Rebetol combined with Urso 250

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Failure Acute Life Threatening 5/13/2006 18 Male 8/18/2006 Japan
Primary
Concomitant
Sepsis Life Threatening 5/16/2006 18 Male 11/21/2006 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/7/2004 54 Male 117 lb 5/15/2007 Physician Japan
Primary
Secondary
Concomitant
Endotoxic Shock Death 1/25/2007 18 Male 106 lb 5/23/2007 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 3/12/2007 64 Female 99 lb 5/18/2007 Physician Japan
Primary
Secondary
Concomitant
Sjogren's Syndrome Hospitalization 2/25/2007 59 Female 88 lb 5/24/2007 Physician Japan
Primary
Secondary
Concomitant
Endotoxic Shock Death 1/25/2007 18 Male 106 lb 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
Tenderness Other Serious 2/25/2007 59 Female 88 lb 6/26/2007 Physician Japan
Primary
Secondary
Concomitant
Bile Duct Stone Hospitalization 6/7/2007 32 Male 190 lb 7/5/2007 Physician Japan
Primary
Secondary
Concomitant
Proteinuria Disability 6/7/2007 58 Female 141 lb 8/20/2007 Physician Japan
Primary
Secondary
Concomitant
Proteinuria 6/7/2007 58 Female 141 lb 9/10/2007 Physician Japan
Primary
Secondary
Concomitant
Ocular Hyperaemia Other Serious 3/3/2007 46 Male 165 lb 9/6/2007 Physician Japan
Primary
Secondary
Concomitant
Schizophreniform Disorder Other Serious 5/2/2007 41 Male 157 lb 9/14/2007 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 7/28/2007 68 Male 123 lb 10/2/2007 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 1/1/2006 65 Male 137 lb 10/26/2007 Physician Japan
Primary
Secondary
Concomitant
Haemoptysis Other Serious 10/22/2007 50 Male 10/29/2007 Physician Japan
Primary
Secondary
Concomitant
Haemoptysis 10/22/2007 50 Male 11/8/2007 Physician Japan
Primary
Secondary
Concomitant
Muscle Abscess Hospitalization 10/7/2005 69 Female 112 lb 11/8/2007 Physician Japan
Primary
Secondary
Concomitant
Retinopathy Hospitalization 3/31/2004 70 Male 110 lb 11/28/2007 Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 60 Male 12/7/2007 Consumer Japan
Primary
Secondary
Concomitant
Fall Death 9/1/2007 75 Female 79 lb 12/10/2007 Physician Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Hospitalization 5/29/2007 64 Female 12/28/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/1/2006 70 Female 148 lb 3/13/2008 Physician Japan
Primary
Secondary
Concomitant
Necrotising Fasciitis Hospitalization 2/15/2008 79 Male 128 lb 4/28/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 35 Female 161 lb 5/22/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 4/7/2008 52 Male 123 lb 6/2/2008 Physician Japan
Primary
Secondary
Concomitant
Mental Disorder Hospitalization 5/9/2008 58 Female 108 lb 6/2/2008 Physician Japan
Primary
Secondary
Concomitant
Mycoplasma Serology Positive Hospitalization 5/9/2008 58 Female 108 lb 7/17/2008 Physician Japan
Primary
Secondary
Concomitant
Wrong Drug Administered Life Threatening 7/3/2008 31 Male 170 lb 8/8/2008 Physician Japan
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 7/17/2008 69 Male 134 lb 8/12/2008 Physician Japan
Primary
Secondary
Concomitant
Insomnia Hospitalization 6/5/2008 59 Male 146 lb 8/20/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 4/13/2006 35 Female 161 lb 9/5/2008 Physician Japan
Primary
Secondary
Concomitant
Vogt-koyanagi-harada Syndrome Hospitalization 12/21/2007 43 Male 112 lb 9/10/2008 Physician Japan
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 7/17/2008 69 Male 134 lb 9/24/2008 Physician Japan
Primary
Secondary
Concomitant
Sick Sinus Syndrome Other Serious 9/9/2008 48 Male 203 lb 10/6/2008 Physician Japan
Primary
Secondary
Concomitant
Pyothorax Other Serious 7/15/2005 68 Male 134 lb 10/7/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 4/13/2006 35 Female 161 lb 10/29/2008 Physician Japan
