Does FLUDARABINE Cause Encephalopathy? 201 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 201 reports of Encephalopathy have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.9% of all adverse event reports for FLUDARABINE.
201
Reports of Encephalopathy with FLUDARABINE
0.9%
of all FLUDARABINE reports
85
Deaths
144
Hospitalizations
How Dangerous Is Encephalopathy From FLUDARABINE?
Of the 201 reports, 85 (42.3%) resulted in death, 144 (71.6%) required hospitalization, and 58 (28.9%) were considered life-threatening.
Is Encephalopathy Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 201 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 Encephalopathy?
BACLOFEN (845)
METHOTREXATE (775)
ACETAMINOPHEN (608)
IFOSFAMIDE (585)
CYCLOPHOSPHAMIDE (552)
TACROLIMUS (523)
PREDNISONE (489)
DEXAMETHASONE (428)
METFORMIN (418)
ETOPOSIDE (404)
Which FLUDARABINE Alternatives Have Lower Encephalopathy Risk?
FLUDARABINE vs FLUDEOXYGLUCOSE F-18
FLUDARABINE vs FLUDROCORTISONE
FLUDARABINE vs FLUINDIONE
FLUDARABINE vs FLUMAZENIL
FLUDARABINE vs FLUMETHASONE