Lactulose combined with Metronidazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 8/24/2004 65 9/12/2005 Physician United States
Primary
Concomitant
International Normalised Ratio Increased 11/29/2004 9/12/2005 Physician United States
Primary
Concomitant
Venoocclusive Disease Life Threatening 11/23/2005 63 Female 121 lb 1/12/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sinus Bradycardia Other Serious 1/1/2004 68 Female 2/3/2006 Physician United States
Primary
Secondary
Concomitant
Sinus Bradycardia Other Serious 1/8/2005 69 Female 4/7/2006 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 10/31/2005 45 Female 7/28/2006 Physician Germany
Primary
Secondary
Concomitant
Psychotic Disorder 5/23/2006 Male 152 lb 8/17/2006 Pharmacist United States
Primary
Concomitant
Tachycardia Hospitalization 8/23/2006 Male 154 lb 9/20/2006 Pharmacist United States
Primary
Concomitant
Proctalgia Other Serious 10/6/2006 70 Male 172 lb 10/24/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Perianal Abscess Other Serious 10/6/2006 70 Male 172 lb 11/6/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 10/14/2006 11 Female 60 lb 11/30/2006 Physician Canada
Primary
Concomitant
Pneumonia Required Intervention 7/23/2006 68 Female 148 lb 7/28/2006 Pharmacist United States
Primary
Secondary
Concomitant
Septic Shock Life Threatening 7/25/2006 Female 119 lb 3/26/2007 Physician Belgium
Primary
Secondary
Concomitant
Hepatitis Other Serious 2/15/2007 Female 4/17/2007 Physician Germany
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 3/13/2006 59 Male 4/20/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Hepatitis Other Serious 2/15/2007 64 Female 238 lb 4/24/2007 Physician Germany
Primary
Concomitant
Peritonitis Sclerosing Hospitalization 3/13/2006 59 Male 5/4/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Nausea Death 4/3/2007 41 Male 152 lb 5/2/2007 Other Health Professional United States
Primary
Concomitant
Small Intestinal Haemorrhage Life Threatening 4/24/2005 44 Female 5/9/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/5/2006 52 Male 5/21/2007 Physician United States
Primary
Secondary
Concomitant
Vein Disorder Death 4/16/2007 65 Female 154 lb 6/8/2007 Pharmacist United States
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 5/1/2007 50 Female 220 lb 6/21/2007 Other Health Professional United Kingdom
Primary
Concomitant
Hepatic Failure Life Threatening 5/30/2007 62 Female 7/17/2007 Other Health Professional France
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 5/1/2007 50 Female 7/6/2007 United Kingdom
Primary
Concomitant
Seroma Hospitalization 4/20/2006 Female 152 lb 9/6/2007 Physician Switzerland
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/23/2007 Male 192 lb 10/17/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 10/14/2006 11 Female 60 lb 11/8/2007 Physician Canada
Primary
Secondary
Concomitant
Septic Shock Life Threatening 8/6/2007 53 Male 11/20/2007 Germany
Primary
Concomitant
Epistaxis Hospitalization 10/31/2007 57 Female 231 lb 1/16/2008 Consumer United Kingdom
Primary
Concomitant
Jaundice Hospitalization 10/15/2007 Female 126 lb 5/12/2008 Physician Denmark
Primary
Concomitant
Jaundice Cholestatic Death 8/1/2008 65 Female 8/26/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Jaundice Cholestatic Death 8/1/2008 65 Female 8/28/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Rash Maculo-papular Hospitalization 7/26/2008 9/8/2008 Other Health Professional United Kingdom
Primary
Concomitant
Prothrombin Time Prolonged Other Serious 8/23/2008 89 Male 132 lb 9/16/2008 Other Health Professional United Kingdom
Primary
Concomitant
Gastric Perforation Hospitalization 9/5/2008 Male 115 lb 9/30/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Renal Failure Acute Required Intervention 8/18/2008 48 Male 243 lb 10/1/2008 United States
Primary
Concomitant
Hepatitis Fulminant Life Threatening 40 Female 2/17/2009
Primary
Concomitant
Vomiting Other Serious 1/6/2009 11 Male 84 lb 4/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Death 1/15/2009 11 Male 4/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 1/6/2009 11 Male 82 lb 5/6/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Injury Other Serious 1/29/2007 59 Female 6/4/2009 Physician Korea, Republic Of
Primary
Concomitant
Urinoma Hospitalization 11/13/2004 Male 163 lb 6/23/2009 Physician Canada
Primary
Secondary
Concomitant
Splenomegaly Other Serious 1/29/2007 59 Female 7/7/2009 Korea, Republic Of
Primary
Secondary
Concomitant
Ureteric Stenosis Required Intervention 7/10/2003 69 Male 8/13/2009 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 7/5/2009 Male 8/31/2009 Netherlands
Primary
Concomitant
Hyperaesthesia Other Serious 62 Male 9/2/2009 Other Health Professional Bulgaria
Primary
Secondary
Concomitant
Depressed Level Of Consciousness Other Serious 8/5/2009 75 Male 9/4/2009 Physician Iran (Islamic Republic Of)
Primary
Concomitant
