Loxonin combined with Peg-Intron

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pruritus Other Serious 7/25/2005 48 Male 187 lb 1/18/2006 Physician Japan
Primary
Secondary
Concomitant
Cough Other Serious 11/22/2005 29 Female 86 lb 2/9/2006 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Other Serious 11/15/2005 Female 2/23/2006 Physician United States
Primary
Secondary
Concomitant
Cardiomegaly Other Serious 11/15/2005 Female 3/7/2006 Physician United States
Primary
Secondary
Concomitant
Pyrexia Life Threatening 1/17/2006 44 Male 3/8/2006 Physician Japan
Primary
Secondary
Concomitant
Cough Other Serious 11/22/2005 29 Female 86 lb 3/15/2006 Physician Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 2/24/2006 45 Female 123 lb 4/26/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 3/1/2006 59 Male 154 lb 4/26/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 5/1/2006 65 Female 5/12/2006 Physician Japan
Primary
Secondary
Concomitant
Suicide Attempt Hospitalization 2/22/2005 55 Female 139 lb 6/23/2006 Physician Japan
Primary
Secondary
Concomitant
Therapy Non-responder Life Threatening 1/1/2006 65 Male 128 lb 6/22/2006 Physician Japan
Primary
Secondary
Concomitant
Motor Dysfunction Other Serious 4/29/2006 59 Male 121 lb 6/14/2006 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 3/26/2006 57 Male 7/4/2006 Physician Japan
Primary
Secondary
Concomitant
Therapy Non-responder Hospitalization 1/1/2006 65 Male 128 lb 7/18/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Hospitalization 5/23/2006 65 Male 128 lb 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
Wheezing Death 11/17/2006 57 Male 143 lb 12/22/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Hospitalization 11/3/2006 57 Male 143 lb 1/2/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 7/1/2003 Male 3/22/2007 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 5/6/2006 65 Female 4/12/2007 Physician Japan
Primary
Secondary
Concomitant
Infection In An Immunocompromised Host Hospitalization 5/10/2006 49 Male 154 lb 6/20/2007 Physician Japan
Primary
Secondary
Concomitant
Tremor Other Serious 5/13/2007 40 Male 137 lb 7/9/2007 Physician Japan
Primary
Secondary
Concomitant
Headache Hospitalization 8/22/2007 24 Female 132 lb 9/10/2007 Physician Japan
Primary
Secondary
Concomitant
Salpingitis Hospitalization 11/26/2006 59 Female 123 lb 9/12/2007 Physician Japan
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 1/22/2007 63 Female 150 lb 9/14/2007 Physician Japan
Primary
Secondary
Concomitant
Tremor Other Serious 5/13/2007 40 Male 137 lb 11/5/2007 Physician Japan
Primary
Secondary
Concomitant
Syncope Other Serious 11/1/2007 66 Female 128 lb 11/21/2007 Physician Japan
Primary
Secondary
Concomitant
Malaise Other Serious 11/27/2007 56 Female 152 lb 1/2/2008 Physician Japan
Primary
Secondary
Concomitant
Malaise Other Serious 11/27/2007 56 Female 152 lb 1/28/2008 Physician Japan
Primary
Secondary
Concomitant
Syncope Vasovagal Other Serious 11/1/2007 66 Female 128 lb 1/30/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/19/2007 71 Female 112 lb 2/8/2008 Physician Japan
Primary
Secondary
Concomitant
Salpingitis Other Serious 11/26/2006 59 Female 123 lb 3/4/2008 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
Paralysis Other Serious 2/19/2008 58 Female 3/19/2008 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
Vogt-koyanagi-harada Syndrome Hospitalization 12/21/2007 43 Male 112 lb 9/10/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 11/26/2006 59 Female 123 lb 2/24/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/1/2009 78 Male 110 lb 4/7/2009 Japan
Primary
Secondary
Concomitant
Psoriasis Life Threatening 11/18/2008 65 Male 134 lb 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Hospitalization 4/9/2009 51 Male 4/21/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 4/26/2009 62 Male 168 lb 4/27/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Hepatic Failure Life Threatening 4/8/2009 51 Male 171 lb 4/28/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Life Threatening 4/27/2009 62 Male 168 lb 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 4/27/2009 62 Male 168 lb 4/30/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 4/27/2009 62 Male 168 lb 5/14/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cells Urine Positive Hospitalization 4/27/2009 62 Male 168 lb 5/26/2009 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 6/9/2009 61 Male 152 lb 6/15/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 4/27/2009 62 Male 168 lb 6/25/2009 Physician Japan
Primary
Secondary
Concomitant
Pyelonephritis Acute Hospitalization 9/25/2009 58 Female 108 lb 10/2/2009 Physician Japan
Primary
Concomitant
Pyelonephritis Acute Hospitalization 9/25/2009 58 Female 108 lb 10/8/2009 Physician Japan
