Infliximab, Recombinant combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Breast Cancer Other Serious 11/21/2005 Female 3/15/2006 Physician Netherlands
Primary
Concomitant
Breast Cancer Life Threatening Female 176 lb 3/21/2006 Physician Netherlands
Primary
Concomitant
Pulmonary Embolism Hospitalization 9/5/2006 Male 229 lb 9/18/2006 Physician Netherlands
Primary
Secondary
Concomitant
Renal Cell Carcinoma Stage Unspecified Life Threatening Male 9/26/2006 Physician Netherlands
Primary
Concomitant
Respiratory Failure Life Threatening 10/13/2006 Male 185 lb 11/6/2006 Physician Netherlands
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 9/5/2006 Male 229 lb 12/7/2006 Physician Netherlands
Primary
Secondary
Concomitant
Transitional Cell Carcinoma Life Threatening 5/8/2006 Male 154 lb 12/27/2006 Physician Netherlands
Primary
Concomitant
Respiratory Failure Life Threatening 10/13/2006 Male 185 lb 12/29/2006 Physician Netherlands
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 5/5/2007 Male 168 lb 5/22/2007 Physician Netherlands
Primary
Concomitant
Pneumonia Hospitalization 8/26/2003 Female 6/11/2007 Physician United States
Primary
Concomitant
Breast Cancer Other Serious 11/21/2005 Female 154 lb 7/2/2007 Physician Netherlands
Primary
Concomitant
Infusion Site Reaction Other Serious 3/1/2007 Female 187 lb 7/5/2007 Consumer United States
Primary
Concomitant
Chronic Tonsillitis Hospitalization 5/8/2007 48 Female 132 lb 7/23/2007 Other Health Professional Korea, Republic Of
Primary
Concomitant
Chronic Tonsillitis Hospitalization 5/8/2007 48 Female 132 lb 7/30/2007 Other Health Professional Korea, Republic Of
Primary
Concomitant
Chronic Tonsillitis Hospitalization 5/8/2007 48 Female 132 lb 2/28/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Fungal Infection Hospitalization 1/8/2008 44 Male 117 lb 4/3/2008 Physician Korea, Republic Of
Primary
Secondary
Gastric Ulcer Hospitalization 12/20/2007 65 Female 99 lb 4/4/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Diarrhoea Hospitalization 5/5/2007 Male 168 lb 4/14/2008 Physician Netherlands
Primary
Concomitant
Pneumonia Cryptococcal Hospitalization 1/28/2007 Female 110 lb 4/17/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pancreatic Carcinoma Death 2/1/2008 Female 176 lb 4/17/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 9/5/2006 Male 229 lb 4/25/2008 Physician Netherlands
Primary
Secondary
Concomitant
Peripheral Vascular Disorder Hospitalization 4/25/2008 Physician Netherlands
Primary
Secondary
Pneumonia Cryptococcal Hospitalization 1/28/2007 Female 110 lb 5/1/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Prostate Cancer Other Serious Male 184 lb 5/20/2008 Physician Netherlands
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 1/8/2008 44 Male 117 lb 5/23/2008 Physician Korea, Republic Of
Primary
Secondary
Pneumonia Cryptococcal Hospitalization 1/28/2007 Female 110 lb 7/2/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Fungal Infection Hospitalization 1/8/2008 44 Male 117 lb 7/2/2008 Physician Korea, Republic Of
Primary
Secondary
Chronic Tonsillitis Hospitalization 5/8/2007 48 Female 132 lb 7/2/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Gastric Ulcer Hospitalization 12/20/2007 65 Female 99 lb 7/2/2008 Other Health Professional Korea, Republic Of
Primary
Concomitant
Tuberculosis Other Serious 11/21/2001 Female 7/29/2008 Physician Spain
Primary
Secondary
Concomitant
Tuberculosis Other Serious 11/21/2001 Female 7/30/2008 Physician Spain
Primary
Secondary
Concomitant
Intestinal Stenosis Other Serious 1/22/2008 Male 106 lb 8/1/2008 Other Health Professional Germany
Primary
Concomitant
Throat Cancer Hospitalization 8/1/2008 Male 119 lb 8/28/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/13/2008 59 Male 58 lb 9/12/2008 Other Health Professional Turkey
Primary
Concomitant
Tumour Lysis Syndrome Hospitalization 1/1/2008 Female 126 lb 12/2/2008 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Pneumothorax Life Threatening 11/1/2008 Male 12/10/2008 Physician Netherlands
Primary
Secondary
Concomitant
Septic Arthritis Staphylococcal Hospitalization 5/5/2007 Male 168 lb 12/15/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pancreatic Carcinoma Death 2/1/2008 Female 176 lb 12/24/2008 Physician Netherlands
