Darunavir combined with Enfuvirtide

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pyrexia Hospitalization 10/2/2006 56 Male 11/4/2006 Other Health Professional France
Primary
Secondary
Concomitant
Status Epilepticus Life Threatening 1/26/2007 58 Female 2/5/2007 Physician France
Primary
Secondary
Concomitant
Urine Output Decreased Life Threatening 2/12/2007 57 Male 181 lb 4/26/2007 Physician Canada
Primary
Secondary
Concomitant
Rectal Haemorrhage Life Threatening 4/20/2007 54 Male 6/1/2007 Physician United Kingdom
Primary
Secondary
Renal Failure Chronic Other Serious 5/25/2004 Male 9/7/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 1/1/2004 Male 220 lb 9/14/2007 Physician France
Primary
Secondary
Concomitant
Renal Tubular Disorder Disability 12/1/2006 Male 161 lb 9/20/2007 Physician France
Primary
Secondary
Concomitant
Renal Failure Chronic Other Serious 5/25/2004 Male 11/20/2007 Physician Japan
Primary
Secondary
Concomitant
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
Jaundice Life Threatening 12/1/2007 48 Male 3/27/2008 Other Health Professional France
Primary
Secondary
Concomitant
Jaundice Life Threatening 12/1/2007 48 Male 4/1/2008 Other Health Professional France
Primary
Secondary
Concomitant
Drug Eruption Hospitalization 3/17/2008 43 Male 4/11/2008 France
Primary
Concomitant
Rhabdomyolysis Hospitalization 4/1/2008 44 Female 4/21/2008 Physician France
Primary
Secondary
Rhabdomyolysis Hospitalization 4/1/2008 44 Female 4/22/2008 Physician France
Primary
Secondary
Folliculitis Hospitalization 3/17/2008 43 Male 5/1/2008 France
Primary
Concomitant
Vomiting Hospitalization 4/18/2008 Female 147 lb 5/30/2008 Brazil
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/18/2008 Female 147 lb 6/11/2008 Brazil
Primary
Secondary
Concomitant
Renal Failure Hospitalization 11/1/2007 45 Male 6/13/2008 Other Health Professional France
Primary
Secondary
Concomitant
Renal Failure Hospitalization 11/1/2007 45 Male 6/18/2008 Other Health Professional France
Primary
Secondary
Concomitant
Renal Failure Hospitalization 11/1/2007 45 Male 6/25/2008 Other Health Professional France
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 4/22/2008 Male 6/27/2008 Netherlands
Primary
Concomitant
Vomiting Hospitalization 4/18/2008 Female 147 lb 6/27/2008 Brazil
Primary
Secondary
Concomitant
Viral Load Increased Other Serious 24 Female 7/9/2008 United States
Primary
Concomitant
Viral Load Increased Other Serious 24 Female 7/11/2008 United States
Primary
Secondary
Vomiting Hospitalization 4/18/2008 Female 147 lb 7/11/2008 Brazil
Primary
Secondary
Concomitant
Death Death 1/1/2008 46 Male 137 lb 7/14/2008 Pharmacist Canada
Primary
Concomitant
Hepatitis B Death 1/1/2008 46 Male 137 lb 7/17/2008 Pharmacist Canada
Primary
Concomitant
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 8/15/2008 United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/30/2008 Female 8/18/2008 Other Health Professional France
Primary
Secondary
Concomitant
Sepsis Hospitalization 8/6/2007 43 Male 8/21/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 3/31/2008 44 Female 8/22/2008 Other Health Professional France
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 3/31/2008 44 Female 8/27/2008 Other Health Professional France
Primary
Secondary
Concomitant
Myalgia Hospitalization 9/7/2001 Male 8/28/2008 Physician Japan
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 6/27/2007 44 Male 9/5/2008 United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 11/1/2007 45 Male 9/9/2008 Other Health Professional France
Primary
Secondary
Concomitant
Pyrexia Hospitalization 8/9/2008 43 Male 165 lb 9/10/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 22 Male 9/12/2008 Physician United States
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 22 Male 9/17/2008 United States
Primary
Secondary
Concomitant
Myalgia Hospitalization 9/7/2001 Male 10/2/2008 Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 3/31/2008 44 Female 12/8/2008 Other Health Professional France
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 3/31/2008 44 Female 12/8/2008 Other Health Professional France
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 3/31/2008 44 Female 12/19/2008 Other Health Professional France
Primary
Secondary
Concomitant
Skin Swelling Other Serious Male 4 lb 12/22/2008 United States
Primary
Secondary
Skin Swelling Other Serious Male 4 lb 1/13/2009 United States
Primary
Secondary
Upper Gastrointestinal Haemorrhage Life Threatening 5/27/2008 Female 116 lb 1/21/2009 Brazil
Primary
Concomitant
Skin Swelling Other Serious Male 4 lb 1/21/2009 United States
Primary
Secondary
