Does MILTEFOSINE Cause Off label use? 83 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 83 reports of Off label use have been filed in association with MILTEFOSINE (IMPAVIDO). This represents 34.3% of all adverse event reports for MILTEFOSINE.
83
Reports of Off label use with MILTEFOSINE
34.3%
of all MILTEFOSINE reports
34
Deaths
14
Hospitalizations
How Dangerous Is Off label use From MILTEFOSINE?
Of the 83 reports, 34 (41.0%) resulted in death, 14 (16.9%) required hospitalization, and 4 (4.8%) 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 MILTEFOSINE. However, 83 reports have been filed with the FAERS database.
What Other Side Effects Does MILTEFOSINE Cause?
Drug ineffective (58)
Drug ineffective for unapproved indication (44)
Nausea (42)
Disease recurrence (23)
Vomiting (19)
Condition aggravated (16)
Visceral leishmaniasis (15)
Decreased appetite (14)
Product use in unapproved indication (14)
Gastrointestinal disorder (13)
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 MILTEFOSINE Alternatives Have Lower Off label use Risk?
MILTEFOSINE vs MINERAL OIL
MILTEFOSINE vs MINERAL OIL\PETROLATUM
MILTEFOSINE vs MINERALS
MILTEFOSINE vs MINERALS\VITAMINS
MILTEFOSINE vs MINIVELLE