Golimumab combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumocystis Jiroveci Pneumonia Hospitalization 2/24/2009 Female 117 lb 5/8/2009 Physician Japan
Primary
Secondary
Concomitant
Large Intestine Carcinoma Other Serious 4/27/2009 Female 121 lb 5/13/2009 Physician Japan
Primary
Secondary
Concomitant
Adenocarcinoma Hospitalization 11/22/2008 Male 192 lb 5/15/2009 Physician Belgium
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/3/2009 Male 5/15/2009 Physician Australia
Primary
Secondary
Concomitant
Uterine Leiomyoma Hospitalization 1/16/2009 Female 212 lb 5/19/2009 Physician Germany
Primary
Concomitant
Pneumonia Hospitalization 4/10/2009 Male 176 lb 5/20/2009 Physician Australia
Primary
Secondary
Concomitant
Large Intestine Carcinoma Other Serious 4/27/2009 Female 121 lb 6/12/2009 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/15/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 11/17/2008 Female 137 lb 6/30/2009 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 11/17/2008 Female 137 lb 7/2/2009 Physician Japan
Primary
Concomitant
Duodenal Ulcer Hospitalization 6/19/2009 Female 115 lb 7/9/2009 Physician Japan
Primary
Secondary
Concomitant
Polyarthritis Other Serious 11/17/2008 Female 137 lb 7/14/2009 Physician Japan
Primary
Concomitant
Duodenal Ulcer Hospitalization 6/16/2009 Female 115 lb 7/22/2009 Physician Japan
Primary
Secondary
Concomitant
Adnexa Uteri Mass Hospitalization 6/16/2009 Female 95 lb 7/22/2009 Physician Japan
Primary
Concomitant
Herpes Zoster Hospitalization 6/22/2009 Female 119 lb 7/27/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 2/24/2009 Female 117 lb 7/27/2009 Physician Japan
Primary
Secondary
Concomitant
Pustular Psoriasis Other Serious 12/2/2008 Male 208 lb 7/30/2009 Physician Korea, Republic Of
Primary
Concomitant
Polyarthritis Other Serious 11/17/2008 Female 137 lb 8/10/2009 Physician Japan
Primary
Concomitant
Intracranial Aneurysm Hospitalization 7/31/2009 Female 9/30/2009 Other Health Professional Japan
Primary
Concomitant
Polyarthritis Other Serious 11/17/2008 Female 137 lb 10/9/2009 Physician Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 10/9/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 10/14/2009 Physician Malaysia
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 10/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 11/2/2009 Physician Malaysia
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 11/6/2009 Physician Malaysia
Primary
Secondary
Concomitant
Intracranial Aneurysm Hospitalization 7/31/2009 Female 11/6/2009 Other Health Professional Japan
Primary
Concomitant
Bursitis Hospitalization 7/1/2009 Female 132 lb 11/6/2009 Physician Germany
Primary
Concomitant
Wound Complication Other Serious 4/27/2009 Female 121 lb 11/10/2009 Physician Japan
Primary
Secondary
Concomitant
Bursitis Hospitalization 7/1/2009 Female 132 lb 11/16/2009 Physician Germany
Primary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 11/20/2009 Physician Finland
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 12/9/2009 Physician Finland
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 2/15/2009 Female 117 lb 12/14/2009 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 12/17/2009 Female 75 lb 1/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 1/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 2/15/2009 Female 117 lb 1/21/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 2/4/2010 Physician Japan
Primary
Secondary
Concomitant
Colon Cancer Other Serious 3/28/2009 Female 121 lb 2/9/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 2/15/2009 Female 117 lb 2/12/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 2/17/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 2/26/2010 Male 3/14/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Haematuria Hospitalization 3/4/2010 3/15/2010 Physician Germany
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 Female 75 lb 3/31/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 12/1/2009 70 Female 134 lb 4/5/2010 Physician Germany
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/9/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 4/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 2/26/2010 51 Male 5/18/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 1/8/2008 55 Female 269 lb 5/21/2010 Physician Germany
Primary
Secondary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 5/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 5/21/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 5/27/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 6/9/2010 Physician Japan
Primary
Secondary
Concomitant
Circulatory Collapse Hospitalization 5/29/2010 61 Female 209 lb 6/11/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/31/2010 36 Male 161 lb 6/14/2010 Physician France
Primary
Concomitant
