Drotrecogin alfa Side Effects

Brand Names: Xigris

Please note - some side effects for Drotrecogin alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Drotrecogin alfa - for the Consumer

Drotrecogin Alfa

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Drotrecogin Alfa . Seek medical attention right away if any of these SEVERE side effects occur when using Drotrecogin Alfa:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black stools; bloody diarrhea; confusion; one-sided weakness; pink-colored/red urine; slurred speech; stomach pain; unusual bruising or bleeding; vision problems; vomit that looks like coffee grounds.

Side Effects by Body System

General

The most common side effect associated with drotrecogin alfa has been bleeding.

Hematologic

Hematologic side effects have most commonly included bleeding (25% vs 18% with placebo). The majority of events were ecchymoses or gastrointestinal tract bleeding. Serious bleeding has been reported in 3.5% of patients (vs 2% with placebo) and included intracranial hemorrhage, life threatening hemorrhage, and any event requiring 3 or more units of packed red blood cells per days for 2 consecutive days.

Serious bleeding events have been reported at the following sites: Gastrointestinal, intra-abdominal, intrathoracic, retroperitoneal, intracranial, genitourinary, skin or soft tissues.

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