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Remicade (Infliximab) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (465)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Remicade (Infliximab) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 465   Next >>

Possible Remicade side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Lung Disorder, Decreased Immune Responsiveness, Infection

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Diovan; Warfarin Sodium; Avonex; Metoprolol Tartrate; Crestor



Possible Remicade side effects in 31 year old female

Reported by a physician from Germany on 2012-08-27

Patient: 31 year old female, weighing 90.0 kg (198.0 pounds)

Reactions: Disseminated Intravascular Coagulation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Vitamin D; Vitamine B12; Iron Therapy; Methylprednisolone



Possible Remicade side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female, weighing 94.8 kg (208.6 pounds)

Reactions: Breast Cancer

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2010-10-14

Remicade
    Indication: Psoriasis
    Start date: 2008-04-01



Possible Remicade side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: 53 year old male

Reactions: Aesthesioneuroblastoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Dosage: 50 mg, weekly
    Indication: Ankylosing Spondylitis
    Start date: 2005-11-01
    End date: 2006-05-01

Humira
    Dosage: 40 mg, every other week
    Indication: Ankylosing Spondylitis
    Start date: 2006-10-01
    End date: 2011-02-18

Remicade
    Dosage: 3 mg/kg, single
    Indication: Ankylosing Spondylitis
    Start date: 2011-03-23
    End date: 2011-04-07



Possible Remicade side effects in male

Reported by a physician from Switzerland on 2012-08-27

Patient: male

Reactions: Thymoma Malignant

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in female

Reported by a physician from Canada on 2012-08-27

Patient: female, weighing 51.0 kg (112.2 pounds)

Reactions: Intracranial Aneurysm

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2010-02-10

Remicade
    Start date: 2012-06-27

Other drugs received by patient: Methotrexate; Folic Acid; Actonel



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27

Patient: female, weighing 52.7 kg (115.9 pounds)

Reactions: Maternal Exposure During Pregnancy, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-04-03
    End date: 2012-04-10

Remicade



Possible Remicade side effects in 61 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 61 year old female

Reactions: Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade



Possible Remicade side effects in male

Reported by a physician from United Kingdom on 2012-08-23

Patient: male, weighing 49.2 kg (108.2 pounds)

Reactions: Dyspnoea, Anaphylactic Reaction, Infusion Related Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2010-10-01

Remicade
    Start date: 2011-06-14

Other drugs received by patient: Azathioprine Sodium; Hydrocortisone



Possible Remicade side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23

Patient: 45 year old male

Reactions: Pancreatic Carcinoma Metastatic

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Azathioprine Sodium
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2008-01-01
    End date: 2012-01-01

Remicade
    Indication: Crohn's Disease
    Start date: 2009-01-01
    End date: 2012-01-01



Possible Remicade side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: 53 year old male

Reactions: Aesthesioneuroblastoma

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enbrel
    Indication: Ankylosing Spondylitis
    Start date: 2005-11-01
    End date: 2006-05-01

Humira
    Dosage: treated for four years
    Indication: Ankylosing Spondylitis
    Start date: 2006-10-01
    End date: 2011-02-01

Remicade
    Indication: Ankylosing Spondylitis
    Start date: 2011-03-23

Remicade
    Start date: 2011-04-07
    End date: 2011-04-07



Possible Remicade side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female

Reactions: Overdose, Hepatic Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication

Remicade
    Start date: 2010-06-07

Remicade
    Indication: Crohn's Disease
    Start date: 2012-04-20

Other drugs received by patient: Antibiotics; Mercaptopurine; Mercaptopurine; Mesalamine; Systemic Corticosteroids; Probiotics



Possible Remicade side effects in male

Reported by a physician from Australia on 2012-08-21

Patient: male, weighing 120.0 kg (264.0 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma, Staphylococcal Sepsis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Azathioprine Sodium
    Dosage: 2-2.5 mg/kg
    Start date: 1993-01-01
    End date: 1994-01-01

Azathioprine Sodium
    Indication: Crohn's Disease
    Start date: 1999-08-01
    End date: 2006-01-01

Prednisolone
    Dosage: varying doses
    Indication: Crohn's Disease
    Start date: 1993-01-01

Remicade
    Dosage: 3 infusions
    Indication: Crohn's Disease
    Start date: 1999-11-01
    End date: 2000-01-01



Possible Remicade side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 44.3 kg (97.5 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2000-12-01

Remicade
    Indication: Crohn's Disease
    Start date: 2002-04-01

Remicade
    Start date: 2005-10-03

Remicade
    Start date: 2003-02-05

Other drugs received by patient: Imuran; Ciprofloxacin HCL; Mercaptopurine; Pentasa



