MELATONIN for Off label use: Side Effects & Safety Data
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There are 52 adverse event reports in the FDA FAERS database where MELATONIN was used for Off label use.
Most Reported Side Effects for MELATONIN
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Somnolence | 642 | 15.6% | 148 | 495 |
| Intentional overdose | 640 | 15.6% | 13 | 598 |
| Off label use | 555 | 13.5% | 213 | 312 |
| Intentional self-injury | 463 | 11.3% | 0 | 444 |
| Drug ineffective | 458 | 11.1% | 94 | 243 |
| Gastrooesophageal reflux disease | 399 | 9.7% | 13 | 378 |
| Nausea | 377 | 9.2% | 225 | 164 |
| Vomiting | 341 | 8.3% | 228 | 175 |
| Coma | 336 | 8.2% | 6 | 305 |
| Constipation | 313 | 7.6% | 226 | 127 |
| Hyponatraemia | 291 | 7.1% | 246 | 151 |
| Pneumonia aspiration | 288 | 7.0% | 1 | 277 |
| Dyspnoea | 285 | 6.9% | 92 | 217 |
| Multiple organ dysfunction syndrome | 274 | 6.7% | 273 | 141 |
| Ascites | 268 | 6.5% | 238 | 111 |
Other Indications for MELATONIN
Product used for unknown indication (2,097)
Insomnia (363)
Sleep disorder (342)
Sleep disorder therapy (275)
Sleep deficit (104)
Intentional product misuse (79)
Suicide attempt (49)
Child abuse (45)
Autism spectrum disorder (26)
Poisoning deliberate (18)
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)