MELATONIN for Sleep disorder therapy: Side Effects & Safety Data
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There are 275 adverse event reports in the FDA FAERS database where MELATONIN was used for Sleep disorder therapy.
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 deficit (104)
Intentional product misuse (79)
Off label use (52)
Suicide attempt (49)
Child abuse (45)
Autism spectrum disorder (26)
Poisoning deliberate (18)
Other Drugs Used for Sleep disorder therapy
DIPHENHYDRAMINE\NAPROXEN (339)
ACETAMINOPHEN (250)
IPRATROPIUM (235)
ACETAMINOPHEN\DIPHENHYDRAMINE (113)
RISPERIDONE (110)
DIPHENHYDRAMINE (88)
SUVOREXANT (73)
CETIRIZINE (55)
IPRATROPIUM\IPRATROPIUM ANHYDROUS (55)
CLONAZEPAM (43)