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What the label lists and what reports show

Floxuridine side effects

Floxuridine's FDA label lists its adverse reactions in its own words. FAERS holds 165 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (17 reports).

  • Generic listed

Check it at the source: the floxuridine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Adverse reactions to the arterial infusion of floxuridine are generally related to the procedural complications of regional arterial infusion. The more common adverse reactions to the drug are nausea, vomiting, diarrhea, enteritis, stomatitis and localized erythema. The more common laboratory abnormalities are anemia, leukopenia, thrombocytopenia and elevations of alkaline phosphatase, serum transaminase, serum bilirubin and lactic dehydrogenase. Other adverse reactions are: Gastrointestinal: duodenal ulcer, duodenitis, gastritis, bleeding, gastroenteritis, glossitis, pharyngitis, anorexia, cramps, abdominal pain; possible intra- and extrahepatic biliary sclerosis, as well as acalculous cholecystitis. Dermatologic: alopecia, dermatitis, nonspecific skin toxicity, rash. Cardiovascular: myocardial ischemia. Miscellaneous Clinical Reactions: fever, lethargy, malaise, weakness. …

Source: FDA drug label, Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set c8edabc1-67cd-421b-a147-7c1f19f05b8e), via openFDA; the full label on DailyMed

What do FAERS reports show?

165 reports list floxuridine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 43 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Diarrhoea (named in the label)17
  • Drug Ineffective (a use or a product term, not a reaction)14
  • Hepatic Steatosis13
  • Steatohepatitis12
  • Alanine Aminotransferase Increased10
  • Nausea (named in the label)9
  • Tachycardia9
  • Abdominal Pain (named in the label)8
  • Death (an outcome recorded in the report)8
  • Neutropenia8
  • Aspartate Aminotransferase Increased7
  • Toxicity To Various Agents7
  • Thrombosis (named in the label)6
  • Tumour Lysis Syndrome6
  • Blood Alkaline Phosphatase Increased5
  • Bone Marrow Failure5
  • Hepatic Failure5
  • Hypertension5
  • Off Label Use (a use or a product term, not a reaction)5
  • Therapy Interrupted (a use or a product term, not a reaction)5
  • Thrombocytopenia (named in the label)5
  • Vomiting (named in the label)5
  • Acute Myeloid Leukaemia4
  • Asthenia4
  • Atrial Fibrillation4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Floxuridine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions