This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xigris (Drotrecogin Alfa) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (11)
Death (6)
Reports by Reaction Type
Brain Death (2),
Death (2),
Finger Amputation (2),
Brain Oedema (2),
Immune System Disorder (2),
Septic Shock (2),
Disseminated Intravascular Coagulation (1),
Cerebral Haemorrhage (1),
Multi-Organ Failure (1),
Myocardial Infarction (1),
International Normalised Ratio Increased (1),
General Physical Health Deterioration (1)
Possible Xigris side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-08
Patient: female
Reactions: Finger Amputation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xigris
Other drugs received by patient: Penicillin G; Clindamycin
Possible Xigris side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-13
Patient: male
Reactions: Immune System Disorder
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in 47 year old male
Reported by a physician from United States on 2012-01-12
Patient: 47 year old male, weighing 72.6 kg (159.7 pounds)
Reactions: Immunoglobulins Decreased, Eosinophilic Oesophagitis, Bursitis, Immune System Disorder, Autoimmune Neuropathy, Plantar Fasciitis
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in 20 year old female
Reported by a physician from United States on 2011-12-13
Patient: 20 year old female, weighing 78.0 kg (171.6 pounds)
Reactions: Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
Other drugs received by patient: Vancomycin; Levophed; Dopamine HCL; Rocephin
Possible Xigris side effects in male
Reported by a physician from Poland on 2011-12-07
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Brain Death, Death, Brain Oedema, Cerebral Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in male
Reported by a physician from Poland on 2011-12-07
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Brain Death, Haemorrhage Intracranial, Brain Oedema
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-24
Patient: female
Reactions: Finger Amputation
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in 54 year old male
Reported by a physician from India on 2011-11-11
Patient: 54 year old male
Reactions: Multi-Organ Failure, International Normalised Ratio Increased, Sepsis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
Other drugs received by patient: Antibiotics
Possible Xigris side effects in female
Reported by a consumer/non-health professional from United States on 2011-10-28
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Death
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
Possible Xigris side effects in 49 year old male
Reported by a physician from United States on 2011-10-27
Patient: 49 year old male
Reactions: Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xigris
Other drugs received by patient: Proton Pump Inhibitors; Antibiotics FOR Topical USE; Antibiotics
Possible Xigris side effects in 35 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-26
Patient: 35 year old male, weighing 63.5 kg (139.7 pounds)
Reactions: Renal Failure, Respiratory Failure, Disseminated Intravascular Coagulation, Platelet Count Decreased, General Physical Health Deterioration, Septic Shock
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xigris
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