Diovan combined with Prograf

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Chest Pain Hospitalization 9/13/2005 55 Male 1/17/2006 United Kingdom
Primary
Secondary
Concomitant
Renal Disorder Other Serious 2/22/2006 46 Female 182 lb 3/9/2006 Consumer United States
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 3/3/2006 Female 128 lb 3/22/2006 United States
Primary
Concomitant
Restlessness Life Threatening 9/1/2005 23 Female 115 lb 5/20/2006 Physician Japan
Primary
Concomitant
Blood Urea Increased Hospitalization 4/19/2006 70 Female 6/5/2006 Physician Japan
Primary
Secondary
Concomitant
Gingival Pain Hospitalization 2/27/2006 34 Male 6/15/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Gingival Pain Hospitalization 2/27/2006 34 Male 6/26/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 8/18/2006 6 Female 43 lb 10/2/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 8/18/2006 6 Female 43 lb 11/1/2006 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 8/18/2006 6 Female 43 lb 11/7/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 8/18/2006 6 Female 43 lb 12/6/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 1/1/2005 51 Female 198 lb 9/12/2006 United States
Primary
Concomitant
Renal Transplant Hospitalization 12/16/2005 Male 2/8/2007 Consumer United States
Primary
Concomitant
Sepsis Death 1/7/2006 57 Male 225 lb 2/10/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/5/2007 Physician Japan
Primary
Secondary
Concomitant
International Normalised Ratio Increased Required Intervention 1/17/2007 63 Female 1/22/2007 Pharmacist United States
Primary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/12/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/18/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 1/1/2007 Female 132 lb 5/7/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 1/1/2007 Female 132 lb 5/14/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/30/2005 42 Male 5/8/2007 United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/1/2007 67 Female 132 lb 6/1/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 11/19/2005 56 Female 5/23/2007 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 2/1/2007 Female 132 lb 6/5/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/18/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/12/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/21/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 7/30/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 8/1/2007 Physician Japan
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 6/2/2006 59 Female 8/6/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 8/8/2007 Female 115 lb 8/9/2007 Physician United States
Primary
Concomitant
Pyelonephritis Hospitalization 6/2/2006 59 Female 8/21/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Life Threatening 8/20/2007 70 Female 97 lb 9/4/2007 Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 8/3/2007 57 Male 9/4/2007 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 11/19/2005 56 Female 9/19/2007 Physician United States
Primary
Secondary
Concomitant
Foot Amputation Hospitalization 10/11/2006 34 Male 154 lb 9/18/2007 Physician United States
Primary
Concomitant
Malaise Other Serious 8/3/2007 57 Male 9/13/2007 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 8/20/2007 70 Female 97 lb 9/12/2007 Physician Japan
Primary
Concomitant
Gun Shot Wound Hospitalization 9/10/2007 63 Male 10/9/2007 Consumer United States
Primary
Concomitant
Rheumatoid Lung Death 8/20/2007 70 Female 97 lb 10/29/2007 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 8/21/2007 Female 101 lb 11/21/2007 Physician Japan
Primary
Concomitant
Diabetes Mellitus Inadequate Control 1/1/2005 57 Female 12/15/2007 Other Health Professional United States
Primary
Concomitant
Interstitial Lung Disease Hospitalization 11/14/2007 76 Female 1/22/2008 Physician Japan
Primary
Concomitant
Weight Increased Hospitalization 2/1/2007 Female 132 lb 2/7/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 2/1/2007 Male 101 lb 2/18/2008 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 6/25/2007 33 Male 148 lb 3/9/2008 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 11/1/2007 50 Female 3/26/2008 Physician United States
Primary
Concomitant
Renal Impairment Other Serious 2/1/2007 Male 101 lb 3/13/2008 Physician Japan
Primary
Secondary
Concomitant
Gait Disturbance Other Serious 1/21/2008 84 Male 4/2/2008 Physician Japan
Primary
Concomitant
Nerve Injury Other Serious 1/21/2008 84 Male 4/14/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 6/28/2007 Male 10/3/2007 Other Health Professional United States
Primary
Concomitant
Renal Impairment Other Serious 2/1/2007 Male 101 lb 6/5/2008 Physician Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/19/2008 58 Female 86 lb 7/18/2008 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 2/26/2007 22 Male 101 lb 7/18/2008 Physician Japan