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 11/14/2008 69 Female 121 lb 12/3/2008 Physician Japan
Primary
Secondary
Concomitant
Sick Sinus Syndrome Other Serious 9/9/2008 48 Male 203 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Syncope Life Threatening 10/17/2008 69 Male 159 lb 12/9/2008 Physician Japan
Primary
Secondary
Concomitant
Periostitis Hospitalization 2/15/2008 79 Male 128 lb 12/23/2008 Physician Japan
Primary
Secondary
Concomitant
Vogt-koyanagi-harada Syndrome Hospitalization 12/21/2007 43 Male 112 lb 12/22/2008 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 2/27/2007 59 Female 88 lb 1/5/2009 Physician Japan
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 11/14/2008 69 Female 121 lb 1/5/2009 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 4/13/2006 35 Female 161 lb 1/6/2009 Physician Japan
Primary
Secondary
Concomitant
Lacunar Infarction Other Serious 6/23/2007 70 Male 141 lb 1/20/2009 Physician Japan
Primary
Secondary
Concomitant
Sick Sinus Syndrome Other Serious 9/9/2008 48 Male 203 lb 1/22/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 1/5/2009 60 Female 1/26/2009 Physician Japan
Primary
Secondary
Concomitant
Sjogren's Syndrome Other Serious 2/27/2007 59 Female 88 lb 2/4/2009 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 2/27/2007 59 Female 88 lb 2/6/2009 Japan
Primary
Secondary
Concomitant
Lacunar Infarction Other Serious 6/23/2007 70 Male 141 lb 3/31/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/1/2009 78 Male 110 lb 4/7/2009 Japan
Primary
Secondary
Concomitant
Endotoxic Shock Death 18 Male 106 lb 4/24/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 4/13/2006 35 Female 161 lb 5/11/2009 Physician Japan
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 6/30/2009 58 Female 151 lb 7/10/2009 Physician Japan
Primary
Secondary
Concomitant
Polyneuropathy Hospitalization 5/25/2009 49 Female 110 lb 7/28/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/30/2009 58 Female 151 lb 8/5/2009 Physician Japan
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 1/5/2009 60 Female 8/7/2009 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 7/28/2007 68 Male 128 lb 11/12/2009 Physician Japan
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 11/16/2009 68 Female 123 lb 2/22/2010 Physician Japan
Primary
Secondary
Concomitant
Schizophrenia Hospitalization 11/16/2009 68 Female 123 lb 3/26/2010 Physician Japan
Primary
Secondary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 3/17/2010 36 Male 159 lb 4/5/2010 Physician Japan
Primary
Secondary
Concomitant
Treatment Noncompliance Other Serious 3/17/2010 36 Male 159 lb 4/27/2010 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 2/27/2007 59 Female 88 lb 5/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Schizophrenia Hospitalization 12/1/2009 68 Female 123 lb 5/26/2010 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 8/10/2009 38 Female 117 lb 7/2/2010 Physician Japan
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Hospitalization 12/9/2009 54 Male 139 lb 7/19/2010 Physician Japan
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Hospitalization 12/9/2009 54 Male 139 lb 8/3/2010 Physician Japan
Primary
Secondary
Concomitant
Ulcerative Keratitis 3/2/2010 63 Female 128 lb 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Psoas Abscess Hospitalization 1/16/2011 69 Male 162 lb 2/3/2011 Physician Japan
Primary
Secondary
Concomitant
Condition Aggravated Hospitalization 12/6/2010 55 Male 163 lb 3/9/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Psoas Abscess Life Threatening 1/13/2011 69 Male 162 lb 3/28/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Hepatic Failure Other Serious 8/10/2009 38 Female 117 lb 4/4/2011 Physician Japan
