Does FLUOROURACIL Cause Cholestasis? 192 Reports in FDA Database
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According to the FDA Adverse Event Reporting System (FAERS), 192 reports of Cholestasis have been filed in association with FLUOROURACIL (FLUOROURACIL). This represents 0.4% of all adverse event reports for FLUOROURACIL.
192
Reports of Cholestasis with FLUOROURACIL
0.4%
of all FLUOROURACIL reports
23
Deaths
90
Hospitalizations
How Dangerous Is Cholestasis From FLUOROURACIL?
Of the 192 reports, 23 (12.0%) resulted in death, 90 (46.9%) required hospitalization, and 6 (3.1%) 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 FLUOROURACIL. However, 192 reports have been filed with the FAERS database.
What Other Side Effects Does FLUOROURACIL Cause?
Diarrhoea (5,373)
Neutropenia (4,400)
Nausea (3,757)
Vomiting (2,836)
Off label use (2,788)
Neuropathy peripheral (2,605)
Thrombocytopenia (2,426)
Fatigue (2,421)
Disease progression (2,377)
Febrile neutropenia (2,230)
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 FLUOROURACIL Alternatives Have Lower Cholestasis Risk?
FLUOROURACIL vs FLUOROURACIL\IRINOTECAN\LEUCOVORIN
FLUOROURACIL vs FLUOROURACIL\IRINOTECAN\LEUCOVORIN\OXALIPLATIN
FLUOROURACIL vs FLUOROURACIL\LEUCOVORIN\OXALIPLATIN
FLUOROURACIL vs FLUOXETINE
FLUOROURACIL vs FLUOXETINE\FLUOXETINE