Does FOTEMUSTINE Cause Sepsis? 13 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 13 reports of Sepsis have been filed in association with FOTEMUSTINE. This represents 4.9% of all adverse event reports for FOTEMUSTINE.
13
Reports of Sepsis with FOTEMUSTINE
4.9%
of all FOTEMUSTINE reports
9
Deaths
1
Hospitalizations
How Dangerous Is Sepsis From FOTEMUSTINE?
Of the 13 reports, 9 (69.2%) resulted in death, 1 (7.7%) required hospitalization, and 3 (23.1%) were considered life-threatening.
Is Sepsis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FOTEMUSTINE. However, 13 reports have been filed with the FAERS database.
What Other Side Effects Does FOTEMUSTINE Cause?
Off label use (66)
Disease progression (38)
Acute myeloid leukaemia (30)
Thrombocytopenia (29)
Mucosal inflammation (25)
Neutropenia (24)
Product use in unapproved indication (23)
Platelet count decreased (22)
Neutrophil count decreased (20)
Septic shock (20)