Primary
Secondary
Concomitant
Meningitis Bacterial Other Serious 1/13/2011 69 Male 162 lb 5/12/2011 Physician Japan
Primary
Secondary
Concomitant
Deafness Unilateral Hospitalization 1/9/2011 64 Female 148 lb 5/24/2011 Physician Japan
Primary
Secondary
Concomitant
Nystagmus Hospitalization 1/9/2011 64 Female 148 lb 6/27/2011 Physician Japan
Primary
Secondary
Concomitant
Encephalopathy Other Serious 10/1/2009 43 Female 123 lb 7/7/2011 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 4/1/2011 41 Female 7/7/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Cheilitis 4/1/2011 41 Female 7/27/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Dissociative Disorder Hospitalization 12/1/2009 68 Female 123 lb 8/26/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatic Encephalopathy Other Serious 8/10/2009 38 Female 117 lb 8/26/2011 Japan
Primary
Secondary
Concomitant
Condition Aggravated Other Serious 10/1/2009 43 Female 123 lb 9/6/2011 Japan
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 10/1/2009 72 Female 99 lb 10/20/2011 Physician Japan
Primary
Concomitant
Osteomyelitis Hospitalization 10/1/2009 72 Female 99 lb 11/9/2011 Physician Japan
Primary
Concomitant
Polyglandular Autoimmune Syndrome Type Ii Other Serious 12/1/2010 66 Male 134 lb 12/22/2011 Japan
Primary
Secondary
Concomitant
Glomerulonephritis Membranous Hospitalization 3/1/2010 65 Male 132 lb 12/30/2011 Physician Japan
Primary
Secondary
Concomitant
Delirium Hospitalization 12/1/2009 68 Female 123 lb 1/4/2012 Physician Japan
Primary
Secondary
Concomitant
Medical Device Complication Hospitalization 10/10/2011 46 Female 174 lb 1/9/2012 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 4/23/2007 60 Female 122 lb 1/24/2012 Physician Japan
Primary
Concomitant
Bacteraemia Hospitalization 10/10/2011 46 Female 174 lb 1/18/2012 Physician Japan
Primary
Secondary
Concomitant
Decreased Appetite Other Serious 2/11/2012 63 Male 2/24/2012 Japan
Primary
Concomitant
Hepatitis B Hospitalization 6/22/2004 38 Female 86 lb 3/1/2012 Physician Japan
Primary
Concomitant
Hyperuricaemia Hospitalization 1/19/2012 53 Female 3/1/2012 Japan
Primary
Concomitant
Hepatic Neoplasm Malignant Recurrent Death 9/21/2005 59 Male 3/5/2012 Japan
Primary
Secondary
Concomitant
Erythema Other Serious 2/27/2012 58 Male 3/9/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Hospitalization 1/31/2012 77 Female 3/26/2012 Other Health Professional Japan
Primary
Concomitant
Sudden Hearing Loss Hospitalization 3/17/2012 68 Female 3/26/2012 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 12/27/2011 61 Female 4/3/2012 Japan
Primary
Concomitant
Dehydration Other Serious 2/11/2012 63 Male 4/8/2012 Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 3/6/2012 52 Male 4/9/2012 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 12/27/2011 61 Female 4/9/2012 Other Health Professional Japan
Primary
Concomitant
Depressive Symptom Other Serious 3/23/2012 57 Female 4/11/2012 Japan
Primary
Concomitant
Renal Impairment Other Serious 69 Male 4/12/2012 Japan
Primary
Concomitant
Haemodialysis Death 3/12/2012 64 Male 141 lb 4/5/2012 Physician Japan
Primary
Secondary
Concomitant
Confusional State Other Serious 40 4/6/2012 Pharmacist Japan
Primary
Secondary
Altered State Of Consciousness Death 3/12/2012 64 Male 141 lb 4/10/2012 Physician Japan
Primary
Secondary
Concomitant
Conjunctival Hyperaemia Hospitalization 3/17/2012 56 Male 148 lb 4/12/2012 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 2/27/2012 58 Male 4/19/2012 Japan
Primary
Concomitant
Rash Other Serious 3/1/2012 60 Male 4/20/2012 Other Health Professional Japan
Primary
Concomitant
