Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nalmefene
Drug ID BADD_D01522
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Marketing Status approved; investigational; withdrawn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 D05111
MeSH ID C038981
PubChem ID 5284594
TTD Drug ID D05VIL
NDC Product Code 82712-1002
UNII TOV02TDP9I
Synonyms nalmefene | Revex | Selincro | 6-desoxy-6-methylenenaltrexone | nalmefene hydrochloride
Chemical Information
Molecular Formula C21H25NO3
CAS Registry Number 55096-26-9
SMILES C=C1CCC2(C3CC4=C5C2(C1OC5=C(C=C4)O)CCN3CC6CC6)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)
Insomnia19.02.01.002; 17.15.03.002--
Libido decreased19.08.03.001; 21.03.02.005--
Loss of libido19.08.03.003--Not Available
Malaise08.01.01.003--
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Myoclonus17.02.05.008--Not Available
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Nervousness19.06.02.003--Not Available
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.007--Not Available
Tension19.06.02.005--Not Available
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Withdrawal syndrome08.06.02.012; 19.07.06.023--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Alcohol withdrawal syndrome19.07.06.005; 08.06.02.002--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Malnutrition14.03.02.004--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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