NALTREXONE for Alcoholism: Side Effects & Safety Data
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There are 11,812 adverse event reports in the FDA FAERS database where NALTREXONE was used for Alcoholism.
Most Reported Side Effects for NALTREXONE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Injection site reaction | 4,360 | 17.0% | 5 | 213 |
| Injection site pain | 2,990 | 11.7% | 4 | 154 |
| Alcoholism | 1,928 | 7.5% | 17 | 255 |
| Injection site mass | 1,849 | 7.2% | 1 | 88 |
| Nausea | 1,782 | 7.0% | 4 | 157 |
| Fatigue | 1,486 | 5.8% | 4 | 143 |
| Pain | 1,348 | 5.3% | 6 | 165 |
| Drug dependence | 1,334 | 5.2% | 70 | 141 |
| Drug ineffective | 1,250 | 4.9% | 4 | 171 |
| Feeling abnormal | 1,241 | 4.8% | 3 | 61 |
| Headache | 1,237 | 4.8% | 2 | 84 |
| Malaise | 1,094 | 4.3% | 7 | 112 |
| Off label use | 1,077 | 4.2% | 32 | 77 |
| Insomnia | 1,042 | 4.1% | 3 | 108 |
| Anxiety | 914 | 3.6% | 3 | 92 |
Other Indications for NALTREXONE
Drug dependence (7,528)
Product used for unknown indication (3,926)
Drug use disorder (1,500)
Alcohol use disorder (327)
Dependence (271)
Alcohol abuse (227)
Drug abuse (80)
Complex regional pain syndrome (67)
Substance abuse (54)
Mast cell activation syndrome (44)
Other Drugs Used for Alcoholism
BACLOFEN (383)
DISULFIRAM (201)
ACAMPROSATE (139)
NALMEFENE (60)
TOPIRAMATE (53)
DIAZEPAM (38)
TIAPRIDE (22)
GABAPENTIN (18)
VIVITROL (18)
ALCOHOL (17)