Actonel combined with Prograf

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Kidney Transplant Rejection Other Serious 12/29/2005 66 Female 105 lb 1/19/2006 United States
Primary
Secondary
Concomitant
Sudden Death Death 2/19/2006 70 Female 3/1/2006 France
Primary
Concomitant
Pain Other Serious 53 Female 179 lb 3/13/2006 United States
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 2/18/2006 70 Female 3/20/2006 France
Primary
Concomitant
Pyrexia Other Serious 1/1/2005 Female 101 lb 6/2/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/1/2005 Female 101 lb 6/5/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/1/2005 Female 101 lb 6/26/2006 Physician Japan
Primary
Secondary
Concomitant
Neurological Symptom Hospitalization 7/17/2005 50 Female 5/17/2006 Consumer United States
Primary
Concomitant
Gynaecomastia Hospitalization 12/1/2005 Male 128 lb 6/30/2006 Other Health Professional France
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Hospitalization 3/10/2006 Male 112 lb 7/13/2006 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased 3/1/2006 Female 161 lb 8/4/2006 Physician United States
Primary
Concomitant
Tooth Extraction Hospitalization 1/1/2004 53 Female 84 lb 8/3/2006 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 7/1/2005 Female 104 lb 8/16/2006 Physician Japan
Primary
Secondary
Concomitant
Leukopenia Hospitalization 12/15/2005 52 Male 128 lb 8/30/2006 Other Health Professional France
Primary
Secondary
Concomitant
Pneumonia Pneumococcal Hospitalization 3/10/2006 Male 112 lb 9/7/2006 Physician Japan
Primary
Secondary
Concomitant
Tooth Disorder Other Serious 1/1/1998 53 Female 84 lb 9/26/2006 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Life Threatening 7/1/2005 Female 104 lb 10/12/2006 Physician Japan
Primary
Secondary
Concomitant
Spinal Laminectomy Life Threatening 7/1/2005 Female 104 lb 11/8/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 7/1/2005 73 Female 104 lb 11/28/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 7/1/2005 73 Female 104 lb 12/4/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Tooth Disorder Other Serious 1/1/1998 53 Female 84 lb 12/15/2006 Physician United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased 3/1/2006 Female 161 lb 12/22/2006 Physician United States
Primary
Concomitant
Tooth Disorder Other Serious 1/1/1998 47 Female 84 lb 1/4/2007 Physician United States
Primary
Secondary
Concomitant
Tooth Disorder Other Serious 1/1/1998 47 Female 84 lb 4/24/2007 Physician United States
Primary
Secondary
Concomitant
Coronary Artery Occlusion Hospitalization 12/13/2006 66 Female 4/25/2007 Physician Japan
Primary
Secondary
Concomitant
Tooth Disorder Other Serious 1/1/1998 47 Female 84 lb 5/8/2007 Physician United States
Primary
Secondary
Concomitant
Vision Blurred Other Serious 35 Female 5/18/2007 Consumer United States
Primary
Concomitant
Tooth Disorder Other Serious 1/1/1998 47 Female 84 lb 5/22/2007 Physician United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 3/19/2007 48 Female 5/14/2007 Physician Japan
Primary
Concomitant
Diarrhoea Haemorrhagic Hospitalization 5/18/2007 57 Male 6/4/2007 Other Health Professional Canada
Primary
Concomitant
Acute Myocardial Infarction Hospitalization 12/13/2006 66 Female 6/26/2007 Physician Japan
Primary
Secondary
Concomitant
Overdose Other Serious 3/27/2007 53 Female 4/26/2007 United States
Primary
Secondary
Concomitant
Pleurisy Other Serious 10/2/2006 Male 7/10/2007 Physician Japan
Primary
Concomitant
Respiratory Failure Life Threatening 6/9/2007 54 Male 95 lb 8/30/2007 Physician Japan
Primary
Secondary
Concomitant
Gait Disturbance 8/1/2006 66 Female 150 lb 10/1/2007 Consumer United States
Primary
Concomitant
Spinal Osteoarthritis Other Serious 54 Male 10/15/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Spinal Compression Fracture Other Serious 8/10/2005 16 Female 10/30/2007 Physician Japan
