Darunavir combined with Ritonavir Soft Gelatin Capsules

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Cardiac Disorder Hospitalization 5/26/2007 Male 212 lb 2/1/2008 Consumer United States
Primary
Secondary
Concomitant
Polydactyly Congenital Anomaly 2/9/2007 Female 7 lb 2/11/2008 United States
Primary
Secondary
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 3/3/2008 Physician United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 3/19/2008 Physician United States
Primary
Secondary
Concomitant
Abortion Induced Other Serious 3/17/2008 38 Female 4/30/2008 United States
Primary
Secondary
Hepatic Failure Other Serious 4/1/2008 Male 137 lb 7/3/2008 Physician United States
Primary
Secondary
Concomitant
Interacting
Retinal Detachment Hospitalization 6/6/2008 Female 130 lb 7/11/2008 Ireland
Primary
Concomitant
Premature Baby Female 6 lb 7/25/2008 United States
Primary
Secondary
Sepsis Other Serious 5/26/2008 49 Male 8/4/2008 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Retinal Detachment Hospitalization 6/6/2008 Female 130 lb 8/8/2008 Ireland
Primary
Concomitant
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 8/15/2008 United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/6/2007 43 Male 8/21/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2008 Male 159 lb 8/22/2008 Ireland
Primary
Concomitant
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 9/5/2008 United States
Primary
Secondary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 9/9/2008 Ireland
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 9/16/2008 Ireland
Primary
Concomitant
Renal Failure Hospitalization 8/29/2006 Male 172 lb 9/18/2008 Ireland
Primary
Concomitant
Pneumonia Hospitalization 8/28/2008 Male 148 lb 10/2/2008 Ireland
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 10/3/2008 Ireland
Primary
Concomitant
Tachycardia Hospitalization 7/7/2008 Male 159 lb 10/14/2008 Ireland
Primary
Concomitant
Pyrexia Hospitalization Male 10/16/2008 Ireland
Primary
Concomitant
Respiratory Distress Hospitalization 8/17/2008 Male 128 lb 10/17/2008 Ireland
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 10/21/2008 Ireland
Primary
Concomitant
Pyrexia Hospitalization 10/7/2008 Male 10/23/2008 Ireland
Primary
Concomitant
Foetal Growth Retardation Other Serious Female 10/24/2008 Israel
Primary
Concomitant
Pneumonia Hospitalization 7/7/2008 Male 159 lb 10/24/2008 Ireland
Primary
Concomitant
Foetal Growth Retardation Other Serious Female 10/27/2008 Israel
Primary
Concomitant
Renal Failure Acute Hospitalization 10/16/2008 Male 167 lb 10/28/2008 Ireland
Primary
Concomitant
Asthma Hospitalization 10/7/2008 Male 10/30/2008 Ireland
Primary
Concomitant
Pneumonia Hospitalization 7/7/2008 Male 159 lb 10/30/2008 Ireland
Primary
Concomitant
Renal Failure Acute Hospitalization 10/16/2008 Male 167 lb 11/4/2008 Ireland
Primary
Concomitant
Respiratory Distress Hospitalization 8/17/2008 Male 128 lb 11/5/2008 Ireland
Primary
Concomitant
Lobar Pneumonia Hospitalization 10/16/2008 Male 167 lb 11/11/2008 Ireland
Primary
Concomitant
Respiratory Failure Death Male 11/13/2008 Consumer United States
Primary
Secondary
Abortion Induced Other Serious Female 12/4/2008 Israel
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 12/10/2008 Ireland
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 12/19/2008 Ireland
Primary
Concomitant
Suicidal Ideation Other Serious 12/9/2008 Male 155 lb 12/22/2008 Ireland
Primary
Concomitant
Pancytopenia Hospitalization 1/7/2009 Female 1/20/2009
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 5/27/2008 Female 116 lb 1/21/2009 Brazil
Primary
Concomitant
Suicidal Ideation Other Serious 12/9/2008 Male 155 lb 1/28/2009 Ireland
Primary
Concomitant
Secondary Syphilis Life Threatening 11/18/2008 Male 132 lb 1/28/2009 Ireland
Primary
Concomitant
Premature Labour Other Serious 11/9/2008 Female 2/9/2009 United Kingdom
Primary
Secondary
Concomitant
Small For Dates Baby Hospitalization 11/8/2008 Female 5 lb 2/9/2009 United Kingdom
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 5/27/2008 Female 116 lb 2/11/2009 Brazil
Primary
Concomitant
Stress Hospitalization 41 Male 2/12/2009 Consumer United States
Primary
Secondary
Pancytopenia Hospitalization 1/7/2009 Female 114 lb 2/13/2009
Primary
Concomitant
Hypercoagulation Hospitalization 12/24/2008 Male 141 lb 2/17/2009 Argentina
Primary
Concomitant
Bicytopenia Death 8/18/2008 Female 138 lb 2/18/2009 Ireland
Primary
Concomitant
Respiratory Failure Death Male 2/26/2009 Consumer United States
Primary
Secondary
Varices Oesophageal Life Threatening 5/27/2008 Female 116 lb 2/26/2009 Brazil
Primary
Concomitant
Respiratory Failure Death Male 2/27/2009 Consumer United States
Primary
Secondary
Thrombocytopenia Hospitalization 11/12/2008 Female 116 lb 3/5/2009 United States
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 1/24/2009 30 Female 145 lb 3/9/2009 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Sinus Bradycardia Hospitalization 2/16/2009 Male 126 lb 3/11/2009 Ireland
Primary
Concomitant
Secondary Syphilis Hospitalization 11/18/2008 Male 132 lb 3/11/2009 Ireland
Primary
Concomitant
Respiratory Failure Death Male 3/12/2009 Consumer United States
Primary
Secondary
Upper Gastrointestinal Haemorrhage Life Threatening 5/27/2008 Female 116 lb 3/13/2009 Brazil
Primary
Concomitant
Sepsis Death 8/13/2008 Female 138 lb 3/19/2009 Ireland
Primary
Concomitant
Sinus Bradycardia Hospitalization 2/16/2009 Male 126 lb 3/19/2009 Ireland
Primary
Concomitant
Pancytopenia Hospitalization 1/7/2009 Female 114 lb 3/20/2009
Primary
Concomitant
Cerebrovascular Accident Hospitalization 12/24/2008 Male 141 lb 3/24/2009 Argentina
Primary
Concomitant
Sinus Bradycardia Hospitalization 2/16/2009 Male 126 lb 3/27/2009 Ireland
Primary
Concomitant
Sinus Bradycardia Life Threatening 2/16/2009 Male 126 lb 4/1/2009 Ireland
Primary
Concomitant
Premature Labour Other Serious 11/9/2008 Female 122 lb 4/3/2009 United Kingdom
Primary
Secondary
Concomitant
Small For Dates Baby Hospitalization 11/8/2008 Female 5 lb 4/3/2009 United Kingdom
Primary
Secondary
Concomitant
Hepatitis Life Threatening 2/16/2009 Male 128 lb 4/28/2009 Ireland
Primary
Concomitant
Pancytopenia Hospitalization 1/7/2009 Female 114 lb 5/1/2009
Primary
Concomitant
Cerebrovascular Accident Hospitalization 12/24/2008 Male 141 lb 5/1/2009 Argentina
Primary
Concomitant
Drug Interaction Other Serious 2/4/2009 Male 119 lb 5/7/2009 Ireland
Primary
Concomitant
Thrombocytopenia Death 8/13/2008 Female 138 lb 5/8/2009 Ireland
Primary
Concomitant
Hepatitis Life Threatening 2/16/2009 Male 128 lb 5/12/2009 Ireland
Primary
Concomitant
Pneumonia Hospitalization 4/29/2009 Male 5/13/2009
Primary
Concomitant
Pancytopenia Hospitalization 1/7/2009 Female 114 lb 5/22/2009
Primary
Concomitant
Vomiting Other Serious 2/4/2009 Male 119 lb 5/28/2009 Ireland
Primary
Concomitant
Stillbirth Other Serious 6/23/2009 Female 150 lb 7/9/2009 Ireland
Primary
Concomitant
Pneumonia Hospitalization 4/29/2009 Male 7/10/2009
Primary
Concomitant
