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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acute hepatic failure09.01.03.0010.000073%Not Available
Acute respiratory failure22.02.06.001; 14.01.04.0040.000073%Not Available
Agranulocytosis01.02.03.0010.000281%Not Available
Alanine aminotransferase increased13.03.01.0030.001828%
Alopecia23.02.02.001--
Altered state of consciousness19.07.01.003; 17.02.04.0010.001828%Not Available
Ammonia increased13.03.01.0230.000422%Not Available
Amnesia17.03.02.001; 19.20.01.001--
Amylase increased13.05.01.0090.000422%
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anuria20.01.03.0020.000422%Not Available
Anxiety19.06.02.002--
Aphasia19.21.01.001; 17.02.03.0010.000422%
Arrhythmia02.03.02.0010.000563%Not Available
Ascites09.01.05.003; 07.07.01.001; 02.05.04.0020.000703%
Aspartate aminotransferase increased13.03.01.0060.002250%
Aspiration22.02.07.0070.000073%
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Blood albumin decreased13.09.01.0010.000422%Not Available
Blood bicarbonate decreased13.11.01.0190.000422%
Blood bilirubin increased13.03.01.0080.001688%
Blood chloride increased13.11.01.0050.000281%Not Available
Blood creatine phosphokinase increased13.04.01.0010.001406%
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