ADVERSE REACTIONS
Adverse reactions to the arterial infusion of FUDR 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.
Laboratory Abnormalities: BSP, prothrombin, total proteins, sedimentation rate and thrombopenia.
Procedural Complications of Regional Arterial Infusion: arterial aneurysm; arterial ischemia; arterial thrombosis; embolism; fibromyositis; thrombophlebitis; hepatic necrosis; abscesses; infection at catheter site; bleeding at catheter site; catheter blocked, displaced or leaking.
The following adverse reactions have not been reported with FUDR but have been noted following the administration of 5-fluorouracil. While the possibility of these occurring following FUDR therapy is remote because of its regional administration, one should be alert for these reactions following the administration of FUDR because of the pharmacological similarity of these two drugs: pancytopenia, agranulocytosis, myocardial ischemia, angina, anaphylaxis, generalized allergic reactions, acute cerebellar syndrome, nystagmus, headache, dry skin, fissuring, photosensitivity, pruritic maculopapular rash, increased pigmentation of the skin, vein pigmentation, lacrimal duct stenosis, visual changes, lacrimation, photophobia, disorientation, confusion, euphoria, epistaxis and nail changes, including loss of nails.
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