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)
Influenza11.05.03.001; 22.07.02.001--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Interstitial lung disease22.01.02.003; 10.02.01.0330.001266%Not Available
Intestinal ischaemia24.04.08.001; 07.15.02.0010.000073%Not Available
Intestinal obstruction07.13.01.0020.000563%Not Available
Lethargy08.01.01.008; 19.04.04.004; 17.02.04.003--
Liver disorder09.01.08.0010.003797%Not Available
Liver function test abnormal13.03.01.0130.000422%Not Available
Loss of consciousness17.02.04.004--Not Available
Lymphocyte count decreased13.01.06.006--
Lymphoma16.20.01.001; 01.12.01.0010.000110%Not Available
Malaise08.01.01.003--
Memory impairment17.03.02.003; 19.20.01.003--
Metabolic acidosis14.01.01.003--Not Available
Micturition urgency20.02.02.006--
Muscle spasms15.05.03.004--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasopharyngitis11.01.13.002; 22.07.03.0020.000984%Not Available
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.000404%Not Available
Nephrolithiasis20.04.01.0020.000281%
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.0030.000281%Not Available
Neutropenia01.02.03.004--Not Available
Nocturia20.02.03.0010.002110%Not Available
Oedema14.05.06.010; 08.01.07.0060.000844%Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophageal varices haemorrhage24.07.02.022; 09.01.06.004; 07.12.01.0030.000257%
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Pain08.01.08.004--
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