Baktar combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Disability 11/4/2005 9 Male 53 lb 3/29/2006 Physician Japan
Primary
Concomitant
Urticaria Other Serious 11/27/2003 Female 95 lb 4/20/2006 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 4/26/2006 Female 123 lb 6/6/2006 Physician Japan
Primary
Secondary
Concomitant
Mucous Membrane Disorder Hospitalization 8/26/2004 8 Male 51 lb 7/21/2006 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/26/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/20/2006 Male 117 lb 3/9/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/20/2006 Male 117 lb 3/22/2007 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Life Threatening 7/29/2005 89 Female 3/29/2007 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Life Threatening 7/29/2005 89 Female 4/11/2007 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 45 Male 143 lb 4/13/2007 Physician Japan
Primary
Concomitant
Platelet Count Decreased Life Threatening 12/18/2006 20 Male 115 lb 8/2/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/27/2007 8 Male 44 lb 8/27/2007 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 10/2/2006 45 Male 143 lb 8/31/2007 Physician Japan
Primary
Concomitant
Metastases To Skin Life Threatening 12/18/2006 20 Male 115 lb 1/4/2008 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 7/17/2007 65 Male 161 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/20/2007 Male 117 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Quadriplegia Hospitalization 12/7/2007 Female 126 lb 4/2/2008 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 7/30/2007 Male 141 lb 4/3/2008 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 8/26/2005 Female 71 lb 5/7/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 5/9/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Death 7/17/2007 65 Male 161 lb 5/20/2008 Physician Japan
Primary
Secondary
Concomitant
Productive Cough Other Serious 1/1/2008 54 Male 6/27/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/20/2007 Male 117 lb 7/1/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 7/16/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/27/2007 8 Male 44 lb 12/9/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 7/30/2007 Male 141 lb 2/2/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/19/2008 Male 48 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/25/2008 18 Male 128 lb 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 2/20/2009 Physician Japan
Primary
Concomitant
Sepsis Other Serious 10/3/2008 60 Female 106 lb 3/12/2009 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/20/2008 45 Male 128 lb 3/12/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 9/28/2008 59 Female 123 lb 3/16/2009 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 10/24/2008 2 Male 27 lb 3/18/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/2/2008 19 Male 110 lb 3/20/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 6/26/2008 49 4/6/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 6/20/2008 62 Female 108 lb 4/27/2009 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 10/20/2008 Male 154 lb 5/14/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 12/19/2008 59 Male 123 lb 5/28/2009 Japan
Primary
Secondary
Concomitant
Ovarian Cancer Hospitalization 2/18/2009 Female 119 lb 6/19/2009 Physician Japan
Primary
Concomitant
Ovarian Epithelial Cancer Hospitalization 2/18/2009 Female 119 lb 6/25/2009 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 10/20/2008 Male 154 lb 6/29/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 9/19/2006 9 Male 51 lb 7/10/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/27/2007 8 Male 44 lb 7/27/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/23/2008 59 Female 123 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/14/2009 62 Male 8/17/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/19/2008 Male 48 lb 8/31/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 6/9/2008 62 Male 154 lb 9/1/2009 Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 6/20/2008 62 Female 108 lb 9/24/2009 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 9/24/2008 57 Female 104 lb 9/25/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 6/4/2008 62 Male 154 lb 10/7/2009 Physician Japan
Primary
Secondary
Concomitant
