Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Indacaterol
Drug ID BADD_D01147
Description Indacaterol is a novel, ultra-long-acting, rapid onset β(2)-adrenoceptor agonist developed for Novartis for the once-daily management of asthma and chronic obstructive pulmonary disease. It was approved by the European Medicines Agency (EMA) on 30 November 2009 and by the FDA on 1 July 2011. It is marketed in Europe as Onbrez and in America as Arcapta Neohaler. Indacaterol is provided as its maleate salt form. Indacaterol is also a chiral molecule but only the pure R-enantiomer is dispensed.
Indications and Usage For the long term, once-daily-dosing maintenance of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Marketing Status approved
ATC Code R03AC18
DrugBank ID DB05039
KEGG ID D09318
MeSH ID C510790
PubChem ID 6918554
TTD Drug ID D03DJL
NDC Product Code Not Available
UNII 8OR09251MQ
Synonyms indacaterol | 5-(2-(5,6-diethylindan-2-ylamino)-1-hydroxyethyl)-8-hydroxy-1H-quinolin-2-one | QAB-149 | arcapta neohaler | Onbrez
Chemical Information
Molecular Formula C24H28N2O3
CAS Registry Number 312753-06-3
SMILES CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC
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)
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Palpitations02.11.04.012--
Paraesthesia17.02.06.005; 23.03.03.094--
Pneumonia11.01.09.003; 22.07.01.003--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rhinorrhoea22.12.03.021--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Tachycardia02.03.02.007--Not Available
Therapeutic response decreased08.06.01.016--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary retention20.02.02.011--
Vertigo17.02.12.002; 04.04.01.003--
Musculoskeletal discomfort15.03.04.001--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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