Prednisolone combined with Simponi

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Myocardial Infarction Hospitalization 8/1/2009 Male 230 lb 3/9/2010 Consumer United States
Primary
Concomitant
Personality Disorder Other Serious 12/7/2009 61 Female 161 lb 4/9/2010 Physician Germany
Primary
Concomitant
B-cell Lymphoma Other Serious 4/15/2010 69 Male 176 lb 6/18/2010 Physician Germany
Primary
Concomitant
Weight Decreased Other Serious 1/1/2010 63 Female 165 lb 7/22/2010 Physician Germany
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 4/5/2010 46 Female 7/22/2010 Physician Norway
Primary
Concomitant
Pneumonia Hospitalization 7/21/2010 53 Female 8/24/2010 Physician Norway
Primary
Concomitant
Pneumonia Hospitalization 6/29/2010 Female 162 lb 8/26/2010 Physician Austria
Primary
Concomitant
Pneumonia Hospitalization 7/21/2010 53 Female 8/27/2010 Physician Norway
Primary
Concomitant
Syphilis Hospitalization Female 109 lb 9/1/2010 Other Health Professional Germany
Primary
Concomitant
Syphilis Hospitalization 8/11/2010 Female 109 lb 10/21/2010 Other Health Professional Germany
Primary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 11/11/2010 77 Female 158 lb 12/10/2010 Other Health Professional Portugal
Primary
Secondary
Concomitant
Kidney Infection Other Serious Female 2/11/2011 Other Health Professional Australia
Primary
Concomitant
Dyspnoea Other Serious 3/25/2011 20 Male 196 lb 4/4/2011 Physician Germany
Primary
Concomitant
Dyspnoea Other Serious 3/25/2011 20 Male 196 lb 4/8/2011 Physician Germany
Primary
Concomitant
Dyspnoea Other Serious 2/12/2011 66 Female 172 lb 4/8/2011 Physician Switzerland
Primary
Concomitant
Dyspnoea Life Threatening 3/25/2011 20 Male 196 lb 4/13/2011 Physician Germany
Primary
Concomitant
Palpitations Other Serious 3/27/2011 67 Female 4/22/2011 Physician Germany
Primary
Concomitant
Diverticulitis Hospitalization 4/14/2011 71 Male 216 lb 5/4/2011 Consumer Germany
Primary
Concomitant
Tuberculosis Liver Hospitalization 3/1/2011 Female 5/4/2011 Physician Germany
Primary
Concomitant
Pneumonia Bacterial Other Serious 3/30/2011 48 Female 143 lb 5/9/2011 Physician Japan
Primary
Concomitant
Dyspnoea Other Serious 2/12/2011 66 Female 172 lb 5/16/2011 Physician Switzerland
Primary
Concomitant
Cellulitis Other Serious 3/9/2011 24 Female 132 lb 5/20/2011 Physician Germany
Primary
Concomitant
Swollen Tongue Other Serious 4/20/2011 71 Female 5/25/2011 Physician Sweden
Primary
Concomitant
Dyspnoea Other Serious 4/20/2011 71 Female 5/31/2011 Physician Sweden
Primary
Concomitant
Erythema Hospitalization 4/14/2011 71 Male 216 lb 6/16/2011 Consumer Germany
Primary
Concomitant
Oedema Peripheral Hospitalization 5/17/2011 67 Female 6/17/2011 Physician Germany
Primary
Concomitant
Oedema Peripheral Hospitalization 5/17/2011 67 Female 6/30/2011 Physician Germany
Primary
Concomitant
Off Label Use Other Serious 5/10/2010 29 Female 165 lb 7/8/2011 Other Health Professional Austria
Primary
Concomitant
Erythema Hospitalization 4/14/2011 71 Male 216 lb 7/14/2011 Consumer Germany
Primary
Concomitant
Malaise Hospitalization 1/1/2011 54 Female 7/19/2011 Pharmacist Ireland
Primary
Concomitant
Pneumonia Death 12/19/2010 76 Female 134 lb 7/20/2011 Physician Denmark
Primary
Concomitant
Pain In Extremity Hospitalization 4/14/2011 71 Male 216 lb 7/27/2011 Consumer Germany
Primary
Concomitant
Psoriasis Life Threatening 12/19/2010 76 Female 134 lb 8/8/2011 Physician Denmark
Primary
Concomitant
Malaise Other Serious 1/1/2011 54 Female 8/22/2011 Pharmacist Ireland
Primary
Concomitant
Arthralgia Hospitalization 1/1/2011 39 Female 9/2/2011 Pharmacist Ireland
Primary
Concomitant
Atrial Fibrillation Other Serious 12/16/2010 68 Female 9/6/2011 Physician Germany
Primary
Secondary
Concomitant
Psoriasis Other Serious 43 Male 10/3/2011 Pharmacist Germany
Primary
Concomitant