Sinus Bradycardia Life Threatening 2/16/2009 Male 128 lb 7/10/2009 Ireland
Primary
Secondary
Concomitant
Hyperamylasaemia Other Serious 7/6/2009 Female 147 lb 7/21/2009 Ireland
Primary
Concomitant
Premature Labour Other Serious 11/9/2008 Female 122 lb 7/23/2009 United Kingdom
Primary
Secondary
Concomitant
Sinus Bradycardia Life Threatening 2/16/2009 Male 128 lb 7/24/2009 Ireland
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/29/2009 Male 7/24/2009
Primary
Concomitant
Stillbirth Other Serious 6/23/2009 Female 150 lb 7/24/2009 Ireland
Primary
Concomitant
Rash Morbilliform Other Serious 49 Female 7/27/2009 Physician United States
Primary
Secondary
Concomitant
Osteomyelitis Life Threatening 8/14/2008 42 Male 139 lb 7/31/2009 United States
Primary
Secondary
Concomitant
Sinus Bradycardia Life Threatening 2/16/2009 Male 128 lb 7/31/2009 Ireland
Primary
Secondary
Concomitant
Hiv Infection Death 6/25/2009 32 Female 8/3/2009 United States
Primary
Secondary
Diffuse Large B-cell Lymphoma Hospitalization 10/30/2008 44 Male 8/13/2009 Physician United States
Primary
Secondary
Hyperamylasaemia Other Serious 7/6/2009 Female 147 lb 8/13/2009 Brazil
Primary
Concomitant
Sinus Bradycardia Life Threatening 2/16/2009 Male 128 lb 8/14/2009 Ireland
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 37 Female 8/14/2009 France
Primary
Concomitant
Cushing's Syndrome Other Serious 9/27/2006 Male 151 lb 8/20/2009 Ireland
Primary
Concomitant
Abortion Spontaneous Other Serious 2/15/2009 29 Female 9/1/2009 United States
Primary
Secondary
Abortion Spontaneous Other Serious 2/15/2009 29 Female 9/8/2009 United States
Primary
Secondary
Somnolence Hospitalization 53 Male 9/10/2009 United Kingdom
Primary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 9/15/2009 Physician United States
Primary
Secondary
Concomitant
Cervix Operation Hospitalization 9/4/2009 Female 147 lb 9/17/2009 Ireland
Primary
Concomitant
Hyperamylasaemia Other Serious 7/6/2009 Female 147 lb 9/17/2009 Brazil
Primary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 9/21/2009 Physician United States
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 9/27/2008 37 Female 9/22/2009 France
Primary
Concomitant
Memory Impairment Hospitalization 10/8/2007 Male 9/25/2009 United Kingdom
Primary
Concomitant
Stillbirth Other Serious 6/23/2009 Female 150 lb 9/25/2009 Argentina
Primary
Concomitant
Cervix Operation Hospitalization 9/3/2009 Female 147 lb 10/28/2009 Ireland
Primary
Concomitant
Weight Decreased Other Serious 1/1/2003 51 Male 10/29/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization Male 10/30/2009
Primary
Concomitant
Stillbirth Other Serious 6/23/2009 Female 150 lb 11/25/2009 Argentina
Primary
Concomitant
Osteoporosis Hospitalization 2/7/2009 Male 161 lb 11/25/2009 Brazil
Primary
Concomitant
Thrombocytopenia Other Serious 5/12/2009 Male 11/30/2009 Ireland
Primary
Concomitant
Hepatorenal Failure Death 10/5/2009 Male 11/30/2009 South Africa
Primary
Concomitant
Cervix Operation Hospitalization 9/3/2009 Female 147 lb 12/3/2009 Ireland
Primary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 44 Male 12/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 12/8/2009 35 Female 12/16/2009 Israel
Primary
Secondary
Osteoporosis Hospitalization 2/7/2009 Male 161 lb 12/29/2009 Brazil
Primary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 10/30/2008 44 Male 12/31/2009 Physician United States
Primary
Secondary
Angina Unstable Life Threatening 10/3/2008 Male 162 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 10/30/2008 44 Male 1/18/2010 Physician United States
