Sildenafil Citrate combined with Tracleer

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Troponin I Increased Other Serious 11/3/2005 35 Male 170 lb 2/6/2006 Physician United States
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Female 2/15/2006 Pharmacist United Kingdom
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 0 Female 2/17/2006 Japan
Primary
Concomitant
Vein Disorder Other Serious 9/7/2005 20 Female 121 lb 2/27/2006 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/3/2006 1 Female 3/2/2006 Pharmacist United Kingdom
Primary
Concomitant
Ventricular Dysfunction Required Intervention 10/12/2004 14 Female 108 lb 3/9/2006 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 11/1/2005 73 Female 227 lb 3/9/2006 Physician United States
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 2/28/2006 36 Female 3/13/2006 Physician Japan
Primary
Concomitant
Right Ventricular Failure Other Serious 10/1/2005 53 Female 3/23/2006 Physician United States
Primary
Concomitant
Vomiting Other Serious 1/1/2005 54 Male 3/24/2006 Physician Belgium
Primary
Concomitant
Fatigue 1/1/2005 42 Male 187 lb 1/25/2006 Other Health Professional United States
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 3/1/2006 53 Female 4/12/2006 Physician United Kingdom
Primary
Secondary
Hepatitis Other Serious 12/7/2005 20 Female 148 lb 4/12/2006 Physician Australia
Primary
Secondary
Respiratory Disorder Other Serious 3/1/2006 53 Female 4/21/2006 Physician United Kingdom
Primary
Secondary
Platelet Count Decreased Other Serious 12/1/2005 1 Female 4/26/2006 Pharmacist Ireland
Primary
Concomitant
Cerebral Haemorrhage Other Serious 5/1/2006 Other Health Professional United States
Primary
Secondary
Drug Ineffective Hospitalization 3/1/2006 53 Female 5/5/2006 Other Health Professional United Kingdom
Primary
Secondary
Platelet Count Decreased Other Serious 12/1/2005 1 Female 5/18/2006 Pharmacist Ireland
Primary
Concomitant
Sudden Death Life Threatening 1/12/2006 16 Female 93 lb 5/18/2006 France
Primary
Concomitant
Multi-organ Failure Death 3/1/2006 53 Female 5/18/2006 United Kingdom
Primary
Secondary
Sputum Discoloured Hospitalization 5/4/2006 50 Female 5/19/2006 Pharmacist United States
Primary
Concomitant
Right Ventricular Failure Other Serious 3/25/2006 47 Female 123 lb 5/19/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Tachycardia Other Serious 43 Male 5/25/2006 Physician United States
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 3/25/2006 53 Female 123 lb 6/2/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 2/27/2006 36 Female 119 lb 6/7/2006 Physician Japan
Primary
Concomitant
Haemoglobin Decreased Hospitalization 60 Male 241 lb 6/8/2006 Pharmacist United States
Primary
Secondary
Concomitant
Retinal Vascular Disorder Other Serious 1/1/2006 39 Male 6/19/2006 Physician Canada
Primary
Concomitant
Right Ventricular Failure Death 3/1/2006 53 Female 6/21/2006 United Kingdom
Primary
Secondary
Concomitant
Hepatic Function Abnormal Required Intervention 4/25/2006 48 Female 6/27/2006 Other Health Professional Netherlands
Primary
Concomitant
White Blood Cell Count Decreased Required Intervention 2/1/2005 73 Female 100 lb 6/27/2006 Physician United States
Primary
Concomitant
Weight Decreased Other Serious 3/21/2006 47 Female 155 lb 7/5/2006 Physician United States
Primary
Secondary
Concomitant
Sudden Death Death 6/10/2006 64 Female 7/18/2006 Physician Netherlands
Primary
Concomitant
Weight Decreased Required Intervention 1/1/2005 75 Female 7/20/2006 Physician United States
Primary
Concomitant
Cardiac Failure Hospitalization 11/13/2004 25 Female 99 lb 7/24/2006 Physician Japan
Primary
Concomitant
Right Ventricular Failure Other Serious 7/31/2004 26 Female 149 lb 7/24/2006 Physician Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 5/1/2006 53 Female 8/1/2006 Physician Japan
