Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nalmefene hydrochloride
Drug ID BADD_D01523
Description Nalmefene is a 6-methylene analogue of naltrexone and opioid system modulator but with no opioid activity [FDA Label]. It mediates a partial agonist effect on kappa receptors [A31301]. It is primarily used in the management of alcohol dependence in adult patients in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption [L1024] when it is exists as the hydrochloride dihydrate form under the trade name Selincro. Selincro is orally administered as tablets. Nalmefene works to reduce alcohol consumption in individuals by positive reward effect of alcohol which involves the opioid system, as well as the sedative and dysphoric properties of alcohol [A31301]. It is also indicated to prevent or reverse the effects of opioids, including respiratory depression, sedation, and hypotension by acting on the opioid receptor as an antagonist [FDA Label] under the trade name Revex for intramuscular, intravenous and subcutaneous injection, where nalmefene hydrochloride is an active ingredient.
Indications and Usage Indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification [L1024]. Indicated for the complete or partial reversal of opioid drug effects, including respiratory depression - induced by either natural or synthetic opioids - or in the management of known or suspected opioid overdose [FDA Label].
Marketing Status approved; investigational; withdrawn
ATC Code N07BB05
DrugBank ID DB06230
KEGG ID D02104
MeSH ID C038981
PubChem ID 5388881
TTD Drug ID D05VIL
NDC Product Code 59011-960; 12496-0003; 0406-5690
UNII K7K69QC05X
Synonyms nalmefene | Revex | Selincro | 6-desoxy-6-methylenenaltrexone | nalmefene hydrochloride
Chemical Information
Molecular Formula C21H26ClNO3
CAS Registry Number 58895-64-0
SMILES C=C1CCC2(C3CC4=C5C2(C1OC5=C(C=C4)O)CCN3CC6CC6)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)
Agitation19.06.02.001; 17.02.05.012--
Arrhythmia02.03.02.001--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Bradycardia02.03.02.002--Not Available
Chills15.05.03.016; 08.01.09.001--
Confusional state19.13.01.001; 17.02.03.005--
Depression19.15.01.001--
Diarrhoea07.02.01.001--
Dizziness24.06.02.007; 17.02.05.003; 02.11.04.006--
Dry mouth07.06.01.002--
Headache17.14.01.001--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Myoclonus17.02.05.008--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Somnolence17.02.04.006; 19.02.05.003--
Tachycardia02.03.02.007--Not Available
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Vasodilatation24.03.02.003; 23.06.05.006--Not Available
Vomiting07.01.07.003--
Withdrawal syndrome19.07.06.023; 08.06.02.012--Not Available
Procedural pain12.02.05.007; 08.01.08.009--Not Available
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