Mannitol combined with Protamine Sulfate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 8/19/2004 21 9/12/2005 Physician United States
Primary
Concomitant
Thrombocytopenia Required Intervention 9/18/2003 65 Female 155 lb 3/3/2006 Physician United States
Primary
Concomitant
Rhabdomyolysis Life Threatening 6/13/2005 49 Female 265 lb 4/25/2006 Pharmacist United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 114 lb 5/18/2006 United States
Primary
Secondary
Concomitant
Wound Secretion Other Serious 8/1/2004 74 Female 114 lb 6/29/2006 United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 12/18/2005 82 Male 185 lb 6/29/2006 United States
Primary
Concomitant
Post Procedural Complication Disability 5/12/2006 85 Female 112 lb 5/24/2006 United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 114 lb 7/18/2006 United States
Primary
Secondary
Concomitant
Postoperative Renal Failure Other Serious 67 Female 139 lb 7/28/2006 Physician Canada
Primary
Secondary
Concomitant
Wound Other Serious 2/1/2006 Female 176 lb 10/10/2006 Physician Poland
Primary
Concomitant
Hypersensitivity Other Serious 8/3/2005 64 Male 201 lb 8/29/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 74 Female 115 lb 10/30/2006 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Life Threatening 12/1/2005 83 Male 185 lb 11/7/2006 Physician United States
Primary
Concomitant
Ventricular Hypokinesia Other Serious 8/1/2004 Female 11/9/2006 Consumer Germany
Primary
Secondary
Concomitant
Wound Other Serious 2/1/2006 Female 176 lb 11/29/2006 Physician Poland
Primary
Concomitant
Post Procedural Haemorrhage Other Serious 9/30/2006 62 Female 141 lb 6/14/2007 Physician Germany
Primary
Concomitant
Renal Failure Other Serious 2/6/2008 51 Male 9/17/2008 Lawyer United States
Primary
Concomitant
Grand Mal Convulsion Hospitalization 8/27/2008 61 Male 229 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/26/2008 83 Male 139 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/25/2008 79 Male 134 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/28/2008 67 Female 121 lb 9/25/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/27/2008 61 Male 229 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Product Quality Issue Hospitalization 8/26/2008 83 Male 139 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/25/2008 79 Male 134 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 8/28/2008 67 Female 121 lb 11/21/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Tardive Dyskinesia Other Serious 8/10/2000 57 Male 344 lb 4/3/2009 Other Health Professional United States
Primary
Concomitant
Hypercholesterolaemia Other Serious 10/14/2007 59 Female 12/22/2009 Lawyer United States
Primary
Concomitant
Angle Closure Glaucoma Other Serious 5/17/2009 56 Female 134 lb 12/21/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/6/2008 51 Male 163 lb 1/25/2010 Consumer United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 11/1/2007 58 Male 137 lb 3/4/2010 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 12/1/2007 69 Male 3/12/2010 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 2/6/2008 51 Male 163 lb 4/16/2010 Other Health Professional United States
Primary
Concomitant
Ventricular Hypertrophy Other Serious 12/1/2007 69 Male 4/23/2010 Physician United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 11/1/2007 58 Male 137 lb 5/28/2010 Physician United States
Primary
Secondary
Concomitant
Ventricular Hypertrophy Other Serious 12/1/2007 69 Male 6/11/2010 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 2/6/2008 51 Male 163 lb 9/21/2010 Other Health Professional United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 11/1/2007 58 Male 137 lb 10/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 2/20/2007 69 Female 139 lb 12/2/2010 Other Health Professional United States
