NALTREXONE for Off label use: Side Effects & Safety Data
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There are 7 adverse event reports in the FDA FAERS database where NALTREXONE was used for Off label use.
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
Alcoholism (11,812)
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)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)