Biofermin combined with Mucosta

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Disability 12/21/2005 75 Male 143 lb 1/5/2006 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Hospitalization 2/5/2004 Female 119 lb 1/9/2006 Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Hospitalization 2/5/2004 Female 119 lb 1/12/2006 Japan
Primary
Secondary
Concomitant
Vomiting Disability 12/21/2005 75 Male 143 lb 1/24/2006 Physician Japan
Primary
Concomitant
Vomiting Disability 12/21/2005 75 Male 143 lb 2/1/2006 Physician Japan
Primary
Concomitant
Rhabdomyolysis Other Serious 12/15/2005 39 Male 2/9/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 2/5/2004 Female 119 lb 2/10/2006 Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Hospitalization 2/5/2004 Female 119 lb 2/14/2006 Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 12/15/2005 39 Male 2/15/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 12/15/2005 39 Male 2/23/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Viral Infection Life Threatening 2/2/2006 74 Female 2/23/2006 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Life Threatening 2/2/2006 74 Female 3/17/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 12/22/2003 36 Female 110 lb 3/20/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/8/2006 26 Female 5/17/2006 Physician Japan
Primary
Secondary
Drug Eruption Hospitalization 4/21/2006 68 Female 5/25/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/8/2006 26 Female 106 lb 5/30/2006 Physician Japan
Primary
Secondary
White Blood Cell Count Decreased Other Serious 5/8/2006 26 Female 106 lb 6/2/2006 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 11/9/2006 Female 110 lb 11/17/2006 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 11/9/2006 Female 110 lb 12/4/2006 Physician Japan
Primary
Secondary
Concomitant
Leukopenia Other Serious 9/29/2006 57 Female 3/30/2007 Physician Japan
Primary
Secondary
Concomitant
Infusion Related Reaction Other Serious 3/12/2007 Female 97 lb 4/10/2007 Physician Japan
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 2/11/2007 71 Female 123 lb 5/14/2007 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 12/22/2003 36 Female 110 lb 5/24/2007 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 6/21/2007 80 Male 7/5/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/17/2006 62 Female 7/27/2007 Japan
Primary
Secondary
Atrial Fibrillation Other Serious 2/11/2007 71 Female 123 lb 8/10/2007 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 6/19/2007 Male 10/4/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Toothache Other Serious 7/4/2006 44 Female 11/1/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Shock Hospitalization 10/17/2007 83 Female 11/14/2007 Pharmacist Japan
Primary
Concomitant
Hypotension Hospitalization 10/19/2007 13 Female 11/27/2007 Physician Japan
Primary
Concomitant
Hypotension Hospitalization 10/19/2007 13 Female 11/28/2007 Physician Japan
Primary
Concomitant
Toothache Other Serious 7/4/2006 44 Female 12/6/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Shock Hospitalization 10/17/2007 83 Female 82 lb 12/19/2007 Pharmacist Japan
Primary
Concomitant
Speech Disorder Hospitalization 10/17/2007 83 Female 82 lb 12/27/2007 Pharmacist Japan
Primary
Concomitant
Intestinal Ischaemia Hospitalization 11/21/2007 73 Female 1/25/2008 Physician Japan
Primary
Secondary
Infusion Related Reaction 3/12/2007 Female 97 lb 2/11/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 11/19/2007 39 Female 2/22/2008 Pharmacist Japan
Primary
Concomitant
Listeria Sepsis Hospitalization 1/19/2007 Female 79 lb 3/7/2008 Physician Japan
Primary
Secondary
Concomitant
Hypotension Other Serious 10/19/2007 13 Female 108 lb 3/11/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 11/19/2007 39 Female 3/12/2008 Other Health Professional Japan
Primary
Concomitant
Lumbar Vertebral Fracture Hospitalization 11/1/2007 Female 146 lb 4/11/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 3/1/2008 Female 4/25/2008 Pharmacist Japan
Primary
Concomitant
Rash Hospitalization 3/30/2008 Female 121 lb 4/25/2008 Physician Japan
Primary
Concomitant
Rash Hospitalization 3/30/2008 Female 121 lb 5/2/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 3/24/2008 Female 5/30/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Rash Hospitalization 3/30/2008 Female 121 lb 6/5/2008 Physician Japan
Primary
Concomitant
Rash Hospitalization 3/30/2008 Female 121 lb 6/16/2008 Physician Japan
Primary
Concomitant
Death Death Female 88 lb 6/18/2008 Physician Japan
Primary
Concomitant
Stevens-johnson Syndrome Other Serious 5/20/2008 Male 7/11/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Interacting
Stevens-johnson Syndrome Other Serious 5/20/2008 Male 7/22/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Interacting
