Loxonin combined with Novamin

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Interstitial Lung Disease Life Threatening 1/23/2006 71 Male 125 lb 2/6/2006 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 2/23/2006 71 Male 123 lb 7/27/2006 Physician Japan
Primary
Secondary
Concomitant
Bronchopneumonia Death 2/23/2006 72 Male 123 lb 8/3/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 6/3/2006 63 Male 121 lb 8/4/2006 Physician Japan
Primary
Concomitant
Disseminated Intravascular Coagulation Life Threatening 7/16/2006 73 Male 121 lb 9/8/2006 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Life Threatening 7/16/2006 73 Male 121 lb 9/14/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 6/3/2006 63 Male 121 lb 10/3/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 6/3/2006 63 Male 121 lb 10/11/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 6/3/2006 63 Male 121 lb 10/24/2006 Physician Japan
Primary
Concomitant
Vomiting Other Serious 11/3/2006 69 Male 366 lb 12/19/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Large Intestinal Ulcer Hospitalization 3/9/2007 74 Female 75 lb 4/4/2007 Physician Japan
Primary
Concomitant
Weight Increased Other Serious Female 4/12/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 1/1/2007 74 Female 75 lb 4/19/2007 Physician Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 1/6/2007 68 Female 4/11/2007
Primary
Concomitant
Pneumonitis Hospitalization 6/5/2007 63 Male 7/12/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6/5/2007 63 Male 7/23/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 6/5/2007 63 Male 7/31/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Cholestasis Life Threatening 8/9/2007 61 Male 9/24/2007
Primary
Secondary
Concomitant
Visual Acuity Reduced Disability 7/1/2007 68 Female 104 lb 9/28/2007 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 9/26/2007 68 Female 10/2/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Cholestasis Life Threatening 8/9/2007 61 Male 10/2/2007
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/26/2007 68 Female 10/24/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/26/2007 68 Female 10/26/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 7/20/2007 68 Female 104 lb 11/2/2007 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 10/26/2005 62 Male 10/29/2007 Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Disability 9/10/2007 65 Female 90 lb 12/3/2007 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 9/26/2007 68 Female 12/4/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 4/11/2007 71 Male 119 lb 12/4/2007 Other Health Professional United States
Primary
Concomitant
Pneumonia Life Threatening 9/25/2007 79 Male 88 lb 1/2/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 12/22/2007 Male 144 lb 1/21/2008 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 6/7/2007 Female 106 lb 1/24/2008 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 6/7/2007 Female 106 lb 1/29/2008 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 1/18/2008 47 Female 106 lb 2/11/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Disability 12/18/2007 43 Female 2/13/2008 Physician Japan
Primary
Concomitant
Rash Hospitalization 1/16/2008 72 Female 99 lb 2/20/2008 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 5/1/2007 Female 106 lb 2/22/2008 Physician Japan
Primary
Concomitant
Rash Hospitalization 1/16/2008 72 Female 99 lb 2/28/2008 Physician Japan
Primary
Concomitant
Pneumonia Death 1/26/2008 Male 2/15/2008 Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 1/18/2008 47 Female 106 lb 3/10/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/22/2007 Male 144 lb 3/11/2008 Physician Japan
Primary
Concomitant
Rash Hospitalization 1/16/2008 72 Female 99 lb 3/26/2008 Physician Japan
Primary
Concomitant
Nausea Death 10/7/2005 49 Female 95 lb 3/31/2008 Physician Japan
Primary
Concomitant
Renal Failure Acute Disability 12/18/2007 43 Female 4/4/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Death 9/26/2007 Male 4/14/2008 Physician Japan
