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)
Lymphatic disorder01.09.01.003--Not Available
Inappropriate antidiuretic hormone secretion14.05.07.001; 05.03.03.0010.000186%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.002--
Cerebral disorder17.02.10.0170.000058%Not Available
Fluid intake reduced14.05.10.0010.000233%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000204%Not Available
Angiopathy24.03.02.007--Not Available
Urine output increased13.13.03.002--Not Available
Neurological symptom17.02.05.010--Not Available
Adverse event08.06.01.0100.000657%Not Available
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Metastatic neoplasm16.16.01.0070.000058%Not Available
Neoplasm progression16.16.02.0050.000204%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.0490.000215%Not Available
Blood disorder01.05.01.004--Not Available
Adverse drug reaction08.06.01.009--Not Available
Disease progression08.01.03.0380.000523%
Drug intolerance08.06.01.013--Not Available
Renal impairment20.01.03.0100.003193%Not Available
Poor quality sleep19.02.05.005; 17.15.04.002--Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000058%Not Available
Chronic kidney disease20.01.03.0170.000087%
Liver injury09.01.07.022; 12.01.17.0120.000465%Not Available
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