Does FLUDARABINE Cause Hyperammonaemic encephalopathy? 11 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 11 reports of Hyperammonaemic encephalopathy have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.1% of all adverse event reports for FLUDARABINE.
11
Reports of Hyperammonaemic encephalopathy with FLUDARABINE
0.1%
of all FLUDARABINE reports
6
Deaths
8
Hospitalizations
How Dangerous Is Hyperammonaemic encephalopathy From FLUDARABINE?
Of the 11 reports, 6 (54.5%) resulted in death, 8 (72.7%) required hospitalization, and 9 (81.8%) were considered life-threatening.
Is Hyperammonaemic encephalopathy Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 11 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 Hyperammonaemic encephalopathy?
VALPROIC ACID (455)
FLUOROURACIL (156)
VALPROATE (120)
DIVALPROEX (119)
OXALIPLATIN (107)
TOPIRAMATE (101)
RISPERIDONE (96)
QUETIAPINE (91)
LEVETIRACETAM (71)
LEUCOVORIN (62)
Which FLUDARABINE Alternatives Have Lower Hyperammonaemic encephalopathy Risk?
FLUDARABINE vs FLUDEOXYGLUCOSE F-18
FLUDARABINE vs FLUDROCORTISONE
FLUDARABINE vs FLUINDIONE
FLUDARABINE vs FLUMAZENIL
FLUDARABINE vs FLUMETHASONE