naltrexone Side Effects
Also known as: Vivitrol, ReVia
Analysis of 29,813 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
29,813
Death-Related
1,301
4.4% of reports
Hospitalizations
3,715
12.5% of reports
Top Indication
Alcoholism
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,301 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 556 |
| OVERDOSE | 321 |
| COMPLETED SUICIDE | 155 |
| DRUG DEPENDENCE | 74 |
| TOXICITY TO VARIOUS AGENTS | 63 |
| DRUG ABUSE | 44 |
| OFF LABEL USE | 32 |
| DRUG DOSE OMISSION | 31 |
| TREATMENT NONCOMPLIANCE | 24 |
| PRODUCT DOSE OMISSION | 20 |
| ALCOHOLISM | 19 |
| ROAD TRAFFIC ACCIDENT | 18 |
| SUSPECTED SUICIDE | 18 |
| FALL | 17 |
| PNEUMONIA | 17 |
| CARDIO-RESPIRATORY ARREST | 15 |
| PRODUCT DOSE OMISSION ISSUE | 15 |
| ACCIDENTAL OVERDOSE | 14 |
| CARDIAC ARREST | 13 |
| INTENTIONAL OVERDOSE | 13 |
Reactions in Hospitalization Reports
Top reactions in 3,715 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 437 |
| ALCOHOLISM | 261 |
| NAUSEA | 231 |
| INJECTION SITE REACTION | 226 |
| PAIN | 225 |
| VOMITING | 191 |
| INJECTION SITE PAIN | 181 |
| DRUG INEFFECTIVE | 168 |
| DRUG DEPENDENCE | 156 |
| ANXIETY | 144 |
| DYSPNOEA | 140 |
| MALAISE | 140 |
| OVERDOSE | 139 |
| PNEUMONIA | 139 |
| SUICIDAL IDEATION | 134 |
| DRUG WITHDRAWAL SYNDROME | 127 |
| FALL | 127 |
| FATIGUE | 127 |
| HEADACHE | 127 |
| DEPRESSION | 124 |
Nearby — Related Medications
What the FAERS Data Reveals About naltrexone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 29,813 voluntary reports linked to naltrexone and its brand equivalents (Vivitrol, ReVia), spanning 2004 through 2025. Of those, 1,301 (4.4%) listed death as an outcome and 3,715 (12.5%) involved hospitalization. The most common indication reported alongside adverse events was Alcoholism.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 47% were female and 52% male; age distribution skews toward 18-44, with 9,536 reports in that bracket. The single most reported reaction is injection site reaction with 4,407 submissions, followed by injection site pain and nausea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.