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 3/2/2008 Female 110 lb 4/22/2008 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 1/30/2008 62 Female 95 lb 4/28/2008 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 80 Female 5/23/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 3/31/2008 Male 114 lb 5/21/2008 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Hospitalization 80 Female 5/28/2008 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 3/6/2007 76 Female 71 lb 5/23/2008 Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 5/31/2008 71 Female 7/1/2008 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 5/31/2008 71 Female 7/9/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 6/6/2008 73 Male 141 lb 7/9/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/23/2008 Male 114 lb 7/11/2008 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Death 1/28/2008 63 Female 95 lb 7/24/2008 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 5/6/2008 80 Female 8/1/2008 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 5/6/2008 80 Female 8/14/2008 Physician Japan
Primary
Concomitant
Pain In Jaw Other Serious 6/1/2008 Female 8/14/2008 Physician
Primary
Secondary
Concomitant
Sudden Death Death 8/1/2008 62 Female 8/12/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Death 6/6/2008 73 Male 141 lb 9/9/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 7/29/2008 71 Male 95 lb 9/11/2008 Physician Japan
Primary
Concomitant
Platelet Count Decreased Death 8/1/2008 62 Female 115 lb 9/12/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 12/11/2006 Male 9/17/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/11/2006 Male 9/30/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/23/2008 Male 114 lb 9/25/2008 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Death 6/5/2008 73 Male 141 lb 10/10/2008 Physician Japan
Primary
Concomitant
Urine Output Decreased Other Serious 8/14/2008 Male 104 lb 10/14/2008 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Hospitalization 7/15/2008 54 Male 108 lb 10/17/2008 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 1/23/2008 Male 104 lb 10/16/2008 Physician Japan
Primary
Secondary
Concomitant
Unevaluable Event Other Serious 8/27/2008 Female 10/28/2008 Pharmacist Japan
Primary
Concomitant
Hepatic Encephalopathy Death 77 Male 11/7/2008 Physician Japan
Primary
Concomitant
Pain In Jaw Other Serious 10/1/2004 Female 11/7/2008 Physician Japan
Primary
Secondary
Concomitant
Pain In Jaw Other Serious 6/1/2008 Female 11/11/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/12/2008 Male 104 lb 11/17/2008 Pharmacist Japan
Primary
Concomitant
Pain In Jaw Other Serious 6/1/2008 Female 115 lb 11/19/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Encephalopathy Death 4/4/2008 Male 11/21/2008 Physician Japan
Primary
Concomitant
Venous Thrombosis Hospitalization 10/3/2008 55 Male 11/20/2008 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 3/1/2008 Male 138 lb 11/25/2008 Physician Japan
Primary
Concomitant
Vena Cava Thrombosis Hospitalization 9/1/2008 Male 151 lb 12/29/2008 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Stage Iv Life Threatening 11/3/2008 40 Male 181 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Cell Carcinoma Stage Iv Life Threatening 11/3/2008 40 Male 181 lb 1/12/2009 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Life Threatening 10/30/2008 59 Male 150 lb 2/3/2009 Physician Japan
Primary
Concomitant
Thirst Other Serious 10/1/2008 2/5/2009 Physician Japan
Primary
Concomitant
Osteitis Other Serious 3/18/2008 Male 2/5/2009 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 7/29/2008 71 Male 95 lb 2/19/2009 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 12/20/2007 Male 3/9/2009 Physician Japan
Primary
Concomitant
Hypercalcaemia Life Threatening 2/18/2009 Female 84 lb 3/13/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 11/3/2008 40 Male 181 lb 3/25/2009 Physician Japan
Primary
Secondary
Concomitant
Concomitant Disease Aggravated Other Serious 2/18/2009 Female 84 lb 3/26/2009 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Other Serious 12/20/2007 Male 4/6/2009 Physician Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 11/3/2008 40 Male 181 lb 4/14/2009 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Perforation Life Threatening 3/23/2009 Male 123 lb 4/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Neoplasm Malignant Death 12/20/2007 Male 4/24/2009 Physician Japan
Primary
Concomitant
Delirium Other Serious 77 Male 5/14/2009 Pharmacist Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 5/23/2009 81 Male 157 lb 6/1/2009 Physician Japan
Primary
Secondary
Concomitant
Pain Other Serious 3/11/2008 Male 6/15/2009 Physician Japan
Primary
Concomitant
Neutrophil Count Decreased Hospitalization 5/14/2009 77 6/23/2009 Physician Japan
Primary
Concomitant
Uterine Cancer Death Female 121 lb 6/26/2009 Physician Japan
Primary
Concomitant
Pain Other Serious 3/11/2008 Male 6/26/2009 Physician Japan
Primary
Concomitant