Possible Remicade side effects in male

Reported by a pharmacist from United States on 2012-08-21

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma, Pancytopenia, Pyrexia, Convulsion, Mucosal Inflammation, Tumour Lysis Syndrome, Small Intestinal Ulcer Haemorrhage, Haemorrhagic Diathesis, Neutropenia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Imuran
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 1997-03-25
    End date: 1997-12-01

Imuran
    Administration route: Oral
    Start date: 1999-06-14
    End date: 2002-05-22

Imuran
    Administration route: Oral
    Start date: 1997-12-01
    End date: 1999-06-13

Imuran
    Administration route: Oral
    Start date: 2001-10-25

Remicade
    Start date: 2001-12-10

Remicade
    Start date: 2001-10-24
    End date: 2001-10-24

Remicade
    Start date: 2002-05-22
    End date: 2002-05-22

Remicade
    Start date: 2001-11-08

Remicade
    Indication: Crohn's Disease
    Start date: 2002-02-25
    End date: 2002-02-25

Other drugs received by patient: Prednisone TAB; Prednisone TAB; Probiotica; Mercaptopurine; Multi-Vitamin; Iron; Budesonide; Calcium; Entocort EC; Vitamin E; Entocort EC; Macrobid



Possible Remicade side effects in male

Reported by a pharmacist from United States on 2012-08-21

Patient: male

Reactions: Aqueductal Stenosis, Antiphospholipid Syndrome, Graft Versus Host Disease, Hepatosplenic T-Cell Lymphoma, Nuclear Magnetic Resonance Imaging Brain Abnormal, Pulmonary Embolism, Hydrocephalus, Hypertension

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Imuran
    Indication: Colitis
    Start date: 2002-11-15

Imuran
    Start date: 2001-12-01
    End date: 2002-11-14

Lovenox
    Indication: Product Used FOR Unknown Indication

Remicade
    Dosage: single infusion
    Indication: Colitis Ulcerative
    Start date: 2001-12-22
    End date: 2001-12-22

Other drugs received by patient: Asacol; Heparin; Heparin; Steroids



Possible Remicade side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 69.0 kg (151.8 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Humira
    Indication: Colitis Ulcerative
    Start date: 2007-06-15

Humira
    Start date: 2007-06-15

Humira
    Start date: 2006-11-01

Humira
    Indication: Irritable Bowel Syndrome
    Start date: 2006-11-01

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Purinethol
    Dosage: also reported with start date of 01-oct-1999
    Start date: 1999-06-02

Purinethol
    Indication: Inflammatory Bowel Disease
    End date: 2007-04-01

Purinethol
    Indication: Colitis Ulcerative
    End date: 2007-04-01

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Inflammatory Bowel Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Colitis Ulcerative
    Start date: 2002-07-10
    End date: 2006-03-07

Remicade
    Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
    Indication: Crohn's Disease
    Start date: 2002-07-10
    End date: 2006-03-07

Other drugs received by patient: Prednisone TAB; Asacol; Prednisone TAB; Asacol



Possible Remicade side effects in 33 year old male

Reported by a physician from Greece on 2012-08-21

Patient: 33 year old male, weighing 80.0 kg (176.0 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Azathioprine Sodium
    Dosage: dosage also reported as ^intermittently for 3 to 4 years^
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2001-01-01
    End date: 2008-10-01

Remicade
    Dosage: 5th infusion
    End date: 2008-10-01

Remicade
    Dosage: week 2- 2nd infusion
    Indication: Crohn's Disease

Remicade
    Dosage: week 6- 3rd infusion

Remicade
    Dosage: 4th infusion

Remicade
    Dosage: week 0-1st infusion
    Start date: 2008-05-01

Other drugs received by patient: Mesalamine; Corticoids



Possible Remicade side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Drug Ineffective, Hepatosplenic T-Cell Lymphoma, Anaemia, Sepsis, Thrombocytopenia, Leukopenia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Azathioprine Sodium
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 1996-01-01
    End date: 2004-05-01

Azathioprine Sodium
    Dosage: variable and lower doses
    Administration route: Oral
    Start date: 2004-01-01
    End date: 2007-04-01

Humira
    Indication: Crohn's Disease
    Start date: 2007-01-01
    End date: 2007-11-01

Humira
    Start date: 2005-05-04
    End date: 2005-11-10

Remicade
    Indication: Crohn's Disease
    Start date: 2004-04-15
    End date: 2004-06-10



Possible Remicade side effects in female

Reported by a physician from Japan on 2012-08-20

Patient: female, weighing 47.7 kg (104.9 pounds)

