Kaletra combined with Tenofovir Disoproxil Fumarate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Unevaluable Event Other Serious 7/9/2005 Male 1/18/2006 Australia
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/17/2004 37 Male 2/9/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/17/2004 37 Male 2/17/2006 Physician Japan
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 12/21/2005 Female 96 lb 2/17/2006 Consumer United Kingdom
Primary
Secondary
Small For Dates Baby Other Serious 44 Female 2/24/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious 44 Female 3/1/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Skeletal Injury Other Serious 2/14/2004 Male 79 lb 3/29/2006 United States
Primary
Concomitant
Vomiting Hospitalization 8/17/2004 37 Male 4/6/2006 Physician Japan
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 2/14/2004 12 Male 79 lb 3/29/2006 Physician United States
Primary
Concomitant
Subdural Haematoma Life Threatening 11/8/2005 43 Male 172 lb 4/14/2006 Physician United States
Primary
Secondary
Concomitant
Oedema Other Serious 12/21/2005 Female 96 lb 4/21/2006 Other Health Professional United Kingdom
Primary
Secondary
Prothrombin Time Prolonged Other Serious 12/21/2005 Female 96 lb 5/12/2006 Physician United Kingdom
Primary
Secondary
Oedema Peripheral Other Serious 10/14/2005 Female 5/17/2006 Spain
Primary
Concomitant
Prothrombin Time Prolonged Other Serious 12/21/2005 Female 96 lb 5/22/2006 Physician United Kingdom
Primary
Secondary
Urine Output Decreased Hospitalization 1/25/2005 25 Male 5/26/2006 Physician Japan
Primary
Concomitant
Oedema Peripheral Other Serious 10/14/2005 Female 6/27/2006 Spain
Primary
Secondary
Concomitant
Stillbirth Death 10/8/2005 Female 1 lb 6/30/2006 Other Health Professional United States
Primary
Secondary
Stillbirth Death 10/8/2005 Male 1 lb 6/30/2006 Other Health Professional United States
Primary
Secondary
Renal Tubular Necrosis Hospitalization 3/16/2006 58 Male 7/5/2006 Physician Japan
Primary
Secondary
Concomitant
Secretion Discharge Hospitalization 7/20/2006 Female 115 lb 8/10/2006 United States
Primary
Secondary
Pharyngeal Cancer Stage Unspecified Disability 1/1/2002 58 Male 8/16/2006 Physician Japan
Primary
Secondary
Concomitant
Protein Urine Present Disability 10/24/2003 36 Male 9/12/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Necrosis Hospitalization 3/16/2006 58 Male 9/25/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/23/2003 28 Male 10/6/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 7/9/2005 56 Male 11/13/2006 Consumer Australia
Primary
Secondary
Myopathy Other Serious 11/1/2004 34 Male 149 lb 12/12/2006 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/1/2005 2/7/2007 Physician Japan
Primary
Secondary
Concomitant
Glucose Tolerance Impaired Other Serious 9/22/2004 Male 2/22/2007 Physician Japan
Primary
Secondary
Concomitant
Overdose Other Serious 5/17/1999 Male 3/1/2007 Physician Japan
Primary
Secondary
Concomitant
Productive Cough Other Serious 9/10/2001 Male 3/16/2007 Physician Japan
Primary
Secondary
Concomitant
Walking Disability Other Serious 10/14/1996 Male 3/16/2007 Physician Japan
Primary
Secondary
Concomitant
Premature Separation Of Placenta Other Serious 37 Female 3/20/2007 Consumer United States
Primary
Secondary
Protein Urine Present Disability 10/24/2003 36 Male 3/21/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/1/2004 Male 3/23/2007 Physician Japan
Primary
Secondary
Concomitant