Stress Hospitalization 41 Male 2/4/2009 Consumer United States
Primary
Secondary
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
Varices Oesophageal Life Threatening 5/27/2008 Female 116 lb 2/26/2009 Brazil
Primary
Concomitant
Renal Failure Hospitalization 11/1/2007 45 Male 3/2/2009 Other Health Professional France
Primary
Secondary
Concomitant
Neurological Symptom Hospitalization 2/15/2009 44 Male 3/12/2009 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Life Threatening 5/27/2008 Female 116 lb 3/13/2009 Brazil
Primary
Concomitant
Neurological Symptom Hospitalization 2/15/2009 44 Male 3/20/2009 Physician United States
Primary
Secondary
Concomitant
Pregnancy Other Serious 38 Female 3/24/2009 Other Health Professional United Kingdom
Primary
Secondary
Pneumococcal Bacteraemia Hospitalization 3/2/2009 3/24/2009 Physician Brazil
Primary
Concomitant
Injection Site Reaction Other Serious 38 Female 3/26/2009 Physician Nigeria
Primary
Secondary
Pregnancy Other Serious 38 Female 3/26/2009 Other Health Professional United Kingdom
Primary
Secondary
Injection Site Reaction Other Serious 38 Female 3/30/2009 Other Health Professional
Primary
Secondary
Stress Hospitalization 41 Male 4/16/2009 Consumer United States
Primary
Secondary
Stress Hospitalization 41 Male 4/16/2009 Consumer United States
Primary
Secondary
Thrombocytopenia Other Serious 4/2/2009 4/29/2009 Physician Brazil
Primary
Secondary
Concomitant
Chest Pain Hospitalization 4/21/2009 Female 196 lb 5/14/2009 Physician United States
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 3/2/2009 Male 123 lb 6/17/2009 United States
Primary
Secondary
Concomitant
Skin Ulcer Hospitalization 58 Male 6/22/2009 Other Health Professional Australia
Primary
Secondary
Death Death Male 178 lb 6/22/2009 Physician United States
Primary
Secondary
Concomitant
Retinal Detachment Other Serious 8/26/2008 59 Male 6/24/2009 Physician Brazil
Primary
Secondary
Concomitant
Rash Maculo-papular Other Serious Male 6/25/2009 Physician Australia
Primary
Secondary
Concomitant
Pain In Extremity Death Male 178 lb 7/16/2009 Physician United States
Primary
Secondary
Concomitant
Death Death Male 178 lb 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 17 Female 7/27/2009 Physician Spain
Primary
Secondary
Death Death Male 178 lb 7/29/2009 Physician United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 17 Female 7/29/2009 Physician Spain
Primary
Secondary
Stress Hospitalization 41 Male 8/13/2009 Consumer United States
Primary
Secondary
Wrong Technique In Drug Usage Process Other Serious 17 Female 9/9/2009 Physician Spain
Primary
Secondary
Squamous Cell Carcinoma Hospitalization 9/1/2007 53 Male 152 lb 9/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 9/15/2009 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 9/17/2009 Other Health Professional Canada
Primary
Secondary
Upper Limb Fracture Death 5/25/2009 Male 178 lb 9/18/2009 Physician United States
Primary
Secondary
Concomitant
Myalgia Hospitalization 9/7/2001 Male 9/18/2009 Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 9/21/2009 Physician United States
Primary
Secondary
Concomitant
Upper Limb Fracture Death 5/26/2009 Male 178 lb 9/23/2009 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 9/1/2008 Male 9/23/2009 Japan
Primary
Secondary
Concomitant
Organising Pneumonia Death 5/26/2009 Male 178 lb 9/29/2009 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 9/1/2008 Male 10/5/2009 Japan
Primary
Secondary
Concomitant
Multiple Fractures Other Serious Female 10/8/2009 Physician Austria
Primary
Concomitant
Acute Coronary Syndrome Hospitalization 4/22/2008 55 10/8/2009 Physician Netherlands
Primary
Concomitant
Abortion Spontaneous Other Serious 3/23/2009 Female 10/12/2009 United States
Primary
Concomitant
Weight Decreased Other Serious 1/1/2003 51 Male 10/29/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization Male 11/13/2009 Consumer United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 9/1/2008 Male 11/23/2009 Japan
Primary
Secondary
Concomitant
Myalgia Hospitalization 9/7/2001 Male 11/25/2009 Japan
Primary
Secondary
Concomitant
Lichenoid Keratosis Hospitalization 3/17/2008 43 Male 12/14/2009 Consumer France
Primary
Concomitant
Neurological Symptom Hospitalization 2/15/2009 Male 213 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 9/1/2008 Male 1/12/2010 Japan
Primary
Secondary
Concomitant
Immune Reconstitution Syndrome Disability 11/5/2009 Male 2/1/2010 Physician Germany
Primary
Secondary
Immune Reconstitution Syndrome Disability 11/5/2009 Male 2/4/2010 Physician Germany
Primary
Secondary
Sepsis Syndrome Hospitalization 9/6/2006 46 Male 2/8/2010 United Kingdom
Primary
