VIVITROL
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.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
By Age Group
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.
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.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA Adverse Event Reporting System (FAERS) via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →