Does POLYSORBATE 20 Cause Off label use? 30 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 30 reports of Off label use have been filed in association with POLYSORBATE 20. This represents 50.9% of all adverse event reports for POLYSORBATE 20.
30
Reports of Off label use with POLYSORBATE 20
50.9%
of all POLYSORBATE 20 reports
0
Deaths
30
Hospitalizations
How Dangerous Is Off label use From POLYSORBATE 20?
Of the 30 reports, 30 (100.0%) required hospitalization, and 30 (100.0%) 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 POLYSORBATE 20. However, 30 reports have been filed with the FAERS database.
What Other Side Effects Does POLYSORBATE 20 Cause?
Cognitive disorder (47)
Fall (47)
Balance disorder (46)
Blood calcium decreased (46)
Constipation (46)
Creatinine renal clearance decreased (46)
Depressed level of consciousness (46)
Hypotension (46)
Mobility decreased (46)
Orthostatic hypotension (46)
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)