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
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Ageusia07.14.03.003; 17.02.07.001--Not Available
Anaphylactoid reaction10.01.07.003; 24.06.03.007--Not Available
Anosmia17.04.04.001; 22.04.03.006--
Application site irritation08.02.01.003; 12.07.01.003--Not Available
Asthma10.01.03.010; 22.03.01.002--Not Available
Atrial fibrillation02.03.03.002--
Chest pain02.02.02.011; 08.01.08.002; 22.02.08.003--Not Available
Confusional state17.02.03.005; 19.13.01.001--
Conjunctivitis06.04.01.002; 11.01.06.012--
Dizziness02.01.02.004; 17.02.05.003; 24.06.02.007--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea02.01.03.002; 22.02.01.004--
Epistaxis22.04.03.001; 24.07.01.005--
Eye irritation06.04.05.003--Not Available
Eye pain06.08.03.002--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hypertension24.08.02.001--
Influenza like illness08.01.03.010--
Muscle contractions involuntary15.05.03.008; 17.05.03.001--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
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
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