Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Solifenacin
Drug ID BADD_D02445
Description Solifenacin is a competitive muscarinic receptor antagonist indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.[L7511] It has a long duration of action as it is usually taken once daily.[L7511] Solifenacin was granted FDA approval on 19 November 2004.[L7511]
Indications and Usage Solifenacin tablets are indicated to treat an overactive bladder with urinary incontinence, urgency, and frequency.[L7511]
Marketing Status approved
ATC Code G04BD08
DrugBank ID DB01591
KEGG ID D08522
MeSH ID D000069464
PubChem ID 154059
TTD Drug ID D0L4YD
NDC Product Code 70771-1604; 47621-301; 65977-0042; 68382-987; 68382-988; 70771-1605
UNII A8910SQJ1U
Synonyms Solifenacin Succinate | Succinate, Solifenacin | Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate | YM905 | YM 905 | 905, YM | Vesicare | Solifenacin | 2(1H)-Isoquinolinecarboxylic acid, 3,4-dihydro-1-phenyl-,1- azabicyclo(2.2.2)oct-3-yl ester, (R-(R*,S*))-
Chemical Information
Molecular Formula C23H26N2O2
CAS Registry Number 242478-37-1
SMILES C1CN2CCC1C(C2)OC(=O)N3CCC4=CC=CC=C4C3C5=CC=CC=C5
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 discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.000729%
Abdominal pain07.01.05.0020.001077%
Abnormal weight gain14.03.02.0100.000174%Not Available
Accommodation disorder06.02.04.0010.000260%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000174%Not Available
Acute psychosis19.03.01.0010.000434%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000260%Not Available
Ageusia17.02.07.001; 07.14.03.0030.000816%Not Available
Agranulocytosis01.02.03.0010.000260%Not Available
Altered state of consciousness19.07.01.003; 17.02.04.0010.000174%Not Available
Amnesia19.20.01.001; 17.03.02.0010.000764%
Angina pectoris24.04.04.002; 02.02.02.0020.000347%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000608%Not Available
Anhidrosis23.02.03.0010.000347%Not Available
Anticholinergic syndrome17.05.01.0010.000174%Not Available
Anuria20.01.03.0020.000260%Not Available
Apathy19.04.04.0020.000174%Not Available
Aphonia17.02.08.009; 22.12.03.001; 19.19.01.0020.000174%
Arrhythmia02.03.02.0010.000955%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000174%
Asthenia08.01.01.001--Not Available
Atrioventricular block complete02.03.01.0030.000260%
Bladder dilatation20.03.01.0070.000347%Not Available
Bladder discomfort20.02.02.0190.000174%Not Available
Blindness06.02.10.003; 17.17.01.0030.000174%Not Available
Blister23.03.01.001; 12.01.06.0020.000556%Not Available
Bradycardia02.03.02.0020.000608%Not Available
Cardiac failure02.05.01.0010.000347%
Cardiac failure congestive02.05.01.0020.000347%Not Available
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