Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Brimonidine tartrate
Drug ID BADD_D00295
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 D02076
MeSH ID D000068438
PubChem ID 11236066
TTD Drug ID D00ARM
NDC Product Code 73309-191; 82182-773; 66022-0110; 73377-228; 0023-9177; 14445-003; 42385-038; 61314-143; 55545-0668; 50090-6368; 0023-9321; 60505-0564; 70069-231; 70069-232; 70069-233; 42571-354; 53296-0050; 64181-0020; 17478-715; 24208-411; 61314-144; 51927-0063; 70600-031; 14445-400; 71921-185; 64330-042; 71052-660; 24208-537; 42385-750; 63278-0488; 65085-0030; 0299-5980; 63629-8792; 51927-4992; 55679-133; 58567-100
UNII 4S9CL2DY2H
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 C15H16BrN5O6
CAS Registry Number 70359-46-5
SMILES C1CN=C(N1)NC2=C(C3=NC=CN=C3C=C2)Br.C(C(C(=O)O)O)(C(=O)O)O
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)
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Blepharitis23.03.04.012; 06.04.04.001--Not Available
Bradycardia02.03.02.002--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Cataract06.06.01.001--
Coma17.02.09.001--Not Available
Conjunctival follicles06.06.02.002--Not Available
Conjunctival haemorrhage24.07.05.001; 06.07.01.001--Not Available
Conjunctival oedema06.04.01.001--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Conjunctivitis allergic10.01.04.002; 06.04.01.003--Not Available
Corneal erosion06.06.03.003--Not Available
Cough22.02.03.001--
Depression19.15.01.001--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dry eye06.08.02.001--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Erythema23.03.06.001--Not Available
Erythema of eyelid23.03.06.006; 06.04.04.003--Not Available
Eye allergy10.01.03.028; 06.04.05.010--Not Available
Eye discharge06.04.05.001--Not Available
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
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