Drug side effects
naltrexone Side Effects
The reactions most often reported to the FDA for naltrexone (also sold as Vivitrol, ReVia), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 29,813
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of naltrexone come from 29,813 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 29,813 reports to the FDA Adverse Event Reporting System (FAERS) for naltrexone (Vivitrol): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
29,813
Reports Mentioning Death
1,301
4.4% of reports — not proof the medicine caused the death
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 |
| 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 |
| 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 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.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to naltrexone's 29,813.
Read our methodology - how this data is sourced, computed, and verified.