Does FIDAXOMICIN Cause Off label use? 51 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 51 reports of Off label use have been filed in association with FIDAXOMICIN (Dificid). This represents 3.4% of all adverse event reports for FIDAXOMICIN.
51
Reports of Off label use with FIDAXOMICIN
3.4%
of all FIDAXOMICIN reports
10
Deaths
14
Hospitalizations
How Dangerous Is Off label use From FIDAXOMICIN?
Of the 51 reports, 10 (19.6%) resulted in death, 14 (27.5%) required hospitalization, and 2 (3.9%) 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 FIDAXOMICIN. However, 51 reports have been filed with the FAERS database.
What Other Side Effects Does FIDAXOMICIN Cause?
Clostridium difficile infection (309)
Drug ineffective (302)
Diarrhoea (144)
Treatment failure (95)
No adverse event (75)
Clostridium difficile colitis (54)
Death (50)
Nausea (49)
Pyrexia (43)
Product use issue (42)
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 FIDAXOMICIN Alternatives Have Lower Off label use Risk?
FIDAXOMICIN vs FILGOTINIB
FIDAXOMICIN vs FILGRASTIM
FIDAXOMICIN vs FILGRASTIM-AAFI
FIDAXOMICIN vs FILGRASTIM-SNDZ
FIDAXOMICIN vs FINASTERIDE