Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naltrexone
Drug ID BADD_D01527
Description Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of naloxone. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.
Indications and Usage Used as an adjunct to a medically supervised behaviour modification program in the maintenance of opiate cessation in individuals who were formerly physically dependent on opiates and who have successfully undergone detoxification. Also used for the management of alcohol dependence in conjunction with a behavioural modification program.
Marketing Status approved; investigational; vet_approved
ATC Code N07BB04
DrugBank ID DB00704
KEGG ID D05113
MeSH ID D009271
PubChem ID 5360515
TTD Drug ID D0PG8O
NDC Product Code 16447-0689; 69641-0002; 82105-003; 0406-3940; 65757-300; 0406-4605; 43798-006; 65757-360; 65757-301
UNII 5S6W795CQM
Synonyms Naltrexone | Antaxone | Trexan | EN-1639A | EN 1639A | EN1639A | ReVia | Nemexin | Nalorex | Naltrexone Hydrochloride | Celupan
Chemical Information
Molecular Formula C20H23NO4
CAS Registry Number 16590-41-3
SMILES C1CC1CN2CCC34C5C(=O)CCC3(C2CC6=C4C(=C(C=C6)O)O5)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)
Dysgeusia17.02.07.003; 07.14.03.001--
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.004--
Dyspnoea02.11.05.003; 22.02.01.004--
Ejaculation delayed21.03.01.001--Not Available
Eosinophilic pneumonia22.01.01.004; 01.02.04.003--Not Available
Epistaxis24.07.01.005; 22.04.03.001--
Euphoric mood19.04.02.006--
Eye disorder06.08.03.001--Not Available
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Frequent bowel movements07.02.04.002--Not Available
Gamma-glutamyltransferase increased13.03.04.024--
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis11.01.07.004; 07.19.03.001--Not Available
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Groin pain15.03.02.004--Not Available
Haemorrhoids07.15.03.001; 24.10.02.002--
Hallucination19.10.04.003--
Headache17.14.01.001--
Heat exhaustion12.05.01.003--Not Available
Heat stroke24.06.02.009; 12.05.01.001--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis C11.05.28.004; 09.01.09.005--Not Available
Hepatotoxicity12.03.01.008; 09.01.07.009--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis08.01.03.028; 23.02.03.004--
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ADReCS-Target
Drug Name ADR Term Target
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