Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rupatadine
Drug ID BADD_D02635
Description Rupatadine is a dual histamine H1 receptor and platelet activating factor receptor antagonist that is used for symptomatic relief in seasonal and perennial rhinitis as well as chronic spontaneous urticaria. It was approved for marketing in Canada under the tradename Rupall and comes in tablet formulation for adult use and liquid formulation for pediatric use.
Indications and Usage For the symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and perennial allergic rhinitis in patients 2 years of age and older [FDA Label]. Also used for the symptomatic relief of chronic spontaneous urticaria in patients 2 years of age and older.
Marketing Status approved
ATC Code R06AX28
DrugBank ID DB11614
KEGG ID D07407
MeSH ID C103639
PubChem ID 133017
TTD Drug ID D0S1CQ
NDC Product Code Not Available
UNII 2AE8M83G3E
Synonyms rupatadine | 8-chloro-6,11-dihydro-11-(1-((5-methyl-3-pyridinyl)methyl)-4-piperidinylidene)-5H-benzo(5,6)cyclohepta(1,2-b)pyridine | UR 12592 | UR-12592
Chemical Information
Molecular Formula C26H26ClN3
CAS Registry Number 158876-82-5
SMILES CC1=CC(=CN=C1)CN2CCC(=C3C4=C(CCC5=C3N=CC=C5)C=C(C=C4)Cl)CC2
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)
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arthralgia15.01.02.001--
Cough22.02.03.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug ineffective08.06.01.006--Not Available
Dysphagia07.01.06.003--
Dyspnoea22.02.01.004; 02.11.05.003--
Erythema23.03.06.001--Not Available
Eye swelling06.08.03.003--Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Headache17.14.01.001--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypotension24.06.03.002--
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001--Not Available
Injection site pain08.02.03.010; 12.07.03.011--Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013--Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.005--Not Available
Malaise08.01.01.003--
Muscular weakness17.05.03.005; 15.05.06.001--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor08.01.03.032; 24.03.04.001; 23.03.03.031--Not Available
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash macular23.03.13.003--Not Available
Skin discolouration23.03.03.005--Not Available
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