Primary
Concomitant
Jaundice Other Serious 65 Female 154 lb 8/1/2006 Other Health Professional Netherlands
Primary
Concomitant
Visual Disturbance Life Threatening 7/22/2006 48 Female 8/10/2006 Physician United States
Primary
Concomitant
Pancytopenia Required Intervention 7/1/2006 81 Male 8/10/2006 Physician United States
Primary
Concomitant
Vomiting Other Serious 6/1/2006 40 Female 8/14/2006 Japan
Primary
Concomitant
Subileus Hospitalization 4/27/2006 53 Female 90 lb 8/23/2006 Japan
Primary
Concomitant
Pulmonary Hypertension Death 6/6/2006 58 Male 140 lb 7/24/2006 Other Health Professional United States
Primary
Concomitant
Vomiting Other Serious 54 Female 90 lb 9/1/2006 France
Primary
Concomitant
Vomiting Other Serious 54 Female 90 lb 9/1/2006 France
Primary
Concomitant
Right Ventricular Failure Other Serious 3/25/2006 53 Female 123 lb 9/18/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 54 Female 90 lb 9/19/2006 France
Primary
Concomitant
Vomiting Other Serious 54 Female 90 lb 9/25/2006 Physician France
Primary
Concomitant
Left Ventricular Failure Other Serious 9/7/2006 Male 9/25/2006 Physician Japan
Primary
Concomitant
Right Ventricular Failure Life Threatening 64 Male 203 lb 11/13/2006 Physician United States
Primary
Concomitant
Leukopenia Other Serious 8/30/2006 37 Female 198 lb 11/21/2006 Physician Brazil
Primary
Concomitant
Unevaluable Event Death 74 Female 11/30/2006 Physician Germany
Primary
Concomitant
Right Ventricular Failure 45 Female 115 lb 11/30/2006 Physician Japan
Primary
Concomitant
Condition Aggravated Hospitalization 11/13/2004 25 Female 99 lb 11/30/2006 Physician Japan
Primary
Concomitant
Weight Decreased Hospitalization 7/31/2004 26 Female 149 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Off Label Use 41 Female 115 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease 70 Female 120 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Vein Stenosis Hospitalization 4/2/2006 53 Female 100 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure 32 Female 139 lb 11/30/2006 Physician Japan
Primary
Concomitant
Hypotension Hospitalization 11/1/2006 64 Female 11/30/2006 Physician Turkey
Primary
Concomitant
Subileus Hospitalization 4/27/2006 54 Female 90 lb 12/6/2006 Japan
Primary
Concomitant
Sudden Cardiac Death Death 12/2/2006 9 Male 12/15/2006 Sweden
Primary
Concomitant
Convulsion Hospitalization 10/25/2006 3 Male 37 lb 12/18/2006 Other Health Professional France
Primary
Secondary
Right Ventricular Failure Other Serious 6/30/2006 63 Male 121 lb 12/18/2006 Physician Japan
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Hospitalization 11/27/2006 41 Male 12/18/2006 Physician United States
Primary
Concomitant
Unresponsive To Stimuli Death 12/6/2006 74 Male 120 lb 12/21/2006 Pharmacist United States
Primary
Concomitant
Throat Irritation 67 Female 171 lb 10/24/2006 United States
Primary
Concomitant
Vision Blurred Female 51 lb 10/24/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting 7/1/2006 51 Female 179 lb 10/24/2006 United States
Primary
Secondary
Concomitant
Muscle Spasms 6/29/2006 49 Female 235 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Respiratory Disorder 1/1/2005 62 Female 141 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Diarrhoea 7/16/2006 43 Female 135 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Diarrhoea 8/1/2006 70 Female 145 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Dry Throat 1/1/2006 47 Female 130 lb 10/24/2006 United States
Primary
Concomitant
Insomnia 1/1/2006 77 Female 174 lb 10/24/2006 United States
Primary
Concomitant
Pulmonary Hypertension Hospitalization 9/27/2006 75 Female 137 lb 10/24/2006 United States
Primary
Concomitant
Pulmonary Hypertension Death 6/21/2006 79 Male 186 lb 10/24/2006 Other Health Professional United States
Primary
Concomitant