Primary
Concomitant
Psychomotor Hyperactivity Hospitalization 9/8/2009 22 Male 143 lb 11/2/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/11/2010 55 Female 134 lb 3/4/2010 Physician Japan
Primary
Concomitant
Liver Disorder Life Threatening 9/1/2009 Female 119 lb 3/24/2010 Physician Japan
Primary
Secondary
Concomitant
Arthritis Reactive Hospitalization 12/1/2009 53 Female 6/28/2010 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 12/1/2009 53 Female 7/23/2010 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 11/30/2010 78 Male 130 lb 12/9/2010 Physician Spain
Primary
Concomitant
Fundoscopy Abnormal Other Serious 12/21/2009 65 Male 127 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Artery Thrombosis Hospitalization 4/27/2009 62 Male 168 lb 2/9/2012 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 12/28/2011 40 Male 3/1/2012 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 2/19/2012 57 Male 3/7/2012 Japan
Primary
Concomitant
Decreased Appetite Hospitalization 2/3/2012 64 Male 3/14/2012 Other Health Professional Japan
Primary
Concomitant
Drug Eruption Hospitalization 2/24/2012 67 Male 3/15/2012 Japan
Primary
Concomitant
Decreased Appetite Other Serious 2/19/2012 57 Male 3/16/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Hospitalization 2/3/2012 64 Male 4/2/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Other Serious 2/19/2012 57 Male 4/18/2012 Japan
Primary
Concomitant
Dehydration Other Serious 3/15/2012 59 Male 141 lb 4/13/2012 Physician Japan
Primary
Secondary
Concomitant
Atrioventricular Block Second Degree Other Serious 3/7/2012 24 Male 119 lb 4/13/2012 Physician Japan
Primary
Secondary
Concomitant
Sudden Hearing Loss Hospitalization 2/17/2012 68 Female 4/20/2012 Japan
Primary
Concomitant
Insomnia Hospitalization 2/10/2012 59 Female 4/23/2012 Other Health Professional Japan
Primary
Concomitant
Malaise Other Serious 1/24/2012 63 Female 4/24/2012 Japan
Primary
Concomitant
Pyrexia Other Serious 3/7/2012 24 Male 119 lb 4/23/2012 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 1/22/2012 59 Male 5/2/2012 Other Health Professional Japan
Primary
Concomitant
Anaemia Hospitalization 1/1/2012 63 Female 5/4/2012 Japan
Primary
Concomitant
Decreased Appetite Other Serious 3/6/2012 59 Female 5/4/2012 Japan
Primary
Concomitant
Malaise Other Serious 1/1/2012 63 Female 5/4/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Other Serious 2/24/2012 67 Male 5/6/2012 Japan
Primary
Concomitant
Mania Other Serious 4/1/2012 60 Female 5/7/2012 Japan
Primary
Concomitant
Renal Impairment Other Serious 2/4/2012 60 Male 5/7/2012 Japan
Primary
Concomitant
Drug Eruption Other Serious 4/26/2012 71 Male 5/8/2012 Japan
Primary
Concomitant
Neutropenia Other Serious 2/23/2012 54 Male 5/8/2012 Other Health Professional Japan
Primary
Concomitant
Neutropenia Hospitalization 2/23/2012 54 Male 5/9/2012 Japan
Primary
Concomitant
Erythema Multiforme Other Serious 2/6/2012 56 Male 5/14/2012 Japan
Primary
Concomitant
Drug Eruption Other Serious 2/28/2012 71 Male 5/16/2012 Other Health Professional Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 2/4/2012 60 Male 5/17/2012 Japan
Primary
Concomitant
Pancytopenia Other Serious 2/9/2012 50 Male 5/17/2012 Japan
Primary
Concomitant
Pancytopenia Other Serious 2/9/2012 50 Male 5/23/2012 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Increased Hospitalization 2/23/2012 50 Female 5/24/2012 Other Health Professional Japan
Primary
Concomitant
Blood Uric Acid Increased Hospitalization 5/8/2012 47 Male 5/25/2012 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Hospitalization Male 5/31/2012 Other Health Professional Japan
Primary
Concomitant
Arrhythmia Life Threatening 5/19/2012 Male 6/1/2012 Other Health Professional Japan
Primary
Concomitant
Erythema Multiforme Other Serious 2/6/2012 56 Male 6/6/2012 Japan
Primary
Concomitant
Anaemia Hospitalization 1/1/2012 63 Female 6/6/2012 Other Health Professional Japan
Primary
Concomitant
Asthenia Other Serious 2/19/2012 57 Male 6/8/2012 Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 3/2/2012 64 Male 6/8/2012 Other Health Professional Japan
Primary
Concomitant
Neutrophil Count Decreased Other Serious 4/11/2012 70 Female 6/8/2012 Other Health Professional Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 2/2/2012 50 Male 6/11/2012 Other Health Professional Japan
Primary
Concomitant
Oral Mucosa Erosion Hospitalization 4/25/2012 45 Male 163 lb 5/30/2012 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 3/2/2012 64 Male 6/11/2012 Japan
Primary
Concomitant
Anaemia Other Serious 1/1/2012 63 Female 6/13/2012 Other Health Professional Japan
Primary
Concomitant
Drug Eruption Other Serious 3/29/2012 62 Male 6/14/2012 Other Health Professional Japan
