Does FLUDARABINE Cause Hyperammonaemia? 33 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 33 reports of Hyperammonaemia have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.1% of all adverse event reports for FLUDARABINE.
33
Reports of Hyperammonaemia with FLUDARABINE
0.1%
of all FLUDARABINE reports
17
Deaths
24
Hospitalizations
How Dangerous Is Hyperammonaemia From FLUDARABINE?
Of the 33 reports, 17 (51.5%) resulted in death, 24 (72.7%) required hospitalization, and 11 (33.3%) were considered life-threatening.
Is Hyperammonaemia Listed in the Official Label?
This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 33 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 Hyperammonaemia?
VALPROIC ACID (581)
VALPROATE (328)
FLUOROURACIL (263)
DIVALPROEX (256)
LEVETIRACETAM (192)
TACROLIMUS (181)
ACETAMINOPHEN (177)
OXALIPLATIN (160)
TOPIRAMATE (156)
GLYCEROL PHENYLBUTYRATE (147)
Which FLUDARABINE Alternatives Have Lower Hyperammonaemia Risk?
FLUDARABINE vs FLUDEOXYGLUCOSE F-18
FLUDARABINE vs FLUDROCORTISONE
FLUDARABINE vs FLUINDIONE
FLUDARABINE vs FLUMAZENIL
FLUDARABINE vs FLUMETHASONE