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 approved; investigational
ATC Code A06AH05
DrugBank ID DB11691
KEGG ID D10188
MeSH ID C000620491
PubChem ID 54732242
TTD Drug ID D0Q3PD
NDC Product Code 59385-041
UNII 03KSI6WLXH
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
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)
Abdominal discomfort07.01.06.0010.000966%Not Available
Abdominal distension07.01.04.0010.000966%
Abdominal pain07.01.05.0020.003425%
Colitis ulcerative10.02.01.004; 07.08.01.0050.000439%Not Available
Colon cancer16.13.01.001; 07.21.01.0010.000659%Not Available
Dehydration14.05.05.0010.000659%
Diarrhoea07.02.01.0010.005840%
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.000439%
Drug ineffective08.06.01.0060.006191%Not Available
Ileus07.13.01.0010.000439%
Neoplasm malignant16.16.01.0010.002634%Not Available
Pancreatic carcinoma16.13.10.001; 07.21.09.0020.000878%Not Available
Shock24.06.02.0020.000439%Not Available
Vomiting07.01.07.0030.000966%
Malignant neoplasm progression16.16.01.0050.003952%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.000659%Not Available
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