Does POLYSORBATE 85 Cause Product use in unapproved indication? 43 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 43 reports of Product use in unapproved indication have been filed in association with POLYSORBATE 85. This represents 50.6% of all adverse event reports for POLYSORBATE 85.
43
Reports of Product use in unapproved indication with POLYSORBATE 85
50.6%
of all POLYSORBATE 85 reports
0
Deaths
42
Hospitalizations
How Dangerous Is Product use in unapproved indication From POLYSORBATE 85?
Of the 43 reports, 42 (97.7%) required hospitalization, and 38 (88.4%) were considered life-threatening.
Is Product use in unapproved indication 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 Product use in unapproved indication?
DUPILUMAB (33,452)
DICLOFENAC (12,197)
METHOTREXATE (8,930)
PREDNISONE (7,625)
RITUXIMAB (7,519)
MYCOPHENOLATE MOFETIL (5,910)
ACETAMINOPHEN (5,819)
CYCLOPHOSPHAMIDE (5,750)
RISPERIDONE (5,551)
TACROLIMUS (5,057)