Primary
Secondary
Concomitant
Graft Thrombosis Hospitalization 12/30/2004 71 Male 10/24/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 10/4/2007 54 Male 10/28/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Spinal Osteoarthritis Hospitalization 9/18/2007 54 Male 10/29/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/22/2006 52 Male 11/12/2007 United States
Primary
Secondary
Concomitant
Renal Failure Acute Death 10/26/2007 50 Female 223 lb 12/11/2007 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 10/26/2007 50 Female 223 lb 1/31/2008 Other Health Professional United States
Primary
Concomitant
Pulmonary Embolism Hospitalization 10/3/2007 54 Male 3/10/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Spinal Osteoarthritis Hospitalization 9/18/2007 54 Male 3/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 10/3/2007 54 Male 6/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 31 Male 6/24/2008 Other Health Professional France
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 31 Male 6/26/2008 Consumer France
Primary
Secondary
Concomitant
Overdose Other Serious 3/27/2007 53 Female 217 lb 4/30/2008 United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 12/15/2007 51 Female 6/25/2008 Other Health Professional France
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 31 Male 7/1/2008 Other Health Professional France
Primary
Secondary
Concomitant
Visual Acuity Reduced Hospitalization 31 Male 6/25/2008 Other Health Professional France
Primary
Secondary
Visual Acuity Reduced Hospitalization 31 Male 6/30/2008 Other Health Professional France
Primary
Secondary
White Blood Cell Count Increased Other Serious 8/15/2006 63 Male 211 lb 7/3/2008 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/15/2006 63 Male 211 lb 7/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/15/2006 63 Male 211 lb 7/30/2008 Physician United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 9/27/2008 Lawyer United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 10/1/2008 Lawyer United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 11/11/2008 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 10/29/2008 Male 203 lb 12/24/2008 Consumer United States
Primary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 1/7/2009 Lawyer United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 1/7/2009 Lawyer United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 10/29/2008 Male 203 lb 1/9/2009 Physician United States
Primary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 194 lb 1/15/2009 Lawyer United States
Primary
Secondary
Concomitant
Vascular Stenosis Death 11/24/2008 61 Female 1/16/2009 Physician Japan
Primary
Secondary
Concomitant
Type 1 Diabetes Mellitus Other Serious 1/1/2005 51 Male 256 lb 4/16/2009 United States
Primary
Concomitant
Overdose Hospitalization 4/9/2009 62 6/5/2009 Japan
Primary
Concomitant
Wound Dehiscence Other Serious 7/10/2003 Male 6/25/2009 Physician Germany
Primary
Secondary
Concomitant
Transmission Of An Infectious Agent Via A Medicinal Product Other Serious 12/10/2008 57 Male 7/10/2009 France
Primary
Secondary
Concomitant
Anaphylactic Shock Hospitalization 3/11/2009 Male 117 lb 8/13/2009 Physician Japan
Primary
Concomitant
Anaphylactic Shock Hospitalization 3/11/2009 Male 117 lb 8/20/2009 Physician Japan
Primary
Concomitant
Gait Disturbance 8/1/2006 66 Female 150 lb 10/2/2009 Consumer United States
Primary
Concomitant
Aplasia Pure Red Cell Other Serious 11/22/2009 Male 12/4/2009 Physician United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 234 lb 12/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Anaphylactic Shock Hospitalization 3/11/2009 Male 117 lb 12/18/2009 Physician Japan
Primary
Concomitant
