Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azelastine
Drug ID BADD_D00198
Description Azelastine, a phthalazine derivative, is an antihistamine available as an intranasal spray for the treatment of allergic and vasomotor rhinitis and as an ophthalmic solution for the treatment of allergic conjunctivitis.[L8240,L8270] It is a racemic mixture, though there is no noted difference in pharmacologic activity between enantiomers, and was first granted FDA approval in 1996.[L8240,L8270] Azelastine is also available in combination with fluticasone propionate as a nasal spray marketed under the trade name Dymista™, which is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 6 years of age and older.[L8309]
Indications and Usage For the symptomatic treatment of seasonal allergic rhinitis and non-allergic rhinitis, as well as symptomatic relief of ocular itching associated with allergic conjunctivitis.
Marketing Status Prescription; Discontinued
ATC Code R01AC03; R06AX19; S01GX07
DrugBank ID DB00972
KEGG ID D07483
MeSH ID C020976
PubChem ID 2267
TTD Drug ID D00JVR
NDC Product Code 65162-676; 50090-3833; 42291-094; 67877-477
Synonyms azelastine | 4-(p-chlorobenzyl)-2-(N-methylperhydroazepinyl-(4))-1-(2H)-phthalazinone | Allergodil | Astelin | azelastine hydrochloride | 4-((4-chlorophenyl)methyl)-2- (hexahydro-1-methyl-1H-azepin-4-yl)-1(2H)- phthalazinone HCl | Corifina | Loxin | Vividrin akut Azelastin | Optivar | Rhinolast | Optilast | Afluon | A 5610 | A-5610 | Azeptin
Chemical Information
Molecular Formula C22H24ClN3O
CAS Registry Number 58581-89-8
SMILES CN1CCCC(CC1)N2C(=O)C3=CC=CC=C3C(=N2)CC4=CC=C(C=C4)Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anosmia22.04.03.006; 17.04.04.001--
Anxiety19.06.02.0020.000142%
Aphthous ulcer07.05.06.002--Not Available
Application site irritation12.07.01.003; 08.02.01.003--Not Available
Arthritis15.01.01.001--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Body temperature increased13.15.01.001--Not Available
Breast pain21.05.05.003--
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.001--
Depressed level of consciousness17.02.04.0020.000142%
Dermatitis23.03.04.002--Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Diarrhoea07.02.01.001--
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