Flolan combined with Spironolactone

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Haemoptysis Life Threatening 3/3/2003 33 Female 1/24/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 2/24/2002 24 Female 1/27/2006 Physician Japan
Primary
Secondary
Concomitant
Sudden Death Other Serious 4/7/2006 40 Female 4/19/2006 Physician France
Primary
Concomitant
Sudden Death Other Serious 4/7/2006 40 Female 4/27/2006 Physician France
Primary
Concomitant
Sudden Death Other Serious 4/7/2006 40 Female 4/26/2006 Physician France
Primary
Concomitant
Sputum Discoloured Life Threatening 3/3/2003 33 Female 5/5/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 2/19/2004 40 Female 5/17/2006 Physician Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Other Serious 2/26/2006 35 Female 220 lb 5/18/2006 Physician Canada
Primary
Secondary
Concomitant
Sudden Death Other Serious 4/7/2006 40 Female 5/15/2006 Physician France
Primary
Concomitant
Weight Decreased Hospitalization 11/8/2001 12 Male 66 lb 6/7/2006 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 11/17/2005 35 Female 6/19/2006 Pharmacist Canada
Primary
Concomitant
Sudden Death Other Serious 4/7/2006 40 Female 6/20/2006 Physician France
Primary
Secondary
Concomitant
Vomiting Other Serious 2/19/2004 40 Female 7/5/2006 Physician Japan
Primary
Concomitant
Asthma Hospitalization 10/6/2005 31 Female 7/18/2006 Physician Japan
Primary
Concomitant
Vulval Disorder Hospitalization 8/2/2006 29 Female 108 lb 8/14/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Urticaria Hospitalization 8/2/2006 29 Female 108 lb 8/25/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vaginal Lesion Hospitalization 8/2/2006 29 Female 108 lb 8/31/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 8/28/2006 38 Male 225 lb 9/7/2006 Consumer United States
Primary
Concomitant
Pulmonary Veno-occlusive Disease Disability 1/19/2006 1 Male 1/2/2007 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 10/15/2006 42 Female 165 lb 1/9/2007 Consumer United States
Primary
Concomitant
Pulmonary Veno-occlusive Disease Death 1/19/2006 1 Male 1/25/2007 Physician Japan
Primary
Concomitant
Cough Hospitalization 10/30/2004 30 Female 2/16/2007 Physician Japan
Primary
Concomitant
Pharmaceutical Product Complaint 2/1/2007 45 Female 134 lb 2/23/2007 Other Health Professional United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 2/3/2007 45 Female 134 lb 3/2/2007 Consumer United States
Primary
Concomitant
Supraventricular Tachycardia Other Serious 1/19/2006 39 Female 3/8/2007 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 2/3/2007 45 Female 134 lb 3/12/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 2/6/2007 45 Female 134 lb 3/28/2007 Consumer United States
Primary
Concomitant
Vomiting Required Intervention 6/23/2005 36 Female 90 lb 3/20/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/17/2007 68 Female 130 lb 3/30/2007 Consumer United States
Primary
Concomitant
Skin Ulcer Hospitalization 8/2/2006 29 Female 5/8/2007 Consumer United States
Primary
Secondary
Concomitant
Infection Life Threatening 9/9/2004 31 Female 110 lb 5/15/2007 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 9/9/2004 31 Female 110 lb 5/21/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 3/17/2007 68 Female 96 lb 5/23/2007 Consumer United States
Primary
Concomitant
Headache 12/4/2006 47 Male 254 lb 5/25/2007 Consumer United States
Primary
Concomitant
Vomiting Required Intervention 6/23/2005 36 Female 90 lb 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 10/30/2004 30 Female 8/31/2007 Physician Japan
Primary
Concomitant
Pancreatitis Other Serious 9/10/2007 50 Female 150 lb 9/21/2007 Consumer United States
Primary
Concomitant
Vomiting Other Serious 12/18/2003 40 Female 10/12/2007 Physician Japan
Primary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 11/13/2007 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/20/2005 17 Female 11/14/2007 Physician Japan
Primary
Secondary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 1/8/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/20/2005 17 Female 1/9/2008 Physician Japan
Primary
Secondary
Concomitant
Fluid Overload Hospitalization 12/7/2007 Female 1/16/2008 Physician United States
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 10/1/2007 70 Female 139 lb 2/1/2008 Physician United States
Primary
Secondary
Concomitant
Right Ventricular Failure Hospitalization 6/2/2007 37 Female 73 lb 4/22/2008 Physician Japan
Primary
Concomitant
Right Ventricular Failure Other Serious 10/1/2007 70 Female 139 lb 5/23/2008 Physician United States
Primary
Secondary
Concomitant
Rash Female 96 lb 5/30/2008 Consumer United States
Primary
Concomitant
Rash 74 Female 5/30/2008 Consumer United States
Primary
Concomitant
Platelet Count Decreased 55 Female 5/30/2008 Consumer United States
Primary
Concomitant
Central Line Infection Hospitalization 1/16/2008 64 Male 5/30/2008 Consumer United States
