Bivalirudin Side Effects

Please note - some side effects for Bivalirudin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Bivalirudin - for the Consumer

Bivalirudin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Bivalirudin:

Anxiety; back, stomach, or pelvic pain; headache; nausea; nervousness; pain at the injection site; trouble sleeping; upset stomach; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain or tenderness; chest pain or tightness; confusion; difficulty urinating; dizziness; easy bruising or bleeding; fainting; fast, slow, or irregular heartbeat; fever; loss of consciousness; one-sided weakness; paralysis of the face; severe bleeding; shortness of breath; vision or speech changes.

Side Effects by Body System

General

Back pain (42%) was the most commonly reported side effect associated with bivalirudin therapy. Pain (15%), injection site pain (5%), pelvic pain (6%), abdominal pain (5%), fever (5%), infection, and sepsis have also been reported.

Cardiovascular

Data from two randomized, double-blind studies in 4312 patients undergoing PTCA for treatment of unstable angina while receiving either bivalirudin or heparin therapy showed the overall incidence of major bleeding in bivalirudin treated patients was 3.7% compared to 9.3% in the heparin group. Retroperitoneal bleeding was reported in five bivalirudin treated patients compared to 15 patients receiving heparin. One patient receiving bivalirudin experienced an intracranial bleed, compared to two patients in the heparin group. Patients requiring transfusions in the bivalirudin group compared to the heparin group were 2% and 5.7% respectively.

Cardiovascular effects have included major bleeding (3.7%), hypotension (12%), hypertension (6%), and bradycardia (5%). Less commonly reported cardiovascular effects include syncope, vascular anomaly, and ventricular fibrillation.

Gastrointestinal

Gastrointestinal effects have included nausea (15%), vomiting (6%), and dyspepsia (5%)

Genitourinary

Genitourinary effects have included urinary retention (4%), and less commonly kidney failure and oliguria.

Nervous system

Nervous system effects have included headache (12%), insomnia (7%), anxiety (6%), and nervousness (5%). Less commonly reported effects include cerebral ischemia, confusion, and facial paralysis.

Respiratory

Respiratory effects have included lung edema (less than 1%).

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis (including fatal shock), hypersensitivity, and urticaria during postmarketing experience.

Hematologic

Hematologic side effects including fatal bleeding and thrombus formation during PCI (with and without intracoronary brachytherapy) with reports of fatal outcomes have been reported in postmarketing experience.

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