Thalidomide combined with Zoledronic Acid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Osteonecrosis Other Serious 56 Male 10/27/2005 Physician United States
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 2/21/2006 Physician Italy
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Death 2/21/2006 Physician Italy
Primary
Secondary
Concomitant
Dialysis Death 2/21/2006 Physician Italy
Primary
Secondary
Concomitant
Sudden Death Death 2/21/2006 Physician Italy
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 1/1/2006 Male 203 lb 7/5/2006 Physician Australia
Primary
Concomitant
Tooth Extraction Other Serious 5/1/2005 68 8/31/2006 Physician Australia
Primary
Concomitant
Tooth Extraction Other Serious 5/1/2005 68 9/16/2006 Physician Australia
Primary
Concomitant
Tooth Extraction Other Serious 60 Male 10/5/2006 Physician Australia
Primary
Concomitant
Osteonecrosis Other Serious Male 10/17/2006 Physician Australia
Primary
Concomitant
Wound Debridement Other Serious 68 Female 10/27/2006 Other Health Professional United Kingdom
Primary
Concomitant
Osteonecrosis Other Serious 75 Female 11/21/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 76 Male 11/21/2006 Other Health Professional Spain
Primary
Concomitant
Osteonecrosis Other Serious 82 Male 11/21/2006 Other Health Professional Spain
Primary
Concomitant
Swelling Other Serious 2/16/2006 46 Male 12/1/2006 Physician Australia
Primary
Concomitant
Pain In Jaw Other Serious 75 Female 12/7/2006 Other Health Professional Spain
Primary
Secondary
Concomitant
Ulcer Other Serious 76 Male 12/7/2006 Other Health Professional Spain
Primary
Concomitant
Ulcer Other Serious 82 Male 12/7/2006 Other Health Professional Spain
Primary
Concomitant
Tooth Extraction Other Serious 6/1/2004 52 Male 12/22/2006 Physician Australia
Primary
Concomitant
Osteonecrosis Other Serious 67 Male 1/13/2007 United Kingdom
Primary
Concomitant
Tooth Extraction Other Serious 6/1/2004 52 Male 1/19/2007 Physician Australia
Primary
Concomitant
Tumour Lysis Syndrome Hospitalization 71 Male 1/17/2007 Physician United States
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 71 Male 1/25/2007 Physician United States
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 73 Male 2/2/2007 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 71 Male 2/12/2007 Physician United States
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 3/1/2004 84 Male 2/23/2007 Other Health Professional Chile
Primary
Concomitant
Tumour Lysis Syndrome Hospitalization 71 Male 2/23/2007
Primary
Secondary
Concomitant
Pain Other Serious 11/1/2005 48 Male 4/13/2007 Spain
Primary
Secondary
Tooth Extraction Other Serious 6/1/2004 52 Male 4/14/2007 Physician Australia
Primary
Concomitant
Pain Other Serious 11/1/2005 48 Male 4/21/2007 Spain
Primary
Secondary
Osteonecrosis Other Serious 66 Female 6/5/2007 Other Health Professional Italy
Primary
Concomitant
Osteonecrosis Other Serious 62 Female 6/5/2007 Other Health Professional Italy
Primary
Concomitant
Renal Impairment Other Serious 2/1/2006 76 Male 6/20/2007 Other Health Professional Finland
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 6/1/2004 52 Male 7/6/2007 Physician Australia
Primary
Concomitant
Swelling Other Serious 2/16/2006 46 Male 8/20/2007 Other Health Professional Australia
Primary
Concomitant
Tooth Extraction Other Serious 66 Male 9/11/2007 Other Health Professional Portugal
Primary
Concomitant
Tooth Extraction Other Serious 7/1/2003 71 Male 9/11/2007 Other Health Professional Portugal
Primary
Concomitant
Dermatitis Artefacta Hospitalization 9/10/2007 77 Female 121 lb 9/13/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 12/1/2004 Male 10/26/2007 Physician New Zealand
Primary
Concomitant
Periodontal Infection Other Serious 4/1/2006 Female 10/28/2007 Physician Australia
Primary
Concomitant
Periodontal Infection Other Serious 6/1/2004 59 Female 12/14/2007 Physician Australia
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 9/21/2007 60 Male 12/14/2007 Physician Germany
Primary
Concomitant
Renal Failure Acute Hospitalization 71 Male 2/4/2008 Physician United States
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 66 Male 3/27/2008 Other Health Professional Portugal
Primary
Concomitant
Tooth Extraction Other Serious 7/1/2003 71 Male 3/27/2008 Other Health Professional Portugal
Primary
Concomitant
Tooth Fracture Other Serious 65 Female 4/7/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 3/1/2004 66 Male 4/16/2008 Other Health Professional Portugal
Primary
Concomitant
