Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Indacaterol maleate
Drug ID BADD_D01148
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 D09319
MeSH ID C510790
PubChem ID 9827599
TTD Drug ID D03DJL
NDC Product Code 64567-0024
UNII 2JEC1ITX7R
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 C28H32N2O7
CAS Registry Number 753498-25-8
SMILES CCC1=C(C=C2CC(CC2=C1)NCC(C3=C4C=CC(=O)NC4=C(C=C3)O)O)CC.C(=CC(=O)O)C(=O)O
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)
Cough22.02.03.001--
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Headache17.14.01.001--
Heart rate increased13.14.04.002--Not Available
Hyperglycaemia05.06.02.002; 14.06.02.002--
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Palpitations02.11.04.012--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Tachycardia02.03.02.007--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Oropharyngeal pain22.12.03.016; 07.05.05.004--
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