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)
Hypoaesthesia17.02.06.023--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.010--
Insomnia19.02.01.002; 17.15.03.0020.000543%
Joint dislocation15.01.07.002; 12.04.02.007--Not Available
Laceration23.03.11.004; 12.01.06.006--Not Available
Lacrimation increased06.08.02.004--
Laryngeal pain22.02.05.036--
Laryngitis22.07.03.001; 11.01.13.001--
Malaise08.01.01.003--
Mental disability26.01.01.001--Not Available
Mouth ulceration07.05.06.004--Not Available
Mucosal inflammation08.01.06.002--Not Available
Mucosal ulceration08.01.06.003--Not Available
Muscle contractions involuntary17.05.03.001; 15.05.03.008--Not Available
Myalgia15.05.02.001--
Nasal dryness22.04.03.002--Not Available
Nasal septum perforation22.04.03.003--Not Available
Nasal ulcer22.04.03.0110.000543%Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.0010.000543%
Nervousness19.06.02.003--Not Available
Pain08.01.08.004--
Palpitations02.01.02.003--
Paraesthesia17.02.06.005--
Parosmia22.04.03.007; 17.04.04.002--Not Available
Pharyngitis11.01.13.003; 22.07.03.004; 07.05.07.004--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
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