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)
Frequent bowel movements07.02.04.0020.002986%Not Available
Gastrointestinal disorder07.11.01.0010.002151%Not Available
Gastrointestinal pain07.01.05.0050.001186%
Haematemesis07.12.02.002; 24.07.02.0110.000439%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.003205%Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.000439%Not Available
Hyperhidrosis23.02.03.004; 08.01.03.0280.022525%
Influenza like illness08.01.03.0100.004479%
Intestinal obstruction07.13.01.0020.000659%Not Available
Irritability19.04.02.013; 08.01.03.0110.001493%
Joint swelling15.01.02.0040.001493%Not Available
Movement disorder17.01.02.0100.000439%Not Available
Muscle spasms15.05.03.0040.022613%
Nausea07.01.07.0010.019539%
Neck pain15.03.04.0090.000439%
Neoplasm malignant16.16.01.0010.001098%Not Available
Nervousness19.06.02.0030.002239%Not Available
Pain08.01.08.0040.024545%
Pain in extremity15.03.04.0100.003205%
Palpitations02.11.04.0120.002239%
Pancreatitis07.18.01.0010.001186%
Penile pain21.12.01.0080.001493%
Pleural effusion22.05.02.0020.000878%
Pollakiuria20.02.02.0070.002459%
Rectal haemorrhage07.12.03.001; 24.07.02.0180.003644%
Renal disorder20.01.02.0020.001493%Not Available
Respiratory failure14.01.04.003; 22.02.06.0020.000439%
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.002239%Not Available
Tachyphylaxis10.02.01.050; 08.06.01.0280.001493%Not Available
Tongue discolouration07.14.02.0060.001493%Not Available
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