Primary
Secondary
Concomitant
Supraventricular Tachycardia Death 3/25/2008 60 Female 122 lb 8/11/2008 Physician United States
Primary
Concomitant
Interstitial Lung Disease Death 8/20/2007 70 Female 97 lb 8/20/2008 Physician Japan
Primary
Concomitant
Periodontitis Other Serious 44 Male 10/9/2008 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Lung Death 8/20/2007 70 Female 97 lb 10/10/2008 Physician Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 9/25/2003 51 Female 141 lb 9/18/2008 Physician United States
Primary
Secondary
Concomitant
Periodontitis Other Serious 44 Male 10/27/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Hospitalization 10/5/2008 Female 11/4/2008 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 10/5/2008 Female 11/10/2008 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 10/5/2008 Female 11/14/2008 Physician United States
Primary
Secondary
Concomitant
Blood Potassium Decreased 8/21/2008 57 Male 11/14/2008 United States
Primary
Concomitant
Pneumonia Hospitalization 7/30/2005 42 Male 1/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 9/1/2008 72 Female 115 lb 3/18/2009 Physician Japan
Primary
Concomitant
Blindness Other Serious Female 3/31/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 9/1/2008 72 Female 115 lb 4/2/2009 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 9/1/2008 72 Female 115 lb 5/15/2009 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 11/18/2002 Male 139 lb 6/23/2009 Physician Japan
Primary
Secondary
Concomitant
Rhinitis Other Serious 11/1/2007 Male 143 lb 8/4/2009 Physician Japan
Primary
Concomitant
Wheezing Hospitalization 7/6/2009 81 Male 10/15/2009 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 4/4/2009 55 Male 136 lb 10/20/2009 Physician Japan
Primary
Concomitant
Pneumonia Aspiration Hospitalization 7/6/2009 81 Male 11/13/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization Female 11/30/2009 Physician Japan
Primary
Concomitant
Stillbirth Other Serious 1/1/2004 32 Female 128 lb 2/16/2010 Other Health Professional United States
Primary
Concomitant
Gait Disturbance Other Serious 11/1/2009 84 Male 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Menorrhagia Other Serious 6/1/2009 42 Female 99 lb 3/26/2010 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Life Threatening 2/16/2010 72 Male 118 lb 4/23/2010 Physician Japan
Primary
Concomitant
Nephropathy Other Serious 1/1/2010 49 Female 5/10/2010 Consumer United States
Primary
Concomitant
Renal Impairment Other Serious 2/26/2007 22 Male 101 lb 5/13/2010 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 2/16/2010 72 Male 118 lb 5/20/2010 Physician Japan
Primary
Concomitant
Vestibular Disorder Congenital Anomaly 11/1/2009 84 Male 6/11/2010 Physician Japan
Primary
Secondary
Concomitant
Vestibular Disorder 11/1/2009 84 Male 6/28/2010 Physician Japan
Primary
Secondary
Concomitant
Heart Transplant Rejection Death 1/24/2010 37 Female 7/9/2010 Physician United States
Primary
Concomitant
Occult Blood Positive Other Serious 6/22/2010 59 Female 7/19/2010 Physician Denmark
Primary
Concomitant
Product Substitution Issue Hospitalization 7/19/2010 45 Male 236 lb 8/5/2010 Consumer United States
Primary
Secondary
Concomitant
Mitral Valve Replacement Other Serious 12/1/2006 53 Male 198 lb 8/11/2010 Consumer United States
Primary
Concomitant
Death Death 56 Female 106 lb 8/13/2010 Physician United States
Primary
Concomitant
Ileostomy Hospitalization 7/19/2010 45 Male 236 lb 8/20/2010 United States
Primary
Secondary
Concomitant
Ileostomy Hospitalization 7/19/2010 45 Male 236 lb 8/19/2010 United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 4/8/2010 81 Female 128 lb 8/20/2010 Physician Japan
Primary
Secondary
Concomitant
Shunt Occlusion Hospitalization 5/10/2010 50 Male 126 lb 8/24/2010 Physician Japan
Primary
Secondary
Concomitant
Ileostomy Hospitalization 7/19/2010 45 Male 236 lb 9/15/2010 United States
Primary
Secondary
Concomitant
Mitral Valve Replacement Other Serious 12/1/2006 53 Male 198 lb 9/16/2010 Physician United States
Primary
Concomitant
Renal Failure Acute Hospitalization 7/1/2010 45 Male 236 lb 9/23/2010 United States
Primary
Secondary
Concomitant
Transfusion Other Serious 1/1/2000 41 Female 165 lb 9/27/2010 United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 12/1/2008 45 Male 236 lb 9/23/2010 Physician United States
Primary
Secondary
Concomitant
Transfusion Other Serious 1/1/2000 41 Female 165 lb 10/15/2010 United States
Primary
Secondary
Concomitant
Sluggishness Hospitalization Female 115 lb 11/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Cardiac Disorder Hospitalization 9/1/2010 59 Male 11/4/2010 Consumer United States
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 6/13/2010 49 Female 113 lb 11/16/2010 Physician Japan
