Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Revefenacin
Drug ID BADD_D02589
Description Revefenacin is a novel biphenyl carbamate tertiary amine agent that belongs to the family of the long-acting muscarinic antagonists (LABA). The labile primary amide in the structure produces a "soft-drug" site that allows rapid systemic clearance and minimizing of the systemically mediated adverse reactions. The LABA group falls into a parent category known as long-acting inhaled bronchodilators and this type of agents are recommended as a maintenance therapy for chronic obstructive pulmonary disease (COPD).[A40025] From the LABA group, revefenacin is the first once-daily nebulized LAMA treatment.[A40026] It was developed by Theravance Biopharma and FDA approved on November 9, 2018.[L4818]
Indications and Usage Revefenacin is indicated as an inhalation solution for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).[L4820] COPD is a growing disease being the third leading cause of death in the US. This disease is characterized by not fully reversible airflow limitation.[L4821]
Marketing Status approved; investigational
ATC Code R03BB08
DrugBank ID DB11855
KEGG ID D10978
MeSH ID C583570
PubChem ID 11753673
TTD Drug ID D0K1ST
NDC Product Code 62009-1912; 59651-683; 53296-0127; 16436-0127; 49502-806; 54893-0122
UNII G2AE2VE07O
Synonyms revefenacin | Yupelri | TD-4208 | biphenyl-2-ylcarbamic acid 1-(2-((4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl)methylamino)ethyl)piperidin-4-yl ester
Chemical Information
Molecular Formula C35H43N5O4
CAS Registry Number 864750-70-9
SMILES CN(CCN1CCC(CC1)OC(=O)NC2=CC=CC=C2C3=CC=CC=C3)C(=O)C4=CC=C(C=C4)CN5CCC(CC5)C(=O)N
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)
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.000177%-
Constipation07.02.02.0010.000052%
Death08.04.01.0010.000078%
Drug ineffective08.06.01.0060.000114%-
Dyspnoea02.11.05.003; 22.02.01.0040.000862%
Feeling abnormal08.01.09.0140.000114%-
Headache17.14.01.0010.000317%
Throat tightness19.01.02.005; 22.12.03.0310.000052%-
Urinary retention20.02.02.0110.000156%
Urticaria10.01.06.001; 23.04.02.0010.000177%
Peripheral swelling02.05.04.015; 08.01.03.0530.000291%-
Therapeutic product effect decreased08.06.01.0500.000177%-
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