Sepsis Hospitalization 12/17/2009 66 Female 75 lb 6/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 6/15/2010 Physician Japan
Primary
Secondary
Concomitant
Disseminated Tuberculosis Hospitalization 4/22/2010 67 Female 115 lb 6/18/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/31/2010 36 Male 161 lb 6/23/2010 Physician France
Primary
Concomitant
Septic Shock Hospitalization 4/22/2010 67 Female 115 lb 7/7/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Septic Shock Hospitalization 4/22/2010 67 Female 115 lb 7/16/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pleural Disorder Hospitalization 3/6/2010 31 Female 7/23/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Life Threatening 5/23/2010 66 Female 121 lb 7/23/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/31/2010 36 Male 161 lb 7/23/2010 Physician France
Primary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 31 Female 8/4/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Life Threatening 5/23/2010 66 Female 121 lb 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 8/13/2010 Physician Japan
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 7/16/2010 46 Female 187 lb 8/13/2010 Other Health Professional Brazil
Primary
Secondary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 32 Female 8/20/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/13/2010 57 Female 106 lb 8/25/2010 Physician Japan
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 7/16/2010 46 Female 187 lb 9/2/2010 Other Health Professional Brazil
Primary
Secondary
Concomitant
Pleuritic Pain Hospitalization 3/6/2010 32 Female 152 lb 9/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 9/8/2010 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 9/10/2010 Physician Japan
Primary
Secondary
Concomitant
Headache Hospitalization 5/31/2010 36 Male 161 lb 10/11/2010 Physician France
Primary
Concomitant
Malignant Melanoma Other Serious 9/27/2010 61 Female 163 lb 10/12/2010 Physician Australia
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/1/2010 36 Male 161 lb 10/13/2010 Physician France
Primary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Cellulitis Other Serious 9/2/2010 58 Female 168 lb 10/18/2010 Physician Japan
Primary
Secondary
Concomitant
Breast Cancer In Situ Other Serious 10/7/2010 54 Female 162 lb 10/19/2010 Other Health Professional United Kingdom
Primary
Concomitant
Interstitial Lung Disease Hospitalization 8/8/2010 57 Female 108 lb 10/21/2010 Physician Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Other Serious 7/26/2010 69 Female 126 lb 10/25/2010 Physician Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 2/26/2010 51 Male 196 lb 10/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 2/26/2010 51 Male 196 lb 11/3/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 10/23/2010 42 Female 121 lb 11/3/2010 Other Health Professional Japan
Primary
Concomitant
Pneumonia Pneumococcal Life Threatening 5/23/2010 66 Female 121 lb 11/5/2010 Physician Japan
Primary
Secondary
Concomitant
Gastric Adenoma Other Serious 9/16/2010 48 Male 11/11/2010 Physician Japan
Primary
Concomitant
Intervertebral Discitis Hospitalization 2/26/2010 51 Male 196 lb 11/15/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 10/23/2010 42 Female 121 lb 11/15/2010 Other Health Professional Japan
Primary
Concomitant
Cellulitis Other Serious 9/2/2010 58 Female 168 lb 11/18/2010 Physician Japan
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 5/23/2010 64 Female 101 lb 11/18/2010 Physician Japan
Primary
Secondary
Concomitant
Pulpitis Dental Hospitalization 9/1/2009 69 Male 132 lb 11/19/2010 Other Health Professional Japan
Primary
Concomitant
Gastric Adenoma Other Serious 9/16/2010 48 Male 11/22/2010 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 9/7/2010 42 Female 93 lb 11/23/2010 Physician Japan
Primary
Secondary
Pharyngitis Hospitalization 11/2/2010 51 Female 174 lb 11/23/2010 Other Health Professional Austria
Primary
Concomitant
Ovarian Neoplasm Hospitalization 11/18/2010 69 Female 121 lb 11/29/2010 Physician Japan
Primary
Concomitant
Gastric Adenoma Other Serious 9/16/2010 48 Male 11/30/2010 Physician Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 11/18/2010 69 Female 121 lb 12/3/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/7/2010 42 Female 93 lb 12/3/2010 Physician Japan
Primary
Secondary
Pharyngitis Hospitalization 11/2/2010 51 Female 174 lb 12/3/2010 Other Health Professional Austria
Primary
Concomitant
Ovarian Neoplasm Hospitalization 11/18/2010 69 Female 121 lb 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumothorax Life Threatening 5/23/2010 66 Female 121 lb 12/10/2010 Physician Japan
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 11/2/2010 51 Female 174 lb 12/16/2010 Other Health Professional Austria
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 7/1/2009 56 Female 163 lb 12/17/2010 Physician Australia