Osteonecrosis Other Serious 7/1/2003 71 Male 4/16/2008 Other Health Professional Portugal
Primary
Concomitant
Osteonecrosis Disability 1/1/2008 62 Female 4/23/2008 Other Health Professional United Kingdom
Primary
Concomitant
Osteonecrosis Other Serious 67 Male 4/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 69 Male 4/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 68 Male 4/25/2008 Other Health Professional United States
Primary
Concomitant
Osteonecrosis Other Serious 75 Female 4/25/2008 Other Health Professional United States
Primary
Concomitant
Osteonecrosis Other Serious 71 Male 4/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Venous Occlusion Hospitalization 12/16/2007 Male 159 lb 7/7/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Sepsis Other Serious 10/2/2008 Physician Greece
Primary
Secondary
Concomitant
Pathological Fracture Other Serious 10/2/2008 Physician Greece
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 10/2/2008 Physician Greece
Primary
Secondary
Concomitant
Necrotising Fasciitis Death 10/2/2008 Physician Greece
Primary
Secondary
Concomitant
Myocardial Infarction Death 10/15/2007 72 Female 4/4/2008 Physician United States
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 4/16/2006 60 Female 12/11/2008 Physician Greece
Primary
Secondary
Concomitant
Pathological Fracture Other Serious 4/15/2006 72 Female 12/10/2008 Physician Greece
Primary
Secondary
Concomitant
Spinal Cord Compression Other Serious 12/31/2008 United Kingdom
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Hospitalization 56 Male 1/13/2009 Physician Italy
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 56 Male 1/20/2009 Italy
Primary
Secondary
Concomitant
Renal Impairment Death 56 Male 1/19/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Pain In Jaw Other Serious 4/25/2007 Male 137 lb 1/29/2009 Physician Belgium
Primary
Concomitant
Swollen Tongue Hospitalization 71 Female 2/4/2009 Other Health Professional United States
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 4/16/2006 60 Female 176 lb 1/30/2009 Physician Greece
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 57 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 63 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 63 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 75 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 48 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 64 Male 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 68 Male 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 79 Male 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 66 Female 2/23/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 54 Female 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 30 Male 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 52 Male 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 70 Female 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 64 Male 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Purulent Discharge Other Serious 76 Female 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Osteonecrosis Other Serious 75 Male 2/24/2009 Other Health Professional Greece
Primary
Concomitant
Renal Impairment Death 56 Male 2/20/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Renal Impairment Other Serious 54 Male 3/3/2009
Primary
Secondary
Renal Impairment Death 56 Male 3/8/2009 Other Health Professional Italy
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 4/16/2006 60 Female 176 lb 3/4/2009 Physician Greece
Primary
Secondary
Concomitant
Tibia Fracture Other Serious 8/1/2003 62 Male 3/18/2009 Physician Australia
Primary
Secondary
Concomitant
Renal Impairment Death 56 Male 3/13/2009 Physician Italy
Primary
Secondary
Concomitant
Toothache Required Intervention Male 3/25/2009 Physician Australia
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 58 Male 3/31/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 77 Male 4/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Tooth Extraction Other Serious 68 Male 4/7/2009 Other Health Professional United States
Primary
Concomitant
Weight Bearing Difficulty Other Serious 1/1/1986 Male 4/8/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 11/1/2007 Male 6/17/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 44 Female 7/8/2009 Other Health Professional Italy
Primary
Concomitant
Osteonecrosis Other Serious 51 Male 7/8/2009 Other Health Professional Italy
Primary
Concomitant
Osteonecrosis Other Serious 44 Male 7/9/2009 Other Health Professional Italy
Primary
Concomitant
Osteonecrosis Other Serious 80 Male 7/9/2009 Other Health Professional Italy
