Argatroban Side Effects

Some side effects of argatroban 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 argatroban: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking argatroban: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• feeling like you might pass out;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• blood in your urine;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• any bleeding that will not stop;

• pain or burning when you urinate;

• sudden numbness or weakness, problems with vision, speech, or balance;

• sudden severe headache, confusion, sudden changes in your senses of taste or touch;

• fever, chills, body aches, flu symptoms;

• cough with yellow or green mucus, stabbing chest pain, feeling short of breath;

• slow heart rate, weak pulse, slow breathing (breathing may stop); or

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects of argatroban may include:

• nausea, vomiting, diarrhea, stomach pain;

• headache;

• back pain; or

• bleeding around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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%).

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.

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%).

Gastrointestinal

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

Respiratory

Respiratory effects include dyspnea (8.1%), pneumonia (3.3%) and coughing (2.8%).

General

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

Genitourinary

Genitourinary side effects include urinary tract infection (4.6%).

Immunologic

Immunological side effects include infection (3.7%).

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