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)
Circulatory collapse24.06.02.0010.000073%Not Available
Colitis ischaemic24.04.08.012; 07.08.01.004--Not Available
Coma17.02.09.001--Not Available
Coma hepatic17.02.09.002; 09.01.03.0050.000073%Not Available
Completed suicide08.04.01.010; 19.12.01.001--Not Available
Compression fracture15.08.02.004; 12.04.02.0080.000281%Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Cough22.02.03.001--
Crying08.01.03.005; 19.04.02.002; 17.02.05.013; 12.02.11.0010.000281%Not Available
Death08.04.01.0010.008108%
Dehydration14.05.05.0010.005204%
Delirium19.13.02.0010.000563%
Dementia19.20.02.001; 17.03.01.0010.000281%Not Available
Demyelination17.16.02.0010.000563%Not Available
Depressed level of consciousness17.02.04.0020.000422%
Depressed mood19.15.02.0010.001688%Not Available
Depression19.15.01.001--
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000422%
Diabetes insipidus14.05.07.003; 05.03.03.0040.000281%Not Available
Diabetes mellitus14.06.01.001; 05.06.01.001--Not Available
Diabetic ketoacidosis14.07.03.001; 05.07.03.001--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.0030.000422%Not Available
Disorientation17.02.05.015; 19.13.01.0020.000563%Not Available
Disseminated intravascular coagulation01.01.02.002; 24.01.01.0100.000183%
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Drug eruption23.03.05.001; 08.01.06.015; 10.01.01.0050.000281%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Dry mouth07.06.01.0020.000563%
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