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)
Adverse reaction08.06.01.0180.000058%-
Brain injury17.11.01.003; 19.07.03.0070.000087%-
Hypertransaminasaemia09.01.02.0050.000058%-
Acute kidney injury20.01.03.0160.000727%
Osmotic demyelination syndrome17.16.02.0040.000523%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000378%-
Hepatic cancer09.04.02.008; 16.07.02.0040.000174%-
Hepatocellular carcinoma09.04.02.010; 16.07.02.0050.000087%-
Multiple organ dysfunction syndrome08.01.03.0570.000320%
Frustration tolerance decreased19.04.02.016---
Bronchial carcinoma16.19.02.004; 22.08.01.0150.000058%-
Cardiac failure chronic02.05.01.0090.000204%-
Lung carcinoma cell type unspecified stage IV16.19.02.006; 22.08.01.0190.000058%-
Ruptured cerebral aneurysm17.08.01.059; 24.02.04.0050.000058%-
Kidney enlargement20.01.06.0030.000186%-
Renal cyst ruptured16.27.01.007; 20.01.06.0120.000145%-
Gastrointestinal oedema07.11.01.0120.000058%-
Haemorrhagic cyst08.03.05.008; 16.02.02.013; 24.07.01.0690.000058%-
Small cell lung cancer metastatic16.19.08.002; 22.08.01.0120.000058%-
Renal cyst haemorrhage16.27.01.005; 20.01.04.017; 24.07.07.0030.000116%-
Appendix disorder07.11.01.020---
Cyst rupture08.03.05.004; 16.02.02.009---
Invasive ductal breast carcinoma16.10.01.013; 21.05.01.021---
Critical illness08.01.03.0650.000058%-
End stage renal disease20.01.03.0190.000465%-
Disease complication08.01.03.0870.000058%-
Hepatic cytolysis09.01.07.0360.000087%-
Illness08.01.03.091---
Pharyngeal swelling22.04.05.0280.000058%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.000570%-
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