Visual Disturbance Life Threatening 3/16/1998 Male 3/24/2007 Physician Japan
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization Male 154 lb 3/24/2007 Physician Brazil
Primary
Concomitant
Abortion Infected Hospitalization 7/20/2006 Female 115 lb 6/8/2007 United States
Primary
Secondary
Anaemia Hospitalization 6/4/2007 34 Female 95 lb 7/20/2007 United States
Primary
Secondary
Concomitant
Abortion Induced Other Serious 3/25/2006 33 Female 7/23/2007 United States
Primary
Secondary
Trisomy 8 Other Serious Male 7 lb 7/27/2007 Other Health Professional United States
Primary
Secondary
Small For Dates Baby Other Serious 9/10/2004 Male 1 lb 8/3/2007 United States
Primary
Secondary
Small For Dates Baby Other Serious 9/10/2004 Male 7 lb 8/8/2007 United States
Primary
Secondary
Cryptorchism Other Serious 9/10/2004 Male 7 lb 8/16/2007 United States
Primary
Secondary
Death Death 7/18/2007 41 Male 129 lb 8/16/2007 United States
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 9/27/2006 Male 8/22/2007 Japan
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 1/10/2007 8/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Urinary Sediment Abnormal Hospitalization 7/27/2000 Male 8/23/2007 Physician Japan
Primary
Secondary
Concomitant
Hiv Infection Hospitalization 6/4/2007 34 Female 95 lb 8/27/2007 United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/3/2003 Male 8/29/2007 Physician Japan
Primary
Secondary
Concomitant
Premature Rupture Of Membranes Other Serious 43 Female 8/30/2007 Other Health Professional Spain
Primary
Secondary
Hydrocephalus Other Serious 1/10/2007 0 Male 5 lb 8/30/2007 Other Health Professional United States
Primary
Secondary
Sepsis Hospitalization 8/6/2007 43 Male 8/31/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 6/1/2004 36 Female 8/31/2007 United States
Primary
Secondary
Sepsis Other Serious 5/26/2007 Male 8/31/2007 Belgium
Primary
Concomitant
Liver Disorder Hospitalization 2/7/2005 73 Male 9/4/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 6/1/2004 36 Female 8/31/2007 United States
Primary
Secondary
Sepsis Other Serious 5/26/2007 Male 8/31/2007 Belgium
Primary
Concomitant
Pneumonia Hospitalization 8/21/2002 Male 117 lb 9/5/2007 Physician Japan
Primary
Secondary
Concomitant
Cryptorchism Other Serious 9/10/2004 Male 7 lb 9/7/2007 United States
Primary
Secondary
Cryptorchism Congenital Anomaly 9/10/2004 Male 7 lb 9/7/2007 Other Health Professional United States
Primary
Secondary
Lung Infiltration Hospitalization 7/30/2007 Male 9/10/2007 Germany
Primary
Concomitant
Muscle Disorder Congenital Anomaly 9/10/2004 Male 7 lb 9/12/2007 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 6/4/2007 34 Female 95 lb 9/13/2007 United States
Primary
Secondary
Concomitant
Skin Depigmentation Other Serious 11/1/2006 Male 165 lb 9/13/2007 Other Health Professional France
Primary
Secondary
Concomitant
Death Death 7/18/2007 41 Male 129 lb 9/18/2007 United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/27/2007 34 Female 132 lb 9/20/2007 United States
Primary
Secondary
Drug Exposure During Pregnancy Congenital Anomaly 9/10/2004 Male 7 lb 9/20/2007 Other Health Professional United States
Primary
Secondary
Lymphoma Life Threatening 2/7/2005 61 Male 9/20/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolysis Hospitalization 9/1/2007 39 Male 9/21/2007 Physician Norway
Primary
Secondary
Pneumonia Bacterial Other Serious 2/1/2007 Male 108 lb 9/27/2007 Israel
Primary
Concomitant
