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Xigris Side Effects

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Common Xigris Side Effects


The most commonly reported Xigris side effects (click to view or check a box to report):

Death (180)
Thrombocytopenia (162)
Platelet Count Decreased (135)
Multi-organ Failure (132)
Haemorrhage (100)
Sepsis (100)
International Normalised Ratio Increased (92)
Activated Partial Thromboplastin Time Prolonged (87)
Cerebral Haemorrhage (70)
Cardiac Arrest (70)
Septic Shock (67)
Haemorrhage Intracranial (58)
Hypotension (48)
Gastrointestinal Haemorrhage (48)
Haemoglobin Decreased (41)
Disseminated Intravascular Coagulation (41)
Respiratory Failure (38)
Renal Failure (37)
Prothrombin Time Prolonged (28)
Haematocrit Decreased (27)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Xigris Side Effects Reported to FDA



Xigris Side Effect Report#8041912-X
Eosinophilic Oesophagitis, Immune System Disorder, Autoimmune Neuropathy, Plantar Fasciitis, Immunoglobulins Decreased, Bursitis
This is a report of a 47-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: sepsis, who was treated with Xigris (dosage: NA, start time:
Sep 08, 2009), combined with: NA. and developed a serious reaction and side effect(s): Eosinophilic Oesophagitis, Immune System Disorder, Autoimmune Neuropathy, Plantar Fasciitis, Immunoglobulins Decreased, Bursitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in male patients, resulting in Eosinophilic Oesophagitis side effect.
Xigris Side Effect Report#7973681-3
Septic Shock
This report suggests a potential Xigris Septic Shock side effect(s) that can have serious consequences. A 20-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: septic shock and used Xigris (dosage: 24 Mcg/kg/hr For 4 Hours) starting
Aug 10, 2011. After starting Xigris the patient began experiencing various side effects, including: Septic ShockAdditional drugs used concurrently:
  • Vancomycin
  • Levophed
  • Dopamine Hcl
  • Rocephin
The patient was hospitalized. Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Septic Shock, may still occur.
Xigris Side Effect Report#7961936-8
Cerebral Haemorrhage, Brain Oedema
This Death problem was reported by a physician from Poland. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: septic shock. On
Mar 15, 2011 this consumer started treatment with Xigris (dosage: NA). The following drugs were being taken at the same time: NA. When using Xigris, the patient experienced the following unwanted symptoms/side effects: Cerebral Haemorrhage, Brain OedemaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7961935-6
Brain Oedema, Haemorrhage Intracranial
This Brain Oedema side effect was reported by a physician from Poland. A male patient (weight:NA) experienced the following symptoms/conditions: septic shock.The patient was prescribed Xigris (drug dosage: NA), which was initiated on
Mar 15, 2011. Concurrently used drugs: NA..After starting to take Xigris the consumer reported adverse symptoms, such as: Brain Oedema, Haemorrhage IntracranialThese side effects may potentially be related to Xigris. The patient was hospitalized.
Xigris Side Effect Report#7910638-2
Multi-organ Failure, Sepsis, International Normalised Ratio Increased
This is a report of a 54-year-old male patient (weight: NA) from India, suffering from the following health symptoms/conditions: sepsis, who was treated with Xigris (dosage: NA, start time:
Oct 21, 2011), combined with:
  • Antibiotics
and developed a serious reaction and side effect(s): Multi-organ Failure, Sepsis, International Normalised Ratio Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in male patients, resulting in Multi-organ Failure side effect. The patient was hospitalized.
Xigris Side Effect Report#7864736-2
This report suggests a potential Xigris Death side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: sepsis and used Xigris (dosage: 15 Mg, Unk) starting
Oct 21, 2011. After starting Xigris the patient began experiencing various side effects, including:Additional drugs used concurrently: NA.The patient was hospitalized. Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Xigris Side Effect Report#7850446-4
Septic Shock, Respiratory Failure, Platelet Count Decreased, Disseminated Intravascular Coagulation, Renal Failure
This Septic Shock problem was reported by a health professional from United States. A 35-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Apr 03, 2011 this consumer started treatment with Xigris (dosage: NA). The following drugs were being taken at the same time: NA. When using Xigris, the patient experienced the following unwanted symptoms/side effects: Septic Shock, Respiratory Failure, Platelet Count Decreased, Disseminated Intravascular Coagulation, Renal FailureThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Septic Shock, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7787338-5
This Death side effect was reported by a consumer or non-health professional from United States. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xigris (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Xigris the consumer reported adverse symptoms, such as: These side effects may potentially be related to Xigris.