Primary
Concomitant
Osteonecrosis Other Serious 68 Male 7/10/2009 Other Health Professional Italy
Primary
Concomitant
Renal Impairment Other Serious 11/1/2007 Male 7/22/2009 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 74 Male 10/20/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 71 Male 11/9/2009 Other Health Professional United States
Primary
Concomitant
Respiratory Failure Hospitalization 56 Male 2/8/2010 Other Health Professional United States
Primary
Secondary
Weight Increased Other Serious 4/19/2001 Female 2/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Polyneuropathy Hospitalization 11/1/2008 Male 3/2/2010 Italy
Primary
Concomitant
Polyneuropathy Hospitalization 11/1/2008 Male 3/4/2010 Italy
Primary
Concomitant
Weight Increased Other Serious 4/19/2001 Female 3/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Death 3/24/2010 Singapore
Primary
Secondary
Thrombocytopenia Other Serious 5/3/2010 Austria
Primary
Concomitant
Urinary Tract Infection Other Serious 9/15/2010 Physician Singapore
Primary
Secondary
Renal Failure Acute Hospitalization 8/24/2010 77 Female 143 lb 9/15/2010 Physician Portugal
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 4/9/2009 53 Male 143 lb 12/30/2010 Physician Malaysia
Primary
Concomitant
Multiple Myeloma Death 67 Male 137 lb 3/17/2011 Other Health Professional Germany
Primary
Concomitant
Death Death 2/18/2011 72 Male 3/17/2011 Pharmacist Portugal
Primary
Concomitant
Pneumonia Other Serious 11/6/2009 53 Male 143 lb 3/21/2011 Physician Malaysia
Primary
Concomitant
Cognitive Disorder Life Threatening 11/6/2009 53 Male 143 lb 3/23/2011 Physician Malaysia
Primary
Concomitant
Nail Dystrophy Other Serious 7/30/2001 62 Female 5/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Death 3/12/2004 66 Male 178 lb 5/23/2011 United States
Primary
Secondary
Concomitant
Pneumonia Death 3/25/2011 64 Female 101 lb 6/9/2011 Pharmacist Australia
Primary
Secondary
Concomitant
Multiple Myeloma Other Serious 6/15/2011 Consumer India
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 60 Male 6/20/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Anaemia Other Serious 3/25/2011 64 Female 101 lb 6/22/2011 Pharmacist Australia
Primary
Secondary
Concomitant
Onychalgia Other Serious 7/30/2001 62 Female 6/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 80 Female 6/23/2011 Other Health Professional Germany
Primary
Concomitant
Conjunctival Haemorrhage Other Serious 5/20/2011 6/30/2011 Physician Colombia
Primary
Concomitant
Pneumonia Hospitalization 3/25/2011 64 Female 101 lb 7/18/2011 Physician Australia
Primary
Secondary
Concomitant
Off Label Use Other Serious 6/14/2011 8/3/2011 Consumer Spain
Primary
Concomitant
Discomfort Other Serious 6/1/2003 57 10/25/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Tenderness Other Serious 53 Male 10/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Paraesthesia Other Serious 60 Male 12/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Rib Fracture Other Serious 6/1/2003 64 Male 12/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Foot Fracture Other Serious 6/1/2003 64 Male 1/2/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 1/18/2012 Physician Singapore
Primary
Secondary
Paraesthesia Other Serious 12/1/2007 60 Male 1/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Neoplasm Progression Other Serious 9/1/2007 64 Male 1/6/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Stress Fracture Other Serious 1/24/2012 Physician United States
Primary
Secondary
Concomitant
Oral Cavity Fistula Other Serious 59 Female 8/7/2012 Other Health Professional Finland
Primary
Concomitant
Somnolence Hospitalization 9/18/2011 Female 8/7/2012 Other Health Professional Germany
Primary
Concomitant
Rectal Haemorrhage Death 5/1/2012 72 Female 159 lb 8/13/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Foot Fracture Other Serious 60 Male 8/22/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Of Jaw Other Serious 59 Female 9/11/2012 Other Health Professional Fi
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 10/23/2012 Physician Kr
Primary
Secondary
Sepsis Death 10/23/2012 Physician Sg
Primary
Secondary
Osteonecrosis Of Jaw Other Serious 59 Female 10/23/2012 Other Health Professional Country Not Specified
Primary
Secondary
Sepsis Other Serious 10/23/2012 Physician Sg
Primary
Secondary
Visual Impairment Disability 10/11/2012 76 Female 11/13/2012 Consumer Gb
Primary
Concomitant
Renal Failure Acute Other Serious 12/10/2012 Other Health Professional Gb
Primary
Secondary

Drug Data