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 approved
ATC Code C03XA01
DrugBank ID DB06212
KEGG ID D01213
MeSH ID D000077602
PubChem ID 216237
TTD Drug ID D03KZM
NDC Product Code 31722-869; 59148-088; 60505-4704; 65977-0100; 59148-082; 67877-637; 59148-079; 60505-4318; 60505-4705; 46602-0031; 59148-089; 14501-0066; 31722-868; 59148-083; 46602-0028; 46602-0030; 49884-770; 59148-020; 67877-635; 14501-0085; 57884-0027; 49884-768; 59148-021; 59148-080; 60505-4317; 67877-636; 46602-0027; 46602-0029; 60862-008; 59148-087
UNII 21G72T1950
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Thirst14.03.02.007; 08.01.09.0210.002012%Not Available
Thrombosis24.01.01.006--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.000087%
Umbilical hernia07.16.03.001--Not Available
Unresponsive to stimuli17.02.05.0310.000087%Not Available
Urethral disorder20.07.01.002--Not Available
Urinary incontinence20.02.02.010; 17.05.01.0080.000058%
Urinary retention20.02.02.0110.000116%
Urinary tract disorder20.08.01.001--Not Available
Urine abnormality20.02.01.013--Not Available
Uterine cancer21.07.02.003; 16.12.05.0010.000058%Not Available
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Ventricular extrasystoles02.03.04.0070.000058%Not Available
Ventricular fibrillation02.03.04.0080.000087%
Visual impairment06.02.10.013--Not Available
Mental status changes19.07.01.0010.000174%Not Available
Tubulointerstitial nephritis20.05.02.0020.000058%Not Available
Mobility decreased17.02.05.018; 15.03.05.023; 08.01.03.030--Not Available
Intracardiac thrombus02.11.01.017; 24.01.05.003--Not Available
Peripheral swelling08.01.03.053; 02.05.04.015--Not Available
Brain oedema17.07.02.003; 12.01.10.0100.000116%
General physical health deterioration08.01.03.0180.000302%Not Available
Upper respiratory tract inflammation22.12.03.0340.000058%Not Available
Urethral haemorrhage24.07.03.006; 20.07.01.003--Not Available
Cardiac death08.04.01.007; 02.03.04.0150.000058%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000145%Not Available
Deep vein thrombosis24.01.02.003--Not Available
Exercise tolerance decreased08.01.03.036--Not Available
Prostatomegaly21.04.01.0020.000058%Not Available
The 8th Page    First    Pre   8 9 10    Next   Last    Total 10 Pages