Primary
Secondary
Concomitant
Pancreatic Carcinoma Death 2/1/2008 Female 176 lb 1/16/2009 Physician Netherlands
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 9/22/2003 Male 161 lb 2/20/2009 Physician Netherlands
Primary
Concomitant
Pyrexia Hospitalization 7/16/2008 59 Male 128 lb 2/23/2009 Other Health Professional Turkey
Primary
Concomitant
Basal Cell Carcinoma Other Serious 2/28/2008 Male 161 lb 2/26/2009 Physician Netherlands
Primary
Concomitant
Chronic Myelomonocytic Leukaemia Other Serious 11/10/2008 Male 203 lb 3/6/2009 Physician Netherlands
Primary
Secondary
Concomitant
Lung Adenocarcinoma Stage Iii Death 5/1/2008 Female 143 lb 3/9/2009 Physician Netherlands
Primary
Secondary
Concomitant
Pneumothorax Life Threatening Male 182 lb 3/10/2009 Physician Netherlands
Primary
Secondary
Concomitant
Lung Adenocarcinoma Stage Iii Death 5/1/2008 Female 143 lb 3/26/2009 Physician Netherlands
Primary
Secondary
Concomitant
Chronic Myelomonocytic Leukaemia Other Serious 11/10/2008 Male 203 lb 3/26/2009 Physician Netherlands
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/22/2008 41 Female 194 lb 5/29/2009 Other Health Professional United Kingdom
Primary
Concomitant
Bursitis Hospitalization 2/3/2009 Female 7/27/2009 Physician Netherlands
Primary
Concomitant
Respiratory Tract Infection Hospitalization 37 Female 10/6/2009 Other Health Professional United Kingdom
Primary
Concomitant
Gastrointestinal Neoplasm Hospitalization Female 10/9/2009 Physician Netherlands
Primary
Secondary
Pneumocystis Jiroveci Pneumonia Life Threatening 10/14/2009 Female 161 lb 11/6/2009 Physician Netherlands
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 10/14/2009 Female 161 lb 11/17/2009 Physician Netherlands
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 9/28/2009 Female 198 lb 11/25/2009 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 8/1/2009 Male 119 lb 12/4/2009 Physician Netherlands
Primary
Secondary
Concomitant
Off Label Use Hospitalization 1/1/2008 44 Male 117 lb 12/29/2009 Physician Korea, Republic Of
Primary
Secondary
Sepsis Hospitalization 8/1/2009 Male 119 lb 1/4/2010 Physician Netherlands
Primary
Secondary
Concomitant
Chronic Myelomonocytic Leukaemia Other Serious 11/10/2008 Male 203 lb 3/12/2010 Physician Netherlands
Primary
Secondary
Concomitant
Colon Cancer Hospitalization Female 3/12/2010 Physician Netherlands
Primary
Secondary
Concomitant
Colon Cancer Hospitalization Female 3/19/2010 Physician Netherlands
Primary
Secondary
Concomitant
Myocardial Ischaemia Other Serious Male 7/12/2010 Physician Italy
Primary
Concomitant
Respiratory Failure Life Threatening 10/13/2006 43 Male 185 lb 7/14/2010 Physician Netherlands
Primary
Secondary
Concomitant
Tenosynovitis Other Serious 72 Female 7/19/2010 Physician United States
Primary
Concomitant
Loss Of Consciousness Life Threatening 6/29/2010 47 Male 192 lb 7/20/2010 Other Health Professional United Kingdom
Primary
Concomitant
Basal Cell Carcinoma Life Threatening 12/7/2009 69 Female 154 lb 7/21/2010 Physician Netherlands
Primary
Concomitant
Perirectal Abscess Hospitalization 7/7/2010 17 Male 132 lb 7/26/2010 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 5/1/2008 71 Male 7/30/2010 Other Health Professional Japan
Primary
Concomitant
Epistaxis Hospitalization 12/15/2009 75 Female 216 lb 7/30/2010 Other Health Professional United Kingdom
Primary
Concomitant
Retinal Oedema Other Serious 12 Female 7/30/2010 Physician United States
Primary
Concomitant
Breast Cancer Other Serious 7/1/2010 60 Female 8/2/2010 Other Health Professional United Kingdom
Primary
Concomitant
Myopathy Other Serious 3/11/2010 46 Male 8/3/2010 Physician United Kingdom
Primary
Concomitant
Sacroiliitis Other Serious 8/26/2009 46 Male 179 lb 8/6/2010 Other Health Professional United Kingdom
Primary
Concomitant
Rectal Haemorrhage Other Serious 10/1/2009 73 Male 134 lb 8/6/2010 Physician United Kingdom
Primary
Concomitant
Cholecystitis Other Serious 6/15/2009 71 Female 157 lb 8/6/2010 Physician United Kingdom
Primary
Concomitant
Ovarian Cancer Other Serious 5/1/2010 78 Female 141 lb 8/6/2010 Other Health Professional United States
Primary
Concomitant