Primary
Concomitant
Convulsion Other Serious 1/10/2011 Other Health Professional Turkey
Primary
Concomitant
Haemorrhage Intracranial Other Serious 1/10/2011 Other Health Professional Turkey
Primary
Concomitant
Klebsiella Sepsis Other Serious 4/15/2000 73 Male 160 lb 2/28/2011 Other Health Professional United States
Primary
Concomitant
Depression Death 4/15/2000 73 Male 160 lb 2/28/2011 Consumer United States
Primary
Concomitant
Pain Death 12/9/2004 62 Female 342 lb 2/28/2011 Consumer United States
Primary
Concomitant
Anhedonia Other Serious 12/9/2004 62 Female 342 lb 2/28/2011 Consumer United States
Primary
Concomitant
Injury Death 9/30/2006 65 Female 126 lb 3/4/2011 Other Health Professional United States
Primary
Concomitant
Injury Death 1/13/2000 49 Male 170 lb 3/7/2011 Consumer United States
Primary
Concomitant
Emotional Distress Other Serious 12/1/1997 75 Male 165 lb 3/8/2011 Lawyer United States
Primary
Concomitant
Pain Other Serious 1/13/2000 49 Male 170 lb 3/7/2011 Consumer United States
Primary
Concomitant
Renal Impairment Other Serious 12/23/2004 44 Female 211 lb 3/9/2011 Consumer United States
Primary
Concomitant
Injury Hospitalization 12/23/2004 44 Female 211 lb 3/9/2011 Other Health Professional United States
Primary
Concomitant
Renal Impairment Death 1/22/2004 64 Male 172 lb 3/10/2011 Consumer United States
Primary
Concomitant
Fear Hospitalization 1/22/2004 64 Male 172 lb 3/10/2011 Lawyer United States
Primary
Concomitant
Anxiety Death 10/8/2004 45 Female 110 lb 3/10/2011 Consumer United States
Primary
Concomitant
Renal Failure Hospitalization 10/8/2004 45 Female 110 lb 3/10/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Death 6/22/2007 64 Male 190 lb 3/10/2011 Physician United States
Primary
Concomitant
Renal Failure Death 6/22/2007 64 Male 190 lb 3/10/2011 Consumer United States
Primary
Concomitant
Emotional Distress Other Serious 1/1/2004 77 Female 116 lb 3/15/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 1/1/2004 77 Female 116 lb 3/15/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious Female 174 lb 3/14/2011 Other Health Professional United States
Primary
Concomitant
Fear Other Serious Female 174 lb 3/14/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 4/27/2005 67 Male 130 lb 3/15/2011 Lawyer United States
Primary
Concomitant
Injury Hospitalization 1/1/2004 68 Male 195 lb 3/15/2011 Other Health Professional United States
Primary
Concomitant
Anhedonia Other Serious 4/27/2005 67 Male 130 lb 3/15/2011 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 6/21/2005 68 Male 286 lb 3/16/2011 Other Health Professional United States
Primary
Concomitant
Fear Hospitalization 6/21/2005 68 Male 286 lb 3/16/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious Male 246 lb 3/16/2011 Lawyer United States
Primary
Concomitant
Asthenia Death 1/6/2004 78 Male 165 lb 3/17/2011 Lawyer United States
Primary
Concomitant
Renal Failure Acute Hospitalization 4/1/2003 56 Male 155 lb 3/17/2011 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Death 12/17/2002 79 Female 244 lb 3/18/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 5/18/2006 52 Male 146 lb 3/18/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 11/15/2004 56 Female 210 lb 3/18/2011 Consumer United States
Primary
Concomitant
Anxiety Hospitalization 5/18/2006 52 Male 146 lb 3/18/2011 Physician United States
Primary
Concomitant
Emotional Distress Other Serious 1/30/2003 53 Male 200 lb 3/22/2011 Consumer United States
Primary
Concomitant
Anxiety Other Serious 1/1/1997 48 Female 185 lb 3/22/2011 Consumer United States
Primary
Concomitant
Emotional Distress Other Serious 12/26/2002 48 Female 208 lb 3/21/2011 Other Health Professional United States
