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)
Dysgeusia07.14.03.001; 17.02.07.003--
Dyskinesia17.01.02.006--
Dysphagia07.01.06.0030.001688%
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.0020.000422%
Eating disorder19.09.01.008; 14.03.01.0080.000422%Not Available
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Embolic stroke24.01.04.010; 17.08.01.0320.000073%Not Available
Encephalopathy17.13.02.0010.000563%
Eosinophil count increased13.01.06.0040.000281%Not Available
Eosinophilia01.02.04.0010.000281%
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.001--Not Available
Failure to thrive14.03.02.008; 19.07.05.001; 18.04.01.0030.000073%Not Available
Fatigue08.01.01.002--
Febrile neutropenia08.05.02.004; 01.02.03.002--
Feeling abnormal08.01.09.014--Not Available
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.000422%
Flatulence07.01.04.002--
Fluid retention20.01.02.003; 14.05.06.0020.000422%Not Available
Fracture15.08.02.001; 12.04.02.0010.000563%
Gait disturbance17.02.05.016; 08.01.02.002--
Gamma-glutamyltransferase increased13.03.01.0110.001547%
Gastroenteritis11.01.07.004; 07.19.03.0010.000563%Not Available
Gastroenteritis viral11.05.04.005; 07.19.03.0050.000281%Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gingivitis11.01.04.013; 07.09.03.0030.000281%
Glaucoma06.03.01.0020.000703%
Glomerular filtration rate decreased13.13.01.0090.002672%Not Available
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