Flutamide combined with Leuprolide Acetate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Life Threatening 8/9/2005 74 Male 12/27/2005 Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 11/10/2006 70 Male 12/5/2006 Hungary
Primary
Secondary
Pulmonary Congestion Life Threatening 2/19/2007 Japan
Primary
Secondary
Concomitant
Pulmonary Congestion Life Threatening 7/21/2006 77 Male 5/17/2007 Japan
Primary
Secondary
Concomitant
Shock Hospitalization 3/23/2007 70 Male 5/30/2007 France
Primary
Concomitant
Pulmonary Congestion Life Threatening 7/21/2006 77 Male 6/4/2007 Japan
Primary
Secondary
Concomitant
Death Death 1/31/2007 81 Male 6/14/2007 France
Primary
Concomitant
Septic Shock Other Serious 3/1/2007 70 Male 6/28/2007 Other Health Professional France
Primary
Concomitant
Shock Death 6/1/2007 81 Male 7/26/2007 France
Primary
Concomitant
Prostatic Specific Antigen Increased Death 6/26/2007 67 Male 10/23/2007 Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 4/17/2007 76 Male 12/5/2007 Japan
Primary
Concomitant
Limb Operation Other Serious 1/1/2007 80 Male 12/14/2007 France
Primary
Concomitant
Wound Necrosis Hospitalization 8/6/2007 79 Male 1/4/2008 France
Primary
Concomitant
Prostatic Specific Antigen Increased Death 10/1/2006 82 Male 1/18/2008 Japan
Primary
Concomitant
Cardiac Failure Death 10/1/2006 82 Male 1/25/2008 Japan
Primary
Concomitant
Wound Necrosis Hospitalization 8/6/2007 79 Male 3/3/2008 France
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 4/19/2007 76 Male 176 lb 3/6/2008 Japan
Primary
Concomitant
Cardiovascular Disorder Death 6/1/2007 81 Male 3/11/2008 Other Health Professional France
Primary
Concomitant
Weight Decreased Hospitalization 5/23/2006 Male 156 lb 5/22/2008 Canada
Primary
Secondary
Weight Increased Other Serious 5/17/2007 85 Male 5/22/2008 Poland
Primary
Concomitant
Weight Increased Other Serious 5/17/2007 85 Male 5/22/2008 Poland
Primary
Concomitant
Extremity Necrosis Other Serious 5/8/2008 69 Male 6/9/2008 Consumer Brazil
Primary
Concomitant
Toe Amputation Other Serious 5/8/2008 69 Male 6/11/2008 Consumer Brazil
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 6/11/2008 Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 9/1/2006 75 Male 6/30/2008 Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 3/3/2008 77 Male 99 lb 7/2/2008 Japan
Primary
Concomitant
Prostate Cancer Death 11/5/2007 83 Male 7/11/2008 Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 9/1/2006 75 Male 7/11/2008 Japan
Primary
Secondary
Concomitant
Injection Site Induration Other Serious 10/30/2006 Male 7/11/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 67 Male 7/11/2008 Japan
Primary
Concomitant
Gastric Haemorrhage Life Threatening 12/28/2006 77 Male 7/16/2008 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Death 6/23/2008 68 Male 7/18/2008 Japan
Primary
Concomitant
Pneumonia Death 80 Male 110 lb 7/21/2008 Japan
Primary
Concomitant
Ileus Hospitalization 3/31/2008 65 Male 7/21/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 6/23/2008 68 Male 7/22/2008 Japan
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 7/22/2008 Japan
Primary
Concomitant
Wheezing Other Serious 1/4/2008 97 Male 7/24/2008 Japan
Primary
Concomitant
Laryngeal Cancer Hospitalization 2/6/2007 88 Male 7/25/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 Male 7/25/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 4/13/2007 83 Male 7/28/2008 Japan
Primary
Concomitant
Laryngeal Cancer Hospitalization 2/6/2007 88 Male 142 lb 8/6/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 11/16/2006 66 Male 8/8/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 Male 8/14/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 1/7/2008 78 Male 8/22/2008 Japan
Primary
Concomitant
Urinary Retention Other Serious 1/1/2006 80 Male 8/26/2008 Japan
Primary
Secondary
Concomitant
Injection Site Ulcer Other Serious 2/16/2007 78 Male 8/28/2008 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Death 1/8/2008 83 Male 8/28/2008 Japan
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 8/29/2008 Japan
Primary
Concomitant
Injection Site Ulcer Other Serious 2/16/2007 78 Male 8/29/2008 Japan
Primary
Concomitant
Vomiting Other Serious 10/12/2004 Male 8/29/2008 Physician Japan