Primary
Concomitant
Injury Death 8/1/2003 54 Male 185 lb 3/22/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Death 8/1/2003 54 Male 185 lb 3/22/2011 Consumer United States
Primary
Concomitant
Pain Hospitalization 1/16/2004 75 Female 165 lb 3/22/2011 Consumer United States
Primary
Concomitant
Pain Other Serious 5/13/2004 67 Male 238 lb 3/22/2011 Consumer United States
Primary
Concomitant
Renal Injury Other Serious 5/13/2004 67 Male 238 lb 3/22/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 6/1/2006 79 Male 163 lb 3/22/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Death 6/1/2006 79 Male 163 lb 3/22/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 7/1/2003 74 Female 175 lb 3/23/2011 Other Health Professional United States
Primary
Concomitant
Fear Other Serious 7/1/2003 74 Female 175 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Stress Other Serious 1/1/2001 68 Female 96 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 1/1/2001 68 Female 96 lb 3/23/2011 Physician United States
Primary
Concomitant
Stress Death 7/25/2005 80 Female 148 lb 3/23/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious 7/25/2005 80 Female 148 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Hospitalization 3/28/2000 53 Female 172 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Cerebrovascular Accident Other Serious 3/28/2000 53 Female 172 lb 3/23/2011 Consumer United States
Primary
Concomitant
Anhedonia Death 1/1/1996 49 Female 135 lb 3/23/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 1/1/1996 49 Female 135 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 10/21/2003 58 Female 180 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Depression Other Serious 6/15/2005 57 Male 190 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Anxiety Hospitalization 12/7/1999 61 Male 212 lb 3/23/2011 Lawyer United States
Primary
Secondary
Concomitant
Injury Other Serious 10/21/2003 58 Female 180 lb 3/23/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious 4/14/2006 65 Male 325 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Emotional Distress Other Serious Female 3/23/2011 Consumer United States
Primary
Concomitant
Fear Other Serious 1/1/2004 68 Male 195 lb 3/23/2011 Consumer United States
Primary
Concomitant
Injury Hospitalization 10/2/2005 52 Female 220 lb 3/23/2011 Physician United States
Primary
Concomitant
Anhedonia Other Serious 10/2/2005 52 Female 220 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Fear Hospitalization 1/1/2006 54 Male 238 lb 3/24/2011 Other Health Professional United States
Primary
Concomitant
Injury Hospitalization 1/1/2006 54 Male 238 lb 3/24/2011 Lawyer United States
Primary
Concomitant
Injury Hospitalization 8/12/2003 63 Male 84 lb 3/24/2011 Lawyer United States
Primary
Concomitant
Pain Hospitalization 9/30/2005 82 Female 120 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Injury Death 5/18/1985 59 Male 190 lb 3/29/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Other Serious 7/12/2006 64 Female 190 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Pain Hospitalization 4/15/2004 71 Female 123 lb 3/29/2011 Consumer United States
Primary
Concomitant
Anxiety Hospitalization 9/30/2005 82 Female 120 lb 3/29/2011 Consumer United States
Primary
Concomitant
Renal Failure Other Serious 7/12/2006 64 Female 190 lb 3/29/2011 Consumer United States
Primary
Concomitant
Disability Hospitalization Male 313 lb 3/29/2011 Consumer United States
Primary
Concomitant
Injury Other Serious 5/23/2008 53 Male 282 lb 3/29/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 5/23/2008 53 Male 282 lb 3/29/2011 Consumer United States
Primary
Concomitant
