Does CROFELEMER Cause Off label use? 52 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 52 reports of Off label use have been filed in association with CROFELEMER (MYTESI). This represents 29.4% of all adverse event reports for CROFELEMER.
52
Reports of Off label use with CROFELEMER
29.4%
of all CROFELEMER reports
3
Deaths
5
Hospitalizations
How Dangerous Is Off label use From CROFELEMER?
Of the 52 reports, 3 (5.8%) resulted in death, 5 (9.6%) required hospitalization.
Is Off label use Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for CROFELEMER. However, 52 reports have been filed with the FAERS database.
What Other Side Effects Does CROFELEMER Cause?
Drug ineffective (42)
Diarrhoea (23)
Death (19)
Product dose omission issue (19)
Constipation (11)
Fatigue (8)
Flatulence (7)
Abdominal discomfort (5)
Back pain (5)
Cough (5)
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 CROFELEMER Alternatives Have Lower Off label use Risk?
CROFELEMER vs CROMOLYN
CROFELEMER vs CROTALIDAE POLYVALENT IMMUNE FAB
CROFELEMER vs CUBICIN
CROFELEMER vs CUPRIC
CROFELEMER vs CUPRIC ANHYDROUS