Humira combined with Sodium Risedronate Hydrate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
White Blood Cell Count Decreased Hospitalization 9/28/2008 Female 93 lb 10/13/2008 Japan
Primary
Secondary
Concomitant
Meningitis Other Serious 9/27/2008 Female 93 lb 11/14/2008 Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 9/27/2008 Female 93 lb 12/11/2008 Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 9/27/2008 Female 93 lb 12/18/2008 Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 12/26/2008 Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 1/4/2009 Female 119 lb 1/26/2009 Japan
Primary
Concomitant
Respiratory Failure Other Serious 1/4/2009 Female 119 lb 1/27/2009 Japan
Primary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 2/4/2009 Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 8/15/2008 Female 119 lb 2/6/2009 Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 9/4/2008 Female 99 lb 2/9/2009 Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 9/4/2008 Female 99 lb 2/23/2009 Japan
Primary
Concomitant
Respiratory Failure Other Serious 8/15/2008 Female 119 lb 3/2/2009 Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 9/4/2008 Female 99 lb 3/4/2009 Japan
Primary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 3/10/2009 Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 9/4/2008 Female 99 lb 3/16/2009 Japan
Primary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 3/18/2009 Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 5/14/2009 Female 80 lb 5/22/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/14/2009 Female 80 lb 6/2/2009 Japan
Primary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 4/16/2009 Female 132 lb 6/5/2009 Physician Japan
Primary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 6/11/2009 Japan
Primary
Secondary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 4/16/2009 Female 132 lb 6/12/2009 Physician Japan
Primary
Concomitant
Pulmonary Embolism Life Threatening 12/2/2008 Female 146 lb 6/16/2009 Japan
Primary
Concomitant
Speech Disorder Hospitalization 9/25/2008 Female 93 lb 6/17/2009 Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/14/2009 Female 80 lb 6/24/2009 Japan
Primary
Concomitant
Vomiting Life Threatening 3/9/2009 Female 6/26/2009 Japan
Primary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 4/16/2009 Female 132 lb 6/29/2009 Physician Japan
Primary
Concomitant
Vomiting Life Threatening 3/9/2009 Female 7/8/2009 Japan
Primary
Concomitant
Polymyalgia Rheumatica Hospitalization 12/4/2008 Female 83 lb 7/27/2009 Japan
Primary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 7/5/2009 Female 126 lb 8/26/2009 Japan
Primary
Concomitant
Arthropathy Hospitalization 4/14/2009 Male 115 lb 8/27/2009 Japan
Primary
Concomitant
Gait Disturbance Hospitalization 8/4/2009 Male 131 lb 8/28/2009 Japan
Primary
Concomitant
Polymyalgia Rheumatica Hospitalization 12/4/2008 Female 83 lb 8/31/2009 Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 1/9/2009 Female 9/2/2009 Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 7/2/2009 Female 9/4/2009 Japan
Primary
Concomitant
Pulmonary Embolism Other Serious 12/4/2008 Female 146 lb 9/16/2009 Japan
Primary
Concomitant
Spinal Compression Fracture Hospitalization 10/4/2008 Male 106 lb 9/17/2009 Japan
Primary
Concomitant
Splenomegaly Life Threatening 7/2/2009 Female 9/21/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/14/2009 Female 80 lb 9/24/2009 Japan
Primary
Concomitant
Vasculitis Hospitalization 2/1/2009 Female 98 lb 9/25/2009 Japan
Primary
Concomitant
Pulmonary Embolism Other Serious 12/4/2008 Female 124 lb 9/28/2009 Japan
Primary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 4/16/2009 Female 132 lb 9/29/2009 Physician Japan
Primary
Concomitant
Gait Disturbance Hospitalization 8/4/2009 Male 131 lb 10/1/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/14/2009 Female 80 lb 10/1/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/14/2009 Female 80 lb 10/8/2009 Japan
Primary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 4/16/2009 Female 132 lb 10/8/2009 Physician Japan
Primary
Concomitant
Pulmonary Embolism Other Serious 12/4/2008 Female 124 lb 10/8/2009 Japan
Primary
Concomitant
Vasculitis Hospitalization 2/1/2009 Female 98 lb 10/19/2009 Japan
Primary
Concomitant
Pulmonary Embolism Other Serious 12/4/2008 Female 146 lb 10/22/2009 Japan
Primary
Concomitant
Spinal Compression Fracture Hospitalization 10/4/2008 Male 106 lb 10/28/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 5/13/2009 Female 80 lb 11/3/2009 Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1/9/2009 Female 11/23/2009 Japan
Primary
Secondary
Concomitant
Vasculitis Hospitalization 2/1/2009 Female 98 lb 12/3/2009 Japan
