Does FLUDARABINE Cause Cholestasis? 45 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 45 reports of Cholestasis have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.2% of all adverse event reports for FLUDARABINE.
45
Reports of Cholestasis with FLUDARABINE
0.2%
of all FLUDARABINE reports
24
Deaths
31
Hospitalizations
How Dangerous Is Cholestasis From FLUDARABINE?
Of the 45 reports, 24 (53.3%) resulted in death, 31 (68.9%) required hospitalization, and 4 (8.9%) were considered life-threatening.
Is Cholestasis Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 45 reports have been filed with the FAERS database.
What Other Side Effects Does FLUDARABINE Cause?
Off label use (3,018)
Febrile neutropenia (2,055)
Drug ineffective (1,630)
Pyrexia (1,606)
Product use in unapproved indication (1,530)
Cytokine release syndrome (1,458)
Neutropenia (1,175)
Cytomegalovirus infection (1,132)
Mucosal inflammation (1,036)
Sepsis (981)
What Other Drugs Cause Cholestasis?
ACETAMINOPHEN (1,269)
ATORVASTATIN (898)
PANTOPRAZOLE (535)
METHOTREXATE (507)
AMOXICILLIN\CLAVULANATE (480)
SULFAMETHOXAZOLE\TRIMETHOPRIM (462)
ENOXAPARIN (404)
PIPERACILLIN\TAZOBACTAM (394)
ESOMEPRAZOLE (363)
NIVOLUMAB (342)
Which FLUDARABINE Alternatives Have Lower Cholestasis Risk?
FLUDARABINE vs FLUDEOXYGLUCOSE F-18
FLUDARABINE vs FLUDROCORTISONE
FLUDARABINE vs FLUINDIONE
FLUDARABINE vs FLUMAZENIL
FLUDARABINE vs FLUMETHASONE