Rash Life Threatening 2/27/2009 57 Male 126 lb 10/26/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/14/2009 62 Male 11/20/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 6/4/2008 62 Male 154 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Oesophageal Carcinoma Other Serious 27 Male 11/25/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 7/30/2007 Male 141 lb 12/23/2009 Physician Japan
Primary
Secondary
Concomitant
Ovarian Epithelial Cancer Hospitalization 2/18/2009 Female 119 lb 1/5/2010 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Other Serious 11/16/2009 Female 1/21/2010 Physician Japan
Primary
Concomitant
Rash Generalised Life Threatening 4/1/2008 55 Male 126 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Ovarian Epithelial Cancer Hospitalization 2/18/2009 Female 119 lb 2/12/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 7/30/2007 Male 141 lb 2/25/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 11/4/2008 Male 150 lb 2/25/2010 Japan
Primary
Secondary
Concomitant
Ovarian Epithelial Cancer Hospitalization 2/18/2009 Female 119 lb 3/1/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 9/25/2008 39 Male 157 lb 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/2/2008 28 Female 112 lb 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
Uterine Cancer Hospitalization 12/21/2009 Female 99 lb 3/11/2010 Other Health Professional Japan
Primary
Secondary
Pyrexia Hospitalization 1/3/2010 Female 90 lb 3/12/2010 Physician Japan
Primary
Secondary
Concomitant
Interacting
Pneumocystis Jiroveci Pneumonia Other Serious 4/26/2006 56 Female 123 lb 9/20/2010 Physician Japan
Primary
Secondary
Concomitant
Hodgkin's Disease Stage Iv Other Serious 8/31/2009 73 Female 157 lb 9/21/2010 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Rash Other Serious 1/7/2010 68 Female 95 lb 9/29/2010 Physician Japan
Primary
Concomitant
Synovitis Hospitalization 11/29/2009 67 Male 10/8/2010 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 6/26/2006 54 Female 115 lb 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 10/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/8/2009 58 Female 106 lb 11/2/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 7/21/2010 75 Male 137 lb 11/8/2010 Physician Japan
Primary
Secondary
Concomitant
Hodgkin's Disease Stage Iv Other Serious 8/31/2009 73 Female 157 lb 11/9/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Life Threatening 10/8/2009 12 Male 92 lb 11/11/2010 Physician Japan
Primary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant
Respiratory Disorder Life Threatening 10/10/2009 12 Male 92 lb 12/6/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 10/28/2009 7 Male 49 lb 12/7/2010 Physician Japan
Primary
Secondary
Concomitant
Mouth Haemorrhage Death 4/25/2009 4 Female 32 lb 12/8/2010 Physician Japan
Primary
Secondary
Concomitant
Uterine Cancer Hospitalization 12/21/2009 47 Female 99 lb 12/15/2010 Other Health Professional Japan
Primary
Secondary
Pneumonia Cytomegaloviral Life Threatening 10/16/2002 51 Male 154 lb 12/20/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/18/2010 5 Female 53 lb 12/21/2010 Physician Japan
Primary
Concomitant
Acute Respiratory Distress Syndrome Life Threatening 11/11/2007 12 Female 80 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/13/2010 58 Male 121 lb 1/6/2011 Physician Japan
Primary
Secondary
Concomitant
Glossitis Hospitalization 9/13/2010 58 Male 121 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 10/16/2002 51 Male 154 lb 1/12/2011 Physician Japan
Primary
Concomitant
Gastric Cancer Other Serious 7/21/2010 75 Male 137 lb 1/12/2011 Physician Japan
Primary
Secondary
Concomitant
Infection Death 4/25/2009 4 Female 32 lb 1/24/2011 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Haematoma Hospitalization 12/8/2010 77 Male 1/27/2011 Other Health Professional Japan
Primary
Concomitant
Pneumonia Life Threatening 4/22/2007 41 Male 132 lb 2/4/2011 Physician Japan
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Rash Hospitalization 1/7/2010 68 Female 95 lb 2/7/2011 Physician Japan
Primary
Concomitant
Drug Eruption Hospitalization 12/8/2010 77 Male 170 lb 2/9/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Life Threatening 2/14/2008 17 Female 134 lb 2/9/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Eruption Hospitalization 12/8/2010 77 Male 170 lb 2/11/2011 Other Health Professional Japan