Myocardial Infarction Hospitalization 8/27/2011 51 Female 10/6/2011 Other Health Professional Sweden
Primary
Concomitant
Psoriasis Hospitalization 1/1/2011 43 Male 10/19/2011 Pharmacist Germany
Primary
Concomitant
Pneumonia Hospitalization 10/6/2011 Female 11/18/2011 Physician Sweden
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/1/2011 50 Female 12/6/2011 Other Health Professional Belgium
Primary
Concomitant
Pneumonia Hospitalization 10/6/2011 Female 12/9/2011 Physician Sweden
Primary
Concomitant
Vomiting Hospitalization 12/10/2011 67 Female 12/22/2011 Physician Japan
Primary
Concomitant
Nephrolithiasis Hospitalization 8/25/2011 52 Male 176 lb 1/11/2012 Physician Germany
Primary
Concomitant
Vomiting Hospitalization 12/10/2011 67 Female 1/12/2012 Physician Japan
Primary
Concomitant
Pulpitis Dental Hospitalization 12/10/2011 67 Female 1/16/2012 Physician Japan
Primary
Concomitant
Lower Respiratory Tract Infection Hospitalization Male 1/25/2012 Pharmacist Ireland
Primary
Concomitant
Bronchitis Hospitalization 7/24/2011 66 Male 2/3/2012 Other Health Professional Germany
Primary
Secondary
Concomitant
Fatigue Other Serious 8/3/2011 54 Male 2/7/2012 Physician Belgium
Primary
Concomitant
Musculoskeletal Pain Other Serious 8/3/2011 54 Male 2/10/2012 Physician Belgium
Primary
Concomitant
Ulcerative Keratitis Other Serious 1/1/2011 50 Female 2/13/2012 Other Health Professional Belgium
Primary
Concomitant
Lower Respiratory Tract Infection Hospitalization Male 2/13/2012 Pharmacist Ireland
Primary
Concomitant
Drug Ineffective Hospitalization 4/14/2011 71 Male 216 lb 2/23/2012 Consumer Germany
Primary
Concomitant
Pleural Effusion Hospitalization 72 Female 2/24/2012 Physician Germany
Primary
Concomitant
Encephalitis Viral Hospitalization 11/15/2011 71 Male 163 lb 2/24/2012 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 12/10/2011 67 Female 128 lb 2/24/2012 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 11/2/2011 77 Female 132 lb 3/2/2012 Physician Japan
Primary
Concomitant
Post Procedural Haematoma Hospitalization 1/19/2012 74 Female 51 lb 3/8/2012 Physician Japan
Primary
Concomitant
Malignant Melanoma Other Serious Male 3/9/2012 Physician Norway
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 3/6/2012 60 Female 3/14/2012 Pharmacist Japan
Primary
Concomitant
Retinal Haemorrhage Other Serious 3/6/2012 60 Female 3/20/2012 Pharmacist Japan
Primary
Concomitant
Pneumonia Hospitalization 11/1/2011 77 Female 132 lb 3/30/2012 Physician Japan
Primary
Secondary
Concomitant
Erysipelas Other Serious 11/29/2011 45 Female 119 lb 4/9/2012 Physician Japan
Primary
Secondary
Concomitant
Femoral Neck Fracture Hospitalization 1/19/2012 74 Female 51 lb 4/10/2012 Physician Japan
Primary
Concomitant
Herpes Zoster Hospitalization 2/27/2012 71 Female 90 lb 4/11/2012 Physician Japan
Primary
Secondary
Implant Site Infection Hospitalization 3/9/2012 49 Female 4/23/2012 Other Health Professional Australia
Primary
Concomitant
Retinal Haemorrhage Other Serious 3/5/2012 60 Female 4/24/2012 Pharmacist Japan
Primary
Concomitant
Retinal Haemorrhage Other Serious 3/5/2012 60 Female 5/2/2012 Pharmacist Japan
Primary
Concomitant
Pneumonia Other Serious 5/9/2012 81 Female 77 lb 5/16/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 3/28/2012 63 Female 86 lb 5/22/2012 Physician Japan
Primary
Concomitant
Pancreatitis Acute Hospitalization 3/1/2012 73 Female 5/24/2012 Physician Japan
Primary
Concomitant
Herpes Zoster Hospitalization 2/27/2012 71 Female 90 lb 5/31/2012 Physician Japan
Primary
Secondary
Pneumonia Hospitalization 5/9/2012 81 Female 77 lb 5/31/2012 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 3/1/2012 63 Male 6/4/2012 Physician Japan
Primary
Concomitant
Condition Aggravated Hospitalization 1/21/2012 54 Male 157 lb 6/7/2012 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 2/27/2012 71 Female 90 lb 6/8/2012 Physician Japan
