Does SIPULEUCEL-T Cause Malaise? 233 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 233 reports of Malaise have been filed in association with SIPULEUCEL-T (PROVENGE). This represents 5.1% of all adverse event reports for SIPULEUCEL-T.
233
Reports of Malaise with SIPULEUCEL-T
5.1%
of all SIPULEUCEL-T reports
8
Deaths
52
Hospitalizations
How Dangerous Is Malaise From SIPULEUCEL-T?
Of the 233 reports, 8 (3.4%) resulted in death, 52 (22.3%) required hospitalization, and 1 (0.4%) were considered life-threatening.
Is Malaise Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for SIPULEUCEL-T. However, 233 reports have been filed with the FAERS database.
What Other Side Effects Does SIPULEUCEL-T Cause?
Chills (447)
Infusion related reaction (414)
Pyrexia (255)
Fatigue (249)
Nausea (205)
Disease progression (185)
Ill-defined disorder (185)
Culture positive (174)
Asthenia (164)
Vomiting (159)
What Other Drugs Cause Malaise?
ADALIMUMAB (15,965)
ETANERCEPT (13,600)
METHOTREXATE (9,970)
TOFACITINIB (9,040)
SECUKINUMAB (8,570)
INFLIXIMAB (7,477)
RITUXIMAB (6,587)
PREGABALIN (6,320)
PREDNISONE (6,319)
ABATACEPT (6,251)
Which SIPULEUCEL-T Alternatives Have Lower Malaise Risk?
SIPULEUCEL-T vs SIROLIMUS
SIPULEUCEL-T vs SIRUKUMAB
SIPULEUCEL-T vs SITAGLIPTIN
SIPULEUCEL-T vs SOAP
SIPULEUCEL-T vs SODIUM