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)
Supraventricular tachycardia02.03.03.0120.000382%
Swelling08.01.03.0150.000938%-
Swollen tongue07.14.02.003; 10.01.05.015; 23.04.01.0140.000469%-
Syncope02.11.04.015; 17.02.04.008; 24.06.02.0120.001424%
Tachycardia02.03.02.0070.000695%-
Therapeutic response unexpected08.06.01.0010.000469%-
Thirst08.01.09.021; 14.03.02.0070.000938%-
Throat irritation07.05.05.037; 22.12.03.0290.000382%-
Thrombocytopenic purpura01.08.01.003; 23.06.01.0070.000174%-
Tinnitus04.04.01.002; 17.04.07.0040.000174%
Torsade de pointes02.03.04.0050.000174%-
Unintended pregnancy18.08.01.0010.000260%-
Urinary incontinence17.05.01.008; 20.02.02.0100.002431%
Urinary retention20.02.02.0110.003282%
Urticaria10.01.06.001; 23.04.02.0010.001441%
Vertigo04.04.01.003; 17.02.12.0020.000903%
Vision blurred06.02.06.007; 17.17.01.0100.003750%
Visual acuity reduced06.02.10.012; 17.17.01.0110.001059%
Visual impairment06.02.10.0130.002379%-
Vulvovaginal discomfort21.08.02.0050.000260%-
Mobility decreased08.01.03.030; 15.03.05.023; 17.02.05.0180.000174%-
Acute generalised exanthematous pustulosis10.01.01.034; 11.07.01.018; 12.03.01.005; 23.03.10.0020.000174%-
General physical health deterioration08.01.03.0180.000695%-
Balance disorder08.01.03.081; 17.02.02.0070.000347%-
Cardiac flutter02.03.02.0120.000347%-
Skin burning sensation17.02.06.009; 23.03.03.0210.000174%-
Faecaloma07.01.03.0040.000260%-
Cognitive disorder17.03.03.003; 19.21.02.0010.002031%
Toxic skin eruption10.01.01.008; 12.03.01.073; 23.03.05.0030.000347%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.000174%-
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