Immune Reconstitution Syndrome Other Serious 1/18/2008 43 Male 8/14/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 12/12/2007 43 Male 8/19/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 12/12/2007 Male 8/20/2008 Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 12/12/2007 Male 8/26/2008 Japan
Primary
Concomitant
Sudden Hearing Loss Hospitalization 10/15/2008 Female 97 lb 10/29/2008 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 12/12/2007 Male 10/30/2008 Japan
Primary
Concomitant
Uterine Leiomyoma Other Serious 4/23/2008 56 Female 11/3/2008 Other Health Professional Japan
Primary
Concomitant
Sudden Hearing Loss Hospitalization 10/15/2008 Female 97 lb 11/7/2008 Other Health Professional Japan
Primary
Concomitant
Uterine Leiomyoma Other Serious 4/23/2008 56 Female 11/18/2008 Other Health Professional Japan
Primary
Concomitant
Unresponsive To Stimuli Other Serious 11/14/2008 69 Female 121 lb 12/3/2008 Physician Japan
Primary
Secondary
Concomitant
Death Death 1/1/2008 71 Male 12/29/2008 Physician Japan
Primary
Concomitant
Unresponsive To Stimuli Other Serious 11/14/2008 69 Female 121 lb 1/5/2009 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 12/1/2008 60 Female 1/16/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 9/29/2008 Male 106 lb 1/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 4/1/2008 60 Female 2/23/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 11/9/2006 Female 110 lb 2/27/2009 Physician Japan
Primary
Secondary
Concomitant
Myalgia Other Serious 63 Male 3/30/2009 Pharmacist Japan
Primary
Concomitant
Renal Disorder Other Serious 10/10/2008 32 Female 137 lb 4/1/2009 Physician Japan
Primary
Secondary
Concomitant
Myalgia Other Serious 63 Male 4/2/2009 Pharmacist Japan
Primary
Concomitant
Somnolence Hospitalization 3/5/2009 Female 101 lb 4/9/2009 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 3/5/2009 Female 101 lb 4/28/2009 Pharmacist Japan
Primary
Concomitant
Gastric Cancer Other Serious 6/9/2009 61 Male 152 lb 6/15/2009 Physician Japan
Primary
Secondary
Concomitant
Psychiatric Symptom Hospitalization 5/22/2009 41 Female 101 lb 7/23/2009 Other Health Professional Japan
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 7/29/2009 Female 8/19/2009 Physician Japan
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 7/29/2009 Female 8/28/2009 Physician Japan
Primary
Secondary
Concomitant
Sensory Disturbance Other Serious 7/31/2009 Female 9/2/2009 Other Health Professional Japan
Primary
Secondary
Pulmonary Embolism Hospitalization 10/15/2009 74 Male 10/27/2009 Physician Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/15/2009 74 Male 10/30/2009 Physician Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/15/2009 74 Male 134 lb 11/16/2009 Physician Japan
Primary
Concomitant
Rash Hospitalization 10/8/2009 Female 88 lb 12/9/2009 Physician Japan
Primary
Secondary
Concomitant
Rectal Ulcer Life Threatening 7/7/2009 62 Male 150 lb 12/28/2009 Physician Japan
Primary
Concomitant
Hypoglycaemia Other Serious 12/16/2009 54 Male 12/30/2009 Japan
Primary
Concomitant
Rash Hospitalization 10/8/2009 Female 88 lb 1/12/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 10/8/2009 Female 88 lb 1/14/2010 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 8/3/2009 Female 121 lb 1/19/2010 Physician Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/15/2009 74 Male 134 lb 1/22/2010 Physician Japan
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/15/2009 74 Male 134 lb 1/26/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 1/14/2010 78 Male 2/1/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 6/20/2008 62 Male 119 lb 2/9/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 1/12/2010 79 Male 90 lb 2/15/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 8/3/2009 Female 121 lb 2/25/2010 Physician Japan
Primary
Concomitant
Suicide Attempt Life Threatening 35 Female 3/3/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/12/2010 78 Male 90 lb 3/4/2010 Physician Japan
Primary
Concomitant
Retinal Vein Occlusion Other Serious 84 Female 75 lb 3/10/2010 Consumer Japan
Primary
Concomitant
Vomiting Life Threatening 1/4/2008 45 Female 3/12/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 2/22/2010 76 Male 3/16/2010 Other Health Professional Japan
Primary
Concomitant
Retinal Vein Occlusion Other Serious 84 Female 75 lb 3/30/2010 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 2/22/2010 Male 93 lb 3/31/2010 Other Health Professional Japan
Primary
Concomitant
Sensory Disturbance Other Serious 7/31/2009 43 Female 4/6/2010 Other Health Professional Japan
Primary
Secondary
Herpes Zoster Hospitalization 3/26/2010 61 Female 112 lb 4/7/2010 Physician Japan
Primary
Secondary
Concomitant
Thirst Other Serious 9/8/2009 71 Male 4/9/2010 Physician Japan