Primary
Secondary
Concomitant
Pulpitis Dental Hospitalization 9/1/2009 69 Male 132 lb 12/22/2010 Other Health Professional Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 11/18/2010 69 Female 121 lb 12/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/22/2010 57 Female 90 lb 12/27/2010 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 10/18/2010 66 Female 205 lb 12/29/2010 Other Health Professional Denmark
Primary
Concomitant
Colorectal Cancer Hospitalization 12/14/2010 67 Female 121 lb 12/30/2010 Physician Korea, Republic Of
Primary
Concomitant
Ovarian Neoplasm Hospitalization 11/18/2010 69 Female 121 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Breast Cancer In Situ Other Serious 10/7/2010 54 Female 162 lb 1/5/2011 Other Health Professional United Kingdom
Primary
Concomitant
Diarrhoea Hospitalization 11/22/2010 57 Female 90 lb 1/5/2011 Physician Japan
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 11/2/2010 51 Female 174 lb 1/5/2011 Other Health Professional Austria
Primary
Concomitant
Gastrointestinal Amyloidosis Hospitalization 11/22/2010 57 Female 90 lb 1/11/2011 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Amyloidosis Death 11/22/2010 57 Female 90 lb 1/21/2011 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Amyloidosis Hospitalization 11/22/2010 57 Female 90 lb 1/28/2011 Physician Japan
Primary
Secondary
Concomitant
Erysipelas Hospitalization 1/14/2011 78 Female 185 lb 1/31/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Death 11/22/2010 57 Female 90 lb 2/3/2011 Physician Japan
Primary
Secondary
Concomitant
Amyloidosis Death 11/22/2010 57 Female 90 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Colon Neoplasm Hospitalization 11/19/2010 67 Female 121 lb 2/9/2011 Physician Korea, Republic Of
Primary
Concomitant
Pneumonia Hospitalization 10/18/2010 66 Female 205 lb 2/14/2011 Other Health Professional Denmark
Primary
Concomitant
Pneumonia Life Threatening 2/4/2011 76 Female 126 lb 2/14/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/22/2010 57 Female 90 lb 2/17/2011 Physician Japan
Primary
Secondary
Concomitant
Testicular Neoplasm Hospitalization 2/7/2011 45 Male 194 lb 2/17/2011 Physician Japan
Primary
Secondary
Pulpitis Dental Hospitalization 9/1/2009 69 Male 132 lb 2/23/2011 Other Health Professional Japan
Primary
Concomitant
Colon Neoplasm Hospitalization 11/19/2010 67 Female 121 lb 2/28/2011 Physician Korea, Republic Of
Primary
Concomitant
Thyroidectomy Hospitalization 2/14/2011 71 Female 116 lb 3/2/2011 Physician Germany
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 2/4/2011 76 Female 126 lb 3/2/2011 Physician Germany
Primary
Secondary
Concomitant
Colon Neoplasm Hospitalization 11/25/2010 67 Female 121 lb 3/8/2011 Physician Korea, Republic Of
Primary
Concomitant
Pneumonia Hospitalization 2/4/2011 76 Female 126 lb 3/8/2011 Physician Germany
Primary
Secondary
Concomitant
Latent Tuberculosis Hospitalization 2/24/2008 65 Male 161 lb 3/8/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Colon Neoplasm Hospitalization 11/25/2010 67 Female 121 lb 3/11/2011 Physician Korea, Republic Of
Primary
Concomitant
Thyroid Neoplasm Hospitalization 12/28/2010 71 Female 116 lb 3/11/2011 Physician Germany
Primary
Secondary
Concomitant
Sepsis Life Threatening 2/4/2011 76 Female 126 lb 3/16/2011 Physician Germany
Primary
Secondary
Concomitant
Haematoma Hospitalization 5/27/2010 63 Female 174 lb 3/25/2011 Physician Germany
Primary
Secondary
Concomitant
Testicular Neoplasm Hospitalization 2/7/2011 45 Male 194 lb 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/26/2011 37 Female 117 lb 4/11/2011 Physician Colombia
Primary
Concomitant
Viral Infection Hospitalization 2/21/2011 52 Female 141 lb 4/13/2011 Physician United Kingdom
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 1/27/2010 25 Female 97 lb 4/20/2011 Physician India
Primary
Concomitant
Ovarian Neoplasm Hospitalization 10/7/2010 68 Female 121 lb 4/21/2011 Physician Japan
Primary
Secondary
Concomitant
Testicular Neoplasm Hospitalization 2/7/2011 45 Male 194 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Bronchial Carcinoma Hospitalization 5/4/2011 74 Male 199 lb 5/20/2011 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Life Threatening 2/4/2011 76 Female 126 lb 5/24/2011 Physician Germany
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 3/15/2011 63 Female 154 lb 5/26/2011 Physician Switzerland
Primary
Secondary
Cerebral Haemorrhage Hospitalization 5/9/2011 71 Male 143 lb 5/31/2011 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Other Serious 3/30/2011 48 Female 143 lb 6/6/2011 Physician Japan
Primary
Concomitant
Bronchial Carcinoma Hospitalization 5/4/2011 74 Male 199 lb 6/6/2011 Physician Germany
Primary
Secondary
Concomitant
Bronchial Carcinoma Hospitalization 5/4/2011 74 Male 199 lb 6/9/2011 Physician Germany
Primary
Secondary
Concomitant

Drug Data