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)
Gait disturbance15.03.05.013; 17.02.05.016; 08.01.02.002--
Gallbladder disorder09.03.02.0010.000116%Not Available
Gastric cancer16.13.03.001; 07.21.02.0010.000058%Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009--Not Available
Gastrointestinal pain07.01.05.005--
Gastrointestinal perforation07.04.04.0010.000058%Not Available
Glaucoma06.03.01.0020.000174%
Gout15.01.06.001; 14.09.01.0010.000128%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.000058%Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.0470.000320%
Blood urine present13.13.02.002--Not Available
Haemolysis01.06.04.002--
Haemothorax12.01.18.005; 24.07.01.008; 22.05.02.0010.000058%
Headache17.14.01.001--
Hepatic cirrhosis09.01.04.0010.000407%Not Available
Hepatic cyst16.06.02.001; 09.01.08.0080.000262%Not Available
Hepatic encephalopathy09.01.03.006; 17.13.01.0030.000727%Not Available
Hepatic failure09.01.03.0020.000407%
Hepatic function abnormal09.01.02.0010.002518%Not Available
Hepatic steatosis09.01.07.003; 14.08.04.0050.000087%Not Available
Hepatitis09.01.07.0040.000145%Not Available
Hepatitis acute09.01.07.0050.000116%Not Available
Hepatomegaly09.01.05.001--Not Available
Hepatorenal syndrome20.01.03.012; 09.01.03.0070.000145%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.003914%Not Available
Hernia08.01.04.001--Not Available
Hydrocephalus17.07.01.0010.000058%
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