Anhedonia Hospitalization 4/25/2007 77 Female 160 lb 3/30/2011 Lawyer United States
Primary
Concomitant
Pain Other Serious 4/25/2007 77 Female 160 lb 3/30/2011 Consumer United States
Primary
Concomitant
Renal Injury Other Serious 5/3/2005 73 Male 134 lb 3/29/2011 Consumer United States
Primary
Concomitant
Injury Death 5/3/2005 73 Male 134 lb 3/29/2011 Lawyer United States
Primary
Concomitant
Injury Death 2/1/2007 65 Female 170 lb 3/30/2011 Lawyer United States
Primary
Concomitant
Injury Other Serious 1/6/2004 78 Male 165 lb 3/30/2011 Other Health Professional United States
Primary
Concomitant
Stress Other Serious 1/1/1997 48 Female 185 lb 3/31/2011 Consumer United States
Primary
Concomitant
Multi-organ Failure Death 6/1/2006 56 Male 250 lb 3/31/2011 Consumer United States
Primary
Concomitant
Renal Failure Acute Hospitalization 10/20/2004 55 Female 320 lb 3/31/2011 Lawyer United States
Primary
Concomitant
Feeling Abnormal Other Serious 4/7/2002 73 Female 132 lb 3/31/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/1/2006 68 Male 248 lb 3/31/2011 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Other Serious 9/9/2006 45 Female 120 lb 4/4/2011 Consumer United States
Primary
Concomitant
Fear Other Serious 12/7/1999 61 Male 212 lb 4/4/2011 Consumer United States
Primary
Concomitant
Pain Death 9/7/1998 80 Male 174 lb 4/5/2011 Consumer United States
Primary
Concomitant
Stress Other Serious 9/7/1998 80 Male 174 lb 4/5/2011 Other Health Professional United States
Primary
Concomitant
Anhedonia Hospitalization 10/10/2005 74 Female 192 lb 4/5/2011 Lawyer United States
Primary
Concomitant
Fear Disability 4/1/2004 51 Female 125 lb 4/5/2011 Consumer United States
Primary
Secondary
Concomitant
Injury Hospitalization 9/1/2006 57 Male 214 lb 4/6/2011 Physician United States
Primary
Concomitant
Death Other Serious 4/26/2005 78 Female 119 lb 4/5/2011 Consumer United States
Primary
Concomitant
Emotional Distress Hospitalization 3/1/2006 48 Male 220 lb 4/6/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Other Serious 5/25/2007 83 Male 220 lb 4/5/2011 Lawyer United States
Primary
Concomitant
Emotional Distress Other Serious 5/25/2007 83 Male 220 lb 4/5/2011 Other Health Professional United States
Primary
Concomitant
Emotional Distress Hospitalization 11/3/2004 65 Male 213 lb 4/6/2011 Lawyer United States
Primary
Concomitant
Pain Other Serious 1/28/2004 61 Female 126 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Injury Hospitalization 3/1/2004 63 Male 185 lb 4/7/2011 Consumer United States
Primary
Concomitant
Anaemia Other Serious 6/2/2007 86 Female 134 lb 4/7/2011 Consumer United States
Primary
Concomitant
Pain Other Serious 12/1/2006 56 Female 173 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Other Serious 12/1/2006 56 Female 173 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Anhedonia Death 11/1/2007 39 Female 254 lb 4/8/2011 Other Health Professional United States
Primary
Concomitant
Pain Other Serious 11/1/2007 39 Female 254 lb 4/8/2011 Consumer United States
Primary
Concomitant
Depression Other Serious 1/1/2003 44 Male 258 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Injury Death 1/1/2003 44 Male 258 lb 4/7/2011 Other Health Professional United States
Primary
Concomitant
Anxiety Other Serious 2/17/2006 52 Female 110 lb 4/8/2011 Lawyer United States
Primary
Concomitant
Renal Impairment Other Serious 2/6/2004 62 Female 126 lb 4/8/2011 Lawyer United States
Primary
Concomitant
Anxiety Other Serious 2/6/2004 62 Female 126 lb 4/8/2011 Lawyer United States
Primary
Concomitant
Unevaluable Event Death 12/3/2005 61 Male 185 lb 4/12/2011 Lawyer United States
Primary
Concomitant
Depression Hospitalization 5/9/2004 64 Male 181 lb 4/13/2011 Physician United States
Primary
Concomitant

Drug Data