Primary
Secondary
Concomitant
Prostatic Specific Antigen Increased Other Serious 7/5/2007 74 Male 9/3/2008 Japan
Primary
Concomitant
Renal Failure Acute Other Serious 5/25/2007 Male 9/3/2008 Japan
Primary
Concomitant
Hypertension Other Serious 3/6/2007 82 Male 9/5/2008 Japan
Primary
Concomitant
Injection Site Ulcer Other Serious 2/16/2007 78 Male 9/10/2008 Japan
Primary
Concomitant
Injection Site Induration Other Serious 10/30/2006 Male 9/10/2008 Japan
Primary
Concomitant
Prostate Cancer Other Serious 4/10/2007 68 Male 9/11/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 10/10/2007 78 Male 9/12/2008 Japan
Primary
Concomitant
Injection Site Nodule Other Serious Male 9/12/2008 Japan
Primary
Concomitant
Prostate Cancer Death 5/27/2008 65 Male 9/18/2008 Japan
Primary
Concomitant
Prostate Cancer Death 5/14/2007 82 Male 9/19/2008 Japan
Primary
Concomitant
Tachycardia Other Serious 5/8/2007 69 Male 9/24/2008 Japan
Primary
Concomitant
Injection Site Induration Hospitalization 4/27/2006 72 Male 9/25/2008 Japan
Primary
Secondary
Concomitant
Pneumonia Death 80 Male 110 lb 9/26/2008 Japan
Primary
Concomitant
Renal Failure Acute Other Serious 5/25/2007 Male 9/30/2008 Japan
Primary
Concomitant
Laryngeal Cancer Hospitalization 2/6/2007 88 Male 142 lb 10/8/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/11/2008 87 Male 10/8/2008 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Other Serious 7/5/2007 74 Male 10/8/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 4/27/2008 77 Male 10/8/2008 Japan
Primary
Concomitant
Gastric Cancer Hospitalization 74 Male 10/9/2008 Japan
Primary
Concomitant
Cardiac Failure Hospitalization 2/18/2008 86 Male 10/10/2008 Japan
Primary
Concomitant
Nausea Other Serious 1/5/2007 61 Male 10/10/2008 Japan
Primary
Secondary
Concomitant
Prostate Cancer Stage Iv Death 10/10/2007 78 Male 10/15/2008 Japan
Primary
Concomitant
Prostate Cancer Death 5/14/2007 82 Male 10/15/2008 Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 12/23/2007 Male 10/16/2008 Japan
Primary
Secondary
Concomitant
Pneumonia Death 8/30/2007 79 Male 10/16/2008 Japan
Primary
Concomitant
Gastric Cancer Hospitalization 74 Male 123 lb 10/21/2008 Japan
Primary
Concomitant
Cardiac Failure Hospitalization 2/18/2008 86 Male 132 lb 10/23/2008 Japan
Primary
Concomitant
Metastases To Bone Other Serious 11/8/2007 79 Male 10/24/2008 Japan
Primary
Concomitant
Pruritus Death 4/26/2007 89 Male 10/24/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 4/13/2007 83 Male 10/28/2008 Japan
Primary
Concomitant
Prostate Cancer Other Serious 11/8/2007 79 Male 10/29/2008 Japan
Primary
Concomitant
Gastric Cancer Hospitalization 74 Male 123 lb 11/6/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/11/2008 87 Male 11/7/2008 Japan
Primary
Concomitant
Prostate Cancer Death 8/4/2008 81 Male 11/17/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/11/2008 87 Male 176 lb 11/24/2008 Japan
Primary
Concomitant
Pollakiuria Hospitalization 6/20/2008 57 Male 11/26/2008 Japan
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Death 5/21/2007 86 Male 12/2/2008 Japan
Primary
Concomitant
Prostate Cancer Death 4/10/2008 81 Male 12/5/2008 Japan
Primary
Concomitant
Duodenal Ulcer Hospitalization 10/18/2006 77 Male 12/10/2008 Japan
Primary
Concomitant
Ureteric Cancer Other Serious 5/30/2008 85 Male 12/16/2008 Japan
Primary
Concomitant
Lung Neoplasm Malignant Death 5/21/2007 86 Male 12/18/2008 Japan
Primary
Concomitant
Hypertension Other Serious 3/6/2007 82 Male 12/26/2008 Japan
Primary
Concomitant
Hypertensive Heart Disease Death 8/15/2008 79 Male 12/29/2008 Japan
Primary
Concomitant
Prostate Cancer Death 9/1/2008 49 Male 12/31/2008 Japan
Primary
Concomitant
Prostate Cancer Death 10/25/2006 75 Male 1/15/2009 Japan
Primary
Concomitant
Prostate Cancer Death 10/25/2006 75 Male 1/16/2009 Japan
Primary
Concomitant
Prostate Cancer Death 10/25/2006 75 Male 106 lb 1/26/2009 Japan
Primary
Concomitant
Hypertensive Heart Disease Death 8/15/2008 79 Male 1/27/2009 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Other Serious 2/18/2008 84 Male 2/2/2009 Japan
Primary
Concomitant
Prostate Cancer Other Serious 11/8/2007 79 Male 2/5/2009 Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 11/2/2006 77 Male 2/9/2009 Japan
Primary