Xigris Side Effect Report#7691088-3
Multi-organ Failure
This is a report of a 33-year-old male patient (weight: NA) from Brazil, suffering from the following health symptoms/conditions: sepsis, who was treated with Xigris (dosage: 24 A?g/kg, Every Hour, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in male patients, resulting in Multi-organ Failure side effect.
Xigris Side Effect Report#7675302-6
Subarachnoid Haemorrhage, Uterine Perforation
This report suggests a potential Xigris Subarachnoid Haemorrhage side effect(s) that can have serious consequences. A female patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: sepsis and used Xigris (dosage: NA) starting NS. After starting Xigris the patient began experiencing various side effects, including: Subarachnoid Haemorrhage, Uterine PerforationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Subarachnoid Haemorrhage, may still occur.
Xigris Side Effect Report#7671340-8
Myocardial Infarction
This Myocardial Infarction problem was reported by a physician from United States. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Jul 22, 2011 this consumer started treatment with Xigris (dosage: 24 Mg/kg, Every Hour). The following drugs were being taken at the same time: NA. When using Xigris, the patient experienced the following unwanted symptoms/side effects: Myocardial InfarctionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myocardial Infarction, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7630576-2
Multi-organ Failure, Shock Haemorrhagic, Intra-abdominal Haemorrhage
This Multi-organ Failure side effect was reported by a consumer or non-health professional from Brazil. A male patient (weight:NA) experienced the following symptoms/conditions: septic shock.The patient was prescribed Xigris (drug dosage: 21 Ml, Other (hour)), which was initiated on
Jul 03, 2011. Concurrently used drugs: NA..After starting to take Xigris the consumer reported adverse symptoms, such as: Multi-organ Failure, Shock Haemorrhagic, Intra-abdominal HaemorrhageThese side effects may potentially be related to Xigris. The patient was hospitalized.
Xigris Side Effect Report#7558320-8
Chest Tube Insertion
This is a report of a 51-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Xigris (dosage: NA, start time:
Jun 07, 2011), combined with: NA. and developed a serious reaction and side effect(s): Chest Tube Insertion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in female patients, resulting in Chest Tube Insertion side effect.
Xigris Side Effect Report#7470879-8
Brain Oedema, Haemorrhage Intracranial
This report suggests a potential Xigris Brain Oedema side effect(s) that can have serious consequences. A male patient (weight: NA) from Poland was diagnosed with the following symptoms/conditions: septic shock and used Xigris (dosage: NA) starting
Mar 15, 2011. After starting Xigris the patient began experiencing various side effects, including: Brain Oedema, Haemorrhage IntracranialAdditional drugs used concurrently: NA.The patient was hospitalized. Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Brain Oedema, may still occur.
Xigris Side Effect Report#7416280-4
Incorrect Dose Administered, Gastrointestinal Haemorrhage
This Incorrect Dose Administered problem was reported by a consumer or non-health professional from India. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: septic shock. On
Mar 15, 2011 this consumer started treatment with Xigris (dosage: NA). The following drugs were being taken at the same time:
  • Antibiotics
When using Xigris, the patient experienced the following unwanted symptoms/side effects: Incorrect Dose Administered, Gastrointestinal HaemorrhageThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Incorrect Dose Administered, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7412511-5
Multi-organ Failure, Sepsis, Platelet Count Decreased
This Multi-organ Failure side effect was reported by a consumer or non-health professional from India. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Xigris (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Xigris the consumer reported adverse symptoms, such as: Multi-organ Failure, Sepsis, Platelet Count DecreasedThese side effects may potentially be related to Xigris. The patient was hospitalized.
Xigris Side Effect Report#7409835-4
Cerebral Haemorrhage, Brain Oedema
This is a report of a male patient (weight: NA) from Poland, suffering from the following health symptoms/conditions: septic shock, who was treated with Xigris (dosage: NA, start time:
Mar 15, 2011), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Haemorrhage, Brain Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in male patients, resulting in Brain Death side effect.
Xigris Side Effect Report#7406543-0
Rectal Haemorrhage
This report suggests a potential Xigris Death side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: NA and used Xigris (dosage: NA) starting NS. After starting Xigris the patient began experiencing various side effects, including: Rectal HaemorrhageAdditional drugs used concurrently: NA. Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Xigris Side Effect Report#7340969-9
Platelet Count Decreased, Mouth Haemorrhage, Multi-organ Failure, Septic Shock, Hypotension
