Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Naltrexone hydrochloride
Drug ID BADD_D01528
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 D02095
MeSH ID D009271
PubChem ID 5485201
TTD Drug ID D0PG8O
NDC Product Code 60870-0395; 51224-206; 63629-1046; 0406-1170; 71335-0014; 12707-038; 38779-0887; 17205-103; 42291-632; 71335-1480; 71335-2062; 52465-103; 58175-0632; 63275-9901; 51552-0737; 16729-081; 47335-326; 68981-037; 68071-2721; 0406-1479; 38779-3296; 51927-0097; 70312-0887; 68084-291; 0904-7036; 49452-4834; 79572-023; 50090-4925; 17205-108; 51927-0157; 65724-0055; 62135-242; 63629-1047; 68094-853; 70518-1146; 69641-0001
UNII Z6375YW9SF
Synonyms Naltrexone | Antaxone | Trexan | EN-1639A | EN 1639A | EN1639A | ReVia | Nemexin | Nalorex | Naltrexone Hydrochloride | Celupan
Chemical Information
Molecular Formula C20H24ClNO4
CAS Registry Number 16676-29-2
SMILES C1CC1CN2CCC34C5C(=O)CCC3(C2CC6=C4C(=C(C=C6)O)O5)O.Cl
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)
Palpitations02.11.04.012--
Paranoia19.05.01.005---
Peripheral coldness08.01.09.010; 23.06.04.008; 24.04.03.006---
Phlebitis12.02.01.002; 24.12.03.004--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Restlessness17.02.05.021; 19.11.02.002--
Rhinorrhoea22.12.03.021--
Seborrhoea23.02.07.001---
Sneezing22.12.03.024--
Somnolence17.02.04.006; 19.02.05.003--
Suicidal ideation19.12.01.003--
Suicide attempt19.12.01.004--
Tachycardia02.03.02.007---
Thinking abnormal17.02.05.023; 19.10.03.001---
Thirst08.01.09.021; 14.03.02.007---
Tinea pedis11.03.08.004; 23.11.03.012---
Tinnitus04.04.01.002; 17.04.07.004--
Tremor17.01.06.002--
Ulcer08.03.06.001---
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Weight increased13.15.01.006--
Yawning22.12.03.037---
Energy increased08.01.03.017---
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