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)
Miliaria23.02.03.014--Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Neonatal disorder18.04.01.001--Not Available
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Night sweats08.01.03.031; 23.02.03.006--Not Available
Nightmare19.02.03.003--Not Available
Obesity14.03.02.009--
Obsessive-compulsive disorder19.06.05.002--Not Available
Oedema08.01.07.006; 14.05.06.010--Not Available
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Pancreatitis acute07.18.01.002--Not Available
Panic attack19.06.04.001--Not Available
Paraesthesia23.03.03.094; 17.02.06.005--
Paranoia19.05.01.005--Not Available
Peripheral coldness08.01.09.010; 23.06.04.008; 24.04.03.006--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pharyngitis streptococcal11.02.06.002; 22.07.04.001--Not Available
Phlebitis24.12.03.004; 12.02.01.002--
Platelet count decreased13.01.04.001--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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