Primary
Secondary
Pregnancy Other Serious 12/8/2009 35 Female 1/21/2010 Israel
Primary
Secondary
Simple Partial Seizures Hospitalization 10/19/2009 Female 73 lb 2/3/2010 Ireland
Primary
Concomitant
Abortion Spontaneous Other Serious 12/8/2009 35 Female 2/8/2010 Israel
Primary
Secondary
Sepsis Syndrome Hospitalization 9/6/2006 46 Male 2/8/2010 United Kingdom
Primary
Concomitant
Abortion Spontaneous Other Serious 2/15/2009 39 Female 2/18/2010 France
Primary
Secondary
Sepsis Syndrome Hospitalization 10/1/2006 46 Male 2/19/2010 United Kingdom
Primary
Concomitant
Abortion Spontaneous Other Serious 12/8/2009 35 Female 2/22/2010 Israel
Primary
Secondary
Osteomyelitis Life Threatening 8/14/2008 42 Male 139 lb 3/4/2010 United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 3/8/2010 Physician United States
Primary
Secondary
Concomitant
Diffuse Large B-cell Lymphoma Other Serious 44 Male 3/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 10/30/2008 44 Male 3/13/2010 Physician United States
Primary
Secondary
Partial Seizures Hospitalization 10/19/2009 Female 73 lb 3/18/2010 Ireland
Primary
Concomitant
Ventricular Hypertrophy Death 6/10/2009 Female 7 lb 3/19/2010 United States
Primary
Secondary
Rash Maculo-papular Hospitalization 10/19/2009 Female 73 lb 3/29/2010 Ireland
Primary
Concomitant
Ventricular Hypertrophy Death 6/10/2009 Female 7 lb 3/30/2010 United States
Primary
Secondary
Renal Failure Acute Life Threatening 10/5/2007 44 Male 232 lb 4/5/2010 Physician United States
Primary
Secondary
Concomitant
Sudden Infant Death Syndrome Death 6/10/2009 -1 Female 8 lb 4/12/2010 Physician United Kingdom
Primary
Secondary
Cervix Operation Hospitalization 9/3/2009 45 Female 147 lb 4/22/2010 Ireland
Primary
Concomitant
Ventricular Hypertrophy Death 6/10/2009 -1 Female 8 lb 5/7/2010 Physician United Kingdom
Primary
Secondary
Ventricular Hypertrophy Death 6/10/2009 Female 7 lb 5/7/2010 United States
Primary
Secondary
Diffuse Large B-cell Lymphoma Hospitalization 10/30/2008 44 Male 5/10/2010 Physician United States
Primary
Secondary
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 5/13/2010 Physician United States
Primary
Secondary
Concomitant
Primary Adrenal Insufficiency Other Serious Male 5/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Interacting
Renal Failure Acute Life Threatening 10/5/2007 44 Male 232 lb 6/1/2010 Physician United States
Primary
Secondary
Concomitant
Chorioamnionitis Other Serious 10/25/2008 40 Female 6/11/2010 Physician United States
Primary
Concomitant
Stillbirth Other Serious 6/23/2009 32 Female 150 lb 6/18/2010 Physician Argentina
Primary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 7/7/2010 Physician United States
Primary
Secondary
Concomitant
Polydactyly Congenital Anomaly 27 Male 5 lb 10/6/2010 Other Health Professional United States
Primary
Secondary
Congenital Anomaly Congenital Anomaly 6/25/2010 Female 10/7/2010 Other Health Professional United States
Primary
Concomitant
Anal Fistula Hospitalization 8/10/2010 32 174 lb 10/7/2010 Physician Argentina
Primary
Concomitant
Congenital Anomaly Congenital Anomaly 11/12/2009 10/8/2010 Physician Spain
Primary
Secondary
Concomitant
Foetal Growth Restriction Congenital Anomaly 10/14/2010 12/3/2010 Physician France
Primary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 5/10/2010 Male 1/13/2011 Physician United States
Primary
Concomitant
Foetal Growth Restriction Congenital Anomaly 10/14/2010 1/19/2011 Physician France
Primary
Concomitant

Drug Data