Does FLUDARABINE Cause Hepatomegaly? 64 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 64 reports of Hepatomegaly have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.3% of all adverse event reports for FLUDARABINE.
64
Reports of Hepatomegaly with FLUDARABINE
0.3%
of all FLUDARABINE reports
32
Deaths
37
Hospitalizations
How Dangerous Is Hepatomegaly From FLUDARABINE?
Of the 64 reports, 32 (50.0%) resulted in death, 37 (57.8%) required hospitalization, and 21 (32.8%) were considered life-threatening.
Is Hepatomegaly Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 64 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 Hepatomegaly?
METHOTREXATE (276)
ADALIMUMAB (225)
RUXOLITINIB (213)
CYCLOPHOSPHAMIDE (170)
VINCRISTINE (136)
ACETAMINOPHEN (126)
RITUXIMAB (115)
DEXAMETHASONE (104)
PREDNISONE (101)
SECUKINUMAB (90)
Which FLUDARABINE Alternatives Have Lower Hepatomegaly Risk?
FLUDARABINE vs FLUDEOXYGLUCOSE F-18
FLUDARABINE vs FLUDROCORTISONE
FLUDARABINE vs FLUINDIONE
FLUDARABINE vs FLUMAZENIL
FLUDARABINE vs FLUMETHASONE