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)
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.0040.000469%
Dysuria20.02.02.0020.001545%
Eructation07.01.02.0030.000347%
Eye disorder06.08.03.0010.000556%Not Available
Eye pain06.08.03.0020.000174%
Fatigue08.01.01.002--
Flatulence07.01.04.0020.000677%
Fluid retention14.05.06.002; 20.01.02.0030.000851%Not Available
Flushing24.03.01.002; 23.06.05.003; 08.01.03.0250.000260%
Gait disturbance17.02.05.016; 15.03.05.013; 08.01.02.0020.000729%
Gastric haemorrhage24.07.02.007; 07.12.01.0010.000260%
Gastritis haemorrhagic24.07.02.008; 07.08.02.0020.000174%Not Available
Gastrooesophageal reflux disease07.02.02.0030.000260%
Generalised oedema14.05.06.007; 08.01.07.0040.000174%
Glaucoma06.03.01.0020.000347%
Haematochezia24.07.02.012; 07.12.02.0030.000174%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000608%
Hallucination19.10.04.0030.001372%
Hallucination, auditory19.10.04.0040.000174%Not Available
Hallucination, visual19.10.04.0070.000174%Not Available
Head discomfort17.02.05.0270.000590%Not Available
Hepatic function abnormal09.01.02.0010.000556%Not Available
Hepatitis acute09.01.07.0050.000174%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000174%Not Available
Hydronephrosis20.01.05.0010.000260%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.0030.001320%
Hypertension24.08.02.0010.000868%
Hypertensive crisis24.08.01.0010.000174%Not Available
Hypertonic bladder20.03.03.003; 17.10.01.0030.000642%Not Available
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