Bivalirudin side effects

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Side Effects

The main risk is the occurrence of severe bleedings in 2.4 % of patients in clinical studies. Elderly patients experienced more bleeding episodes than younger patients. Cases of deaths due to severe bleeding attributable to bivalirudin were seen.

Cases of local (skin) or generalized, sometimes severe, anaphylactic allergic reactions (including shock) were observed. Isolated cases of death from anaphylactic reactions were seen. Thrombocytopenia was only infrequently encountered. Unspecific pains and anxiety were frequent but tolerable side-effects.

Cardiovascular

Hypotension (12%); hypertension (6%); bradycardia (5%); thrombus formation during PCI with and without intracoronary brachytherapy (postmarketing). CNS

Headache (12%); insomnia (7%); anxiety (6%); nervousness (5%). GI

Nausea (15%); vomiting (6%); abdominal pain, dyspepsia (5%). Genitourinary

Urinary retention (4%). Hematologic

Major hemorrhage (4%); fatal bleeding (postmarketing). Miscellaneous

Back pain (42%); pain (15%); injection site pain (8%); pelvic pain (6%); fever (5%); hypersensitivity and allergic reactions including rare reports of anaphylaxis (postmarketing).