In a retrospective review, 22 of a total of 244 patients (9%) patients with head and neck or gastrointestinal cancer who were treated with infusional 5-fluorouracil (5-FU)-based chemotherapy regimens experienced thrombotic vascular events. These events occurred concurrently with treatment or several months following the completion of therapy and consisted mainly of cardiac arrhythmias, myocardial infarction, sudden death, and thromboembolism. The temporal relationship of these vascular events to the time of treatment suggests that infusional 5-FU may have been the underlying cause.