Bicalutamide combined with Leuprolide Acetate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pneumothorax Hospitalization 2/1/2003 72 Male 3/17/2006 Japan
Primary
Concomitant
Sepsis Hospitalization 8/1/2006 74 Male 1/29/2007 Belgium
Primary
Concomitant
Sepsis Hospitalization 8/1/2006 74 Male 2/7/2007 Belgium
Primary
Concomitant
Septic Shock Death 11/22/2006 74 Male 2/26/2007 Korea, Republic Of
Primary
Concomitant
Septic Shock Death 11/22/2006 74 Male 3/8/2007 Korea, Republic Of
Primary
Concomitant
Intestinal Obstruction Hospitalization 3/28/2006 Male 180 lb 5/22/2007 United States
Primary
Concomitant
Rhabdomyolysis Other Serious 84 Male 6/11/2007 United States
Primary
Concomitant
Myocardial Ischaemia Hospitalization 12/27/2006 Male 6/29/2007 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 73 Male 7/9/2007 Other Health Professional United States
Primary
Concomitant
Interacting
Cushing's Syndrome Other Serious 78 Male 7/26/2007 Other Health Professional Japan
Primary
Secondary
Syncope Vasovagal Hospitalization 2/7/2007 Male 8/16/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 84 Male 10/30/2007 United States
Primary
Secondary
Concomitant
Respiratory Failure Death Male 3/3/2008 Belgium
Primary
Concomitant
Respiratory Failure Death Male 3/18/2008 Belgium
Primary
Concomitant
Prostate Cancer Stage Iv Other Serious 3/26/2007 73 Male 6/5/2008 Japan
Primary
Concomitant
Prostate Cancer Metastatic Death 4/25/2007 76 Male 6/5/2008 Japan
Primary
Concomitant
Oesophageal Carcinoma Death 5/22/2007 79 Male 6/6/2008 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Death 11/26/2007 88 Male 6/6/2008 Japan
Primary
Concomitant
Hypertension Hospitalization 5/2/2007 78 Male 6/6/2008 Japan
Primary
Concomitant
Prostate Cancer Death 7/26/2006 66 Male 6/6/2008 Japan
Primary
Concomitant
Aortic Dissection Rupture Death 1/25/2008 85 Male 6/6/2008 Japan
Primary
Concomitant
Pancreatic Carcinoma Life Threatening 12/18/2006 76 Male 6/10/2008 Japan
Primary
Concomitant
Arteriosclerosis Coronary Artery Other Serious 12/26/2006 75 Male 6/11/2008 Japan
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 6/11/2008 Japan
Primary
Concomitant
Prostate Cancer Death 9/4/2007 80 Male 88 lb 6/12/2008 Japan
Primary
Concomitant
Lung Neoplasm Malignant Death 8/8/2007 77 Male 6/16/2008 Japan
Primary
Concomitant
Oesophageal Carcinoma Death 5/22/2007 79 Male 6/17/2008 Japan
Primary
Concomitant
Vocal Cord Polyp Hospitalization 9/7/2006 70 Male 6/17/2008 Japan
Primary
Concomitant
Pneumonia Death 2/29/2008 78 Male 6/20/2008 Japan
Primary
Concomitant
Pyrexia Other Serious 1/24/2008 85 Male 121 lb 6/20/2008 Japan
Primary
Concomitant
Lung Neoplasm Malignant Hospitalization 10/16/2006 74 Male 6/24/2008 Japan
Primary
Concomitant
Prostate Cancer Recurrent Death 5/15/2006 62 Male 6/27/2008 Japan
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 6/22/2006 77 Male 6/27/2008 Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 9/1/2006 75 Male 6/30/2008 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/14/2008 82 Male 7/1/2008 Japan
Primary
Concomitant
