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 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 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 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 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 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 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 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 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 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 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 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 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 Canada on 2012-08-10
Patient: female, weighing 93.0 kg (204.6 pounds)
Reactions: Phlebitis, Pulmonary Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Birth Control Pills
Indication: Contraception
Start date: 2012-06-01
Remicade
Indication: Crohn's Disease
Start date: 2011-12-08
Other drugs received by patient: Topamax; Warfarin Sodium; Cetirizine HCL
Page 1 Next >>
|