Adverse Effects

Bleeding is the major adverse effect of bivalirudin and occurs more commonly in patients with renal impairment. Injection site pain has been reported in individuals given sc bivalirudin (Fox et al., 1993). Mild headache, diarrhea, nausea, and abdominal cramps have also been reported (Fox et al., 1993). In the Hirulog Angioplasty Study (HAS) (now known as the Bivalirudin Angioplasty Trial [BAT]), the most frequent adverse effects included back pain, nausea, hypotension, pain, and headache. Approximately 5-10% of patients reported insomnia, hypertension, vomiting, anxiety, dyspepsia, bradycardia, abdominal pain, fever, nervousness, pelvic pain, and pain at the injection site (Bittl et al., 1995; Sciulli and Mauro, 2002) (Table 3).

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