Does FLUDARABINE Cause Colitis? 167 Reports in FDA Database

Q: Does FLUDARABINE cause Colitis?

167 reports of Colitis have been filed with the FDA for FLUDARABINE, representing 0.7% of all FLUDARABINE adverse event reports.

Q: How dangerous is Colitis from FLUDARABINE?

Of 167 reports, 50 (29.9%) resulted in death and 88 required hospitalization.

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According to the FDA Adverse Event Reporting System (FAERS), 167 reports of Colitis have been filed in association with FLUDARABINE (Fludarabine Phosphate). This represents 0.7% of all adverse event reports for FLUDARABINE.

167

Reports of Colitis with FLUDARABINE

0.7%

of all FLUDARABINE reports

Deaths

Hospitalizations

How Dangerous Is Colitis From FLUDARABINE?

Of the 167 reports, 50 (29.9%) resulted in death, 88 (52.7%) required hospitalization, and 26 (15.6%) were considered life-threatening.

Is Colitis Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for FLUDARABINE. However, 167 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 Colitis?

ADALIMUMAB (3,043) NIVOLUMAB (2,123) IPILIMUMAB (1,988) PEMBROLIZUMAB (1,638) INFLIXIMAB (1,254) METHOTREXATE (1,166) PREDNISONE (1,100) VEDOLIZUMAB (1,077) CARBOPLATIN (993) MESALAMINE (839)

Which FLUDARABINE Alternatives Have Lower Colitis Risk?

FLUDARABINE vs FLUDEOXYGLUCOSE F-18 FLUDARABINE vs FLUDROCORTISONE FLUDARABINE vs FLUINDIONE FLUDARABINE vs FLUMAZENIL FLUDARABINE vs FLUMETHASONE

FLUDARABINE Full Profile All Colitis Reports All Drugs Causing Colitis FLUDARABINE Demographics