Concomitant
Prostate Cancer Hospitalization 4/23/2007 89 Male 2/9/2009 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 11/16/2006 66 Male 2/17/2009 Japan
Primary
Concomitant
Prostate Cancer Death 4/20/2008 78 Male 2/18/2009 Japan
Primary
Concomitant
Prostate Cancer Death 9/1/2008 49 Male 2/18/2009 Japan
Primary
Concomitant
Prostate Cancer Hospitalization 4/23/2007 89 Male 2/26/2009 Japan
Primary
Concomitant
Prostate Cancer Death 5/20/2008 76 Male 3/26/2009 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 6/1/2008 46 Male 3/27/2009 Japan
Primary
Concomitant
Micturition Urgency Other Serious 3/6/2007 82 Male 4/28/2009 Japan
Primary
Concomitant
Prostate Cancer Death 2/9/2007 83 Male 4/28/2009 Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 5/27/2008 87 Male 4/30/2009 Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 2/9/2007 83 Male 5/14/2009 Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 5/27/2008 87 Male 5/26/2009 Japan
Primary
Secondary
Concomitant
Muscle Contracture Disability 7/24/2006 58 Male 6/18/2009 Physician Japan
Primary
Concomitant
Muscle Contracture Disability 7/24/2006 58 Male 7/2/2009 Physician Japan
Primary
Concomitant
Insomnia Hospitalization 4/30/2009 72 Male 10/30/2009 Japan
Primary
Secondary
Concomitant
Prostate Cancer Death Male 12/28/2009 Japan
Primary
Concomitant
Prostate Cancer Death Male 12/30/2009 Japan
Primary
Concomitant
Prostate Cancer Death 1/18/2007 69 Male 1/27/2010 Japan
Primary
Concomitant
Micturition Urgency Other Serious 3/6/2007 82 Male 3/1/2010 Japan
Primary
Concomitant
Prostate Cancer Death 1/18/2007 69 Male 134 lb 3/4/2010 Japan
Primary
Concomitant
Metastases To Bone Life Threatening 1/30/2007 74 Male 112 lb 3/9/2010 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 8/23/2008 75 Male 3/12/2010 Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 11/5/2007 93 Male 3/15/2010 Japan
Primary
Concomitant
Cardiac Failure Hospitalization 1/14/2008 87 Male 3/31/2010 Japan
Primary
Concomitant
Perineal Pain Hospitalization 10/17/2007 93 Male 4/5/2010 Japan
Primary
Concomitant
Perineal Pain Hospitalization 10/17/2007 93 Male 5/26/2010 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 3/18/2010 78 Male 6/7/2010 Other Health Professional Japan
Primary
Concomitant
Death Death 11/1/2009 84 Male 6/7/2010 Consumer Japan
Primary
Concomitant
Death Death 11/1/2009 84 Male 6/11/2010 Consumer Japan
Primary
Concomitant
Metastases To Bone Other Serious 12/1/2008 68 Male 6/18/2010 Physician Japan
Primary
Concomitant
Prostate Cancer Other Serious 12/1/2008 68 Male 6/21/2010 Physician Japan
Primary
Concomitant
Respiratory Arrest Death 5/14/2010 80 Male 6/23/2010 Other Health Professional Japan
Primary
Concomitant
Respiratory Arrest Death 5/14/2010 80 Male 157 lb 7/6/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Death 2/9/2007 83 Male 130 lb 7/19/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 6/25/2008 81 Male 7/23/2010 Other Health Professional Japan
Primary
Concomitant
Death Death 11/1/2009 84 Male 150 lb 7/28/2010 Consumer Japan
Primary
Concomitant
Prostate Cancer Other Serious 12/1/2008 68 Male 7/26/2010 Physician Japan
Primary
Concomitant
Prostate Cancer Death 6/25/2008 81 Male 8/6/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Hospitalization 78 Male 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Death 6/25/2008 81 Male 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Hospitalization 78 Male 8/10/2010 Other Health Professional Japan
Primary
Concomitant
Death Death 11/28/2009 88 Male 9/16/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Hospitalization Male 9/22/2010 Other Health Professional Japan
Primary
Concomitant
Femur Fracture Hospitalization 6/3/2009 59 Male 9/23/2010 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 1/21/2010 62 Male 9/24/2010 Physician Japan
Primary
Concomitant
Death Death 11/28/2009 88 Male 9/30/2010 Other Health Professional Japan
Primary
Concomitant
Death Death 11/28/2009 88 Male 10/14/2010 Other Health Professional Japan
Primary
Concomitant
Ileus Hospitalization 4/20/2006 74 Male 10/15/2010 Physician Japan
Primary
Concomitant
Blood Lactate Dehydrogenase Increased Death 7/5/2007 83 Male 10/15/2010 Other Health Professional Japan
Primary
Concomitant

Drug Data