Bivalirudin Side Effects

Not all side effects for bivalirudin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to bivalirudin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by bivalirudin. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking bivalirudin, check with your doctor or nurse immediately:

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
  • confusion
  • coughing up blood
  • decreased alertness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • headache
  • joint pain or swelling
  • nausea
  • nervousness
  • nosebleeds
  • pounding in the ears
  • shortness of breath
  • slow, fast, or irregular heartbeat
  • sweating
  • unusual tiredness or weakness
Less common
  • Decrease in frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • lightheadedness or fainting
  • painful urination
Rare
  • 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
  • vomiting
  • weight gain
Incidence not known
  • Bleeding gums
  • difficulty in swallowing
  • hives
  • increased menstrual flow or vaginal bleeding
  • irritation
  • itching
  • joint stiffness
  • pains in the chest, groin, or legs, especially calves of legs
  • paralysis
  • prolonged bleeding from cuts
  • rash
  • 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
  • wheezing

Some of the side effects that can occur with bivalirudin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Fear or nervousness
  • pain where the needle is placed
  • pelvic pain
  • sleeplessness
  • trouble sleeping
  • unable to sleep
Less common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to bivalirudin: intravenous powder for injection

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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