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%Not Available
Brain injury19.07.03.007; 17.11.01.0030.000087%Not Available
Hypertransaminasaemia09.01.02.0050.000058%Not Available
Acute kidney injury20.01.03.0160.000727%
Osmotic demyelination syndrome17.16.02.0040.000523%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000378%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.000174%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.000087%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000320%
Frustration tolerance decreased19.04.02.016--Not Available
Bronchial carcinoma22.08.01.015; 16.19.02.0040.000058%Not Available
Cardiac failure chronic02.05.01.0090.000204%Not Available
Lung carcinoma cell type unspecified stage IV22.08.01.019; 16.19.02.0060.000058%Not Available
Ruptured cerebral aneurysm24.02.04.005; 17.08.01.0590.000058%Not Available
Kidney enlargement20.01.06.0030.000186%Not Available
Renal cyst ruptured20.01.06.012; 16.27.01.0070.000145%Not Available
Gastrointestinal oedema07.11.01.0120.000058%Not Available
Haemorrhagic cyst24.07.01.069; 16.02.02.013; 08.03.05.0080.000058%Not Available
Small cell lung cancer metastatic22.08.01.012; 16.19.08.0020.000058%Not Available
Renal cyst haemorrhage16.27.01.005; 24.07.07.003; 20.01.04.0170.000116%Not Available
Appendix disorder07.11.01.020--Not Available
Cyst rupture16.02.02.009; 08.03.05.004--Not Available
Invasive ductal breast carcinoma21.05.01.021; 16.10.01.013--Not Available
Critical illness08.01.03.0650.000058%Not Available
End stage renal disease20.01.03.0190.000465%Not Available
Disease complication08.01.03.0870.000058%Not Available
Hepatic cytolysis09.01.07.0360.000087%Not Available
Illness08.01.03.091--Not Available
Pharyngeal swelling22.04.05.0280.000058%Not Available
Treatment noncompliance12.09.02.006; 08.06.01.0670.000570%Not Available
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