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)
Tremor17.01.06.0020.014929%
Urticaria10.01.06.001; 23.04.02.0010.002986%
Vomiting07.01.07.0030.012206%
Withdrawal syndrome08.06.02.012; 19.07.06.0230.012733%-
Haemorrhage24.07.01.0020.002459%-
Lung neoplasm malignant16.19.02.001; 22.08.01.0010.000439%-
Infrequent bowel movements07.02.02.0110.001932%-
Hot flush08.01.03.027; 21.02.02.001; 24.03.01.0050.002986%
Abdominal symptom07.01.06.0070.001493%-
Adverse event08.06.01.0100.001712%-
Gastrointestinal motility disorder07.02.03.0010.001493%-
Abnormal behaviour19.01.01.0010.002239%-
Drug intolerance08.06.01.0130.004479%-
Gastrointestinal obstruction07.13.01.0050.000439%-
Bowel movement irregularity07.02.03.0030.003732%-
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.001712%-
Inadequate analgesia08.06.01.040; 12.02.20.0060.002239%-
Inhibitory drug interaction08.06.03.0140.001493%-
Therapeutic product effect decreased08.06.01.0500.002986%-
Therapeutic product effect incomplete08.06.01.0520.001493%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.000966%-
The 3th Page    First    Pre   3    Total 3 Pages