Primary
Concomitant
Eye Pruritus Other Serious 2/27/2012 63 Female 108 lb 6/7/2012 Physician Japan
Primary
Secondary
Concomitant
Erythema Hospitalization 2/2/2012 50 Male 6/14/2012 Other Health Professional Japan
Primary
Concomitant
Pancytopenia Other Serious 3/2/2012 64 Male 6/15/2012 Other Health Professional Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 4/9/2012 67 Male 6/16/2012 Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 5/15/2012 Male 6/18/2012 Other Health Professional Japan
Primary
Concomitant
Pyelonephritis Hospitalization 3/19/2012 55 Female 143 lb 6/4/2012 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Life Threatening 5/15/2012 Male 6/18/2012 Other Health Professional Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 3/15/2012 59 Male 141 lb 6/13/2012 Physician Japan
Primary
Secondary
Concomitant
Anaemia Hospitalization 1/1/2012 63 Female 6/26/2012 Japan
Primary
Concomitant
Insomnia Other Serious 5/23/2012 67 Male 150 lb 6/21/2012 Physician Japan
Primary
Secondary
Concomitant
Hypoalbuminaemia Hospitalization 2/24/2012 59 Female 143 lb 6/15/2012 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 1/22/2012 59 Male 6/29/2012 Other Health Professional Japan
Primary
Concomitant
Haemoglobin Decreased Hospitalization 6/14/2012 62 Female 7/2/2012 Japan
Primary
Concomitant
Off Label Use Other Serious 5/11/2012 62 Male 7/5/2012 Japan
Primary
Concomitant
Diabetes Mellitus Hospitalization 5/23/2012 48 Male 7/5/2012 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Other Serious 4/23/2012 64 Male 7/6/2012 Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 6/14/2012 62 Female 7/6/2012 Other Health Professional Japan
Primary
Concomitant
Renal Impairment Hospitalization Male 7/6/2012 Japan
Primary
Concomitant
Somnolence Hospitalization 6/14/2012 61 Male 7/10/2012 Japan
Primary
Concomitant
Erythema Hospitalization 4/27/2012 56 Male 7/10/2012 Japan
Primary
Concomitant
Decreased Appetite Other Serious 3/6/2012 59 Female 7/10/2012 Japan
Primary
Concomitant
Rash Hospitalization 4/20/2012 69 Female 172 lb 6/29/2012 Physician Japan
Primary
Secondary
Concomitant
Collagen Disorder Other Serious 1/20/2012 7/3/2012 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 12/28/2011 40 Male 7/17/2012 Japan
Primary
Concomitant
Diabetes Mellitus Hospitalization 5/23/2012 7/18/2012 Physician Japan
Primary
Secondary
Concomitant
Anaemia Hospitalization 1/1/2012 63 Female 7/20/2012 Other Health Professional Japan
Primary
Concomitant
Neutrophil Count Decreased Hospitalization 5/17/2012 63 Male 7/20/2012 Other Health Professional Japan
Primary
Concomitant
Rash Hospitalization 6/18/2012 61 Female 7/23/2012 Japan
Primary
Secondary
Concomitant
Rash Other Serious 4/22/2012 7/23/2012 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 5/29/2012 51 Male 7/23/2012 Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 2/4/2012 60 Male 7/24/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Hospitalization 7/13/2012 70 Female 7/25/2012 Other Health Professional Japan
Primary
Concomitant
Erythema Hospitalization 4/27/2012 56 Male 7/27/2012 Japan
Primary
Concomitant
Blood Creatinine Increased Other Serious 7/4/2012 66 Male 7/30/2012 Japan
Primary
Concomitant
Dizziness Hospitalization 4/10/2012 64 Male 7/31/2012 Japan
Primary
Concomitant
Rash Hospitalization 4/11/2012 53 Male 7/31/2012 Japan
Primary
Concomitant
Anaemia Other Serious 1/1/2012 7/31/2012 Physician Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Other Serious 6/1/2012 7/31/2012 Physician Japan
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 2/9/2012 50 Male 8/1/2012 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 8/30/2010 8/1/2012 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/18/2012 61 Female 8/2/2012 Other Health Professional Japan
Primary
Concomitant
Decreased Appetite Hospitalization 7/5/2012 70 Female 8/2/2012 Japan
Primary
Concomitant
Drug Eruption Other Serious 2/27/2012 67 Male 8/2/2012 Other Health Professional Japan
Primary
Concomitant
Rash Other Serious 5/15/2012 8/2/2012 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 2/2/2012 50 Male 8/2/2012 Japan
Primary
Concomitant
Pyelonephritis Hospitalization 5/25/2012 8/3/2012 Physician Japan
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 4/20/2012 8/3/2012 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 6/18/2012 8/3/2012 Pharmacist Japan
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/13/2012 8/3/2012 Physician Japan
Primary
Secondary
Concomitant
Decreased Appetite Hospitalization 7/5/2012 70 Female 8/3/2012 Other Health Professional Japan
Primary
Concomitant
Haemoglobin Decreased Other Serious 2/4/2012 60 Male 8/6/2012 Other Health Professional Japan
Primary
Concomitant

Drug Data