Rhabdomyolysis Other Serious 9/1/2003 Male 9/27/2007 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Disability 40 Female 9/28/2007 United Kingdom
Primary
Concomitant
Skin Depigmentation Other Serious 11/1/2006 Male 165 lb 9/28/2007 Other Health Professional France
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/6/2005 Male 9/28/2007 Physician Japan
Primary
Secondary
Concomitant
Salivary Hypersecretion Other Serious 6/12/2005 Male 154 lb 10/18/2007 Physician Austria
Primary
Concomitant
Sepsis Other Serious 8/6/2007 43 Male 11/2/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Bundle Branch Block Left Other Serious 9/27/2007 32 Male 11/5/2007 United States
Primary
Concomitant
Atrioventricular Block Other Serious 10/17/2007 40 Male 11/7/2007 United States
Primary
Concomitant
Demyelination Hospitalization 9/3/2007 Female 117 lb 11/7/2007 Spain
Primary
Concomitant
Abortion Induced Other Serious 2/1/2006 Female 11/14/2007 United States
Primary
Concomitant
Renal Pain Hospitalization 9/1/2007 Male 132 lb 11/14/2007 Other Health Professional France
Primary
Concomitant
Oesophageal Candidiasis Hospitalization 10/1/2007 Male 11/16/2007 Belgium
Primary
Concomitant
Focal Nodular Hyperplasia Hospitalization 1/1/2006 Female 11/20/2007 Physician Spain
Primary
Concomitant
Pneumonia Hospitalization 8/21/2002 Male 117 lb 11/20/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/27/2007 34 Female 132 lb 11/21/2007 United States
Primary
Secondary
Drug Exposure During Pregnancy Congenital Anomaly 1/10/2007 11/27/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Impairment Disability 7/25/2005 Male 112 lb 11/28/2007 Physician Japan
Primary
Secondary
Concomitant
Hydrocephalus Other Serious 1/10/2007 0 Male 5 lb 11/29/2007 Other Health Professional United States
Primary
Secondary
Septic Shock Death 12/5/2007 Male 12/12/2007 Belgium
Primary
Concomitant
Vision Blurred Hospitalization 12/1/2007 Female 181 lb 12/13/2007
Primary
Secondary
Concomitant
Enterocolitis Haemorrhagic Hospitalization 5/26/2004 Male 12/14/2007 Physician Japan
Primary
Concomitant
Pyrexia Life Threatening 10/1/2007 Male 12/21/2007 Physician Switzerland
Primary
Secondary
Concomitant
Interacting
Septic Shock Death 12/5/2007 Male 12/21/2007 Belgium
Primary
Concomitant
Neoplasm Malignant Hospitalization 7/30/2007 Male 170 lb 12/27/2007 Germany
Primary
Concomitant
Pruritus Hospitalization 11/8/2007 40 Male 12/28/2007 Physician Spain
Primary
Secondary
Pyrexia Life Threatening 10/1/2007 Male 1/17/2008 Physician Switzerland
Primary
Secondary
Concomitant
Interacting
Pyrexia Hospitalization 8/13/2007 45 Male 137 lb 1/18/2008 Poland
Primary
Concomitant
Pneumonia Hospitalization 7/30/2007 Male 170 lb 1/24/2008 Germany
Primary
Secondary
Concomitant
Renal Impairment Disability 7/25/2005 Male 112 lb 1/25/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/5/2007 Male 1/25/2008 Belgium
Primary
Concomitant
Vision Blurred Hospitalization 12/1/2007 Female 181 lb 1/25/2008 Netherlands
Primary
Secondary
Concomitant
Skin Depigmentation Other Serious 11/1/2006 Male 165 lb 1/28/2008 Other Health Professional France
Primary
Secondary
Concomitant
Premature Baby Other Serious 12/12/2006 Male 2 lb 1/31/2008 Netherlands
Primary
Secondary
Renal Failure Acute Life Threatening 1/1/2007 Female 2/1/2008 Other Health Professional France
Primary
Concomitant
Interacting
Treatment Noncompliance Death 1/14/2008 Female 108 lb 2/4/2008 Chile
Primary
Concomitant
Glycogen Storage Disease Type I Other Serious 10/5/2004 Female 2/7/2008 United States
