Does MELATONIN Cause Off label use? 555 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 555 reports of Off label use have been filed in association with MELATONIN (Melatonin 1527). This represents 13.5% of all adverse event reports for MELATONIN.
555
Reports of Off label use with MELATONIN
13.5%
of all MELATONIN reports
213
Deaths
312
Hospitalizations
How Dangerous Is Off label use From MELATONIN?
Of the 555 reports, 213 (38.4%) resulted in death, 312 (56.2%) required hospitalization, and 123 (22.2%) were considered life-threatening.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for MELATONIN. However, 555 reports have been filed with the FAERS database.
What Other Side Effects Does MELATONIN Cause?
Somnolence (642)
Intentional overdose (640)
Intentional self-injury (463)
Drug ineffective (458)
Gastrooesophageal reflux disease (399)
Nausea (377)
Vomiting (341)
Coma (336)
Constipation (313)
Hyponatraemia (291)
What Other Drugs Cause Off label use?
RITUXIMAB (39,751)
INFLIXIMAB (34,801)
DENOSUMAB (34,612)
METHOTREXATE (24,020)
VEDOLIZUMAB (21,017)
ETANERCEPT (20,178)
TOCILIZUMAB (18,256)
PREDNISONE (17,867)
LENALIDOMIDE (17,017)
ADALIMUMAB (16,417)
Which MELATONIN Alternatives Have Lower Off label use Risk?
MELATONIN vs MELOXICAM
MELATONIN vs MELPERONE
MELATONIN vs MELPHALAN
MELATONIN vs MEMANTINE
MELATONIN vs MENINGOCOCCAL GROUP B VACCINE