Bivalirudin Side Effects
Some side effects of bivalirudin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to bivalirudin: intravenous powder for solution
Along with its needed effects, bivalirudin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking bivalirudin:More common
- Abdominal pain or swelling
- arm, back, or jaw pain
- black, tarry stools
- blood in the eyes
- blood in the urine
- blurred vision
- bruising or purple areas on the skin
- chest pain or discomfort
- chest tightness or heaviness
- coughing up blood
- decreased alertness
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- joint pain or swelling
- pounding in the ears
- shortness of breath
- slow, fast, or irregular heartbeat
- unusual tiredness or weakness
- Decrease in frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- lightheadedness or fainting
- painful urination
- Blue lips and fingernails
- changes in skin color
- cold hands and feet
- cough or hoarseness
- coughing that sometimes produces a pink frothy sputum
- difficult, fast, noisy breathing, sometimes with wheezing
- fever or chills
- increased blood pressure
- increased thirst
- loss of appetite
- lower back or side pain
- pain, redness, or swelling in the arm or leg
- pale skin
- paralysis of the face
- rapid, shallow breathing
- severe numbness, especially on one side of the face or body
- swelling in the legs and ankles
- swelling of the face, fingers, or lower legs
- troubled breathing
- weight gain
- Bleeding gums
- difficulty in swallowing
- increased menstrual flow or vaginal bleeding
- joint stiffness
- pains in the chest, groin, or legs, especially calves of legs
- prolonged bleeding from cuts
- red or dark brown urine
- redness of the skin
- severe headaches of sudden onset
- sudden loss of coordination
- sudden onset of shortness of breath for no apparent reason
- sudden onset of slurred speech
- sudden vision changes
- swelling of the eyelids, lips, hands, or feet
Some side effects of bivalirudin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Fear or nervousness
- pain where the needle is placed
- pelvic pain
- trouble sleeping
- unable to sleep
- Acid or sour stomach
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to bivalirudin: intravenous powder for injection
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.
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 effects have included nausea (15%), vomiting (6%), and dyspepsia (5%)
Genitourinary effects have included urinary retention (4%), and less commonly kidney failure and oliguria.
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 effects have included lung edema (less than 1%).
Hypersensitivity side effects have included anaphylaxis (including fatal shock), hypersensitivity, and urticaria during postmarketing experience.
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.
More bivalirudin resources
- bivalirudin Concise Consumer Information (Cerner Multum)
- bivalirudin MedFacts Consumer Leaflet (Wolters Kluwer)
- bivalirudin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information
- Bivalirudin Professional Patient Advice (Wolters Kluwer)
- Bivalirudin Monograph (AHFS DI)
- Angiomax Prescribing Information (FDA)
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