Applies to bivalirudin: intravenous powder for solution, intravenous solution.

Serious side effects of Bivalirudin

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
• 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

Other side effects of Bivalirudin

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
• 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, intravenous solution.

Cardiovascular

Common (1% to 10%): Atrial fibrillation, ventricular tachycardia, angina pectoris, bradycardia, hypertension, hypotension, chest pain

Rare (less than 0.1%): Myocardial infarction, cardiac tamponade, pericardial hemorrhage, coronary artery thrombosis, coronary stent thrombosis (including reports with fatal outcome), arteriovenous fistula, catheter thrombosis, vascular pseudoaneurysm

Postmarketing reports: Cardiac tamponade, ventricular fibrillation^[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis, hemoptysis, pharyngeal hemorrhage

Rare (less than 0.1%): Pulmonary hemorrhage, dyspnea^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, dyspepsia

Uncommon (0.1% to 1%): GI hemorrhage (i.e., hematemesis, melena, esophageal hemorrhage, anal hemorrhage), retroperitoneal hemorrhage, gingival hemorrhage

Rare (less than 0.1%): Retroperitoneal hematoma^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematuria^[Ref]

Hematologic

Very common (10% or more): Minor hemorrhage at any site (22%)

Common (1% to 10%): Hemoglobin decreased, major hemorrhage at any site (including fatal outcomes)

Uncommon (0.1% to 1%): Thrombocytopenia, anemia, hematoma

Rare (less than 0.1%): INR increased

Postmarketing reports: Catheter thrombosis, arteriovenous fistula, compartment syndrome^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylaxis (including fatal shock)^[Ref]

Local

Common (1% to 10%): Access site hemorrhage, vessel puncture site hematoma (5 cm or less), vessel puncture site hematoma (greater than 5 cm), injection site pain

Rare (less than 0.1%): Injection site reactions (i.e., injection site discomfort, injection site pain, puncture site reaction)^[Ref]

Musculoskeletal

Very common (10% or more): Back pain

Common (1% to 10%): Chest pain^[Ref]

Nervous system

Common (1% to 10%): Headache, insomnia

Rare (less than 0.1%): Intracranial hemorrhage^[Ref]

Ocular

Rare (less than 0.1%): Intraocular hemorrhage^[Ref]

Other

Rare (less than 0.1%): Ear hemorrhage^[Ref]

Psychiatric

Common (1% to 10%): Nervousness^[Ref]