Temporomandibular Joint Syndrome 12/16/2005 57 Female 110 lb 10/24/2006 Consumer United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 12/31/2006 63 Male 1/11/2007 Germany
Primary
Concomitant
Oedema Peripheral Other Serious 8/8/2006 64 Female 1/30/2007 Physician United States
Primary
Secondary
Concomitant
Embolism Other Serious 1/25/2007 54 Male 164 lb 2/6/2007 Consumer United States
Primary
Concomitant
Sudden Cardiac Death Death 12/2/2006 9 Male 2/13/2007 Sweden
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 4/27/2006 54 Female 90 lb 2/21/2007 Japan
Primary
Concomitant
Red Blood Cell Schistocytes Present Other Serious 8/8/2006 64 Female 2/23/2007 Physician United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/14/2007 37 Male 209 lb 3/7/2007 Consumer United States
Primary
Concomitant
Respiratory Disorder Hospitalization 3/1/2007 74 Male 3/20/2007 Pharmacist France
Primary
Concomitant
Nasopharyngitis Death 2/14/2007 77 Female 115 lb 3/20/2007 Other Health Professional Netherlands
Primary
Concomitant
Septic Embolus Death 3/3/2007 15 Female 88 lb 3/20/2007 Physician Belgium
Primary
Concomitant
Pruritus 1/1/2006 74 Female 119 lb 1/23/2007 Consumer United States
Primary
Concomitant
Pain In Extremity 8/1/2006 74 Male 175 lb 1/23/2007 Other Health Professional United States
Primary
Concomitant
Thirst 7/7/2006 59 Female 160 lb 1/23/2007 Consumer United States
Primary
Concomitant
Nausea 11/9/2006 16 Female 107 lb 1/23/2007 Consumer United States
Primary
Concomitant
Oedema Peripheral 1/1/2006 70 Female 145 lb 1/23/2007 Consumer United States
Primary
Concomitant
Epistaxis 11/28/2006 74 Male 167 lb 1/23/2007 Consumer United States
Primary
Secondary
Concomitant
Pericarditis Hospitalization 3/12/2007 37 Male 3/23/2007 Physician United States
Primary
Concomitant
Oral Pain 10/1/2006 58 Female 200 lb 1/23/2007 Consumer United States
Primary
Concomitant
Fatigue 56 Female 140 lb 1/23/2007 Pharmacist United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/14/2007 37 Male 209 lb 4/17/2007 Consumer United States
Primary
Concomitant
Right Ventricular Failure Hospitalization 1/1/2006 Female 196 lb 4/25/2007 Physician France
Primary
Secondary
Concomitant
Sepsis Required Intervention 3/29/2007 58 Female 132 lb 5/8/2007 Physician Germany
Primary
Concomitant
Pneumonia Hospitalization 11/25/2006 42 Female 148 lb 5/24/2007 Other Health Professional Japan
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 6/19/2007 Pharmacist Ireland
Primary
Concomitant
Pregnancy Other Serious 5/16/2007 27 Female 86 lb 6/14/2007 Thailand
Primary
Concomitant
Vomiting Other Serious 1/1/2007 49 Female 6/19/2007 Other Health Professional United States
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 6/27/2007 Pharmacist Ireland
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 7/2/2007 Pharmacist Ireland
Primary
Concomitant
Respiratory Failure Hospitalization 6/13/2007 70 Female 132 lb 6/28/2007 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 6/13/2007 70 Female 132 lb 7/9/2007 Physician United States
Primary
Concomitant
Staphylococcal Infection Required Intervention 4/1/2006 63 Male 148 lb 1/15/2007 Physician United States
Primary
Concomitant
Right Ventricular Failure Required Intervention 12/1/2006 67 Female 192 lb 7/31/2007 Physician Belgium
Primary
Concomitant
Right Ventricular Failure Required Intervention 12/1/2006 67 Female 192 lb 8/8/2007 Other Health Professional Belgium
Primary
Concomitant
Shock Required Intervention 8/1/2007 64 Male 9/26/2007 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 8/1/2007 68 Female 10/11/2007 Physician United States
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 2/24/2006 76 Female 175 lb 10/23/2007 Other Health Professional United States
Primary
Concomitant
Dizziness Hospitalization 10/1/2007 Female 11/14/2007 Physician Japan
