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)
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.000938%
Prostate cancer21.04.02.002; 16.25.01.0010.000608%Not Available
Adverse event08.06.01.0100.001146%Not Available
Bladder disorder20.03.01.0020.000764%Not Available
Limb discomfort15.03.04.014--Not Available
Mental disorder19.07.01.0020.000469%Not Available
Motor dysfunction17.01.02.031; 15.05.06.0060.000174%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.001372%
Erectile dysfunction21.03.01.007; 19.08.04.0010.000347%
Parkinson's disease17.01.05.0100.000608%Not Available
Adverse reaction08.06.01.0180.000469%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000174%Not Available
Sinus node dysfunction02.03.03.0170.000260%
Terminal state08.01.03.0790.000174%Not Available
Myasthenia gravis crisis17.05.04.007; 15.05.08.004; 10.04.05.0070.000174%Not Available
Age-related macular degeneration06.09.03.0180.000174%Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.0380.001268%Not Available
Graves' disease10.04.08.014; 06.09.04.009; 05.02.02.0090.000260%Not Available
Pregnancy on oral contraceptive18.08.01.0050.000174%Not Available
Therapeutic product effect incomplete08.06.01.0520.002084%Not Available
Therapeutic response changed08.06.01.059--Not Available
Therapy non-responder08.06.01.0630.000260%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.003716%Not Available
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