Index of reports
> Cases with Sepsis ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Remicade (Infliximab) where reactions include sepsis. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of Next >>
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-27
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Dermatitis Allergic, Movement Disorder, Back Pain, Dyspnoea, Paralysis, Muscular Weakness, Oropharyngeal Pain, Joint Swelling, Arthralgia, Sepsis, Oedema Peripheral, Dizziness, Heart Rate Irregular
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Dipyrone INJ; Multi-Vitamins; Mesalamine
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female, weighing 67.1 kg (147.7 pounds)
Reactions: Pneumonia, Vomiting, Goitre, Body Temperature Increased, Clavicle Fracture, Tuberculosis, Headache, Device Related Infection, Bronchoscopy, Herpes Zoster, Shunt Infection, Malaise, Sepsis, RIB Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2012-04-19
End date: 2012-01-01
Remicade
Start date: 2005-01-01
End date: 2012-03-01
Remicade
Indication: Rheumatoid Arthritis
Start date: 2012-04-19
End date: 2012-01-01
Remicade
Indication: Osteoarthritis
Start date: 2005-01-01
End date: 2012-03-01
Other drugs received by patient: Methotrexate; Benadryl; Zantac; Unspecifed Medications
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 male
Reported by a physician from United Kingdom on 2012-08-21
Patient: male
Reactions: Pelvic Pain, Pyrexia, Anal Fistula, C-Reactive Protein Increased, Splenomegaly, Rectal Abscess, Lethargy, Hepatosplenic T-Cell Lymphoma, Crohn's Disease, Sepsis, Platelet Count Decreased, Diabetic Ketoacidosis, Neutropenia, Rectal Discharge, Leukopenia, Influenza Like Illness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Azathioprine Sodium
Dosage: 2.5 mg/kg
Indication: Crohn's Disease
Azathioprine Sodium
Start date: 2002-01-01
End date: 2006-09-01
Azathioprine Sodium
Start date: 2001-06-01
Mercaptopurine
Indication: Crohn's Disease
Prednisolone
Indication: Product Used FOR Unknown Indication
Remicade
Indication: Crohn's Disease
End date: 2005-09-29
Remicade
Dosage: stopped in february - march (3rd infusion)
End date: 2006-02-01
Other drugs received by patient: Metronidazole; Vitamin B-12
Possible Remicade side effects in male
Reported by a physician from United States on 2012-08-21
Patient: male, weighing 115.7 kg (254.5 pounds)
Reactions: Gastrointestinal Haemorrhage, Cholecystitis Acute, T-Cell Lymphoma, Disseminated Intravascular Coagulation, Pancytopenia, Atrial Fibrillation, Multi-Organ Failure, Sepsis, Acute Respiratory Distress Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Adriamycin PFS
Indication: T-Cell Lymphoma
Start date: 2006-09-10
Cyclophosphamide
Indication: T-Cell Lymphoma
Start date: 2006-01-01
Prednisone TAB
Indication: T-Cell Lymphoma
Start date: 2006-01-01
Remicade
Dosage: 3 dose induction followed by maint. q 8 weeks, 300 mg on 29-jun-2006, total 27 infusions
Indication: Rheumatoid Arthritis
Start date: 2001-10-01
End date: 2006-06-29
Vincristine
Indication: T-Cell Lymphoma
Start date: 2006-09-10
Other drugs received by patient: Azulfadine; Lisinopril
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: female, weighing 57.7 kg (126.9 pounds)
Reactions: Pneumonia, Dysstasia, Pain in Extremity, Sepsis, Bronchitis, Gait Disturbance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 81 year old female
Reported by a physician from Japan on 2012-08-14
Patient: 81 year old female
Reactions: Bronchopulmonary Aspergillosis, Interstitial Lung Disease, Cerebral Infarction, Sepsis, Oral Disorder, Disseminated Intravascular Coagulation, Bone Marrow Failure, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Etanercept
Indication: Product Used FOR Unknown Indication
Levoleucovorin Calcium
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-01
Remicade
Indication: Rheumatoid Arthritis
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2011-10-01
Other drugs received by patient: Cefepime Hydrochloride; ALL Other Therapeutics
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: female, weighing 77.1 kg (169.6 pounds)
Reactions: Cystitis, Arthralgia, Diarrhoea, Sepsis, Transient Ischaemic Attack, Clostridial Infection, Sinusitis, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Dosage: dose was reported as 40 (units unspecified)
Indication: Rheumatoid Arthritis
Start date: 2011-12-01
End date: 2012-04-01
Remicade
Dosage: dose was reported as 20 (units unspecified)
Start date: 2011-06-15
End date: 2011-11-01
Other drugs received by patient: Pradaxa; Xarelto; Atenolol; Acetaminophen
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-13
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Movement Disorder, Dermatitis Allergic, Back Pain, Dyspnoea, Paralysis, Muscular Weakness, Oropharyngeal Pain, Joint Swelling, Arthralgia, Sepsis, Oedema Peripheral, Dizziness, Heart Rate Irregular