Primary
Concomitant
Shunt Thrombosis Hospitalization 5/10/2010 50 Male 126 lb 11/18/2010 Physician Japan
Primary
Secondary
Concomitant
Dysuria 63 Male 12/9/2010 Consumer United States
Primary
Concomitant
Diverticulum Hospitalization 7/19/2010 64 163 lb 2/4/2011 Physician Germany
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 7/19/2010 64 163 lb 2/4/2011 Physician Germany
Primary
Secondary
Concomitant
Renal Failure Death 1/13/2011 75 Female 2/10/2011 Consumer United States
Primary
Concomitant
Transplant Rejection Other Serious 7/19/2010 64 Female 163 lb 2/16/2011 Physician Germany
Primary
Secondary
Concomitant
Folliculitis Other Serious 1/1/2007 13 Female 2/22/2011 Physician United States
Primary
Secondary
Concomitant
Hyperlipidaemia Hospitalization 1/1/2003 13 Female 3/1/2011 Other Health Professional Japan
Primary
Secondary
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 3/31/2011 Physician Japan
Primary
Secondary
Off Label Use Hospitalization 7/10/2010 51 Female 88 lb 4/11/2011 Physician Japan
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 180 lb 5/21/2011 Lawyer United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 180 lb 5/31/2011 Lawyer United States
Primary
Secondary
Concomitant
Device Related Infection Death 9/1/2010 62 Male 5/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Gastritis Atrophic Other Serious 1/1/2000 41 Female 165 lb 6/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 6/6/2011 52 Male 317 lb 6/13/2011 Physician United States
Primary
Concomitant
Complications Of Transplant Surgery Hospitalization 5/28/2003 6/13/2011 Consumer United States
Primary
Concomitant
Bacteraemia Hospitalization 11/1/2008 60 Male 6/14/2011 Physician United States
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 5/18/2009 69 Female 7/5/2011 Physician Japan
Primary
Secondary
Concomitant
Pain Other Serious 6/19/2003 54 Male 217 lb 7/15/2011 Physician United States
Primary
Concomitant
Amputation Hospitalization 1/1/2009 68 Male 220 lb 7/15/2011 Physician United States
Primary
Concomitant
Mobility Decreased Other Serious Male 180 lb 7/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Anhedonia Disability 6/15/2004 25 Female 74 lb 7/22/2011 Physician United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 180 lb 7/27/2011 Physician United States
Primary
Secondary
Concomitant
Gallbladder Cholesterolosis Other Serious 1/1/2000 41 Female 165 lb 7/28/2011 United States
Primary
Secondary
Concomitant
Cell Marker Increased Other Serious 5/24/2011 60 Female 8/4/2011 Physician Japan
Primary
Concomitant
Mobility Decreased Other Serious Male 180 lb 8/10/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Anxiety Other Serious Male 181 lb 8/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Vascular Calcification Other Serious 1/11/2011 38 Female 8/15/2011 Physician Japan
Primary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 180 lb 8/24/2011 Physician United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 181 lb 8/31/2011 Lawyer United States
Primary
Secondary
Concomitant
Pulmonary Fibrosis Other Serious 6/21/2011 60 Female 9/6/2011 Physician Japan
Primary
Concomitant
Mobility Decreased Other Serious Male 181 lb 9/7/2011 Consumer United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 181 lb 9/14/2011 Lawyer United States
Primary
Secondary
Concomitant
Anxiety Other Serious 6/19/2003 54 Male 216 lb 9/14/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Other Serious Male 181 lb 9/14/2011 Consumer United States
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 181 lb 9/16/2011 Physician United States
Primary
Secondary
Concomitant
Anxiety Other Serious Male 181 lb 9/16/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Paronychia Hospitalization 6/1/2011 37 Female 82 lb 9/16/2011 Physician Japan
Primary
Secondary
Concomitant
Nephrogenic Systemic Fibrosis Other Serious Male 181 lb 9/19/2011 Physician United States
Primary
Secondary
Concomitant
Cerebrovascular Accident Other Serious 1/1/2006 27 Female 174 lb 9/27/2011 Consumer United States
Primary
Concomitant
Cell Marker Increased Other Serious 6/21/2011 60 Female 9/27/2011 Physician Japan
Primary
Concomitant
Gingivitis Hospitalization 12/28/2010 37 Female 82 lb 10/6/2011 Physician Japan
Primary
Secondary
Concomitant
Unevaluable Event Other Serious 6/19/2003 54 Male 216 lb 10/10/2011 Lawyer United States
Primary
Concomitant
Muscular Weakness Other Serious 1/1/2002 28 Female 124 lb 10/10/2011 Physician United States
Primary
Secondary
Concomitant
Colitis Ulcerative Other Serious 10/1/2011 59 Male 11/7/2011 Physician Japan
Primary
Concomitant
Death Death 9/7/2011 62 Male 185 lb 11/8/2011 Physician United States
Primary
Concomitant
Kidney Transplant Rejection Other Serious Female 11/10/2011 Consumer United States
Primary
Concomitant