Primary
Concomitant
Cardiac Failure Death 7/25/2010 60 Female 93 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Hospitalization 3/27/2010 23 Male 117 lb 2/14/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/18/2010 5 Female 53 lb 2/23/2011 Physician Japan
Primary
Concomitant
Systemic Mycosis Hospitalization 4/22/2007 41 Male 132 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Death 3/12/2009 16 Male 82 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 11/7/2008 59 Male 148 lb 3/11/2011 Physician Japan
Primary
Concomitant
Enterococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 3/9/2009 16 Male 82 lb 3/14/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 11/7/2010 59 Male 99 lb 3/31/2011 Physician Japan
Primary
Concomitant
Blood Creatinine Increased Death 6/30/2002 16 Female 73 lb 4/6/2011 Physician Japan
Primary
Secondary
Concomitant
Mucous Membrane Disorder Disability 3/23/2010 Female 123 lb 4/12/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Disability 10/4/2010 20 Female 106 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Death 8/30/2002 6 Male 35 lb 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 8/19/2009 55 Female 121 lb 4/13/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Death 2/18/2009 56 Female 128 lb 4/14/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Bilirubin Increased Death 6/2/2007 47 Male 119 lb 4/14/2011 Physician Japan
Primary
Secondary
Concomitant
Melaena Other Serious 10/18/2009 48 Female 97 lb 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 7/25/2010 60 Female 93 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 9/4/2010 Male 33 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 1/7/2010 68 Female 95 lb 4/25/2011 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/13/2010 58 Male 121 lb 4/25/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Acute Death 6/30/2002 16 Female 73 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Cystitis Disability 1/11/2005 7 Male 55 lb 4/28/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 8/19/2009 55 Female 121 lb 5/2/2011 Physician Japan
Primary
Concomitant
Sepsis Death 6/30/2002 16 Female 73 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 8/30/2002 6 Male 35 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Blood Creatine Increased Death 5/29/2007 47 Male 119 lb 5/5/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 4/22/2007 41 Male 132 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 2/18/2009 56 Female 128 lb 5/6/2011 Physician Japan
Primary
Secondary
Concomitant
Diabetes Mellitus Hospitalization 5/28/2010 54 Female 104 lb 5/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Gastric Cancer Hospitalization 7/21/2010 75 Male 137 lb 5/12/2011 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Death 6/6/2011 13 Female 88 lb 11/8/2011 Physician Japan
Primary
Concomitant
Blood Creatinine Increased Life Threatening 10/8/2011 20 Female 6/27/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Interacting
Septic Shock Other Serious 4/14/2009 68 Female 3/29/2013 Physician Jp
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 1/11/2011 Male 9/4/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Other Serious 1/5/2011 75 Female 10/18/2012 Consumer Jp
Primary
Secondary
Concomitant
Skin Cancer Metastatic Hospitalization 12/4/2009 52 Female 8/29/2012 Physician Jp
Primary
Concomitant
Premature Labour Other Serious 7/1/2011 24 Female 1/2/2013 Physician Jp
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/8/2007 8/31/2012 Consumer Jp
Primary
Secondary
Concomitant
Vomiting Other Serious 4/25/2012 4 Female 22 lb 11/1/2012 Physician Jp
Primary
Concomitant
Lymphoma Other Serious 9/12/2012 63 Male 170 lb 2/21/2013 Physician Jp
Primary
Concomitant
Sepsis Hospitalization 5/10/2004 75 Male 1/7/2013 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Atypical Femur Fracture Other Serious 8/10/2012 49 Female 10/25/2012 Consumer Jp
Primary
Concomitant
Weight Decreased Hospitalization 1/31/2011 65 Male 121 lb 11/8/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Intestinal Perforation Hospitalization 9/2011 Female 3/14/2013 Physician Jp
Primary
Concomitant
Tremor Other Serious 5/21/2009 Male 68 lb 1/30/2013 Physician Jp
Primary
Concomitant

Drug Data