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)
Rhabdomyolysis15.05.05.002--
Seizure17.12.03.001--
Sepsis11.01.11.003--
Septic shock24.06.02.011; 11.01.11.0040.000110%Not Available
Shock24.06.02.0020.000147%Not Available
Skin disorder23.03.03.007--Not Available
Skin ulcer23.07.03.003; 24.04.03.0070.000281%
Sleep disorder19.02.04.0010.000703%Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.02.05.034; 19.19.02.002; 17.02.08.0030.000422%Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.03.020; 23.03.01.007; 12.03.01.0140.000281%
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.000110%Not Available
Sudden death08.04.01.003; 02.03.04.0130.000110%
Suicidal ideation19.12.01.003--
Swelling08.01.03.015--Not Available
Swelling face23.04.01.018; 10.01.05.018--Not Available
Syncope17.02.04.008; 02.01.02.008; 24.06.02.012--
Thirst14.03.02.007; 08.01.09.0210.003938%Not Available
Thrombosis24.01.01.006--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Unresponsive to stimuli17.02.05.0310.000281%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000281%
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Ventricular extrasystoles02.03.04.0070.000073%Not Available
Ventricular fibrillation02.03.04.0080.000281%
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