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Xigris Side Effects

Generic Name: drotrecogin alfa

Note: This page contains side effects data for the generic drug drotrecogin alfa. It is possible that some of the dosage forms included below may not apply to the brand name Xigris.

For the Consumer

Applies to drotrecogin alfa: parenteral diluted iv solutions, parenteral powder for injection

Side effects include:

Bleeding (e.g., ecchymoses, GI bleeding, intracranial hemorrhage).

For Healthcare Professionals

Applies to drotrecogin alfa: intravenous powder for injection


The most common side effect associated with drotrecogin alfa (the active ingredient contained in Xigris) has been bleeding.[Ref]


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.[Ref]

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


1. Bernard GR, Vincent JL, Laterre PF, et al. "Efficacy and safety of recombinant human activated protein C for severe sepsis." N Engl J Med 344 (2001): 699-709

2. "Product Information. Xigris (drotrecogin alfa)." Lilly, Eli and Company, Indianapolis, IN.

It is possible that some side effects of Xigris may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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