Vivitrolnaltrexone
According to the FDA label: Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL contains naltrexone, an opioid antagonist, and is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration ( 1.1 ).
30,201 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Vivitrol in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Injection Site Reaction 4,408 reports
A general report of a reaction at the spot where a medication was injected, such as redness, swelling, or pain.
Full definition in the glossary →Injection Site Pain 3,130 reports
Pain at the spot on the body where a medication was injected.
Full definition in the glossary →Nausea 2,115 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →- Alcoholism 1,948 reports
Injection Site Mass 1,900 reports
A lump that forms at the spot where a medication was injected.
Full definition in the glossary →Fatigue 1,791 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pain 1,640 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Drug Ineffective 1,527 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Headache 1,483 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,435 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Feeling Abnormal 1,395 reports
A general report that the person did not feel like themselves, without a more specific description.
Full definition in the glossary →Drug Dependence 1,372 reports
A report that the body or mind has come to rely on a medication, so that stopping it causes difficulty. The term describes a physical or psychological state, not a judgment about the person.
Full definition in the glossary →Malaise 1,252 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Insomnia 1,143 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Anxiety 1,092 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 13,360 |
| Female | 12,114 |
| Unknown | 65 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 350 |
| 18-34 | 5,707 |
| 35-49 | 5,745 |
| 50-64 | 4,561 |
| 65-74 | 728 |
| 75+ | 147 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Vivitrol. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 21,633 |
| Other Serious | 4,415 |
| Hospitalization | 3,802 |
| Death | 1,310 |
| Life-Threatening | 334 |
| Disability | 236 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Vivitrol. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 7 |
| 2005 | 36 |
| 2006 | 23 |
| 2007 | 52 |
| 2008 | 62 |
| 2009 | 38 |
| 2010 | 51 |
| 2011 | 55 |
| 2012 | 123 |
| 2013 | 151 |
| 2014 | 281 |
| 2015 | 1,180 |
| 2016 | 1,861 |
| 2017 | 2,273 |
| 2018 | 6,405 |
| 2019 | 3,346 |
| 2020 | 3,690 |
| 2021 | 2,783 |
| 2022 | 2,581 |
| 2023 | 1,962 |
| 2024 | 1,463 |
| 2025 | 1,419 |
| 2026 (partial) | 359 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Vivitrol
In FDA adverse event reports that mention Vivitrol, these medications appeared most often in the same report.
- Gabapentin (1,943 reports)
- Ergocalciferol (1,042 reports)
- Quetiapine (1,034 reports)
- Bupropion (796 reports)
- Acetaminophen (794 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026