Brotizolam combined with Prednisolone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hyperkalaemia Hospitalization 5/2/2005 69 Female 1/17/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 5/2/2005 69 Female 1/26/2006 Physician Japan
Primary
Secondary
Concomitant
Pyelonephritis Acute Hospitalization 10/1/2005 Female 130 lb 2/3/2006 Physician Japan
Primary
Secondary
Concomitant
Ovarian Cancer Hospitalization 7/1/2005 Female 3/9/2006 Physician Japan
Primary
Concomitant
Restlessness Hospitalization 12/15/2005 Female 97 lb 3/21/2006 Physician Japan
Primary
Concomitant
Restlessness Hospitalization 12/15/2005 Female 97 lb 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Pemphigus Hospitalization 9/28/2005 Female 88 lb 5/1/2006 Physician Austria
Primary
Concomitant
Restlessness Hospitalization 12/14/2005 Female 97 lb 5/12/2006 Physician Japan
Primary
Secondary
Concomitant
Muscle Spasms Hospitalization 5/11/2006 74 Male 6/1/2006 Physician Japan
Primary
Concomitant
Rash Other Serious 12/4/2003 Female 108 lb 6/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/6/2004 Female 8/7/2006 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 5/11/2006 74 Male 8/7/2006 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 1/16/2004 Male 132 lb 9/12/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Klebsiella Hospitalization 1/16/2004 Male 132 lb 10/6/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 5/6/2004 Female 12/7/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/10/2006 Female 79 lb 12/13/2006 Physician Japan
Primary
Secondary
Concomitant
Hallucination Other Serious 3/20/2007 77 Female 4/10/2007 Physician Japan
Primary
Secondary
Thrombocytopenia Other Serious 7/9/2007 Female 104 lb 8/2/2007 Physician Japan
Primary
Concomitant
Juvenile Arthritis Life Threatening 9/23/2006 Male 121 lb 8/9/2007 Japan
Primary
Concomitant
Colorectal Cancer Metastatic Other Serious 1/22/2008 Male 2/28/2008 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 12/4/2003 Female 108 lb 3/21/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 3/28/2008 Female 4/17/2008 Germany
Primary
Concomitant
Pneumonia Klebsiella Hospitalization 1/16/2004 Male 132 lb 6/30/2008 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 3/28/2008 Female 8/6/2008 Germany
Primary
Secondary
Concomitant
Weight Increased Other Serious 29 Female 120 lb 10/18/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Fluctuation Other Serious 29 Female 11/17/2008 Japan
Primary
Secondary
Concomitant
Unevaluable Event Hospitalization 94 Female 12/1/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Portal Vein Thrombosis Hospitalization 8/14/2008 12/24/2008 Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 7/31/2008 1/6/2009 Physician Japan
Primary
Concomitant
Ileus Paralytic Other Serious 11/5/2008 1/21/2009 Other Health Professional Japan
Primary
Concomitant
Portal Vein Thrombosis Hospitalization 8/14/2008 2/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Ileus Paralytic Other Serious 11/5/2008 2/20/2009 Other Health Professional Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 10/27/2008 Male 2/26/2009 Japan
Primary
Concomitant
Mouth Haemorrhage Hospitalization 1/18/2009 Female 3/10/2009 Physician Japan
Primary
Concomitant
Interacting
Tongue Neoplasm Malignant Stage Unspecified Other Serious 10/27/2008 Male 6/2/2009 Japan
Primary
Concomitant
Renal Failure Other Serious 4/1/2009 Female 88 lb 6/23/2009 Pharmacist Japan
Primary
Concomitant
Dizziness Other Serious 6/7/2009 Female 7/6/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/9/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/15/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/20/2009 Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 10/27/2008 Male 7/21/2009 Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 10/27/2008 Male 8/11/2009 Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 10/27/2008 Male 8/18/2009 Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 4/11/2009 Female 99 lb 8/21/2009 Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 4/11/2009 Female 99 lb 9/3/2009 Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 4/11/2009 Female 99 lb 9/15/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 9/18/2009 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 5/18/2009 Female 79 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/20/2009 Female 157 lb 10/30/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 5/18/2009 Female 79 lb 11/4/2009 Physician Japan
Primary
Secondary
Concomitant
Skin Ulcer Disability 8/31/2009 Female 11/4/2009 Physician Japan
Primary
Concomitant
