StudySide effects and safety2000
O'Malley 2000: who gets nausea on naltrexone
O'Malley SS, Krishnan-Sarin S, Farren C, O'Connor PG. Naltrexone-induced nausea in patients treated for alcohol dependence: clinical predictors and evidence for opioid-mediated effects
What it found
In the first week of naltrexone, 18 of 120 people with alcohol dependence (15%) had moderate or severe nausea, and it was linked to missed doses and heavier drinking during treatment. Nausea was more likely in younger people and women, and less likely the longer someone had been sober before starting.
- Moderate to severe nausea, week one
- 18 subjects (15%)
- Starting dose
- 25 mg
- Daily dose after that
- 50 mg
What they tested
After 5 to 30 days without alcohol, 120 people with alcohol dependence took naltrexone 25 mg for the first dose and then 50 mg daily for 10 weeks. Everyone knew they were taking naltrexone.
After 1 week, new side effects were rated mild, moderate or severe. The researchers then used statistics to see which traits before treatment predicted moderate to severe nausea. They expected recent and heavy drinking to matter, because of how long-term alcohol use may change the body's own opioid system.
What they found
Moderate to severe nausea was reported by 18 people (15%) and was linked to poorer pill-taking and heavier drinking during treatment.
Age, sex, how heavily people drank, how long they had been abstinent, and the combination of the last two all predicted nausea. Younger people and women had higher rates.
The pattern depended on recent drinking. With shorter abstinence, lighter drinkers were more likely to have nausea than heavier drinkers. With longer abstinence the risk fell, especially for lighter drinkers.
Limits
- There was no placebo group, so some of the nausea may not have been caused by naltrexone.
- Nausea was rated only after the first week.
- The predictors are links found in one group of 120 people, not tested by random assignment.
What it means if you're considering naltrexone
Nausea is the side effect most likely to make people give up on naltrexone, and this study suggests it isn't random. Younger people, women and people who have only just stopped drinking were more likely to get it. The paper discusses ways to lower the risk, and those are worth talking through with a prescriber, but this abstract doesn't spell them out.
Frequently asked questions
How common is nausea on naltrexone?
In this study, 15% of 120 people had moderate or severe nausea in their first week on naltrexone. It was linked to missing doses and heavier drinking during treatment.
Who is more likely to get nausea from naltrexone?
Younger people and women had higher rates. Risk also depended on recent drinking: it fell with longer abstinence before starting, especially in lighter drinkers.
The paper
O'Malley SS, Krishnan-Sarin S, Farren C, O'Connor PG. Naltrexone-induced nausea in patients treated for alcohol dependence: clinical predictors and evidence for opioid-mediated effects. J Clin Psychopharmacol. 2000;20(1):69-76. doi:10.1097/00004714-200002000-00012
Read the paperdoi:10.1097/00004714-200002000-00012
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.