Myoclonus Other Serious 5/10/2009 60 Male 8/18/2009 Physician United Kingdom
Primary
Concomitant
Mental Status Changes Other Serious 1/29/2007 59 Female 8/31/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 7/27/2009 77 Female 9/16/2009 Pharmacist Ireland
Primary
Concomitant
Ballismus Hospitalization 59 Female 9/29/2009 Other Health Professional Korea, Republic Of
Primary
Concomitant
Mental Impairment Other Serious 59 Female 10/5/2009 Other Health Professional Korea, Republic Of
Primary
Concomitant
Myoclonus Other Serious 60 Male 8/18/2009 Physician United Kingdom
Primary
Concomitant
Vomiting Other Serious 1/6/2009 11 Male 84 lb 1/20/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Myoclonus Other Serious 60 Male 1/21/2010 Physician Chile
Primary
Concomitant
Sepsis Death 1/15/2009 11 Male 83 lb 1/29/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pancytopenia Other Serious 12/30/2005 41 Male 154 lb 2/11/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 60 Male 2/12/2010 Physician Chile
Primary
Concomitant
Pyrexia Other Serious 12/30/2005 41 Male 154 lb 2/15/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Sepsis Death 1/15/2009 11 Male 83 lb 2/10/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/14/2007 69 Male 3/4/2010 Lawyer United States
Primary
Secondary
Concomitant
Vasogenic Cerebral Oedema Other Serious 60 Male 3/4/2010 Chile
Primary
Concomitant
Weight Decreased Other Serious 9/12/2000 Female 134 lb 3/26/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Incorrect Route Of Drug Administration Hospitalization 62 Male 3/29/2010 Other Health Professional Bulgaria
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 3/12/2002 Female 201 lb 3/31/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 9/12/2000 65 Female 134 lb 4/6/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 4/17/2001 44 Female 201 lb 4/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 60 Male 4/22/2010 Physician Chile
Primary
Concomitant
Wound Dehiscence Other Serious 4/17/2001 44 Female 201 lb 5/4/2010 United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 5/5/2010 United States
Primary
Secondary
Concomitant
White Blood Cells Urine Positive Other Serious 1/29/2007 59 Female 4/23/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Weight Decreased Other Serious 10/16/2003 68 Female 134 lb 5/11/2010 United States
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 1/21/2009 45 Male 5/12/2010 Physician Germany
Primary
Secondary
Concomitant
Weight Decreased Other Serious 10/16/2003 68 Female 134 lb 5/13/2010 United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 5/17/2010 United States
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 12/27/2008 54 Male 216 lb 5/18/2010 Physician Canada
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 5/26/2010 United States
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 12/27/2008 54 Male 216 lb 5/28/2010 Physician Canada
Primary
Secondary
Concomitant
Loss Of Consciousness Life Threatening 10/28/2008 54 Male 216 lb 6/2/2010 Physician Canada
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 6/3/2010 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 1/2/2007 69 Male 187 lb 6/7/2010 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 10/16/2003 68 Female 134 lb 6/18/2010 United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 6/30/2010 United States
Primary
Secondary
Concomitant
Hepatic Failure Hospitalization 2/24/2010 51 Male 146 lb 6/29/2010 Pharmacist United States
Primary
Secondary
Concomitant
Wound Dehiscence Other Serious 10/9/2001 44 Female 201 lb 9/3/2010 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2003 46 Male 178 lb 9/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/27/2010 62 Male 104 lb 9/14/2010 Physician India
Primary
Concomitant
Weight Decreased Other Serious 10/16/2003 68 Female 134 lb 10/4/2010 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2003 46 Male 178 lb 10/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 12/14/2007 69 Male 187 lb 10/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 10/16/2003 68 Female 134 lb 10/11/2010 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2003 46 Male 178 lb 10/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Swelling Other Serious 10/18/2007 40 Female 227 lb 10/15/2010 Other Health Professional United States
Primary
Concomitant
Disease Progression Death 7/13/2010 81 Female 123 lb 10/29/2010 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2003 46 Male 179 lb 11/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2003 46 Male 179 lb 11/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/14/2007 69 Male 187 lb 1/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Fistula Discharge Other Serious 1/3/2005 58 Female 2/8/2011 Lawyer United States
Primary
Concomitant
Lethargy Death 10/18/2007 40 Female 227 lb 2/15/2011 Lawyer United States
Primary
Concomitant
Candidiasis Hospitalization Male 2/11/2011 United States
Primary
Concomitant