Skin Ulcer 7/31/2009 Female 11/16/2009 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 6/25/2009 Female 86 lb 11/17/2009 Japan
Primary
Secondary
Concomitant
Polymyositis Other Serious 7/27/2006 55 Male 163 lb 11/20/2009 Consumer Japan
Primary
Secondary
Concomitant
Cardiac Failure Acute Death 6/10/2009 Female 11/30/2009 Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/20/2009 Female 157 lb 12/10/2009 Physician Japan
Primary
Concomitant
Cardiac Failure Acute Death 6/11/2009 Female 12/21/2009 Japan
Primary
Concomitant
Shock Hospitalization 8/8/2009 Female 90 lb 12/30/2009 Japan
Primary
Concomitant
Shock Hospitalization 8/8/2009 Female 90 lb 1/27/2010 Japan
Primary
Concomitant
Tachycardia Other Serious 6/25/2009 Female 86 lb 2/3/2010 Japan
Primary
Secondary
Concomitant
Shock Hospitalization 8/8/2009 Female 90 lb 2/5/2010 Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Hospitalization 8/20/2009 Female 157 lb 2/19/2010 Physician Japan
Primary
Concomitant
Shock Hospitalization 8/8/2009 Female 90 lb 2/24/2010 Japan
Primary
Concomitant
Dizziness Other Serious 6/7/2009 Female 3/17/2010 Japan
Primary
Concomitant
Shock Hospitalization 8/8/2009 Female 90 lb 3/23/2010 Japan
Primary
Concomitant
Tachycardia Other Serious 6/25/2009 71 Female 86 lb 4/22/2010 Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 4/11/2009 67 Female 99 lb 6/15/2010 Other Health Professional Japan
Primary
Concomitant
Spinal Osteoarthritis Other Serious 3/11/2010 64 Male 121 lb 6/28/2010 Physician Japan
Primary
Concomitant
Spinal Osteoarthritis Other Serious 3/11/2010 64 Male 121 lb 7/12/2010 Physician Japan
Primary
Concomitant
Spinal Osteoarthritis Other Serious 3/11/2010 64 Male 121 lb 7/26/2010 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 6/25/2009 71 Female 86 lb 8/2/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Death 7/17/2009 74 Male 132 lb 8/11/2010 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 6/25/2009 71 Female 86 lb 8/17/2010 Physician Japan
Primary
Secondary
Concomitant
Spinal Osteoarthritis Other Serious 3/11/2010 64 Male 121 lb 8/18/2010 Physician Japan
Primary
Concomitant
Spinal Compression Fracture Hospitalization 2/4/2010 70 Female 9/1/2010 Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 2/4/2010 70 Female 9/21/2010 Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 2/4/2010 70 Female 10/11/2010 Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/17/2009 74 Male 132 lb 10/27/2010 Physician Japan
Primary
Concomitant
Still's Disease Adult Onset Other Serious 1/1/2006 11/5/2010 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 4/11/2009 67 Female 99 lb 12/1/2010 Other Health Professional Japan
Primary
Concomitant
Loss Of Consciousness Hospitalization 11/5/2010 48 Female 90 lb 12/2/2010 Physician Japan
Primary
Concomitant
Loss Of Consciousness Hospitalization 11/5/2010 49 Female 90 lb 12/20/2010 Physician Japan
Primary
Concomitant
Dizziness Other Serious 6/7/2009 49 Female 12/28/2010 Physician Japan
Primary
Concomitant
Memory Impairment Hospitalization 10/28/2010 48 Female 90 lb 1/3/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 10/29/2009 53 Female 159 lb 1/10/2011 Physician Japan
Primary
Concomitant
Herpes Zoster Death 9/3/2010 1/10/2011 Pharmacist Japan
Primary
Concomitant
Gastrointestinal Necrosis Life Threatening 7/15/2009 71 Female 137 lb 1/31/2011 Physician Japan
Primary
Concomitant
Dizziness Other Serious 6/7/2009 49 Female 3/2/2011 Physician Japan
Primary
Concomitant
Systemic Lupus Erythematosus Hospitalization 7/23/2008 36 Female 139 lb 4/7/2011 Physician Japan
Primary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 12/21/2010 69 Male 121 lb 4/14/2011 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 3/31/2011 68 Female 5/6/2011 Physician Japan
Primary
Concomitant
Clostridium Difficile Colitis Hospitalization 3/31/2011 68 Female 5/6/2011 Physician Japan
Primary
Concomitant
Immune System Disorder Other Serious 3/10/2011 90 Female 85 lb 5/26/2011 Physician Japan
Primary
Concomitant
Haemorrhage Subcutaneous Hospitalization 6/1/2010 69 Male 137 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 6/1/2010 69 Male 137 lb 6/8/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 12/20/2010 69 Male 121 lb 6/21/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 3/13/2011 65 Male 119 lb 7/8/2011 Physician Japan
Primary
Concomitant
Enterococcal Sepsis Hospitalization 11/4/2010 77 Male 110 lb 7/22/2011 Physician Japan
Primary
Concomitant
Cryptococcosis Other Serious 9/10/2008 58 Female 134 lb 8/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 7/19/2011 54 Male 8/10/2011 Physician Japan
Primary
Secondary
Concomitant