Primary
Concomitant
Pleural Effusion Other Serious 6/17/2009 62 Male 119 lb 4/20/2010 Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 3/26/2010 61 Female 112 lb 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Retinal Vein Occlusion Other Serious 84 Female 75 lb 4/30/2010 Physician Japan
Primary
Concomitant
Respiratory Depression Life Threatening 5/7/2010 80 Female 5/16/2010 Physician Japan
Primary
Concomitant
Skin Exfoliation Other Serious 7/7/2009 62 Male 150 lb 5/19/2010 Physician Japan
Primary
Concomitant
Respiratory Depression Other Serious 5/7/2010 80 Female 6/14/2010 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome 6/20/2008 62 Male 119 lb 6/29/2010 Physician Japan
Primary
Concomitant
Diarrhoea Life Threatening 12/8/2009 83 Female 68 lb 7/6/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Depression Other Serious 5/7/2010 80 Female 7/15/2010 Physician Japan
Primary
Concomitant
Diarrhoea Life Threatening 12/8/2009 83 Female 68 lb 7/16/2010 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 62 Male 130 lb 7/23/2010 Physician Japan
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 1/22/2010 76 Male 141 lb 7/30/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 5/3/2010 76 Male 8/11/2010 Physician Japan
Primary
Concomitant
Arthritis Bacterial Hospitalization 4/18/2010 76 Female 104 lb 8/27/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 62 Male 130 lb 8/30/2010 Physician Japan
Primary
Concomitant
Stomatitis Other Serious 5/3/2010 76 Male 9/16/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 62 Male 130 lb 9/20/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 62 Male 130 lb 10/5/2010 Physician Japan
Primary
Concomitant
Completed Suicide Death 8/24/2010 74 Female 88 lb 10/7/2010 Physician Japan
Primary
Concomitant
Completed Suicide Death 8/24/2010 74 Female 88 lb 10/8/2010 Physician Japan
Primary
Concomitant
Sinoatrial Block Hospitalization 9/16/2010 26 Female 60 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Sinoatrial Block Hospitalization 9/16/2010 26 Female 60 lb 10/12/2010 Physician Japan
Primary
Secondary
Concomitant
Completed Suicide Death 8/24/2010 74 Female 88 lb 10/19/2010 Physician Japan
Primary
Concomitant
Osteomyelitis Hospitalization 10/9/2010 61 Female 112 lb 10/21/2010 Physician Japan
Primary
Secondary
Concomitant
Sinoatrial Block Hospitalization 9/16/2010 26 Female 60 lb 10/22/2010 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 8/23/2010 72 Female 128 lb 10/28/2010 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 1/1/2010 62 Male 130 lb 11/4/2010 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 8/23/2010 72 Female 128 lb 11/5/2010 Physician Japan
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 4/7/2010 61 Female 112 lb 11/9/2010 Physician Japan
Primary
Secondary
Concomitant
Hyponatraemia Other Serious 9/21/2010 80 Female 11/24/2010 Physician
Primary
Concomitant
Malaise Hospitalization 8/3/2009 60 Female 121 lb 12/13/2010 Physician Japan
Primary
Concomitant
Osteomyelitis Hospitalization 4/7/2010 61 Female 112 lb 12/29/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 1/1/2010 12/31/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 1/1/2010 76 Male 132 lb 2/2/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Death 11/9/2010 72 Male 126 lb 2/3/2011 Physician Japan
Primary
Concomitant
Pain In Jaw Hospitalization 12/24/2010 63 Female 179 lb 2/4/2011 Physician Japan
Primary
Concomitant
Haematochezia Hospitalization 12/14/2010 54 Male 165 lb 2/7/2011 Physician Japan
Primary
Concomitant
Osteonecrosis Of Jaw Hospitalization 12/12/2010 63 Female 179 lb 2/21/2011 Other Health Professional Japan
Primary
Concomitant
Cervix Carcinoma Hospitalization 8/28/2010 48 Female 141 lb 3/4/2011 Physician Japan
Primary
Concomitant
Oral Disorder Hospitalization 9/22/2010 69 Female 123 lb 3/8/2011 Physician Japan
Primary
Concomitant
Cervix Carcinoma Hospitalization 8/28/2010 48 Female 141 lb 3/14/2011 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 6/30/2009 57 Female 121 lb 3/16/2011 Physician Japan
Primary
Concomitant
Haematochezia Hospitalization 12/14/2010 54 Male 165 lb 3/21/2011 Physician Japan
Primary
Concomitant
Haematochezia Hospitalization 12/14/2010 54 Male 165 lb 4/25/2011 Physician Japan
Primary
Concomitant
Hyperkalaemia Death 11/9/2010 72 Male 126 lb 4/27/2011 Physician Japan
Primary
Concomitant
Rash Death 10/1/2009 80 Male 110 lb 5/25/2011 Physician Japan
Primary
Concomitant
Haematochezia Hospitalization 12/14/2010 54 Male 165 lb 6/1/2011 Physician Japan
Primary
Concomitant
Lung Disorder Hospitalization 2/17/2011 65 Female 79 lb 6/13/2011 Physician Japan
Primary
Concomitant
Malaise Hospitalization 8/3/2009 60 Female 121 lb 6/15/2011 Physician Japan
Primary
Concomitant

Drug Data