Epiglottitis Hospitalization 1/11/2008 67 Male 7/1/2008 Japan
Primary
Concomitant
Gastric Cancer Other Serious 4/16/2007 79 Male 7/2/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 77 Male 99 lb 7/2/2008 Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 12/21/2006 79 Male 7/2/2008 Japan
Primary
Concomitant
Aspiration Death 1/22/2008 76 Male 130 lb 7/8/2008 Japan
Primary
Concomitant
Cardiac Failure Acute Death 1/4/2008 82 Male 7/8/2008 Japan
Primary
Concomitant
Post Procedural Haematoma Hospitalization 11/25/2006 78 Male 7/9/2008 Japan
Primary
Concomitant
Respiratory Failure Other Serious 2/1/2007 79 Male 133 lb 7/10/2008 Japan
Primary
Concomitant
Pharyngeal Cancer Stage Unspecified Other Serious 7/24/2007 76 Male 7/10/2008 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 3/10/2008 81 Male 7/10/2008 Japan
Primary
Concomitant
Colon Cancer Death 5/4/2007 76 Male 7/11/2008 Japan
Primary
Concomitant
Aspiration Death 3/8/2007 81 Male 7/11/2008 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
Prostate Cancer Death 3/3/2008 67 Male 7/11/2008 Japan
Primary
Concomitant
Face Oedema Other Serious 3/1/2007 75 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
Cardiomegaly Other Serious 9/11/2007 81 Male 7/17/2008 Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 2/14/2008 Male 7/17/2008 Physician Japan
Primary
Secondary
Concomitant
Prostate Cancer Stage Iv Death 3/25/2008 81 Male 7/17/2008 Japan
Primary
Concomitant
Inguinal Hernia Other Serious 1/26/2007 69 Male 7/17/2008 Japan
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 6/22/2006 77 Male 7/17/2008 Japan
Primary
Concomitant
Prostate Cancer Death 6/5/2007 82 Male 7/18/2008 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Hospitalization 6/28/2007 70 Male 7/18/2008 Japan
Primary
Concomitant
Diabetes With Hyperosmolarity Hospitalization 6/13/2008 Male 7/18/2008 Physician Japan
Primary
Concomitant
Pneumonia Death 80 Male 110 lb 7/21/2008 Japan
Primary
Concomitant
Cardiac Failure Hospitalization 1/14/2008 87 Male 7/21/2008 Japan
Primary
Concomitant
Cardiac Failure Death 2/26/2007 88 Male 7/21/2008 Japan
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization 6/22/2006 77 Male 7/21/2008 Japan
Primary
Concomitant
Nausea Life Threatening 1/17/2007 80 Male 7/22/2008 Japan
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 7/22/2008 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/14/2008 82 Male 7/22/2008 Japan
Primary
Concomitant
Pharyngeal Cancer Stage Unspecified Other Serious 7/24/2007 76 Male 7/23/2008 Japan
Primary
Concomitant
Pleural Effusion Hospitalization 5/9/2006 75 Male 7/23/2008 Japan
Primary
Concomitant
Lymphoma Disability 7/13/2007 82 Male 7/23/2008 Japan
Primary
Concomitant
Cardiac Failure Acute Death 1/4/2008 82 Male 88 lb 7/23/2008 Japan
Primary
Concomitant
Laryngeal Cancer Hospitalization 2/6/2007 88 Male 7/25/2008 Japan
Primary
Concomitant
Pollakiuria Other Serious 5/3/2006 85 Male 7/25/2008 Japan
Primary
Concomitant
Oesophageal Carcinoma Death 1/1/2007 71 Male 7/25/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 3/25/2008 81 Male 7/25/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 Male 7/25/2008 Japan
