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)
Abdominal pain07.01.05.002--
Ageusia17.02.07.001; 07.14.03.003--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anosmia22.04.03.006; 17.04.04.001--
Application site irritation12.07.01.003; 08.02.01.003--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
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--
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspnoea22.02.01.004; 02.01.03.002--
Epistaxis22.04.03.001; 24.07.01.005--
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypertension24.08.02.001--
Influenza like illness08.01.03.010--
Muscle contractions involuntary17.05.03.001; 15.05.03.008--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Palpitations02.01.02.003--
Paraesthesia17.02.06.005--
Parosmia17.04.04.002; 22.04.03.007--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
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