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)
Pain in extremity15.03.04.010--
Palpitations02.01.02.003--
Pancreatitis07.18.01.001--
Pancytopenia01.03.03.0030.001266%Not Available
Peritonitis11.01.07.007; 07.19.05.0040.000281%
Platelet count decreased13.01.04.0010.003235%
Pleural effusion22.05.02.0020.000844%
Pneumonia22.07.01.003; 11.01.09.0030.003375%Not Available
Pneumonia aspiration22.01.01.0050.000183%Not Available
Pollakiuria20.02.02.0070.001828%
Polydipsia14.05.02.001; 05.03.03.0020.001688%Not Available
Polyuria20.02.03.0020.001969%Not Available
Protein total decreased13.09.01.0040.000281%Not Available
Prothrombin level increased13.01.02.011--Not Available
Prothrombin time prolonged13.01.02.012--Not Available
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.0030.000422%
Pyelonephritis20.01.09.001; 11.01.14.0020.000422%Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Rash generalised23.03.13.002--Not Available
Rash pruritic23.03.12.002--Not Available
Red blood cell count decreased13.01.05.0070.000422%Not Available
Renal cancer20.01.04.002; 16.08.02.0010.000073%Not Available
Renal disorder20.01.02.0020.000844%Not Available
Renal failure20.01.03.005--Not Available
Renal pain20.02.03.0030.000563%Not Available
Respiratory failure22.02.06.002; 14.01.04.003--
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