Thoracic Outlet Syndrome Hospitalization 12/18/2010 42 Female 8/12/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 7/19/2011 54 Male 8/12/2011 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/7/2011 Male 99 lb 8/16/2011 Physician Japan
Primary
Concomitant
Enteritis Infectious Hospitalization 12/18/2010 42 Female 8/18/2011 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 7/19/2011 54 Male 136 lb 8/22/2011 Physician Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Death 12/28/2010 83 Female 99 lb 8/26/2011 Physician Japan
Primary
Concomitant
Diarrhoea Hospitalization Female 90 lb 9/7/2011 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 2/7/2011 Male 99 lb 9/8/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 7/19/2011 54 Male 136 lb 9/14/2011 Physician Japan
Primary
Secondary
Concomitant
Sick Sinus Syndrome Other Serious 1/1/2011 70 Female 9/28/2011 Physician Japan
Primary
Concomitant
Atrial Fibrillation Other Serious 8/27/2011 71 Female 9/30/2011 Physician Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 10/7/2011 Japan
Primary
Secondary
Concomitant
Thoracic Outlet Syndrome Hospitalization 12/18/2010 42 Female 10/20/2011 Physician Japan
Primary
Concomitant
Oedema Peripheral Hospitalization 12/28/2010 83 Female 99 lb 10/21/2011 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 3/13/2011 65 Male 119 lb 11/2/2011 Physician Japan
Primary
Concomitant
Intestinal Stenosis Hospitalization 5/2/2011 33 Female 90 lb 11/4/2011 Physician Japan
Primary
Concomitant
Convulsion Other Serious 10/16/2011 78 Male 11/23/2011 Consumer Japan
Primary
Secondary
Concomitant
Lymphocyte Count Decreased Hospitalization 8/4/2011 70 Female 11/29/2011 Other Health Professional Japan
Primary
Concomitant
Infection Disability 4/28/2010 19 Female 115 lb 11/29/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 9/23/2011 66 Female 139 lb 12/21/2011 Physician Japan
Primary
Concomitant
Enteritis Infectious Hospitalization 12/18/2010 42 Female 12/22/2011 Physician Japan
Primary
Concomitant
Convulsion Other Serious 10/16/2011 78 Male 12/26/2011 Consumer Japan
Primary
Secondary
Concomitant
Migraine Hospitalization 12/18/2010 42 Female 12/27/2011 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 2/7/2011 Male 99 lb 12/28/2011 Physician Japan
Primary
Concomitant
Diarrhoea Hospitalization 5/2/2011 33 Female 90 lb 12/30/2011 Physician Japan
Primary
Concomitant
Anaemia Hospitalization 9/22/2011 48 Male 88 lb 1/25/2012 Physician Japan
Primary
Concomitant
B-cell Lymphoma Hospitalization 1/21/2011 57 Female 115 lb 2/9/2012 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 11/4/2010 77 Male 110 lb 2/28/2012 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Hospitalization 1/21/2011 57 Female 115 lb 3/12/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/28/2011 22 Female 106 lb 3/12/2012 Physician Japan
Primary
Secondary
Concomitant
Atrial Flutter Death 6/16/2009 61 Male 3/13/2012 Physician Japan
Primary
Secondary
Concomitant
Depression Death 11/6/2009 46 Male 132 lb 3/14/2012 Physician Japan
Primary
Concomitant
Rash 6/1/2011 22 Female 106 lb 3/16/2012 Physician Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Death 11/11/2010 85 Male 128 lb 3/18/2012 Consumer Japan
Primary
Concomitant
Eosinophilic Pneumonia Hospitalization 9/1/2011 67 Male 163 lb 3/21/2012 Physician Japan
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Disability 4/28/2010 19 Female 115 lb 3/21/2012 Physician Japan
Primary
Concomitant
Hypoalbuminaemia Other Serious 8/19/2009 65 Female 121 lb 3/23/2012 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Other Serious 8/19/2009 65 Female 121 lb 3/26/2012 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 12/1/2008 83 Male 125 lb 3/27/2012 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Death 6/16/2009 61 Male 3/30/2012 Physician Japan
Primary
Secondary
Concomitant
Staphylococcus Test Positive Hospitalization 12/1/2008 83 Male 125 lb 4/5/2012 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 8/26/2010 30 Female 4/16/2012 Physician Japan
Primary
Concomitant
Rash 6/30/2011 22 Female 106 lb 4/23/2012 Physician Japan
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 9/1/2011 67 Male 163 lb 5/2/2012 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal 2/8/2012 35 Male 5/14/2012 Physician Japan
Primary
Concomitant
Cellulitis Life Threatening 9/1/2011 67 Male 163 lb 5/24/2012 Physician Japan
Primary
Secondary
Concomitant
Alopecia 6/30/2011 22 Female 106 lb 5/29/2012 Physician Japan
Primary
Secondary
Concomitant
Fractured Coccyx Hospitalization 8/26/2010 30 Female 6/21/2012 Physician Japan
Primary
Concomitant
Subarachnoid Haemorrhage Hospitalization 8/10/2010 57 Female 146 lb 6/27/2012 Physician Japan
Primary
Concomitant

Drug Data