Primary
Secondary
Concomitant
Uterine Leiomyoma Hospitalization 10/31/2004 33 Female 6/5/2008 Physician Japan
Primary
Concomitant
Supraventricular Tachycardia Other Serious 1/19/2006 39 Female 6/11/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/5/2005 Female 104 lb 7/2/2008 United States
Primary
Concomitant
Interacting
Therapeutic Response Decreased Other Serious 12/7/2006 42 Female 7/3/2008 Physician Japan
Primary
Concomitant
Oedema Peripheral Hospitalization 9/26/2007 Female 223 lb 7/3/2008 Other Health Professional United States
Primary
Concomitant
Central Line Infection Hospitalization 6/20/2008 Female 7/10/2008 Consumer United States
Primary
Concomitant
Catheter Related Infection Hospitalization 6/20/2008 46 Female 7/14/2008 Consumer United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 12/7/2006 42 Female 7/18/2008 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 12/7/2006 42 Female 7/23/2008 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 12/28/2007 42 Female 8/5/2008 Physician Japan
Primary
Concomitant
Hyperthyroidism Hospitalization 6/29/2007 42 Female 8/5/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Death 6/19/2007 56 Female 112 lb 8/5/2008 Physician Japan
Primary
Concomitant
Pain Life Threatening 10/18/2006 47 Female 88 lb 8/8/2008 Physician Japan
Primary
Concomitant
Right Ventricular Failure Hospitalization 6/2/2007 37 Female 73 lb 9/2/2008 Physician Japan
Primary
Concomitant
Shock Hospitalization 8/26/2008 Female 125 lb 9/4/2008 Physician United States
Primary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 9/11/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Life Threatening 6/19/2007 56 Female 112 lb 9/15/2008 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 6/1/2000 30 Male 116 lb 9/18/2008 Physician Japan
Primary
Concomitant
Thyroiditis Other Serious 10/19/2005 39 Female 9/30/2008 Physician Japan
Primary
Secondary
Concomitant
Haemoptysis Death 5/6/2007 18 Female 10/1/2008 Physician Japan
Primary
Secondary
Concomitant
Thyroiditis Other Serious 10/19/2005 39 Female 10/9/2008 Physician Japan
Primary
Secondary
Concomitant
Blood Potassium Decreased Hospitalization Female 83 lb 10/10/2008 Consumer United States
Primary
Concomitant
Right Ventricular Failure Other Serious Female 150 lb 10/14/2008 Physician United States
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 22 Male 10/15/2008 Physician Japan
Primary
Concomitant
Central Line Infection Hospitalization Female 11/13/2008 Consumer United States
Primary
Concomitant
Blood Potassium Decreased Hospitalization Female 83 lb 11/17/2008 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 15 Female 11/19/2008 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 22 Male 11/19/2008 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 6/29/2007 42 Female 11/20/2008 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 6/29/2007 42 Female 11/25/2008 Physician Japan
Primary
Concomitant
Right Ventricular Failure Other Serious 6/1/2000 14 Female 93 lb 12/15/2008 Physician Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 9/29/2008 Female 135 lb 12/17/2008 Other Health Professional United States
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 15 Female 12/30/2008 Physician Japan
Primary
Concomitant
Pain Other Serious Female 1/21/2009 Consumer United States
Primary
Concomitant
Splenomegaly Hospitalization 67 Female 1/23/2009 Consumer United States
Primary
Concomitant
Atrial Fibrillation Hospitalization 8/5/2008 28 Female 2/27/2009 Physician Japan
Primary
Secondary
Abdominal Neoplasm Hospitalization Male 230 lb 3/5/2009 Consumer United States
Primary
Concomitant
Staphylococcal Infection Hospitalization 9/29/2008 Female 135 lb 3/23/2009 Other Health Professional United States
Primary
Concomitant
Splenomegaly Hospitalization 1/1/2009 67 Female 4/6/2009 Consumer United States
Primary
Concomitant
Electrocardiogram Change Hospitalization 3/31/2008 Female 121 lb 4/20/2009 Other Health Professional United States
Primary
Concomitant
Convulsion Other Serious 4/7/2006 4/21/2009 Physician France
Primary
Concomitant
Atrial Fibrillation Hospitalization 8/5/2008 Female 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Pain Other Serious Female 139 lb 5/14/2009 Physician United States
Primary
Concomitant
Pain Other Serious Female 139 lb 5/22/2009 Physician United States
Primary
Concomitant
Vomiting 1/1/2008 69 Female 119 lb 5/29/2009 Consumer United States
Primary
Concomitant
Convulsion Other Serious 4/7/2006 40 5/29/2009 Physician France
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 Female 6/1/2009 Physician Japan
Primary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 6/9/2009 Physician Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 9/29/2008 Female 135 lb 6/12/2009 Other Health Professional United States
Primary
Concomitant
