Applies to argatroban: intravenous solution.

Serious side effects of Argatroban

Along with its needed effects, argatroban 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 argatroban:

More common

• Bleeding from the bladder
• blood in the urine
• blurred vision
• chest pain
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fever
• no blood pressure or pulse
• stopping of heart
• sweating
• unconsciousness
• unusual tiredness or weakness

Less common

• Arm, back, or jaw pain
• bloody or black, tarry stools
• chest tightness or heaviness
• constipation
• cough or hoarseness
• coughing or spitting up blood
• fast, slow, or irregular heartbeat
• fast, pounding, or irregular heartbeat or pulse
• lower back or side pain
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• painful or difficult urination
• palpitations
• severe stomach pain
• shortness of breath
• sweating
• vomiting
• vomiting of blood or material that looks like coffee grounds

Rare

• Abdominal pain or swelling
• back pain or backaches
• blue lips and fingernails
• changes in skin color
• cold hands and feet
• coughing that sometimes produces a pink frothy sputum
• diarrhea
• difficult, fast, noisy breathing, sometimes with wheezing
• increased sweating
• indigestion
• loss of appetite
• pain, redness, or swelling in the arm or leg
• pains in the chest, groin, or legs, especially calves of the legs
• pale skin
• passing of gas
• severe headaches of sudden onset
• stomach pain, fullness, or discomfort
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling in the legs and ankles

For Healthcare Professionals

Applies to argatroban: intravenous solution.

Hematologic

Hematologic side effects including overt bleeding or hemorrhage are the most common complications of argatroban therapy. Major hemorrhagic events reported by the manufacturer include gastrointestinal bleeding (2.3%), intracranial bleeding (about 1% in patients receiving both argatroban and thrombolytic therapy), genitourinary bleeding and hematuria (0.9%), decreases in hemoglobin/hematocrit (0.7%), multisystem hemorrhage/DIC (0.5% ), and limb/below the knee amputation (0.5%). Minor hemorrhagic events reported by the manufacturer include gastrointestinal bleeding (14.4%), genitourinary bleeding and hematuria (11.6%), minor decreases in hemoglobin/hematocrit (10.4%), groin bleeding (5.4%), hemoptysis (2.9%), brachial bleeding (2.4%).^[Ref]

In a study of patients given argatroban for the treatment of heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome, one patient experienced intracranial hemorrhage 4 days after the discontinuation of argatroban therapy and following urokinase and oral anticoagulation therapy.^[Ref]

Cardiovascular

Cardiovascular side effects include hypotension (7.2%), cardiac arrest (5.8%), ventricular tachycardia (4.8%), atrial fibrillation (3.0%) and cerebrovascular disorder (2.3%).^[Ref]

Gastrointestinal

Gastrointestinal side effects include diarrhea (6.2%), nausea (4.8%), vomiting (4.2%), and abdominal pain (2.6%).^[Ref]

Respiratory

Respiratory effects include dyspnea (8.1%), pneumonia (3.3%) and coughing (2.8%).^[Ref]

General

General side effects include fever (6.9%), sepsis (6.0%) and pain (4.6%).^[Ref]

Genitourinary

Genitourinary side effects include urinary tract infection (4.6%).^[Ref]

Immunologic

Immunological side effects include infection (3.7%).^[Ref]