Sudden Hearing Loss Hospitalization 2/17/2012 68 Female 4/20/2012 Japan
Primary
Concomitant
Malaise Hospitalization 4/9/2012 64 Female 4/20/2012 Japan
Primary
Concomitant
Decreased Appetite Other Serious 3/9/2012 55 Male 4/24/2012 Other Health Professional Japan
Primary
Concomitant
Cholangitis Death 6/22/2004 38 Female 86 lb 4/24/2012 Physician Japan
Primary
Concomitant
Insomnia Hospitalization 2/9/2012 57 Female 4/24/2012 Japan
Primary
Concomitant
Decreased Appetite Other Serious 3/9/2012 55 Male 4/25/2012 Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 3/9/2012 51 Male 4/26/2012 Japan
Primary
Concomitant
Pleural Effusion Other Serious 3/5/2012 61 Female 4/26/2012 Japan
Primary
Concomitant
Dialysis Death 3/12/2012 64 Male 141 lb 4/24/2012 Physician Japan
Primary
Secondary
Concomitant
Hyperuricaemia Other Serious 2/20/2012 67 Female 117 lb 4/25/2012 Physician Japan
Primary
Secondary
Concomitant
Potentiating Drug Interaction Other Serious 3/13/2012 66 Male 5/1/2012 Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 3/9/2012 51 Male 5/1/2012 Japan
Primary
Concomitant
Renal Impairment Other Serious 3/9/2012 70 Female 5/3/2012 Other Health Professional Japan
Primary
Concomitant
Pyrexia Other Serious 1/25/2012 55 Male 5/7/2012 Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 4/17/2012 68 Male 5/7/2012 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 3/1/2012 51 Male 5/8/2012 Other Health Professional Japan
Primary
Concomitant
Drug Eruption Other Serious 4/26/2012 71 Male 5/8/2012 Japan
Primary
Concomitant
Liver Disorder Other Serious 4/17/2012 68 Male 5/8/2012 Other Health Professional Japan
Primary
Concomitant
Ascites Other Serious 3/5/2012 61 Female 117 lb 5/7/2012 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 3/22/2012 65 Female 5/11/2012 Japan
Primary
Concomitant
Renal Impairment Other Serious 3/13/2012 72 Male 5/14/2012 Japan
Primary
Concomitant
Erythema Other Serious 3/17/2012 56 Male 5/14/2012 Japan
Primary
Concomitant
Erythema Multiforme Other Serious 3/7/2012 42 Male 5/16/2012 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Increased Hospitalization 2/9/2012 57 Female 5/16/2012 Japan
Primary
Concomitant
Retinal Haemorrhage Other Serious 2/16/2012 51 Male 5/16/2012 Other Health Professional Japan
Primary
Concomitant
Drug Eruption Other Serious 2/28/2012 71 Male 5/16/2012 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Hospitalization 3/22/2012 64 Female 5/17/2012 Japan
Primary
Concomitant
Headache Other Serious 4/10/2012 64 Male 5/18/2012 Japan
Primary
Concomitant
Drug Eruption Hospitalization 2/4/2012 55 Female 5/21/2012 Japan
Primary
Concomitant
Dysgeusia Other Serious 2/24/2012 51 Male 5/21/2012 Japan
Primary
Concomitant
Erythema Multiforme Other Serious 3/14/2012 66 Male 5/22/2012 Japan
Primary
Concomitant
Blood Creatinine Increased Hospitalization 3/16/2012 62 Male 5/24/2012 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 2/8/2012 60 Female 5/24/2012 Japan
Primary
Concomitant
Hyperuricaemia Other Serious 2/21/2012 52 Male 5/25/2012 Other Health Professional Japan
Primary
Concomitant
Pneumonia Hospitalization 5/14/2012 70 Male 5/25/2012 Japan
Primary
Concomitant
Blood Uric Acid Increased Hospitalization 1/23/2012 69 Female 104 lb 5/21/2012 Physician Japan
Primary
Secondary
Concomitant
Insomnia Other Serious 5/1/2012 49 Male 5/29/2012 Japan
Primary
Concomitant
Blood Albumin Decreased Death 3/12/2012 64 Male 141 lb 5/15/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 2/22/2012 66 Male 5/30/2012 Japan
Primary
Concomitant
Conjunctival Hyperaemia Hospitalization 3/17/2012 56 Male 148 lb 5/23/2012 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 4/10/2012 64 Male 152 lb 5/23/2012 Physician Japan
Primary
Secondary
Concomitant