This Platelet Count Decreased problem was reported by a consumer or non-health professional from India. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: septic shock. On
Feb 22, 2011 this consumer started treatment with Xigris (dosage: NA). The following drugs were being taken at the same time:
  • Antibiotics
When using Xigris, the patient experienced the following unwanted symptoms/side effects: Platelet Count Decreased, Mouth Haemorrhage, Multi-organ Failure, Septic Shock, HypotensionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Platelet Count Decreased, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7326427-6
Multi-organ Failure
This Multi-organ Failure side effect was reported by a physician from Austria. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: septic shock.The patient was prescribed Xigris (drug dosage: 24mc/kg/h, Unk), which was initiated on
Feb 08, 2011. Concurrently used drugs:
  • Hydrocortison (10mg/h)
  • Anaerobex (500 Mg, 3/d)
  • Cilastatin W/imipenem (1 G, 3/d)
  • Pitressin (0.03units/kg/min)
  • Zyvox (600 Mg, 2/d)
  • Arterenol
.After starting to take Xigris the consumer reported adverse symptoms, such as: Multi-organ FailureThese side effects may potentially be related to Xigris.
Xigris Side Effect Report#7309167-9
Septic Shock
This is a report of a 56-year-old female patient (weight: NA) from Austria, suffering from the following health symptoms/conditions: NA, who was treated with Xigris (dosage: 24mc/kg/h, Unk, start time:
Feb 10, 2011), combined with: NA. and developed a serious reaction and side effect(s): Septic Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in female patients, resulting in Septic Shock side effect.
Xigris Side Effect Report#7291175-8
Septic Shock
This report suggests a potential Xigris Septic Shock side effect(s) that can have serious consequences. A 19-year-old male patient (weight: NA) from Russian Federation was diagnosed with the following symptoms/conditions: NA and used Xigris (dosage: NA) starting NS. After starting Xigris the patient began experiencing various side effects, including: Septic ShockAdditional drugs used concurrently:
  • Cancidas
  • Primaxin
  • Zyvox
Although Xigris demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Septic Shock, may still occur.
Xigris Side Effect Report#7289309-4
Nosocomial Infection
This Nosocomial Infection problem was reported by a consumer or non-health professional from Argentina. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Jan 05, 2011 this consumer started treatment with Xigris (dosage: Unk, Daily (1/d)). The following drugs were being taken at the same time: NA. When using Xigris, the patient experienced the following unwanted symptoms/side effects: Nosocomial InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nosocomial Infection, may become evident only after a product is in use by the general population.
Xigris Side Effect Report#7289306-9
Tachycardia, Urinary Tract Infection, Multi-organ Failure, Sepsis
This Tachycardia side effect was reported by a consumer or non-health professional from India. A 72-year-old female patient (weight:NA) experienced the following symptoms/conditions: sepsis.The patient was prescribed Xigris (drug dosage: NA), which was initiated on
Jan 26, 2011. Concurrently used drugs: NA..After starting to take Xigris the consumer reported adverse symptoms, such as: Tachycardia, Urinary Tract Infection, Multi-organ Failure, SepsisThese side effects may potentially be related to Xigris. The patient was hospitalized.
Xigris Side Effect Report#7281417-7
Sepsis, Tachycardia, Urinary Tract Infection, Multi-organ Failure
This is a report of a 72-year-old female patient (weight: NA) from India, suffering from the following health symptoms/conditions: sepsis, who was treated with Xigris (dosage: NA, start time:
Jan 26, 2011), combined with: NA. and developed a serious reaction and side effect(s): Sepsis, Tachycardia, Urinary Tract Infection, Multi-organ Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Xigris treatment in female patients, resulting in Sepsis side effect. The patient was hospitalized.


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The appearance of Xigris on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Xigris reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Xigris Safety Alerts, Active Ingredients, Usage Information

    More About Xigris

    Side Effects reported to FDA: 1238

    Xigris safety alerts: 2011 2009 2005

    Reported deaths: 900

    Reported hospitalizations: 380

    Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit

    [Posted 10/25/2011]

    AUDIENCE: Critical Care Medicine

    ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.

    BACKGROUND: Xigris is indicated for the reduction of mortality in adult patients with severe sepsis who have a high risk of death.

    RECOMMENDATION: Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris. All remaining Xigris product should be returned to the supplier from whom it was purchased.

    [10/25/2011 - Drug Safety Communication - FDA]

     

    Previous MedWatch Alert:

    [02/04/2009] Xigris - Early Communication about an Ongoing Safety Review
     

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