Weight Decreased Other Serious 6/1/2000 Female 93 lb 6/23/2009 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 Male 7/1/2009 Physician Japan
Primary
Secondary
Concomitant
Thyroiditis Life Threatening 10/19/2005 Female 95 lb 7/1/2009 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 7/24/2009 Physician Japan
Primary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 8/3/2009 Physician Japan
Primary
Concomitant
Pulmonary Arterial Hypertension Hospitalization Female 8/18/2009 Other Health Professional United States
Primary
Concomitant
Haemorrhage Death 11/4/2009 Female 119 lb 11/11/2009 Other Health Professional United States
Primary
Concomitant
Death Death Male 11/13/2009 Consumer United States
Primary
Concomitant
Varices Oesophageal Hospitalization Male 11/17/2009 Physician United States
Primary
Concomitant
Death Death 1/7/2010 Female 131 lb 1/12/2010 Consumer United States
Primary
Concomitant
Right Ventricular Failure Hospitalization 1/7/2010 Female 131 lb 1/19/2010 Physician United States
Primary
Concomitant
Right Ventricular Failure Hospitalization Female 131 lb 1/22/2010 Physician United States
Primary
Concomitant
Presyncope Hospitalization Female 98 lb 2/5/2010 Consumer United States
Primary
Concomitant
Therapeutic Response Decreased Other Serious 11/1/2009 49 Female 213 lb 2/17/2010 Physician Canada
Primary
Concomitant
Cardiac Failure High Output Hospitalization Female 200 lb 3/1/2010 Physician United States
Primary
Secondary
Concomitant
Death Death Female 3/8/2010 Consumer United States
Primary
Concomitant
Pulmonary Veno-occlusive Disease Death Female 4/1/2010 Physician United States
Primary
Concomitant
Vasodilation Procedure Hospitalization Female 183 lb 4/1/2010 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 15 Female 4/7/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/20/2005 17 Female 4/7/2010 Physician Japan
Primary
Secondary
Concomitant
Venous Insufficiency Other Serious 3/15/2010 53 Female 145 lb 5/24/2010 Physician United States
Primary
Concomitant
Platelet Count Decreased Other Serious 10 Male 59 lb 5/28/2010 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Other Serious 57 Male 156 lb 5/28/2010 Consumer United States
Primary
Concomitant
Hypokalaemia Hospitalization 7/27/2010 42 Female 9/1/2010 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 64 Female 122 lb 9/22/2010 Pharmacist United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Death 60 Male 10/1/2010 Pharmacist Netherlands
Primary
Concomitant
Pyrexia Hospitalization 9/28/2010 43 Female 10/15/2010 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 64 Female 122 lb 10/19/2010 Pharmacist United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 43 Female 10/20/2010 Physician Japan
Primary
Secondary
Concomitant
Pregnancy Other Serious 1/30/2008 29 Female 10/28/2010 Physician Canada
Primary
Concomitant
Pneumonia Hospitalization 41 Female 201 lb 1/28/2011 Consumer United States
Primary
Concomitant
Catheter Site Infection Hospitalization 66 Female 134 lb 4/5/2011 Pharmacist United States
Primary
Concomitant
Anaemia Other Serious 2/25/2011 73 Female 205 lb 5/4/2011 Other Health Professional United States
Primary
Concomitant
Mineral Supplementation Hospitalization 3/1/2011 66 Female 134 lb 5/6/2011 Pharmacist United States
Primary
Concomitant
General Physical Health Deterioration Hospitalization 3/25/2011 67 Female 133 lb 5/26/2011 Pharmacist United States
Primary
Concomitant
Nausea 1/1/2008 44 Female 170 lb 5/19/2011 Consumer United States
Primary
Concomitant
Alopecia 47 Male 179 lb 5/19/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea 52 Female 134 lb 5/19/2011 Pharmacist United States
Primary
Concomitant
Dysgeusia 11/8/2010 38 Female 5/19/2011 Pharmacist United States
Primary
Secondary
Diarrhoea 55 Female 140 lb 5/19/2011 Pharmacist United States
Primary
Concomitant
Photophobia 54 Male 139 lb 5/19/2011 Consumer United States
Primary
Concomitant
Pain In Jaw 49 Male 132 lb 5/19/2011 Consumer United States
Primary
Concomitant
Pain In Jaw 53 Female 117 lb 5/19/2011 Pharmacist United States
Primary
Concomitant
Treatment Noncompliance 3/3/2011 56 Female 126 lb 5/19/2011 Other Health Professional United States
Primary
Concomitant
Pulmonary Arterial Hypertension Hospitalization 5/1/2011 6/30/2011 Physician United States
Primary
Concomitant
Pyrexia Hospitalization 43 Female 7/14/2011 Physician Japan
Primary
Secondary
Concomitant
Tendonitis Hospitalization 6/17/2011 36 Female 197 lb 7/15/2011 Consumer United States
Primary
Concomitant
Bronchopneumonia Other Serious 3/25/2011 67 Female 133 lb 8/4/2011 Consumer United States
Primary
Concomitant
Eye Swelling Other Serious 10/11/2011 46 Male 248 lb 10/17/2011 Consumer United States
Primary
Concomitant
Deafness Disability 9/1/2011 10/25/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Diarrhoea Other Serious 9/19/2011 57 Female 194 lb 11/8/2011 Pharmacist United States
Primary
Concomitant

Drug Data