Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Umeclidinium bromide
Drug ID BADD_D02315
Description Umeclidinium is a long-acting muscarinic antagonist (LAMA) used as maintenance treatment for symptoms of chronic obstructive pulmonary disease (COPD). It is available as a once-daily inhalation monotherapy or as a fixed-dose combination product with the long-acting beta2-agonist vilanterol. COPD is a progressive obstructive lung disease characterized by shortness of breath, cough, sputum production, and chronically poor airflow with a forced expiratory volume in 1 second (FEV1) of less than 80%. By blocking the M3 muscarinic receptor which is highly expressed in airway smooth muscle of the lungs, umeclidinium inhibits the binding of acetylcholine and thereby opens up the airways by preventing bronchoconstriction. Its use has been shown to provide clinically significant, sustained improvements in lung function.
Indications and Usage Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
Marketing Status approved
ATC Code R03BB07
DrugBank ID DB09076
KEGG ID D10181
MeSH ID C573971
PubChem ID 11519069
TTD Drug ID D09ZOQ
NDC Product Code 64918-1918; 64918-1920; 52482-012; 58175-0626; 47848-055; 59057-011; 59057-012; 64567-0030
UNII 7AN603V4JV
Synonyms GSK573719 | umeclidinium
Chemical Information
Molecular Formula C29H34BrNO2
CAS Registry Number 869113-09-7
SMILES C1C[N+]2(CCC1(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)CCOCC5=CC=CC=C5.[Br-]
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 pain upper07.01.05.003--
Angle closure glaucoma06.03.01.001--Not Available
Arthralgia15.01.02.001--
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bronchospasm paradoxical22.03.01.006--Not Available
Cough22.02.03.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspepsia07.01.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Headache17.14.01.001--
Infection11.01.08.002--Not Available
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Myalgia15.05.02.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neck pain15.03.04.009--
Nervous system disorder17.02.10.001--Not Available
Pain in extremity15.03.04.010--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Rash23.03.13.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhythm idioventricular02.03.04.019--Not Available
Sinus headache22.12.03.022; 17.14.01.002--
Sinus tachycardia02.03.03.010--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
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