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 Intranasal azelastine is indicated for the symptomatic treatment of seasonal allergic rhinitis in patients 5 years and older and for the symptomatic treatment of vasomotor rhinitis in patients 12 years and older.[L8240] Ophthalmic azelastine solution is indicated for the treatment of itchy eyes associated with allergic conjunctivitis.[L8270] As a 0.15% nasal spray, azelastine hydrochloride is also indicated for over-the-counter treatment of allergies in patients aged six years and older.[L34640]
Marketing Status approved
ATC Code R01AC03; R06AX19; S01GX07
DrugBank ID DB00972
KEGG ID D07483
MeSH ID C020976
PubChem ID 2267
TTD Drug ID D00JVR
NDC Product Code 67877-477; 65162-676; 42291-094
UNII ZQI909440X
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
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)
Abdominal pain07.01.05.002--
Ageusia17.02.07.001; 07.14.03.003---
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.04.005--
Albuminuria20.02.01.001---
Amenorrhoea21.01.02.001; 05.05.01.002--
Anaphylactic shock24.06.02.004; 10.01.07.002---
Anaphylactoid reaction24.06.03.007; 10.01.07.003---
Anosmia22.04.03.006; 17.04.04.001--
Anxiety19.06.02.0020.000157%
Aphthous ulcer07.05.06.002---
Application site irritation12.07.01.003; 08.02.01.003---
Arthritis15.01.01.001--
Asthenia08.01.01.001---
Asthma22.03.01.002; 10.01.03.010---
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Body temperature increased13.15.01.001---
Breast pain21.05.05.003--
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011---
Confusional state19.13.01.001; 17.02.03.005--
Conjunctivitis11.01.06.012; 06.04.01.002--
Constipation07.02.02.001--
Cough22.02.03.0010.000105%
Depressed level of consciousness17.02.04.0020.000157%
Dermatitis23.03.04.002---
Dermatitis contact10.01.01.003; 23.03.04.004; 12.03.01.040---
Diarrhoea07.02.01.001--
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ADReCS-Target
Drug Name ADR Term Target
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