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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does POLYSORBATE 85 Cause Off label use? 43 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 43 reports of Off label use have been filed in association with POLYSORBATE 85. This represents 50.6% of all adverse event reports for POLYSORBATE 85.

43
Reports of Off label use with POLYSORBATE 85
50.6%
of all POLYSORBATE 85 reports
0
Deaths
43
Hospitalizations

How Dangerous Is Off label use From POLYSORBATE 85?

Of the 43 reports, 43 (100.0%) required hospitalization, and 38 (88.4%) 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 85. However, 43 reports have been filed with the FAERS database.

What Other Side Effects Does POLYSORBATE 85 Cause?

Cognitive disorder (79) Fall (79) Balance disorder (78) Blood calcium decreased (78) Constipation (78) Creatinine renal clearance decreased (78) Depressed level of consciousness (78) Hypotension (78) Mobility decreased (78) Orthostatic hypotension (78)

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)

Related Pages

POLYSORBATE 85 Full Profile All Off label use Reports All Drugs Causing Off label use POLYSORBATE 85 Demographics