Aplasia Pure Red Cell Other Serious 11/22/2009 Male 12/22/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/8/2009 47 Male 154 lb 1/11/2010 Physician United States
Primary
Concomitant
Large Intestinal Haemorrhage Hospitalization 12/25/2009 Male 86 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Aplasia Pure Red Cell Other Serious 11/22/2009 Male 2/1/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Life Threatening 11/16/2008 Male 165 lb 2/3/2010 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 8/7/2008 Male 117 lb 2/11/2010 Physician Japan
Primary
Secondary
Concomitant
Aplasia Pure Red Cell Other Serious 11/22/2009 Male 2/12/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 1/1/2008 53 Female 2/18/2010 Lawyer United States
Primary
Concomitant
Aplasia Pure Red Cell Other Serious 11/22/2009 Male 2/23/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 3/17/2010 49 Female 166 lb 3/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 2/16/2010 46 Female 116 lb 3/26/2010 Physician Japan
Primary
Concomitant
Loss Of Consciousness Other Serious 2/16/2010 46 Female 116 lb 4/13/2010 Physician Japan
Primary
Concomitant
Gastric Cancer Hospitalization 4/7/2009 75 Male 4/13/2010 Physician Japan
Primary
Secondary
Concomitant
Wrist Fracture Other Serious 3/1/2010 58 Female 150 lb 4/21/2010 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Life Threatening 11/14/2008 60 Male 165 lb 4/26/2010 Physician Japan
Primary
Concomitant
Vomiting Other Serious 12/1/2007 53 Female 150 lb 5/24/2010 Other Health Professional United States
Primary
Concomitant
Device Related Infection Hospitalization 4/24/2010 49 Female 171 lb 5/26/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Embolism Other Serious 12/8/2009 75 Female 5/27/2010 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 8/7/2008 70 Male 117 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 12/10/2007 18 Male 115 lb 8/6/2010 Other Health Professional United States
Primary
Concomitant
Road Traffic Accident Death 8/21/2010 49 Male 8/30/2010 Physician United States
Primary
Concomitant
Fasciitis Hospitalization 6/25/2010 10 Male 79 lb 9/4/2010 Physician Japan
Primary
Concomitant
Type 2 Diabetes Mellitus Other Serious 1/1/2005 51 Male 256 lb 9/17/2010 United States
Primary
Concomitant
Fasciitis Hospitalization 6/25/2010 10 Male 79 lb 10/1/2010 Physician Japan
Primary
Concomitant
Platelet Count Decreased Hospitalization 6/13/2009 74 Female 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 8/11/2010 48 Female 130 lb 10/29/2010 Pharmacist United States
Primary
Concomitant
Oedema Hospitalization 6/13/2009 74 Female 11/12/2010 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 234 lb 11/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Subcutaneous Nodule Other Serious 1/1/1998 63 Male 234 lb 11/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tuberculosis Other Serious 6/24/2010 48 Male 139 lb 11/17/2010 Consumer United States
Primary
Concomitant
Breast Cancer Hospitalization 5/1/2010 1/5/2011 Physician Japan
Primary
Concomitant
C-reactive Protein Increased Life Threatening 9/3/2010 63 Male 115 lb 1/31/2011 Physician Japan
Primary
Concomitant
Anaemia Life Threatening 9/3/2010 63 Male 115 lb 3/3/2011 Physician Japan
Primary
Concomitant
Colitis Ischaemic Hospitalization 7/10/2010 51 Female 88 lb 3/4/2011 Physician Japan
Primary
Concomitant
Colitis Ischaemic Other Serious 7/10/2010 51 Female 88 lb 4/5/2011 Physician Japan
Primary
Secondary
Colitis Ischaemic Other Serious 7/10/2010 51 Female 88 lb 3/31/2011 Physician Japan
Primary
Secondary
Off Label Use Other Serious 7/10/2010 51 Female 88 lb 4/14/2011 Physician Japan
Primary
Secondary
Concomitant
Off Label Use Hospitalization 7/10/2010 51 Female 88 lb 4/11/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Level Decreased Other Serious 67 Female 4/26/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 9/9/2010 34 Female 73 lb 5/9/2011 Physician Japan
