Nalmefene: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: October 7, 2025🚩 Report this page

Nalmefene

Drugs Used In Alcohol Dependence

Sold as Selincro

EU EMA

Drug class: Drugs Used In Alcohol Dependence
Availability: See label
Markets covered: 1
Products on record: 1

Overview

Nalmefene is an active pharmaceutical ingredient in the Drugs Used In Alcohol Dependence group (N07BB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
EU European Union	EMA	1	October 7, 2025

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised October 7, 2025[1]

1], without physical withdrawal symptoms and who do not require immediate detoxification. Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.
Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.

How to take

Drug interactions

Known interactions involving Nalmefene. Select one for details. This list is informational and not a complete interaction checker.

Droperidol Glimepiride Methylnaltrexone Naldemedine Naloxegol Flumazenil

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]European Medicines Agency · EMEA/H/C/002583 · revised October 7, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

EUOfficial regulatory label· Adverse reactions· revised October 7, 2025[1]

Summary of the safety profile The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence. The most common adverse reactions were nausea, dizziness, insomnia, and headache.
The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration. Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days).
Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration. While these events were generally short- lasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.
Tabulated list of adverse reactions Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).
7 Table 1. Frequencies of adverse reactions System Organ Class Frequency Adverse Reaction Metabolism and nutrition disorders Common Decreased appetite Psychiatric disorders Very common Insomnia Common Sleep disorder Confusional state Restlessness Libido decreased (including loss of libido) Uncommon Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination) Dissociation Nervous system disorders Very Common Dizziness Headache Common Somnolence Tremor Disturbance in attention Paraesthesia Hypoaesthesia Eye disorders Not known Visual impairment (mostly transient) Cardiac disorders Common Tachycardia Palpitations Gastrointestinal disorders Very Common Nausea Common Vomiting Dry mouth Diarrhoea Skin and subcutaneous tissue disorders Common Hyperhidrosis Not known Angioedema Urticaria Pruritus Rash Erythema Musculoskeletal and connective tissue disorders Common Muscle spasms Not known Myalgia Reproductive system and breast disorder Not known Priapism General disorders and administration site conditions Common Fatigue Asthenia Malaise Feeling abnormal Investigations Common Weight decreased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 8

EUOfficial regulatory label· Warnings and precautions· revised October 7, 2025[1]

Selincro is not for patients for whom the treatment goal is immediate abstinence. Reduction of alcohol consumption is an intermediate goal on the way to abstinence. 4 Opioid administration In an emergency situation when opioids must be administered to a patient taking Selincro, the amount of opioid required to obtain the desired effect may be greater than usual.
The patient should be closely monitored for symptoms of respiratory depression as a result of the opioid administration and for other adverse reactions. If opioids are needed in an emergency, the dose must always be titrated individually.
If unusually large doses are required, close observation is necessary. Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.
The prescriber should advise patients that it is important to inform their health care professional of last Selincro intake if opioid use becomes necessary. 5)). 8). If patients develop psychiatric symptoms that are not associated with treatment initiation with Selincro, and/or that are not transient, the prescriber should consider alternative causes of the symptoms and assess the need for continuing treatment with Selincro.
Selincro has not been investigated in patients with unstable psychiatric disease. Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder. The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.
Seizure disorders There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures. Caution is advised if treatment aimed at reduction of alcohol consumption is started in such patients.
Renal or hepatic impairment Selincro is extensively metabolised by the liver and excreted predominantly in the urine. Therefore, caution should be exercised when prescribing Selincro to patients with mild or moderate hepatic or mild or moderate renal impairment, for example, by more frequent monitoring.
Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme. Elderly patients (≥65 years of age) Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

EUEuropean Union· EMA

Drug interactions

Drugs in the same class

Sources & citations