9616; 45802-078
UNII E6GNX3HHTE
Synonyms Brimonidine Tartrate | 5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline D-tartrate | Brimonidine Tartrate (1:1), (S-(R*,R*))-Isomer | Brimonidine Purite | AGN 190342 | AGN-190342 | AGN190342 | Sanrosa | Alphagan | Brimonidine | 5-bromo-6-(imidazolidinylideneamino)quinoxaline | 5-bromo-6-(imidazolin-2-ylamino)quinoxaline | Bromoxidine | Alphagan P | UK 14,304 | UK-14304 | UK14304 | UK 14304 | Ratio-Brimonidine | Ratio Brimonidine | UK 14,304-18 | UK 14,304 18 | UK 14,30418 | UK-14,304-18 | UK14,30418 | UK 14308 | UK-14,308 | UK 14,308 | UK14,308 | Brimonidine Tartrate, (R-(R*,R*))-Isomer | Brimonidine Tartrate (1:1) | Mirvaso
Chemical Information
Molecular Formula C11H10BrN5
CAS Registry Number 59803-98-4
SMILES C1CN=C(N1)NC2=C(C3=NC=CN=C3C=C2)Br
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Coronary artery dissection12.02.01.035; 24.02.02.001; 02.02.01.0040.000141%Not Available
Hypoacusis04.02.01.0060.000719%
Application site paraesthesia17.02.06.012; 12.07.01.026; 08.02.01.026--Not Available
Foreign body sensation in eyes06.01.01.0060.001747%Not Available
Conjunctival hyperaemia06.04.01.0040.000282%Not Available
Eyelids pruritus23.03.12.005; 06.08.03.0070.000859%Not Available
Eye oedema06.08.03.013--Not Available
Eye pruritus06.04.05.0060.006100%Not Available
Ocular discomfort06.08.03.0080.000549%Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.002888%Not Available
Corneal neovascularisation24.03.07.009; 06.07.01.0030.000451%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000310%Not Available
Vasodilation procedure25.03.01.001--Not Available
Muscle relaxant therapy25.16.01.001--Not Available
Scleral hyperaemia06.04.07.0030.001916%Not Available
Angiopathy24.03.02.007--Not Available
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000141%
Cardiac disorder02.11.01.003--Not Available
Inflammation10.02.01.089; 08.01.05.0070.000211%Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.0020.000141%Not Available
Conjunctival disorder06.06.02.0040.000141%Not Available
Corneal disorder06.08.01.0040.000211%Not Available
Sensation of foreign body08.01.09.002--Not Available
Pulmonary function test decreased13.19.01.001--Not Available
Pigmentation disorder23.05.03.0010.000141%Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
Reaction to preservatives10.01.01.0240.000719%Not Available
Meibomian gland dysfunction06.04.04.0150.000310%Not Available
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