Primary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 6/9/2009 Female 126 lb 12/11/2009 Japan
Primary
Concomitant
Post Procedural Infection Life Threatening 4/12/2009 Male 148 lb 12/21/2009 Japan
Primary
Concomitant
Pyrexia Other Serious 7/1/2009 Female 88 lb 12/23/2009 Japan
Primary
Concomitant
Interacting
Pyrexia Other Serious 7/1/2009 Female 88 lb 12/28/2009 Japan
Primary
Concomitant
Interacting
Vasculitis Hospitalization 2/1/2009 Female 98 lb 12/30/2009 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/1/2009 Female 88 lb 1/14/2010 Japan
Primary
Concomitant
Interacting
White Blood Cell Count Decreased Other Serious 11/15/2009 Female 1/29/2010 Japan
Primary
Secondary
Concomitant
Vasculitis Other Serious 2/1/2009 Female 98 lb 1/29/2010 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 7/1/2009 Female 88 lb 2/4/2010 Japan
Primary
Concomitant
Interacting
Pyrexia Other Serious 7/1/2009 Female 88 lb 2/12/2010 Japan
Primary
Concomitant
Interacting
Large Intestine Perforation Life Threatening 4/12/2009 Male 148 lb 2/19/2010 Japan
Primary
Concomitant
Pyrexia Other Serious 7/1/2009 Female 88 lb 3/12/2010 Japan
Primary
Concomitant
Interacting
Thrombosis Other Serious 11/12/2009 Female 95 lb 3/19/2010 Japan
Primary
Concomitant
Right Ventricular Failure Hospitalization 1/7/2010 Female 3/26/2010 Physician Japan
Primary
Concomitant
Haematemesis Hospitalization 1/30/2010 74 Male 99 lb 4/6/2010 Japan
Primary
Secondary
Concomitant
Metastases To Liver Life Threatening 11/25/2009 70 Female 4/9/2010 Japan
Primary
Concomitant
Pyrexia Hospitalization 9/29/2009 61 Male 106 lb 4/9/2010 Japan
Primary
Secondary
Concomitant
Right Ventricular Failure Hospitalization 10/1/2009 74 Female 4/12/2010 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 3/2/2010 73 Female 90 lb 4/14/2010 Japan
Primary
Secondary
Concomitant
Haematemesis Hospitalization 1/30/2010 74 Male 99 lb 4/15/2010 Japan
Primary
Secondary
Concomitant
Metastases To Liver Life Threatening 11/25/2009 70 Female 4/23/2010 Japan
Primary
Concomitant
Spinal Compression Fracture Hospitalization 9/29/2009 61 Male 106 lb 4/23/2010 Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 9/29/2009 61 Male 106 lb 5/3/2010 Japan
Primary
Secondary
Concomitant
Metastases To Liver Life Threatening 11/25/2009 70 Female 5/7/2010 Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 3/2/2010 74 Female 5/26/2010 Physician Japan
Primary
Secondary
Concomitant
Metastases To Liver Life Threatening 11/25/2009 70 Female 6/18/2010 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 12/7/2009 75 Female 6/24/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 73 Female 77 lb 7/16/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 73 Female 77 lb 7/21/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 73 Female 77 lb 7/28/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/30/2010 74 Male 98 lb 8/2/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 7/5/2009 68 Female 126 lb 8/11/2010 Physician Japan
Primary
Concomitant
Sciatica Hospitalization 5/8/2010 75 Female 83 lb 8/13/2010 Physician Japan
Primary
Concomitant
Metastases To Liver Life Threatening 11/25/2009 70 Female 8/17/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/30/2010 74 Male 98 lb 8/17/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Life Threatening 6/26/2010 64 Female 8/20/2010 Physician Japan
Primary
Concomitant
Spondylitis Other Serious 6/2/2010 64 Female 8/27/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 3/13/2010 73 Female 77 lb 8/27/2010 Physician Japan
Primary
Concomitant
Spinal Column Stenosis Hospitalization 2/15/2010 79 Female 90 lb 8/30/2010 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious 4/19/2010 64 Female 61 lb 9/7/2010 Physician Japan
Primary
Secondary
Concomitant
Pelvic Fracture Hospitalization 8/28/2009 78 Female 93 lb 9/10/2010 Physician Japan
Primary
Concomitant
Road Traffic Accident Hospitalization 9/19/2009 66 Female 104 lb 9/13/2010 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious 4/1/2010 64 Female 61 lb 9/13/2010 Physician Japan
Primary
Secondary
Concomitant
Pelvic Fracture Hospitalization 5/9/2010 78 Female 93 lb 9/13/2010 Physician Japan
Primary
Concomitant
Spinal Column Stenosis Hospitalization 2/15/2010 79 Female 90 lb 9/14/2010 Physician Japan
Primary
Concomitant
Road Traffic Accident Hospitalization 9/19/2009 66 Female 104 lb 9/16/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Other Serious 3/13/2010 73 Female 77 lb 9/20/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/30/2010 74 Male 98 lb 9/22/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 4/1/2010 64 Female 61 lb 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 4/1/2010 64 Female 61 lb 10/1/2010 Physician Japan