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Mesalamine; Multi-Vitamins; Dipyrone INJ
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: female, weighing 61.2 kg (134.7 pounds)
Reactions: Back Pain, Weight Increased, Arachnoiditis, Sepsis, Cystitis, Withdrawal Syndrome, Paraesthesia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Arthritis
Remicade
Indication: Crohn's Disease
Other drugs received by patient: Cymbalta; Lyrica
Possible Remicade side effects in 42 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-03
Patient: 42 year old male
Reactions: Blood Creatine Phosphokinase Increased, Gastrointestinal Haemorrhage, Colitis Ulcerative, Transfusion Reaction, Muscular Weakness, Condition Aggravated, Encephalitis Viral, Myalgia, Sepsis, Nervous System Disorder, Renal Tubular Necrosis, Asthenia, Deep Vein Thrombosis, Renal Failure Acute, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Adalimumab
Dosage: 1 every 2 weeks for 2 doses
Indication: Colitis Ulcerative
Adalimumab
Azathioprine Sodium
Dosage: 50 to 150 mg once daily
Indication: Colitis Ulcerative
Mesalamine
Mesalamine
Administration route: Oral
Indication: Colitis Ulcerative
Mesalamine
Prednisolone
Dosage: 10 to 60 mg once daily
Administration route: Oral
Indication: Colitis Ulcerative
Probiotica
Indication: Colitis Ulcerative
Remicade
Indication: Colitis Ulcerative
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-08-03
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Back Pain, Dermatitis Allergic, Dyspnoea, Paralysis, Oropharyngeal Pain, Arthralgia, Joint Swelling, Oedema Peripheral, Sepsis, Dizziness, Heart Rate Irregular
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Mesalamine; Dipyrone INJ
Possible Remicade side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: male, weighing 119.8 kg (263.5 pounds)
Reactions: Diabetes Mellitus, Abasia, Perineal Cyst, Decreased Immune Responsiveness, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, Intervertebral Disc Protrusion, Fistula, Gout, Convulsion, Cholelithiasis, Diarrhoea, Sepsis, Heart Rate Increased, Arthritis, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Colchicine
Administration route: Oral
Indication: Gout
Start date: 2012-05-01
Levemir
Dosage: 52 units/ at night/subcutaneous
Indication: Diabetes Mellitus
Methotrexate
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-01-01
End date: 2011-01-01
Novolog
Dosage: 40 units/solution before meals
Indication: Diabetes Mellitus
Start date: 2011-01-01
End date: 2011-01-01
Remicade
Indication: Crohn's Disease
Start date: 2004-09-09
End date: 2010-01-01
Remicade
Start date: 2010-01-01
Other drugs received by patient: Flomax; Dilaudid; Ambien; Valium; Hydrochlorothiazide; Cymbalta; Lyrica; Lisinopril; Simvastatin; Nexium; Humalog; Onglyza
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-07-30
Patient: male, weighing 70.0 kg (154.0 pounds)
Reactions: Sepsis, Anastomotic Leak, Colectomy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Azathioprine; Prednisone
Possible Remicade side effects in 81 year old female
Reported by a physician from Japan on 2012-07-20
Patient: 81 year old female
Reactions: Death, Bronchopulmonary Aspergillosis, Interstitial Lung Disease, Cerebral Infarction, Sepsis, Oral Disorder, Disseminated Intravascular Coagulation, Bone Marrow Failure, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Methotrexate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-01
Remicade
Indication: Rheumatoid Arthritis
Possible Remicade side effects in female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-19
Patient: female, weighing 52.2 kg (114.8 pounds)
Reactions: Sepsis, Pyelonephritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Simvastatin; Alprazolam; Morphine; Zofran; Trazodone Hydrochloride; Xanax; Imovane; Multivitamin; Ativan
Possible Remicade side effects in male
Reported by a consumer/non-health professional from Brazil on 2012-07-19
Patient: male, weighing 90.0 kg (198.0 pounds)
Reactions: Dermatitis Allergic, Dyspnoea, Oedema Peripheral, Sepsis, Dizziness, Paralysis, Oropharyngeal Pain
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 70 year old male
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-07-19
Patient: 70 year old male
Reactions: Gastrointestinal Haemorrhage, Pseudomonas Infection, Gastric Ulcer, Gastritis, DRY Gangrene, Sepsis, Bacterial Infection, LEG Amputation, Myocardial Infarction
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Fentanyl-100; Omeprazol Actavis; Prednisolone; Vitamin D; Aspirin; Actrapid; Moviprep; Acetaminophen; Felodipine; Calcium Carbonate; Novolog MIX 70 / 30; Alendronate Sodium; Primperan TAB; Simvastatin; Methotrexate; Lasix; Metoprolol Succinate
Possible Remicade side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-17
Patient: male, weighing 98.0 kg (215.6 pounds)
