Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naldemedine
Drug ID BADD_D02481
Description Naldemedine is an opioid receptor antagonist [FDA Label]. It is a modified form of [DB00704] to which a side chain has been added to increase molecular weight and polar surface area resulting in restricted transport across the blood brain barrier. Naldemedine was approved in 2017 in both the US and Japan for the treatment of Opioid-induced Constipation.
Indications and Usage For the treatment of opioid-induced constipation [FDA Label].
Marketing Status Not Available
ATC Code A06AH05
DrugBank ID DB11691
KEGG ID D10188
MeSH ID C000620491
PubChem ID 54732242
TTD Drug ID D0Q3PD
NDC Product Code 59385-041
Synonyms naldemedine | S-297995 | Symproic
Chemical Information
Molecular Formula C32H34N4O6
CAS Registry Number 916072-89-4
SMILES CC(C)(C1=NC(=NO1)C2=CC=CC=C2)NC(=O)C3=C(C4C56CCN(C(C5(C3)O)CC7=C6C(=C(C=C7)O)O4) CC8CC8)O
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)
Abdominal distension07.01.04.0010.001220%
Abdominal pain07.01.05.0020.002440%
Colon cancer16.13.01.001; 07.21.01.0010.000477%Not Available
Dehydration14.05.05.0010.001830%
Diarrhoea07.02.01.0010.006710%
Ileus07.13.01.0010.001220%
Nausea07.01.07.001--
Neoplasm malignant16.16.01.0010.001114%Not Available
Pancreatic carcinoma16.13.10.001; 07.21.09.0020.000318%Not Available
Shock24.06.02.0020.001220%Not Available
Malignant neoplasm progression16.16.01.0050.002546%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000318%Not Available
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