Listeria Sepsis Hospitalization 73 Female 8/9/2010 Physician United Kingdom
Primary
Concomitant
Renal Impairment Other Serious 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Cell Marker Increased Other Serious 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Skin Ulcer Hospitalization 1/30/2009 67 Male 179 lb 8/9/2010 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Failure Hospitalization 4/1/2010 79 Female 154 lb 8/9/2010 Other Health Professional United Kingdom
Primary
Secondary
Squamous Cell Carcinoma Other Serious 55 Female 8/10/2010 Other Health Professional Ireland
Primary
Secondary
Concomitant
Colectomy Hospitalization 8/4/2010 13 Male 65 lb 8/13/2010 Physician Netherlands
Primary
Secondary
Infusion Related Reaction Other Serious 53 Female 8/16/2010 Other Health Professional Brazil
Primary
Concomitant
Listeriosis Life Threatening 62 Female 8/16/2010 Physician United States
Primary
Concomitant
Ovarian Cancer Hospitalization 1/1/2007 53 Female 8/16/2010 Consumer United Kingdom
Primary
Concomitant
Basal Cell Carcinoma Life Threatening 9/22/2009 68 Female 154 lb 8/16/2010 Physician Netherlands
Primary
Concomitant
Crohn's Disease Hospitalization 2/16/2010 7 Female 66 lb 8/20/2010 Other Health Professional United States
Primary
Concomitant
Actinic Keratosis Other Serious 2/15/2010 81 Female 8/20/2010 Other Health Professional United Kingdom
Primary
Concomitant
Urticaria Other Serious 2/1/2010 27 Female 8/23/2010 Other Health Professional France
Primary
Concomitant
Colectomy Hospitalization 8/4/2010 13 Male 65 lb 8/23/2010 Physician Netherlands
Primary
Secondary
B-cell Lymphoma Other Serious 7/20/2010 76 Female 8/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Paraesthesia Hospitalization 6/24/2010 43 Female 205 lb 8/26/2010 Other Health Professional United Kingdom
Primary
Concomitant
Thymic Cancer Metastatic Hospitalization 4/2/2010 60 Female 143 lb 8/27/2010 Other Health Professional United Kingdom
Primary
Concomitant
Colitis Hospitalization 8/3/2010 13 Male 65 lb 8/31/2010 Physician Netherlands
Primary
Secondary
Vith Nerve Paralysis Other Serious 4/15/2010 72 Female 9/3/2010 Other Health Professional United Kingdom
Primary
Concomitant
Lepromatous Leprosy Other Serious 44 Male 9/13/2010 Physician Brazil
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 8/30/2010 73 Male 228 lb 9/13/2010 Physician United States
Primary
Concomitant
Sarcoidosis Other Serious 49 Female 9/20/2010 Physician United States
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 9/21/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Left Ventricular Failure Life Threatening 64 Female 108 lb 9/23/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pulmonary Fibrosis Death 2/11/2010 60 Female 139 lb 9/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Rash Generalised Hospitalization 2/10/2010 43 Female 9/24/2010 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Failure Life Threatening 11/16/2009 80 Female 99 lb 10/1/2010 Other Health Professional United Kingdom
Primary
Concomitant
Therapeutic Response Unexpected Other Serious 1/1/2008 59 Female 10/4/2010 Physician Japan
Primary
Concomitant
Loss Of Consciousness Life Threatening 3/4/2009 60 Male 185 lb 10/4/2010 Other Health Professional United Kingdom
Primary
Concomitant
Loss Of Consciousness Life Threatening 3/4/2009 60 Male 185 lb 10/6/2010 Other Health Professional United Kingdom
Primary
Concomitant
Basal Cell Carcinoma Life Threatening 9/22/2009 68 Female 154 lb 10/7/2010 Physician Netherlands
Primary
Concomitant
Leukopenia Other Serious 1/1/2009 62 Female 10/8/2010 Physician United States
Primary
Secondary
Concomitant
Proctalgia Hospitalization 9/21/2010 16 Male 100 lb 10/8/2010 Physician United States
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 10/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Therapeutic Response Unexpected Other Serious 1/1/2008 59 Female 10/11/2010 Physician Japan
Primary
Secondary
Drug Ineffective For Unapproved Indication Other Serious 14 Male 10/19/2010 Physician United States
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 10/19/2010 Other Health Professional France
Primary
Concomitant
Respiratory Distress Other Serious 10/19/2010 Other Health Professional France