Reactions: Large Intestine Perforation, Gastroenteritis Norovirus, Incision Site Infection, Sepsis, Intestinal Obstruction, Abscess
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Remicade
Dosage: 14th dose
Start date: 2012-02-20
End date: 2012-02-20
Remicade
Indication: Crohn's Disease
Start date: 2012-07-09
Remicade
Other drugs received by patient: Imuran
Possible Remicade side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-11
Patient: 60 year old female
Reactions: Pneumonia, Sepsis, Gastroenteritis
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in female
Reported by a physician from United States on 2012-07-11
Patient: female
Reactions: Sepsis, Urinary Tract Infection, Escherichia Infection, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Methotrexate
Possible Remicade side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-07-11
Patient: 59 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Pneumonia, Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Methotrexate
Indication: Psoriatic Arthropathy
Start date: 2003-01-01
Remicade
Dosage: second dose
Start date: 2010-07-22
Remicade
Dosage: seventh dose
Indication: Psoriatic Arthropathy
End date: 2011-05-04
Remicade
Dosage: fourth dose
Start date: 2010-10-20
Remicade
Dosage: fifth dose
Start date: 2010-12-21
Remicade
Dosage: first dose
Start date: 2010-07-08
Remicade
Dosage: third dose
Start date: 2010-08-23
Remicade
Dosage: sixth dose
Start date: 2011-02-16
Other drugs received by patient: Arava; Lubor; Sulfasalazine; Prednisone TAB; Pantoprazole; Folic Acid
Possible Remicade side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Croatia (Local Name: Hrvatska) on 2012-07-09
Patient: 59 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Pneumonia, Sepsis
Adverse event resulted in: death
Drug(s) suspected as cause:
Methotrexate
Indication: Psoriatic Arthropathy
Start date: 2003-01-01
Remicade
Dosage: first dose
Start date: 2010-07-08
Remicade
Dosage: fifth dose
Start date: 2010-12-21
Remicade
Dosage: fourth dose
Start date: 2010-10-20
Remicade
Dosage: third dose
Start date: 2010-08-23
Remicade
Dosage: second dose
Start date: 2010-07-22
Remicade
Dosage: seventh dose
Indication: Psoriatic Arthropathy
End date: 2011-05-04
Remicade
Dosage: sixth dose
Start date: 2011-02-16
Other drugs received by patient: Lubor; Folic Acid; Prednisone TAB; Arava; Sulfasalazine; Pantoprazole
Possible Remicade side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-09
Patient: 67 year old male, weighing 85.0 kg (187.0 pounds)
Reactions: Diabetes Mellitus, Bronchopneumonia, Sepsis, Amyloidosis, Renal Failure Chronic
Adverse event resulted in: death
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Methotrexate
Possible Remicade side effects in female
Reported by a consumer/non-health professional from Canada on 2012-07-06
Patient: female, weighing 89.0 kg (195.8 pounds)
Reactions: Intestinal Ischaemia, Sepsis, Cholecystitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-28
Patient: 69 year old female
Reactions: Sepsis, Cardiovascular Disorder, Infection
Drug(s) suspected as cause:
Remicade
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: female
Reactions: Sepsis, Urinary Tract Infection, Memory Impairment
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
End date: 2012-01-01
Remicade
Possible Remicade side effects in 1 year old male
Reported by a physician from Israel on 2012-06-22
Patient: 1 year old male
Reactions: Sepsis, Delayed Fontanelle Closure, Hypertension
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Corticosteroid Unspecified; Acetaminophen; Imuran; Methotrexate
Possible Remicade side effects in female
Reported by a physician from United States on 2012-06-21
Patient: female, weighing 49.0 kg (107.8 pounds)
Reactions: Interstitial Lung Disease, Sepsis, Dizziness, Immunodeficiency, Acute Respiratory Failure, Sinusitis, Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisone TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Remicade
Dosage: also reported as 0, 2, 6 weeks
Indication: Rheumatoid Arthritis
Start date: 2011-11-02
Remicade
Start date: 2012-01-03
End date: 2012-01-03
Remicade
Start date: 2011-11-15
Other drugs received by patient: Celebrex; Alprazolam; Soma; Neurontin; Elavil; Norvasc; Norco; Synthroid; Plaquenil; Dexilant; Tenormin
Possible Remicade side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female, weighing 83.0 kg (182.6 pounds)
Reactions: Back Pain, Weight Decreased, Pneumonia, Psychotic Disorder DUE To A General Medical Condition, Anaemia, Pleurisy, Polyneuropathy, Arthralgia, Adenovirus Infection, Sepsis, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Other drugs received by patient: Simvastatin; Bisoprolol and Hydrochlorothiazide; Leucovorin Calcium; Sulfasalazine; Sulfasalazine; Methotrexate; Zoloft; Prilosec; Levothyroxine Sodium
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