Primary
Secondary
Concomitant
Anxiety Death 12/20/2008 57 Male 216 lb 5/19/2011 Consumer United States
Primary
Concomitant
Listeria Sepsis Hospitalization 9/8/2010 56 Female 77 lb 5/27/2011 Physician Japan
Primary
Secondary
Concomitant
Glomerulonephritis Membranoproliferative Hospitalization 11/16/2007 45 Male 188 lb 6/11/2011 Physician United States
Primary
Concomitant
Listeria Sepsis Hospitalization 9/8/2010 56 Female 77 lb 6/28/2011 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Life Threatening 9/3/2010 63 Male 115 lb 7/13/2011 Other Health Professional Japan
Primary
Concomitant
Device Related Infection Hospitalization 7/30/2010 21 Female 93 lb 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Arrest Other Serious 3/1/2011 74 Female 93 lb 7/14/2011 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 7/30/2010 21 Female 93 lb 7/19/2011 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 3/30/2011 54 Female 7/7/2011 Other Health Professional France
Primary
Concomitant
Staphylococcal Sepsis Death 6/16/2011 74 Female 92 lb 8/11/2011 Physician Japan
Primary
Secondary
Concomitant
Large Intestine Carcinoma Hospitalization 5/14/2011 71 Female 121 lb 8/19/2011 Physician Japan
Primary
Concomitant
Large Intestine Carcinoma Hospitalization 5/14/2011 71 Female 122 lb 9/5/2011 Physician Japan
Primary
Concomitant
Colon Cancer Hospitalization 5/1/2011 71 Female 122 lb 9/16/2011 Physician Japan
Primary
Concomitant
Dehydration Hospitalization 5/16/2011 81 Male 93 lb 9/27/2011 Physician Japan
Primary
Secondary
Concomitant
Iga Nephropathy Other Serious Female 9/27/2011 Physician United States
Primary
Concomitant
Diarrhoea Other Serious 9/9/2010 34 Female 73 lb 9/29/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Mass Hospitalization 3/1/2011 73 Female 110 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Appendix Disorder Hospitalization 11/24/2010 63 Male 110 lb 10/27/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatic Carcinoma Hospitalization 3/1/2011 73 Female 110 lb 11/14/2011 Physician Japan
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 11/24/2010 63 Male 110 lb 11/22/2011 Physician Japan
Primary
Secondary
Concomitant
Hydronephrosis Hospitalization 10/13/2011 11 Male 104 lb 1/5/2012 Japan
Primary
Secondary
Concomitant
Hydronephrosis Hospitalization 10/13/2011 11 Male 104 lb 1/18/2012 Physician Japan
Primary
Secondary
Concomitant
Pancreatic Carcinoma Hospitalization 3/1/2011 73 Female 110 lb 1/31/2012 Physician Japan
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/31/2011 59 Male 2/2/2012 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 9/9/2010 34 Female 73 lb 2/27/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Pleurisy Other Serious 1/28/2012 66 Female 104 lb 3/13/2012 Pharmacist Japan
Primary
Concomitant
Renal Transplant Other Serious 7/10/1998 3/19/2012 Consumer United States
Primary
Concomitant
Lung Disorder Hospitalization 8/10/2010 74 Female 99 lb 3/26/2012 Consumer Japan
Primary
Concomitant
Immune System Disorder Other Serious 7/10/1998 4/19/2012 Consumer United States
Primary
Concomitant
Renal Transplant Other Serious 7/10/1998 49 Female 130 lb 4/19/2012 Physician United States
Primary
Concomitant
Small Intestine Ulcer Hospitalization 9/3/2010 63 Male 115 lb 4/27/2012 Japan
Primary
Concomitant
Insomnia Other Serious 75 Male 6/17/2011 Physician United States
Primary
Secondary
Concomitant
Lung Disorder Hospitalization 8/10/2010 74 Female 99 lb 6/12/2012 Consumer Japan
Primary
Concomitant
Full Blood Count Decreased Hospitalization 6/15/2011 75 Male 170 lb 8/26/2011 Physician United States
Primary
Concomitant
Blood Pressure Decreased Life Threatening 4/24/2012 85 Female 80 lb 7/10/2012 Physician Japan
Primary
Secondary
Concomitant

Drug Data