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 Prescription; Discontinued
ATC Code C03XA01
DrugBank ID DB06212
KEGG ID D01213
MeSH ID D000077602
PubChem ID 216237
TTD Drug ID D03KZM
NDC Product Code 46602-0027; 46602-0028; 14501-0066; 67877-637; 60505-4705; 49884-768; 59148-020; 31722-869; 46602-0031; 59148-083; 60505-4704; 49884-770; 59148-082; 59148-089; 14501-0085; 46602-0029; 59148-087; 59148-079; 65977-0100; 60862-008; 46602-0030; 59148-021; 59148-080; 57884-0027; 59148-088; 67877-636
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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Breast disorder21.05.04.004--Not Available
Cardiac disorder02.01.01.003--Not Available
Connective tissue disorder15.06.01.006--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Metastatic neoplasm16.16.01.0070.000073%Not Available
Neoplasm progression16.16.02.0050.000183%Not Available
Upper limb fracture12.04.01.018; 15.08.03.0180.000422%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
Blood disorder01.05.01.004--Not Available
Disease progression08.01.03.038--
Drug intolerance08.06.01.013--Not Available
Renal impairment20.01.03.0100.007172%Not Available
Unevaluable event08.01.03.051--Not Available
Hepatic enzyme abnormal13.03.01.0200.000281%Not Available
Hypophagia19.09.01.004; 14.03.01.006; 07.01.06.0100.000281%Not Available
Chronic kidney disease20.01.03.0170.000422%
Liver injury12.01.02.003; 09.01.07.0220.000703%Not Available
Oral herpes11.05.02.005; 07.05.07.0020.000281%Not Available
Brain injury19.07.03.007; 17.11.01.0030.000110%Not Available
Acute kidney injury20.01.03.0160.002953%
Osmotic demyelination syndrome17.16.02.0040.000660%Not Available
Drug-induced liver injury12.03.01.044; 09.01.07.0230.000844%Not Available
Hepatic cancer16.07.02.004; 09.04.02.0080.000183%Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.0100.000073%Not Available
Multiple organ dysfunction syndrome08.01.03.0570.000220%
Liver function test increased13.03.01.0440.000703%Not Available
Cardiac failure chronic02.05.01.0090.000147%Not Available
PCO2 increased13.02.01.0300.000281%Not Available
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