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 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 S01GX07; R06AX19; R01AC03
DrugBank ID DB00972
KEGG ID D00659
MeSH ID C020976
PubChem ID 54360
TTD Drug ID D00JVR
NDC Product Code 51927-0302; 53002-2279; 53002-5279; 50090-2330; 70069-091; 72266-141; 49274-1101; 55486-1575; 53002-1803; 51927-5005; 57572-0713; 47335-938; 50383-942; 59651-215; 65841-164; 59651-214; 68382-415; 0054-0293; 53002-1279; 68083-287; 14501-0048; 47335-779; 60505-0578; 60505-0833; 71205-449; 51991-814; 60505-0848; 61314-308; 70771-1313; 49076-7601; 54752-0008; 60656-1839
UNII 0L591QR10I
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
*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--
Ageusia07.14.03.003; 17.02.07.001---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Anosmia17.04.04.001; 22.04.03.006--
Application site irritation08.02.01.003; 12.07.01.003---
Asthma10.01.03.010; 22.03.01.002---
Atrial fibrillation02.03.03.002--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003---
Confusional state17.02.03.005; 19.13.01.001--
Conjunctivitis06.04.01.002; 11.01.06.012--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis22.04.03.001; 24.07.01.005--
Eye irritation06.04.05.003---
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---
Nausea07.01.07.001--
Nervousness19.06.02.003---
Palpitations02.11.04.012--
Paraesthesia17.02.06.005; 23.03.03.094--
Parosmia17.04.04.002; 22.04.03.007---
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pruritus23.03.12.001--
Rash23.03.13.001---
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