Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Vibegron
Drug ID BADD_D02606
Description Vibegron is a potent, selective beta-3 adrenergic receptor (β3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity.[L28305] Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder,[A226050] a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults. It is available as oral tablets under the market name GEMTESA.[L28310] Vibegron is the second beta-3 adrenergic agonist approved for the treatment of overactive bladder following [mirabegron], which was approved in 2012. Unlike mirabegron, vibegron is less likely to be associated with drug-drug interactions involving the CYP3A4, 2D6, or 2C9 enzymes.[A226065]
Indications and Usage Vibegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.[L28305]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB14895
KEGG ID D10433
MeSH ID C000608232
PubChem ID 44472635
TTD Drug ID D0DH5X
NDC Product Code 73336-075; 50683-0536; 75877-0008
UNII M5TSE03W5U
Synonyms N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide | vibegron | MK-4618
Chemical Information
Molecular Formula C26H28N4O3
CAS Registry Number 1190389-15-1
SMILES C1CC(NC1CC2=CC=C(C=C2)NC(=O)C3CCC4=NC=CC(=O)N34)C(C5=CC=CC=C5)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)
Arrhythmia02.03.02.001--
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.003--
Condition aggravated08.01.03.004--
Death08.04.01.001-
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007-
Drug ineffective08.06.01.006--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002-
Headache17.14.01.001-
Muscle spasms15.05.03.004-
Nausea07.01.07.001-
Nightmare19.02.03.003--
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011-
Palpitations02.11.04.012-
Rash23.03.13.001--
Urinary retention20.02.02.011-
Vomiting07.01.07.003-
Peripheral swelling02.05.04.015; 08.01.03.053--
Adverse event08.06.01.010--
Therapeutic product effect decreased08.06.01.050--
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