Concomitant
Vision Blurred Hospitalization 2/1/2010 Male 215 lb 2/16/2010 Physician United States
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization Male 2/18/2010 Consumer United States
Primary
Secondary
Concomitant
Sepsis Syndrome Hospitalization 10/1/2006 46 Male 2/19/2010 United Kingdom
Primary
Concomitant
Immune Reconstitution Syndrome Disability 8/21/2009 16 Male 2/24/2010 Physician Germany
Primary
Secondary
Hospitalisation Hospitalization 2/1/2010 Male 215 lb 3/2/2010 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 3/4/2010 Consumer United States
Primary
Secondary
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 3/8/2010 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 3/8/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 3/11/2010 Physician Canada
Primary
Secondary
Vomiting Hospitalization 4/18/2008 55 Female 147 lb 3/29/2010 Physician Brazil
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 4/1/2010 Physician Canada
Primary
Secondary
Subdural Haematoma Hospitalization Male 4/6/2010 Consumer United States
Primary
Secondary
Concomitant
Acute Coronary Syndrome Hospitalization 4/22/2008 55 Male 4/20/2010 Physician Netherlands
Primary
Concomitant
Wrong Technique In Drug Usage Process Disability 11/24/2008 16 Male 4/22/2010 Physician Germany
Primary
Secondary
Vomiting Hospitalization 1/1/2008 55 Female 147 lb 4/23/2010 Physician Brazil
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 4/28/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 5/12/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 5/13/2010 Physician Canada
Primary
Secondary
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 5/13/2010 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 5/17/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 5/18/2010 Consumer United States
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 5/21/2010 Physician Canada
Primary
Secondary
Wrong Technique In Drug Usage Process Disability 11/24/2008 16 Male 5/28/2010 Physician Germany
Primary
Secondary
Vomiting Hospitalization 4/18/2008 55 Female 147 lb 6/18/2010 Physician Brazil
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 6/21/2010 Physician Canada
Primary
Secondary
Vomiting Hospitalization 4/18/2008 55 Female 147 lb 6/25/2010 Physician Brazil
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 7/7/2010 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 7/7/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 7/8/2010 Physician Canada
Primary
Secondary
Virologic Failure Other Serious 7/21/2010 Other Health Professional France
Primary
Secondary
Acute Coronary Syndrome Hospitalization 4/22/2008 55 Male 8/4/2010 Physician Netherlands
Primary
Concomitant
Vomiting Hospitalization 1/1/2008 54 Female 147 lb 8/4/2010 Physician Brazil
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 8/12/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 8/16/2010 Consumer United States
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 8/18/2010 Physician Canada
Primary
Secondary
Pneumonia Cytomegaloviral Other Serious 27 Female 9/3/2010 Other Health Professional Italy
Primary
Secondary
Interacting
Treatment Noncompliance Other Serious 5/1/2008 27 Female 9/20/2010 Other Health Professional Italy
Primary
Concomitant
Interacting
Weight Decreased Hospitalization 9/1/2007 53 Male 152 lb 9/23/2010 Physician United States
Primary
Secondary
Concomitant
Progressive External Ophthalmoplegia Other Serious 52 Male 10/18/2010 Consumer United States
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 11/1/2010 Consumer United States
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 11/1/2010 Physician Canada
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 11/1/2010 Physician Canada
Primary
Secondary
Virologic Failure Other Serious 11/23/2010 Physician France
Primary
Secondary
Virologic Failure Other Serious 11/29/2010 Physician France
Primary
Secondary
Progressive External Ophthalmoplegia Other Serious 52 Male 12/15/2010 Physician Canada
Primary
Secondary
Toxic Skin Eruption Hospitalization 12/1/2010 Male 12/21/2010 Physician France
Primary
Secondary
Concomitant
Accessory Auricle Congenital Anomaly 4/1/2011 Other Health Professional Belgium
Primary
Secondary
Anaemia Other Serious 9/11/2010 21 Female 130 lb 4/4/2011 Physician United States
Primary
Secondary
Drug Resistance Other Serious 42 Male 8/18/2011 Other Health Professional Japan
Primary
Secondary
Psychiatric Symptom Other Serious 42 Male 10/3/2011 Other Health Professional Japan
Primary
Secondary
Neutropenia Death 2/14/2012 42 Male 3/23/2012 Other Health Professional France
Primary
Secondary
Concomitant

Drug Data