Primary
Secondary
Hepatic Function Abnormal Other Serious 11/29/2011 45 Female 119 lb 6/21/2012 Physician Japan
Primary
Secondary
Concomitant
Cerebellar Infarction Hospitalization 3/24/2012 41 Male 176 lb 6/22/2012 Other Health Professional Germany
Primary
Concomitant
Retinal Haemorrhage Other Serious 3/5/2012 60 Female 207 lb 6/25/2012 Pharmacist Japan
Primary
Concomitant
Malignant Melanoma Other Serious Male 6/27/2012 Physician Norway
Primary
Secondary
Concomitant
Pyelonephritis Acute Hospitalization 5/10/2012 57 Female 93 lb 6/27/2012 Physician Japan
Primary
Secondary
Concomitant
Eye Disorder Other Serious 2/1/2012 61 Female 6/29/2012 Consumer Sweden
Primary
Concomitant
Renal Disorder Other Serious 3/28/2012 63 Female 86 lb 7/5/2012 Physician Japan
Primary
Concomitant
Lip And/or Oral Cavity Cancer Hospitalization 8/1/2011 76 Female 7/11/2012 Physician Japan
Primary
Secondary
Concomitant
Lip And/or Oral Cavity Cancer Hospitalization 8/1/2011 76 Female 7/12/2012 Physician Japan
Primary
Secondary
Concomitant
Lung Infection Pseudomonal Hospitalization 1/1/2012 82 Female 93 lb 7/12/2012 Physician Japan
Primary
Concomitant
Lung Neoplasm Hospitalization 1/21/2012 54 Male 157 lb 7/12/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/9/2012 81 Female 77 lb 7/18/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 6/23/2012 73 Female 7/19/2012 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 3/1/2012 63 Male 7/19/2012 Physician Japan
Primary
Concomitant
Tuberculosis Hospitalization 6/6/2012 81 Male 128 lb 7/23/2012 Physician Japan
Primary
Concomitant
Arthralgia Other Serious 5/31/2012 80 Female 7/23/2012 Physician Japan
Primary
Secondary
Concomitant
Colonic Polyp Other Serious 12/26/2011 66 Female 130 lb 7/23/2012 Physician Japan
Primary
Concomitant
Haemorrhoidal Haemorrhage Hospitalization 12/20/2011 83 Male 7/24/2012 Other Health Professional United Kingdom
Primary
Concomitant
Renal Disorder Other Serious 3/28/2012 63 Female 86 lb 7/27/2012 Physician Japan
Primary
Concomitant
Pyelonephritis Acute Hospitalization 5/10/2012 57 Female 93 lb 7/30/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 5/31/2012 80 Female 7/30/2012 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/18/2012 63 Female 7/31/2012 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 12/10/2011 67 Female 128 lb 8/6/2012 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 6/26/2012 53 Male 8/8/2012 Physician Japan
Primary
Concomitant
Lip And/or Oral Cavity Cancer Hospitalization 3/1/2012 76 Female 8/8/2012 Physician Japan
Primary
Secondary
Concomitant
Coronary Artery Bypass Other Serious 2/1/2012 70 Female 112 lb 8/8/2012 Physician Japan
Primary
Concomitant
Melaena Other Serious 12/26/2011 66 Female 130 lb 8/13/2012 Physician Japan
Primary
Concomitant
Lip And/or Oral Cavity Cancer Hospitalization 3/1/2012 76 Female 8/14/2012 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 3/1/2012 63 Male 8/14/2012 Physician Japan
Primary
Concomitant
Tuberculosis Hospitalization 6/6/2012 81 Male 128 lb 8/16/2012 Physician Japan
Primary
Concomitant
Pneumonia Death 5/1/2012 79 Female 88 lb 8/16/2012 Physician Japan
Primary
Concomitant
Bronchitis Hospitalization 7/24/2011 70 Male 8/16/2012 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/18/2012 63 Female 123 lb 8/16/2012 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 12/10/2011 61 Female 99 lb 8/17/2012 Physician Japan
Primary
Concomitant
Cardiac Failure Hospitalization 5/1/2012 79 Female 88 lb 8/23/2012 Physician Japan
Primary
Concomitant
Bile Duct Stone Hospitalization 3/1/2012 73 Female 8/24/2012 Physician Japan
Primary
Concomitant
Arthritis Bacterial Hospitalization 7/24/2012 76 Female 8/27/2012 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 5/1/2012 79 Female 88 lb 8/27/2012 Physician Japan
