Does AGOMELATINE Cause Off label use? 58 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 58 reports of Off label use have been filed in association with AGOMELATINE. This represents 6.4% of all adverse event reports for AGOMELATINE.
58
Reports of Off label use with AGOMELATINE
6.4%
of all AGOMELATINE reports
18
Deaths
23
Hospitalizations
How Dangerous Is Off label use From AGOMELATINE?
Of the 58 reports, 18 (31.0%) resulted in death, 23 (39.7%) required hospitalization, and 6 (10.3%) 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 AGOMELATINE. However, 58 reports have been filed with the FAERS database.
What Other Side Effects Does AGOMELATINE Cause?
Fall (229)
Insomnia (215)
Coma (207)
Tachycardia (206)
Arthralgia (204)
Diarrhoea (204)
Dizziness (204)
Fatigue (204)
Pruritus (203)
Dyspnoea (202)
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 AGOMELATINE Alternatives Have Lower Off label use Risk?
AGOMELATINE vs ALAWAY
AGOMELATINE vs ALBENDAZOLE
AGOMELATINE vs ALBIGLUTIDE
AGOMELATINE vs ALBUMIN
AGOMELATINE vs ALBUMIN HUMAN