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)
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000157%
Diabetes insipidus14.05.07.003; 05.03.03.0040.000244%Not Available
Diabetes mellitus05.06.01.001; 14.06.01.0010.000116%Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.001--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Disorientation17.02.05.015; 19.13.01.0020.000256%Not Available
Disseminated intravascular coagulation24.01.01.010; 01.01.02.0020.000145%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Drug eruption10.01.01.005; 08.01.06.015; 23.03.05.0010.000116%Not Available
Dry eye06.08.02.0010.000157%
Dry mouth07.06.01.0020.000698%
Dry skin23.03.03.001--
Dry throat22.12.03.005; 07.06.01.005--Not Available
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.0030.000564%
Dyspnoea exertional02.11.05.005; 22.02.01.0050.000058%Not Available
Dysuria20.02.02.0020.000116%
Eating disorder19.09.01.008; 14.03.01.0080.000157%Not Available
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.001--Not Available
Electrolyte imbalance14.05.01.0020.000058%Not Available
Embolic stroke17.08.01.032; 24.01.04.0100.000058%Not Available
Encephalopathy17.13.02.0010.000145%
Eosinophilia01.02.04.0010.000058%
Eye haemorrhage12.02.02.012; 24.07.05.002; 06.07.02.001--Not Available
Failure to thrive19.07.05.001; 18.04.01.003; 14.03.02.0080.000058%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flank pain20.02.03.006; 15.03.04.003; 08.01.08.0070.000116%
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