Primary
Concomitant
Cryptococcosis Other Serious 10/19/2010 Other Health Professional France
Primary
Concomitant
Leukoencephalopathy Other Serious 10/19/2010 Other Health Professional France
Primary
Concomitant
Herpes Zoster Other Serious 10/19/2010 Other Health Professional France
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 10/20/2010 Other Health Professional France
Primary
Concomitant
Pelvic Abscess Hospitalization 9/21/2010 16 Male 100 lb 10/22/2010 Physician United States
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 10/11/2010 73 Male 228 lb 10/26/2010 Physician United States
Primary
Concomitant
Ventricular Extrasystoles Hospitalization 7/6/2010 70 Male 194 lb 10/29/2010 Other Health Professional United Kingdom
Primary
Concomitant
Crohn's Disease Hospitalization 8/17/2010 11 Female 70 lb 10/29/2010 Physician United States
Primary
Concomitant
Retinal Vein Occlusion Other Serious 46 Male 11/1/2010 Physician Greece
Primary
Concomitant
Pneumonia Aspiration Hospitalization Female 194 lb 11/1/2010 Other Health Professional United Kingdom
Primary
Concomitant
Carcinoma In Situ Of Skin Other Serious 9/8/2008 67 Female 170 lb 11/4/2010 Other Health Professional United Kingdom
Primary
Concomitant
Skin Cancer Other Serious 3/22/2008 82 Female 126 lb 11/5/2010 Other Health Professional United Kingdom
Primary
Concomitant
Bladder Cancer Other Serious 9/22/2008 70 Female 128 lb 11/5/2010 Other Health Professional United Kingdom
Primary
Concomitant
Ovarian Cancer Hospitalization 1/1/2007 53 Female 11/8/2010 Other Health Professional United Kingdom
Primary
Concomitant
Skin Cancer Other Serious 7/22/2003 55 Female 159 lb 11/9/2010 Other Health Professional United Kingdom
Primary
Concomitant
Cervix Carcinoma Stage 0 Other Serious 10/16/2008 45 Female 11/9/2010 Physician United Kingdom
Primary
Concomitant
Lung Carcinoma Cell Type Unspecified Stage 0 Other Serious 6/5/2009 31 Female 174 lb 11/12/2010 Other Health Professional United Kingdom
Primary
Concomitant
Tuberculosis Other Serious 1/5/2010 77 Female 112 lb 11/12/2010 Other Health Professional United Kingdom
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 1/8/2009 61 Female 126 lb 11/18/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pancreatic Carcinoma Life Threatening 8/12/2010 81 Female 138 lb 11/19/2010 Physician United States
Primary
Concomitant
Skin Cancer Other Serious 9/28/2008 68 Female 168 lb 11/19/2010 Other Health Professional United Kingdom
Primary
Concomitant
Myeloproliferative Disorder Other Serious 3/10/2009 68 Female 159 lb 11/22/2010 Other Health Professional United Kingdom
Primary
Concomitant
Metastases To Central Nervous System Other Serious 1/1/2010 77 Female 112 lb 11/22/2010 Other Health Professional United Kingdom
Primary
Concomitant
Soft Tissue Neoplasm Other Serious 12/14/2009 64 Female 143 lb 11/22/2010 Other Health Professional United Kingdom
Primary
Concomitant
Abdominal Pain Hospitalization 10/8/2010 14 Female 150 lb 11/22/2010 Physician United States
Primary
Concomitant
Bladder Cancer Other Serious 9/15/2009 62 Male 245 lb 11/23/2010 Other Health Professional United Kingdom
Primary
Concomitant
Cerebellar Infarction Hospitalization 8/23/2010 59 Female 11/23/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pancreatic Carcinoma Life Threatening 8/12/2010 81 Female 138 lb 11/23/2010 Physician United States
Primary
Concomitant
Latent Tuberculosis Other Serious 57 Female 11/24/2010 Physician Israel
Primary
Secondary
Concomitant
Ventricle Rupture Life Threatening 62 Female 11/24/2010 Physician United States
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 20 Female 11/24/2010 Physician Australia
Primary
Concomitant
Herpes Zoster Disseminated Hospitalization 36 Female 11/24/2010 Physician Australia
Primary
Concomitant
Herpes Zoster Disseminated Hospitalization 30 Male 11/24/2010 Physician Australia
Primary
Concomitant
Hodgkin's Disease Other Serious 6/22/2010 76 Male 176 lb 12/2/2010 Physician Greece
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 12/7/2010 Other Health Professional France
Primary
Concomitant
Respiratory Distress Other Serious 12/7/2010 Other Health Professional France
Primary
Concomitant

Drug Data