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)
Haematocrit decreased13.01.05.0010.000281%Not Available
Haematuria24.07.01.047; 20.02.01.0060.000984%
Blood urine present13.13.02.0020.000281%Not Available
Haemoglobin decreased13.01.05.003--Not Available
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000440%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000563%Not Available
Hepatic encephalopathy17.13.01.003; 09.01.03.0060.002672%Not Available
Hepatic failure09.01.03.0020.000257%
Hepatic function abnormal09.01.02.0010.009141%Not Available
Hepatic steatosis09.01.07.003; 14.08.04.0050.000281%Not Available
Hepatitis09.01.07.0040.000422%Not Available
Hepatitis acute09.01.07.0050.000422%Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.0070.000110%Not Available
Hepatotoxicity09.01.07.009; 12.03.01.0080.005625%Not Available
Hydrocephalus17.07.01.0010.000281%
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperkalaemia14.05.03.0010.001266%
Hypernatraemia14.05.04.0010.007172%
Hypersensitivity10.01.03.003--
Hypertension24.08.02.0010.001547%
Hyperuricaemia14.09.01.0030.001125%
Hypoglycaemia14.06.03.001; 05.06.03.0010.000703%
Hypokalaemia14.05.03.0020.000984%
Hypokinesia17.01.02.0090.000281%Not Available
Hyponatraemia14.05.04.0020.006751%
Hypotension24.06.03.002--
Hypoxia22.02.02.0030.000422%
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
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