Primary
Secondary
Tinnitus Other Serious 10/22/2007 Female 112 lb 11/27/2007 Physician Japan
Primary
Secondary
Liver Injury Required Intervention 11/13/2007 46 Female 110 lb 11/27/2007 Physician Germany
Primary
Concomitant
Renal Impairment Hospitalization 8/1/2007 68 Female 11/29/2007 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 11/5/2007 66 Male 11/29/2007 Physician France
Primary
Concomitant
Serum Ferritin Increased Other Serious 11/14/2007 65 Female 12/14/2007 Physician United States
Primary
Concomitant
Jaundice Cholestatic Required Intervention 11/13/2007 46 Female 110 lb 12/14/2007 Other Health Professional Germany
Primary
Concomitant
Pneumonia Death 8/1/2007 65 Male 12/19/2007 Physician France
Primary
Concomitant
Dizziness Hospitalization 9/12/2007 33 Female 119 lb 12/19/2007 Consumer Japan
Primary
Secondary
Concomitant
Pancreatitis Required Intervention 11/17/2007 79 Male 170 lb 12/21/2007 Physician United States
Primary
Concomitant
Renal Failure Acute Other Serious 11/14/2007 65 Female 12/26/2007 Physician United States
Primary
Concomitant
Right Ventricular Failure Other Serious 7/18/2006 31 Female 1/5/2008 Other Health Professional United Kingdom
Primary
Concomitant
Vitreous Haemorrhage Other Serious Male 1/17/2008 Other Health Professional United States
Primary
Concomitant
Vaginal Haemorrhage Other Serious 1/5/2006 42 Female 90 lb 1/21/2008 Japan
Primary
Concomitant
Thrombocytopenia Other Serious 11/26/2007 1 Female 23 lb 1/30/2008 Consumer Germany
Primary
Concomitant
International Normalised Ratio Abnormal Hospitalization 57 Female 2/1/2008 Philippines
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/21/2008 20 Male 152 lb 2/12/2008 Physician Germany
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/30/2007 65 Female 2/8/2008 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 11/26/2007 1 Female 23 lb 2/22/2008 Other Health Professional Germany
Primary
Concomitant
Scleroderma Death 1/8/2004 66 Female 140 lb 2/29/2008 Physician United States
Primary
Concomitant
White Blood Cell Count Decreased Required Intervention 12/1/2006 40 Female 86 lb 2/29/2008 Physician Australia
Primary
Concomitant
Sepsis Other Serious 2/1/2008 59 Female 3/14/2008 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/1/2006 51 Female 148 lb 3/14/2008 Germany
Primary
Concomitant
Sudden Death Death 49 Female 152 lb 3/18/2008 Physician Czech Republic
Primary
Concomitant
Vaginal Haemorrhage Other Serious 1/5/2006 42 Female 90 lb 3/19/2008 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 10/1/2007 44 Female 3/25/2008 Physician United States
Primary
Secondary
Concomitant
Death Death 11/12/2007 76 Male 5/1/2008 Other Health Professional Belgium
Primary
Concomitant
Transfusion Other Serious 40 Female 5/6/2008 Physician France
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 6/1/2006 51 Female 148 lb 5/15/2008 Physician Germany
Primary
Concomitant
Supraventricular Tachycardia Other Serious 1/19/2006 39 Female 6/11/2008 Physician Japan
Primary
Secondary
Concomitant
Pregnancy Other Serious 4/1/2007 31 Female 111 lb 6/12/2008 Other Health Professional United States
Primary
Concomitant
Ventricular Dysfunction Required Intervention 10/12/2004 14 Female 108 lb 6/26/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 5/26/2008 25 Female 77 lb 6/30/2008 Consumer Malaysia
Primary
Concomitant
International Normalised Ratio Decreased Hospitalization 12/1/2007 44 Female 220 lb 7/7/2008 Physician France
Primary
Secondary
Concomitant
Sudden Cardiac Death Life Threatening 6/11/2008 9 Male 46 lb 7/7/2008 Physician Australia
Primary
Concomitant
Vomiting Hospitalization 3/1/2006 53 Female 7/18/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Weight Increased Other Serious 2/25/2008 12 Female 115 lb 7/14/2008 Physician United States
Primary
Concomitant

Drug Data