Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azelastine hydrochloride
Drug ID BADD_D00199
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 D00659
MeSH ID C020976
PubChem ID 54360
TTD Drug ID D00JVR
NDC Product Code 59651-215; 57572-0713; 70069-091; 60505-0848; 54752-0008; 65162-706; 49076-7601; 47335-938; 53002-1279; 51927-5005; 50383-942; 65841-164; 68071-2497; 61314-308; 71205-449; 68382-415; 47335-779; 50090-2330; 51991-814; 63629-2057; 49274-1101; 68071-2498; 0054-0293; 60656-1839; 60505-0578; 53002-2279; 50383-738; 55486-1575; 14501-0048; 70771-1313; 17478-718; 72266-141; 60505-0833; 68083-287; 59651-214
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 C22H25Cl2N3O
CAS Registry Number 79307-93-0
SMILES CN1CCCC(CC1)N2C(=O)C3=CC=CC=C3C(=N2)CC4=CC=C(C=C4)Cl.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)
Rhinitis22.07.03.006; 11.01.13.004--
Sneezing22.02.05.011--
Somnolence17.02.04.006; 19.02.05.003--
Tachycardia02.03.02.007--Not Available
Throat irritation22.02.05.013; 07.05.03.004--Not Available
Urinary retention20.02.02.011--
Vision blurred06.02.06.007; 17.17.01.010--
Xerophthalmia14.12.03.002; 06.06.03.008--Not Available
Nasal discomfort22.02.05.020--Not Available
Drug tolerance08.06.01.003--Not Available
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