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Remicade (Infliximab) - Sepsis - Suspected Cause - Side Effect Reports

 
 



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, 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 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 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 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 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 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 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 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 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 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 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 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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