Gingival Swelling Other Serious 10/16/2003 68 Female 134 lb 3/11/2011 United States
Primary
Secondary
Concomitant
Hyperaesthesia Death 62 Male 3/15/2011 Physician Bulgaria
Primary
Secondary
Oropharyngeal Blistering Death 10/16/2003 68 Female 134 lb 3/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Blood Sodium Decreased Other Serious 2/9/2011 71 Male 3/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Lethargy Other Serious 1/1/2007 40 Female 227 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Pain In Jaw 49 Male 132 lb 5/19/2011 Consumer United States
Primary
Concomitant
Hypoxia Other Serious 7/1/2011 72 Female 7/14/2011 Physician Australia
Primary
Secondary
Concomitant
Hypoxia Other Serious 7/1/2011 72 Female 161 lb 8/8/2011 Physician Australia
Primary
Secondary
Concomitant
Hyperlipidaemia Other Serious 10/16/2003 68 Female 134 lb 8/11/2011 Physician United States
Primary
Secondary
Concomitant
Oliguria Death 10/16/2003 68 Female 134 lb 10/11/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Life Threatening 69 Male 187 lb 10/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 27 Male 11/15/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 27 Male 11/14/2011 Other Health Professional
Primary
Secondary
Concomitant
Loss Of Libido Other Serious 27 Male 11/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 27 Male 11/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Libido Other Serious 27 Male 11/18/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 27 Male 11/23/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemothorax Other Serious 11/24/2011 Korea, Republic Of
Primary
Concomitant
Sinusitis Hospitalization 10/9/1996 23 Female 276 lb 11/18/2011 Lawyer United States
Primary
Secondary
Concomitant
Loss Of Libido Other Serious 10/14/2011 27 Male 12/1/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Libido Other Serious 10/14/2011 27 Male 12/5/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Loss Of Libido Other Serious 10/14/2011 27 Male 11/30/2011 Other Health Professional
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 10/14/2011 27 Male 12/8/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 10/14/2011 27 Male 12/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Erectile Dysfunction Other Serious 10/14/2011 27 Male 12/12/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Large Intestinal Ulcer Other Serious 12/11/2009 53 Female 145 lb 12/13/2011 Lawyer United States
Primary
Concomitant
Abdominal Discomfort Hospitalization 10/8/2011 77 Female 12/27/2011 Physician United Kingdom
Primary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 10/8/2011 77 Female 1/3/2012 Other Health Professional United Kingdom
Primary
Concomitant
Nail Bed Inflammation Hospitalization 1/5/2012 67 Male 161 lb 1/10/2012 Physician Germany
Primary
Concomitant
Aggression Hospitalization 8/1/2008 56 Female 1/17/2012 Lawyer United States
Primary
Concomitant
Nail Bed Inflammation Hospitalization 1/5/2012 67 Male 161 lb 1/18/2012 Physician Germany
Primary
Concomitant
Loss Of Consciousness Other Serious 8/1/2008 56 Female 2/3/2012 Lawyer United States
Primary
Concomitant
Goitre Hospitalization Male 142 lb 2/24/2012 Lawyer United States
Primary
Concomitant
Metastases To Retroperitoneum Other Serious 1/3/2005 58 Female 3/9/2012 Consumer United States
Primary
Concomitant
Drug Ineffective Death 52 Male 4/2/2012 Consumer Lithuania
Primary
Secondary
Concomitant
Suicide Attempt Hospitalization 3/1/2010 44 Female 4/6/2012 Lawyer United States
Primary
Concomitant
Drug Ineffective Death 52 Male 4/17/2012 Other Health Professional Lithuania
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 3/20/2012 65 Male 190 lb 4/25/2012 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Life Threatening 11/2/2007 78 Female 182 lb 6/7/2012 Consumer United States
Primary
Concomitant
Nail Bed Inflammation Hospitalization 1/5/2012 67 Male 161 lb 6/22/2012 Physician Germany
Primary
Concomitant
Anaphylactic Reaction Other Serious 56 Female 6/17/2012 United Kingdom
Primary
Concomitant
Anaphylactic Reaction Other Serious 56 Female 6/29/2012 Consumer United Kingdom
Primary
Secondary
Concomitant
Sinusitis Other Serious 1/3/2005 58 Female 7/20/2012 Consumer United States
Primary
Concomitant
Trismus Hospitalization 1/3/2005 59 Female 3/6/2013 Consumer Us
Primary
Concomitant
Ballismus Hospitalization 59 Female 9/25/2012 Other Health Professional Kr
Primary
Concomitant
Systemic Candida Hospitalization 4/11/2011 73 Male 236 lb 11/30/2012 Other Health Professional De
Primary
Concomitant
Thrombocytopenia Hospitalization 3/25/2012 66 Male 190 lb 12/31/2012 Physician Us
Primary
Secondary
Concomitant
Weight Decreased Other Serious Female 140 lb 2/8/2013 Physician Us
Primary
Concomitant
Device Related Infection Hospitalization 12/10/2012 82 Female 155 lb 2/12/2013 Physician Us
Primary
Concomitant
Tenderness Other Serious 1/10/2013 34 Female 2/7/2013 Other Health Professional Gb
Primary
Concomitant

Drug Data