Uterine Cancer Death Female 121 lb 7/6/2009 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 5/11/2009 77 7/30/2009 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 7/7/2009 Male 99 lb 8/7/2009 Physician Japan
Primary
Concomitant
Nausea Hospitalization 3/24/2009 78 Male 128 lb 8/18/2009 Physician Germany
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 7/29/2009 Female 8/19/2009 Physician Japan
Primary
Secondary
Concomitant
Off Label Use Death 6/11/2009 Male 112 lb 8/20/2009 Physician Japan
Primary
Concomitant
Lung Adenocarcinoma Hospitalization 6/8/2009 78 Female 95 lb 8/24/2009 Physician Japan
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 7/29/2009 Female 8/28/2009 Physician Japan
Primary
Secondary
Concomitant
Pain Other Serious 3/11/2008 Male 9/8/2009 Physician Japan
Primary
Concomitant
Pneumonia Death 7/15/2009 67 Male 9/11/2009 Physician Japan
Primary
Concomitant
Pyrexia Death 1/25/2008 Female 9/21/2009 Physician Japan
Primary
Concomitant
Nausea Hospitalization 3/24/2009 78 Male 128 lb 9/22/2009 Consumer United States
Primary
Secondary
Concomitant
Nausea Hospitalization 3/24/2009 78 Male 128 lb 9/24/2009 Consumer United States
Primary
Secondary
Concomitant
Off Label Use Death 6/11/2009 Male 112 lb 10/9/2009 Physician Japan
Primary
Concomitant
Pneumonia Death 7/15/2009 67 Male 106 lb 10/8/2009 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 6/17/2009 58 Male 117 lb 10/19/2009 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 3/1/2008 Male 138 lb 10/27/2009 Physician Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 1/21/2008 63 Male 10/30/2009 Japan
Primary
Concomitant
Pneumonia Aspiration Life Threatening 10/14/2009 Female 117 lb 10/30/2009 Physician Japan
Primary
Concomitant
Prostate Cancer Death 1/21/2008 63 Male 11/3/2009 Japan
Primary
Concomitant
Nausea Hospitalization 3/24/2009 78 Male 128 lb 11/13/2009 Consumer United States
Primary
Secondary
Concomitant
Prostate Cancer Death 5/31/2009 46 Male 11/13/2009 Japan
Primary
Concomitant
Myocardial Infarction Death 10/8/2009 73 Male 124 lb 11/17/2009 Physician Japan
Primary
Concomitant
Lung Disorder Death 7/15/2008 83 Male 123 lb 11/19/2009 Physician Japan
Primary
Concomitant
Prostate Cancer Death 5/31/2009 46 Male 11/25/2009 Japan
Primary
Concomitant
White Blood Cell Count Increased Death 10/8/2009 73 Male 124 lb 11/27/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 12/22/2007 Male 144 lb 11/30/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 3/2/2008 Female 110 lb 12/1/2009 Physician Japan
Primary
Concomitant
Vena Cava Thrombosis Hospitalization 9/1/2008 Male 151 lb 12/1/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Death 7/15/2009 Male 106 lb 12/10/2009 Physician Japan
Primary
Concomitant
Prostate Cancer Death 1/21/2008 63 Male 12/11/2009 Japan
Primary
Concomitant
Rectal Cancer Death 3/25/2009 56 Female 12/14/2009 Physician Japan
Primary
Concomitant
Venous Thrombosis Other Serious 10/20/2009 71 Female 126 lb 12/16/2009 Physician Germany
Primary
Concomitant
Myocardial Infarction Death 10/8/2009 73 Male 124 lb 12/18/2009 Physician Japan
Primary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 8/14/2009 59 Male 139 lb 12/22/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Life Threatening 8/20/2009 Male 116 lb 12/29/2009 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 12/29/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/18/2009 58 Female 128 lb 12/30/2009 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Palmar-plantar Erythrodysaesthesia Syndrome Other Serious 8/14/2009 59 Male 139 lb 1/11/2010 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 9/4/2009 66 Male 128 lb 1/15/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 3/6/2007 Female 71 lb 1/18/2010 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 10/10/2009 Female 117 lb 1/23/2010 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Life Threatening 8/15/2009 60 Male 116 lb 1/29/2010 Physician Japan
Primary
Concomitant
Thyroiditis Hospitalization 12/11/2009 74 Male 130 lb 2/1/2010 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 11/18/2009 81 Female 95 lb 2/1/2010 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/25/2009 2/8/2010 Physician Japan
Primary
Concomitant
Off Label Use Death 6/11/2009 Male 112 lb 2/8/2010 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 11/5/2009 Male 161 lb 2/8/2010 Physician Japan
Primary
Secondary
Concomitant
Toothache Other Serious 11/14/2007 71 Female 2/17/2010 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 11/5/2009 Male 161 lb 2/25/2010 Physician Japan
Primary
Secondary
Concomitant