MID-VOLUME · INJECTION SITE REACTION
naltrexone Side Effects
naltrexone (also sold as Vivitrol, ReVia) sits MID-VOLUME #192 of 524 by FAERS report count. Lead signal: INJECTION SITE REACTION - INJECTION SITE REACTION leads at 4,407 reports (14.8% of the book). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 29,813
- FAERS reports
FDA Adverse Event Reporting System extract for naltrexone. Stamp set CASELOAD · DEATH-MARKED · HOSP-MID. How figures are compiled.
Among 29,813 FAERS reports for naltrexone, INJECTION SITE REACTION is the most-reported reaction (4,407). Volume band MID-VOLUME #192 of 524 by FAERS report count.
Mid-book FAERS page for naltrexone (Vivitrol) (29,813 reports). Signature INJECTION SITE REACTION. Dominant age band on file: 18-44. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
INJECTION SITE REACTION leads 4,407 of 29,813 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (9,536 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 1,301 reports (4.4% - MARKED). Reactions below co-occur in those rows only.
| 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
Hospitalization mid-share (3,715, 12.5%). Co-reported reactions:
| 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 |
How to read naltrexone FAERS figures (CASELOAD · DEATH-MARKED · HOSP-MID)
FAERS holds 29,813 voluntary reports linked to naltrexone (Vivitrol, ReVia), 2004-2025. Death is listed on 1,301 (4.4%). Hospitalization appears on 3,715 (12.5%). Top co-reported indication: Alcoholism.
Mid-volume extract - treat DEATH-MARKED · HOSP-MID as signal-detection rates next to INJECTION SITE REACTION leads at 4,407 reports (14.8% of the book).
Read with naltrexone
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 29,874 FAERS cases (Δ 61 heavier vs naltrexone); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 29,879 FAERS cases (Δ 66 heavier vs naltrexone); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 29,554 FAERS cases (Δ 259 lighter vs naltrexone); DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 30,089 FAERS cases (Δ 276 heavier vs naltrexone); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.7 pp vs naltrexone's DEATH-MARKED): CASELOAD · HOSP-MID.
naltrexone sits in CASELOAD; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.