Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Tolvaptan
Drug ID BADD_D02246
Description Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.
Indications and Usage Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.
Marketing Status approved
ATC Code C03XA01
DrugBank ID DB06212
KEGG ID D01213
MeSH ID D000077602
PubChem ID 216237
TTD Drug ID D03KZM
NDC Product Code 31722-869; 59148-088; 60505-4704; 65977-0100; 59148-082; 67877-637; 59148-079; 60505-4318; 60505-4705; 46602-0031; 59148-089; 14501-0066; 31722-868; 59148-083; 46602-0028; 46602-0030; 49884-770; 59148-020; 67877-635; 14501-0085; 57884-0027; 49884-768; 59148-021; 59148-080; 60505-4317; 67877-636; 46602-0027; 46602-0029; 60862-008; 59148-087
UNII 21G72T1950
Synonyms Tolvaptan | 7-Chloro-5-hydroxy-1-(2-methyl-4-(2-methylbenzoylamino)benzoyl)2,3,4,5-tetrahydro-1H-1-benzazepine | Samsca | OPC 41061 | OPC-41061 | OPC41061
Chemical Information
Molecular Formula C26H25ClN2O3
CAS Registry Number 150683-30-0
SMILES CC1=CC=CC=C1C(=O)NC2=CC(=C(C=C2)C(=O)N3CCCC(C4=C3C=CC(=C4)Cl)O)C
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)
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gallbladder disorder09.03.02.0010.000116%-
Gastric cancer07.21.02.001; 16.13.03.0010.000058%-
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Gastrointestinal perforation07.04.04.0010.000058%-
Glaucoma06.03.01.0020.000174%
Gout14.09.01.001; 15.01.06.0010.000128%-
Haematemesis07.12.02.002; 24.07.02.0110.000058%-
Haematochezia07.12.02.003; 24.07.02.012---
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.000320%
Blood urine present13.13.02.002---
Haemolysis01.06.04.002--
Haemothorax12.01.18.005; 22.05.02.001; 24.07.01.0080.000058%
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000407%-
Hepatic cyst09.01.08.008; 16.06.02.0010.000262%-
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.000727%-
Hepatic failure09.01.03.0020.000407%
Hepatic function abnormal09.01.02.0010.002518%-
Hepatic steatosis09.01.07.003; 14.08.04.0050.000087%-
Hepatitis09.01.07.0040.000145%-
Hepatitis acute09.01.07.0050.000116%-
Hepatomegaly09.01.05.001---
Hepatorenal syndrome09.01.03.007; 20.01.03.0120.000145%-
Hepatotoxicity09.01.07.009; 12.03.01.0080.003914%-
Hernia08.01.04.001---
Hydrocephalus17.07.01.0010.000058%
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