Primary
Concomitant
Pneumothorax Death 7/9/2007 80 Male 7/28/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 4/13/2007 83 Male 7/28/2008 Japan
Primary
Concomitant
Cardiac Failure Death 2/26/2007 88 Male 97 lb 7/29/2008 Japan
Primary
Concomitant
Prostate Cancer Death 1/4/2002 87 Male 110 lb 7/30/2008 Japan
Primary
Concomitant
Insomnia Death 1/23/2007 80 Male 7/31/2008 Japan
Primary
Concomitant
Ileus Hospitalization 6/13/2008 85 Male 7/31/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 3/25/2008 81 Male 8/1/2008 Japan
Primary
Concomitant
Oesophageal Carcinoma Death 1/1/2007 71 Male 8/1/2008 Japan
Primary
Concomitant
Cerebral Infarction Death 1/22/2008 83 Male 8/1/2008 Japan
Primary
Concomitant
Lung Squamous Cell Carcinoma Stage Unspecified Death 8/24/2007 73 Male 8/1/2008 Japan
Primary
Concomitant
Ureteric Obstruction Life Threatening 7/13/2008 Male 8/4/2008 Other Health Professional France
Primary
Secondary
Concomitant
Hospitalisation Hospitalization 82 Male 8/5/2008 Japan
Primary
Concomitant
Cardiomegaly Other Serious 9/11/2007 81 Male 8/6/2008 Japan
Primary
Secondary
Concomitant
Laryngeal Cancer Hospitalization 2/6/2007 88 Male 142 lb 8/6/2008 Japan
Primary
Concomitant
Injection Site Swelling Other Serious 5/15/2007 Male 8/6/2008 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/1/2008 82 Male 8/7/2008 Japan
Primary
Concomitant
Femoral Neck Fracture Hospitalization Male 8/8/2008 Japan
Primary
Concomitant
Diabetes Mellitus Hospitalization 9/1/2005 69 Male 8/8/2008 Japan
Primary
Secondary
Concomitant
Pollakiuria Other Serious 5/3/2006 85 Male 8/11/2008 Japan
Primary
Concomitant
Pancytopenia Death 8/18/2007 86 Male 8/11/2008 Japan
Primary
Concomitant
Stress Other Serious 10/6/2006 74 Male 8/13/2008 Japan
Primary
Concomitant
Sudden Death Death 5/15/2007 82 Male 8/14/2008 Japan
Primary
Concomitant
Prostate Cancer Death 3/3/2008 Male 8/14/2008 Japan
Primary
Concomitant
Stress Other Serious 10/6/2006 74 Male 8/14/2008 Japan
Primary
Concomitant
Ileus Hospitalization 6/13/2008 85 Male 86 lb 8/14/2008 Japan
Primary
Concomitant
Pulmonary Infarction Death 6/29/2007 80 Male 8/14/2008 Japan
Primary
Concomitant
Injection Site Induration Other Serious 10/10/2006 80 Male 8/15/2008 Japan
Primary
Concomitant
Prostate Cancer Recurrent Death 7/26/2006 66 Male 139 lb 8/15/2008 Japan
Primary
Concomitant
Pancytopenia Death 8/18/2007 86 Male 8/15/2008 Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 3/1/2008 Male 8/15/2008 Physician Japan
Primary
Concomitant
Death Death 5/15/2007 82 Male 8/15/2008 Japan
Primary
Concomitant
Inguinal Hernia Other Serious 1/26/2007 69 Male 8/19/2008 Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 12/13/2007 90 Male 8/19/2008 Japan
Primary
Concomitant
Prostate Cancer Death 1/19/2008 76 Male 8/19/2008 Japan
Primary
Secondary
Concomitant
Oesophageal Carcinoma Death 1/1/2007 71 Male 8/21/2008 Japan
Primary
Concomitant
Pleural Effusion Death 1/25/2007 85 Male 8/21/2008 Japan
Primary
Concomitant
Enterovesical Fistula Death 4/13/2007 73 Male 8/21/2008 Japan
