Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naloxegol
Drug ID BADD_D02467
Description Naloxegol, for "PEGylated naloxol" is a peripherally-selective opioid antagonist developed by AstraZeneca. It was approved by the FDA in September 2014 and is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non‑cancer pain. The advantage of naloxegol over the opioid antagonist naloxone is that its PEGylated structure allows for high selectivity for peripheral opioid receptors and lack of entry into the central nervous system through the blood-brain barrier.
Indications and Usage Indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.
Marketing Status approved
ATC Code A06AH03
DrugBank ID DB09049
KEGG ID D10479
MeSH ID C000589308
PubChem ID 56959087
TTD Drug ID D07LCF
NDC Product Code 24584-1116; 24584-1115
UNII 44T7335BKE
Synonyms naloxegol | Movantik | NKTR-118
Chemical Information
Molecular Formula C34H53NO11
CAS Registry Number 854601-70-0
SMILES COCCOCCOCCOCCOCCOCCOCCOC1CCC2(C3CC4=C5C2(C1OC5=C(C=C4)O)CCN3CC=C)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 distension07.01.04.0010.008430%
Abdominal pain07.01.05.0020.030077%
Abdominal pain upper07.01.05.0030.003425%
Anger19.04.02.0010.002239%Not Available
Anorectal disorder07.03.01.0010.001493%Not Available
Arrhythmia02.03.02.0010.000439%Not Available
Back pain15.03.04.0050.001932%
Cardiac failure congestive02.05.01.0020.000966%Not Available
Chills15.05.03.016; 08.01.09.0010.017300%
Colitis07.08.01.0010.002678%
Confusional state19.13.01.001; 17.02.03.0050.002678%
Constipation07.02.02.0010.016026%
Crohn's disease10.02.01.005; 07.08.01.0150.000966%Not Available
Death08.04.01.0010.009089%
Defaecation urgency07.02.04.0010.001493%Not Available
Dehydration14.05.05.0010.001625%
Delirium19.13.02.0010.001712%
Diarrhoea07.02.01.0010.030911%
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.001493%Not Available
Discomfort08.01.08.0030.002239%Not Available
Dizziness24.06.02.007; 02.11.04.006; 17.02.05.0030.007684%
Drug ineffective08.06.01.0060.021120%Not Available
Drug interaction08.06.03.0010.005445%Not Available
Drug withdrawal syndrome08.06.02.004; 19.07.06.0130.030165%Not Available
Dry mouth07.06.01.0020.002239%
Dysgeusia17.02.07.003; 07.14.03.0010.002239%
Dysphagia07.01.06.0030.001712%
Feeling abnormal08.01.09.0140.004698%Not Available
Flatulence07.01.04.0020.001493%
Formication17.02.06.018; 19.10.04.0020.000966%Not Available
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