Reactions: Cardio-Respiratory Arrest, Metabolic Acidosis, Hepatic Function Abnormal, Arthralgia, Disseminated Intravascular Coagulation, Platelet Count Decreased, Pyrexia, Device Related Infection, Septic Shock

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisolone
    Administration route: Oral
    Indication: Rheumatoid Arthritis

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-06

Remicade
    Start date: 2010-09-03

Remicade
    Dosage: 20th dose
    Start date: 2012-06-01

Remicade
    Start date: 2009-08-21

Other drugs received by patient: Folic Acid; Edirol; Lansoprazole; Cefazolin Sodium; Warfarin Sodium



Possible Remicade side effects in male

Reported by a physician from Germany on 2012-08-17

Patient: male

Reactions: Pancreatic Carcinoma Metastatic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Azathioprine



Possible Remicade side effects in male

Reported by a physician from Japan on 2012-08-17

Patient: male, weighing 51.0 kg (112.2 pounds)

Reactions: Decubitus Ulcer, Lymphoma, Herpes Zoster

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2007-10-01

Remicade
    Start date: 2007-08-20

Remicade
    Start date: 2007-11-26

Remicade
    Indication: Behcet's Syndrome

Remicade
    Start date: 2007-09-05

Remicade
    Start date: 2008-01-24

Other drugs received by patient: Prednisolone; Vitamin B12; Prednisolone; Rabeprazole Sodium; Alfarol; Neoral; Maglax; Vitamin B12; Sandimmune; Aspirin; Maglax; Colchicine



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17

Patient: female, weighing 84.0 kg (184.8 pounds)

Reactions: Blood Pressure Increased, Dyspnoea, Vomiting, Paraesthesia Oral, Adverse Drug Reaction, Pallor, Flushing, Palpitations, Heart Rate Increased, Infusion Related Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade
    Start date: 2011-01-01

Remicade
    Indication: Crohn's Disease
    Start date: 2012-07-13

Remicade
    Dosage: 3rd dose
    Start date: 2012-08-08

Other drugs received by patient: Benadryl; Tylenol; Imuran; Solu-Cortef; Synthroid; Atenolol



Possible Remicade side effects in male

Reported by a physician from Czech Republic on 2012-08-16

Patient: male, weighing 84.0 kg (184.8 pounds)

Reactions: Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Indication: Product Used FOR Unknown Indication

Remicade
    Dosage: 13th infliximab infusion
    Start date: 2012-05-30

Other drugs received by patient: Methotrexate; Aulin; Acidum Folicum; Medrol; Arava; Atoris; ALL Other Therapeutics; Aspirin; Metoprolol Tartrate; Nolpaza; Corticosteroids; Prenessa



Possible Remicade side effects in male

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-14

Patient: male, weighing 98.0 kg (215.6 pounds)

Reactions: Cholelithiasis, Cholecystitis, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Calcium; Tylenol; Escitalopram; Ursodiol; Codeine Sulfate; Prednisone TAB; Vitamin D; Pantoprazole Sodium; Actonel; Trazodone Hydrochloride; Hydroxyzine; Asacol



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: female, weighing 58.1 kg (127.7 pounds)

Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia, Premature Delivery

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Zyrtec; Tylenol; Trandate



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13

Patient: female, weighing 74.9 kg (164.8 pounds)

Reactions: Flushing, Blood Pressure Increased, Dyspnoea, Nausea, Erythema, Muscle Spasms, Infusion Related Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade
    Indication: Crohn's Disease
    Start date: 2012-06-15

Remicade
    Dosage: 3rd infusion
    Start date: 2012-08-02

Other drugs received by patient: Tylenol; Solu-Cortef; Asacol; Benadryl; Prednisone TAB



Possible Remicade side effects in 55 year old female

Reported by a physician from France on 2012-08-13

Patient: 55 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Drug Ineffective, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade
    Start date: 2010-12-01
    End date: 2012-02-10

Remicade
    Indication: Rheumatoid Arthritis
    Start date: 2005-09-01
    End date: 2009-10-01

Other drugs received by patient: Levothyroxine Sodium



Possible Remicade side effects in male

Reported by a physician from Denmark on 2012-08-13

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Death, Carcinoid Tumour Pulmonary, Metastases To Lymph Nodes

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Remicade

Other drugs received by patient: Methotrexate



Possible Remicade side effects in female

Reported by a health professional (non-physician/pharmacist) from Romania on 2012-08-10

Patient: female

Reactions: Dyspnoea, Chest Discomfort, Nausea, Chills, Erythema, Tremor, Malaise, Infusion Related Reaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Remicade
    Start date: 2010-06-09
    End date: 2012-07-25

Remicade
    Indication: Ankylosing Spondylitis
    Start date: 2012-07-25
    End date: 2012-07-25



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