Primary
Concomitant
Prostate Cancer Death 10/17/2007 79 Male 8/21/2008 Japan
Primary
Concomitant
Lung Neoplasm Malignant Death 5/29/2007 82 Male 8/21/2008 Japan
Primary
Concomitant
Prostate Cancer Stage Iv Death 1/7/2008 78 Male 8/22/2008 Japan
Primary
Concomitant
Bladder Cancer Recurrent Other Serious 1/25/2007 70 Male 8/26/2008 Japan
Primary
Concomitant
Prostate Cancer Other Serious 74 Male 8/26/2008 Other Health Professional Japan
Primary
Concomitant
Injection Site Induration Other Serious 10/10/2006 80 Male 8/26/2008 Japan
Primary
Concomitant
Pollakiuria Other Serious 5/3/2006 85 Male 8/26/2008 Japan
Primary
Concomitant
Urinary Retention Other Serious 1/1/2006 80 Male 8/26/2008 Japan
Primary
Secondary
Concomitant
Pneumonia Aspiration Hospitalization 4/3/2007 71 Female 8/27/2008 Japan
Primary
Concomitant
Osteoporosis Other Serious 12/12/2007 78 Male 8/28/2008 Japan
Primary
Secondary
Concomitant
Prostatic Specific Antigen Increased Death 1/8/2008 83 Male 8/28/2008 Japan
Primary
Concomitant
Lymphoma Disability 7/13/2007 82 Male 8/28/2008 Japan
Primary
Concomitant
Unevaluable Event Death 73 Male 8/28/2008 Japan
Primary
Concomitant
Death Death 5/15/2007 82 Male 8/28/2008 Japan
Primary
Concomitant
Fracture Hospitalization 80 Male 8/29/2008 Japan
Primary
Concomitant
Stomach Discomfort Death 9/4/2006 52 Male 8/29/2008 Japan
Primary
Concomitant
Pancreatic Carcinoma Life Threatening 12/18/2006 76 Male 8/29/2008 Japan
Primary
Concomitant
Fracture Hospitalization 80 Male 8/29/2008 Japan
Primary
Concomitant
Pollakiuria Other Serious 11/10/2007 70 Male 9/2/2008 Japan
Primary
Concomitant
Trigger Finger Hospitalization 5/3/2007 77 Male 9/3/2008 Japan
Primary
Concomitant
Prostate Cancer Death 10/17/2007 79 Male 9/3/2008 Japan
Primary
Concomitant
Prostatic Specific Antigen Increased Other Serious 7/5/2007 74 Male 9/3/2008 Japan
Primary
Concomitant
Pneumonia Death 78 Male 9/3/2008 Japan
Primary
Concomitant
Pancreatitis Acute Hospitalization 3/28/2007 69 Male 139 lb 9/4/2008 Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 3/25/2008 Male 9/4/2008 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 3/1/2007 72 Male 9/4/2008 Japan
Primary
Concomitant
Prostate Cancer Death 1/19/2008 76 Male 9/4/2008 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/19/2006 76 Male 9/5/2008 Japan
Primary
Concomitant
Pleural Effusion Hospitalization 5/9/2006 75 Male 9/5/2008 Japan
Primary
Concomitant
Pneumonia Hospitalization 6/19/2006 76 Male 9/5/2008 Japan
Primary
Concomitant
Tachycardia Other Serious 59 Male 9/5/2008 Pharmacist United States
Primary
Concomitant
Pancreatic Carcinoma Death 7/27/2006 79 Male 9/5/2008 Japan
Primary
Concomitant
Injection Site Pain Other Serious 10/29/2007 74 Male 9/5/2008 Japan
Primary
Concomitant
Diabetes Mellitus Hospitalization 9/1/2005 69 Male 9/8/2008 Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Life Threatening 2/27/2007 84 Male 9/8/2008 Japan
Primary
Concomitant
Pneumothorax Death 7/9/2007 80 Male 9/8/2008 Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 12/13/2007 90 Male 9/10/2008 Japan
Primary
Concomitant

Drug Data