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StudySide effects and safety2025

Diaz 2025: naltrexone shots in advanced alcohol-related liver disease

Díaz LA, Collier S, Yin J, Loomba R. Safety and tolerability of injectable extended-release naltrexone for the management of alcohol use disorder in advanced alcohol-associated liver disease

What it found

None of 14 people with advanced alcohol-associated liver disease who received the extended-release naltrexone injection had liver toxicity or liver decompensation over a median of 127 days. Four (29%) had mild side effects, and 8 (57%) cut their drinking, though the fall in a blood alcohol marker was not statistically significant.

People
14
Mild side effects
4 (29%)
Cut their drinking
8 (57%)
Median follow-up
127 days

What they tested

Doctors at one tertiary care centre reviewed the records of adults with alcohol-associated liver disease who got at least one 380 mg intramuscular injection of extended-release naltrexone between 2023 and March 2025. Each was followed for at least 12 weeks.

They tracked side effects, liver blood tests and liver disease scores (MELD and Child-Pugh). Drinking was measured with phosphatidylethanol (PEth), a blood test that reflects recent alcohol use.

What they found

Of the 14, 2 had advanced liver scarring (stage F3) and 9 had cirrhosis rated Child A–B. The median age was 51, and 64% were men.

Four people (29%) had mild side effects: pain at the injection site, nausea and vomiting, fatigue, and sexual side effects. None had liver toxicity or liver decompensation, and liver tests and MELD and Child-Pugh scores didn't change significantly.

Eight (57%) drank less, but the decline in PEth levels was not statistically significant.

Limits

  • With 14 people and no comparison group, it can't detect rare liver harm or show that the shot reduced drinking.
  • It was a retrospective review of records from a single centre.
  • Follow-up was short, a median of 127 days.

What it means if you're considering naltrexone

Worry about liver damage is one reason alcohol medicines are underused in people with serious liver disease. The shot avoids first-pass metabolism in the liver, which is why some see it as a safer option for them. This small series found no liver harm, which is reassuring but far from proof.

Frequently asked questions

Is Vivitrol safe for people with cirrhosis?

In this case series of 14 people with advanced alcohol-related liver disease, the extended-release naltrexone shot caused no liver toxicity or decompensation over a median of 127 days. The study was small and had no comparison group.

The paper

Díaz LA, Collier S, Yin J, Loomba R. Safety and tolerability of injectable extended-release naltrexone for the management of alcohol use disorder in advanced alcohol-associated liver disease. Aliment Pharmacol Ther. 2025;62(7):692-698. doi:10.1111/apt.70237

Read the paperdoi:10.1111/apt.70237

We wrote this page from the paper's published abstract, and the study's numbers here come from there. Updated October 17, 2026.

Medical disclaimer

This page is for information only and is not medical advice, diagnosis, or treatment. Don't start, stop, or change any medicine — including naltrexone — without your prescriber. Naltrexone must not be used by people taking opioid pain medicines, people dependent on opioids, or people in opioid withdrawal (FDA label). In an emergency call 911; for crisis support call or text 988. Full medical disclaimer.