Primary
Concomitant
Oral Infection Hospitalization 9/2/2011 80 Female 8/27/2012 Physician Germany
Primary
Secondary
Concomitant
Rheumatoid Lung Hospitalization 1/19/2012 74 Female 112 lb 12/6/2012 Physician Jp
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 11/17/2011 68 Female 93 lb 11/15/2012 Physician Jp
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/9/2012 81 Female 77 lb 12/28/2012 Physician Jp
Primary
Secondary
Concomitant
Cerebellar Infarction Hospitalization 3/24/2012 41 Male 176 lb 11/29/2012 Other Health Professional De
Primary
Concomitant
Squamous Cell Carcinoma Of The Oral Cavity Hospitalization 2/19/2012 77 Female 101 lb 11/27/2012 Physician Jp
Primary
Secondary
Concomitant
Pneumonia Pseudomonas Aeruginosa Hospitalization 1/11/2012 82 Female 93 lb 12/12/2012 Physician Jp
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 6/23/2012 73 Female 119 lb 10/5/2012 Physician Jp
Primary
Secondary
Concomitant
Pneumonia Other Serious 6/26/2012 54 Male 141 lb 3/13/2013 Physician Jp
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 8/8/2012 61 Female 1/3/2013 Physician Jp
Primary
Secondary
Concomitant
Procedural Haemorrhage Other Serious 8/11/2012 62 Female 9/6/2012 Other Health Professional Au
Primary
Secondary
Concomitant
Inflammation Hospitalization 4/30/2012 62 Male 249 lb 9/7/2012 Physician De
Primary
Concomitant
Interstitial Lung Disease Other Serious 4/6/2012 57 Female 11/14/2012 Physician Jp
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 8/8/2012 69 Female 101 lb 11/21/2012 Physician Jp
Primary
Concomitant
Lymphocyte Count Decreased Hospitalization 5/8/2012 65 Female 117 lb 12/17/2012 Physician Jp
Primary
Secondary
Concomitant
Pneumonia Bacterial Hospitalization 6/28/2012 76 Male 101 lb 12/12/2012 Physician Jp
Primary
Secondary
Concomitant
Off Label Use Other Serious 4/2012 Female 112 lb 10/12/2012 Physician Jp
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/15/2012 68 Male 2/7/2013 Physician De
Primary
Concomitant
Liver Disorder Other Serious 6/26/2012 65 Female 101 lb 12/5/2012 Physician Jp
Primary
Concomitant
Herpes Virus Infection Other Serious 10/18/2012 Male 11/7/2012 Physician Jp
Primary
Secondary
Concomitant
Ventricular Arrhythmia Other Serious 4/20/2012 66 Female 134 lb 12/5/2012 Physician Jp
Primary
Secondary
Concomitant
Tuberculous Pleurisy Other Serious 3/8/2012 78 Female 128 lb 2/4/2013 Physician Jp
Primary
Concomitant
Psychiatric Symptom Hospitalization 2/24/2012 62 Female 12/25/2012 Physician Jp
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 6/14/2012 53 Female 159 lb 12/20/2012 Physician Jp
Primary
Concomitant
Vasculitis Other Serious 9/2012 Female 12/10/2012 Pharmacist Ie
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 5/23/2012 64 Male 143 lb 1/4/2013 Physician Jp
Primary
Concomitant
Infected Skin Ulcer Hospitalization 2/23/2012 77 Female 119 lb 2/4/2013 Physician Jp
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 5/30/2012 76 Female 110 lb 11/29/2012 Physician Jp
Primary
Secondary
Concomitant
Mouth Ulceration Other Serious Female 11/29/2012 Other Health Professional Au
Primary
Concomitant
Uterine Leiomyoma Hospitalization 7/16/2012 Female 2/14/2013 Physician De
Primary
Concomitant
Sudden Death Death 63 Female 1/18/2013 Physician Jp
Primary
Concomitant
Keloid Scar Other Serious 3/22/2012 34 Female 108 lb 12/5/2012 Physician Jp
Primary
Concomitant
Pneumonia Hospitalization 6/6/2012 75 Male 123 lb 2/14/2013 Physician Jp
Primary
Secondary
Concomitant
Erysipelas Hospitalization 8/23/2011 72 Male 187 lb 1/9/2013 Physician De
Primary
Concomitant
Weight Decreased Hospitalization 12/7/2012 61 Female 3/26/2013 Consumer Tw
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 7/20/2012 63 Male 119 lb 2/14/2013 Physician Jp
Primary
Secondary
Concomitant

Drug Data