Primary
Secondary
Concomitant
Spondylitis Other Serious 6/2/2010 64 Female 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 4/1/2010 64 Female 61 lb 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 1/30/2010 74 Male 98 lb 10/20/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Pelvic Fracture Hospitalization 5/9/2010 78 Female 93 lb 10/27/2010 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/30/2010 74 Male 98 lb 11/2/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 11/3/2010 Physician Japan
Primary
Concomitant
Oesophageal Candidiasis Hospitalization 2/17/2010 65 Female 90 lb 12/8/2010 Physician Japan
Primary
Concomitant
Pelvic Fracture Hospitalization 5/9/2010 78 Female 93 lb 12/8/2010 Physician Japan
Primary
Concomitant
Sciatica Hospitalization 5/8/2010 75 Female 83 lb 12/9/2010 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 8/1/2010 79 Female 83 lb 12/13/2010 Physician Japan
Primary
Concomitant
Aortic Dissection Hospitalization 11/26/2010 77 Female 95 lb 12/15/2010 Physician Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 12/17/2010 Physician Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 1/3/2011 Physician Japan
Primary
Concomitant
Aortic Dissection Hospitalization 11/26/2010 77 Female 95 lb 1/5/2011 Physician Japan
Primary
Concomitant
Oesophageal Candidiasis Hospitalization 2/17/2010 65 Female 90 lb 1/7/2011 Physician Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 12/9/2010 41 Male 170 lb 1/14/2011 Physician Japan
Primary
Secondary
Concomitant
Cerebral Infarction Hospitalization 12/9/2010 41 Male 170 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Deep Vein Thrombosis Hospitalization 2/17/2010 65 Female 90 lb 2/4/2011 Physician Japan
Primary
Concomitant
Cardio-respiratory Arrest Death 8/1/2010 79 Female 83 lb 2/17/2011 Physician Japan
Primary
Concomitant
Hepatic Cirrhosis Life Threatening 7/2/2009 74 Female 4/21/2011 Physician Japan
Primary
Concomitant
Chronic Myeloid Leukaemia Life Threatening 62 Female 105 lb 4/26/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 7/2/2009 74 Female 5/9/2011 Physician Japan
Primary
Concomitant
Chronic Myeloid Leukaemia Transformation Life Threatening 62 Female 105 lb 5/13/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 3/1/2011 76 Female 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Transformation Hospitalization 4/14/2011 62 Female 107 lb 6/1/2011 Physician Japan
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Transformation Hospitalization 4/7/2011 62 Female 107 lb 6/6/2011 Physician Japan
Primary
Secondary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 6/6/2011 Physician Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 6/9/2011 Physician Japan
Primary
Concomitant
Fall Other Serious 10/1/2010 62 Female 142 lb 6/21/2011 Physician Japan
Primary
Concomitant
Drug Eruption Hospitalization 3/1/2011 76 Female 6/21/2011 Physician Japan
Primary
Secondary
Concomitant
Heart Rate Increased Hospitalization 11/30/2010 84 Female 94 lb 7/5/2011 Physician Japan
Primary
Concomitant
Aortic Dissection Hospitalization 11/26/2010 77 Female 95 lb 7/6/2011 Physician Japan
Primary
Concomitant
Arthralgia Hospitalization 10/1/2010 62 Female 142 lb 7/13/2011 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 11/30/2010 84 Female 94 lb 8/12/2011 Physician Japan
Primary
Concomitant
Clostridial Infection Hospitalization 5/18/2011 46 Male 134 lb 8/16/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 6/9/2011 73 Female 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Heart Rate Increased Death 11/30/2010 84 Female 94 lb 9/9/2011 Physician Japan
Primary
Concomitant
Osteoporosis Death 11/12/2010 72 Female 12/2/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Adhesions Hospitalization 10/8/2011 34 Female 97 lb 12/6/2011 Physician Japan
Primary
Concomitant
Back Pain Hospitalization 11/12/2010 72 Female 12/7/2011 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Death 11/12/2010 72 Female 12/13/2011 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 5/18/2011 46 Male 134 lb 12/15/2011 Physician Japan
Primary
Concomitant
Hypersensitivity Hospitalization 10/8/2011 34 Female 97 lb 12/21/2011 Physician Japan
Primary
Concomitant
Ovarian Neoplasm Hospitalization 6/7/2010 72 Female 135 lb 12/28/2011 Physician Japan
Primary
Concomitant
Sensory Disturbance Hospitalization 10/8/2011 34 Female 97 lb 12/29/2011 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 8/1/2010 79 Female 83 lb 2/9/2012 Physician Japan
Primary
Concomitant
Abasia Hospitalization 5/8/2011 73 Female 98 lb 2/10/2012 Physician Japan
Primary
Concomitant
Cardio-respiratory Arrest Hospitalization 8/1/2010 79 Female 83 lb 2/13/2012 Physician Japan
Primary
Concomitant

Drug Data