Primary
Secondary
Cryptorchism Congenital Anomaly 9/10/2004 Male 7 lb 2/8/2008 Other Health Professional United States
Primary
Secondary
Liver Function Test Abnormal Other Serious 1/9/2008 37 Male 2/8/2008 Physician United States
Primary
Secondary
Concomitant
Oesophageal Candidiasis Hospitalization 10/1/2007 Male 2/8/2008 Belgium
Primary
Concomitant
Renal Failure Acute Other Serious 1/1/2007 Female 2/15/2008 Other Health Professional France
Primary
Concomitant
Interacting
Glycogen Storage Disease Type I Other Serious 10/5/2004 Female 2/18/2008 United States
Primary
Secondary
Glucose-6-phosphate Dehydrogenase Deficiency Hospitalization 10/5/2004 Female 6 lb 2/18/2008 United States
Primary
Secondary
Concomitant
Haemolysis Other Serious 39 Male 2/20/2008 Consumer Norway
Primary
Secondary
Treatment Noncompliance Death 1/14/2008 Female 108 lb 2/20/2008 Chile
Primary
Concomitant
Rash 8/18/2005 47 Female 159 lb 2/4/2008 Consumer United States
Primary
Secondary
Concomitant
Optic Neuritis Retrobulbar Hospitalization 52 Male 2/25/2008 Physician France
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 1/1/2007 Female 2/28/2008 Other Health Professional France
Primary
Concomitant
Interacting
Renal Failure Hospitalization 6/30/2007 Female 2/28/2008 United Kingdom
Primary
Concomitant
Glucose-6-phosphate Dehydrogenase Deficiency Hospitalization 10/5/2004 Female 6 lb 3/3/2008 United States
Primary
Secondary
Concomitant
Viral Load Increased Other Serious 7/1/2003 Male 3/7/2008 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 10/24/2003 36 Male 3/14/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 10/1/2007 Male 168 lb 3/14/2008 Physician Switzerland
Primary
Secondary
Concomitant
Interacting
Retinopathy Other Serious 11/15/2007 Female 3/14/2008 Belgium
Primary
Concomitant
Rectal Cancer Death Male 3/21/2008 Belgium
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2006 Female 3/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 10/24/2003 36 Male 3/28/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 1/1/2006 Female 3/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 6/30/2007 Female 4/10/2008 United Kingdom
Primary
Concomitant
Pyrexia Hospitalization 8/13/2007 45 Male 137 lb 4/10/2008 Poland
Primary
Concomitant
Squamous Cell Carcinoma Death Male 4/14/2008 Belgium
Primary
Concomitant
Pyrexia Hospitalization 3/1/2008 50 Male 4/24/2008 Physician Switzerland
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 9/10/2001 Male 4/25/2008 Physician Japan
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 37 Male 4/11/2008 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 1/1/2008 47 Male 5/8/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Diarrhoea 1/1/2008 Female 127 lb 5/12/2008 United States
Primary
Concomitant
Weight Decreased Hospitalization 1/10/2008 Male 196 lb 5/20/2008 Belgium
Primary
Concomitant
Pneumonia Hospitalization 7/30/2007 Male 163 lb 5/20/2008 Germany
Primary
Secondary
Concomitant
Renal Failure Hospitalization 6/30/2007 Female 5/23/2008 United Kingdom
Primary
Concomitant
Renal Failure Hospitalization 1/1/2008 47 Male 5/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 5/30/2008 Other Health Professional United States
Primary
Secondary
Pneumonia Hospitalization 7/30/2007 Male 163 lb 6/3/2008 Germany
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious 4/12/2008 6/4/2008 United States
Primary
Secondary
Abortion Spontaneous Other Serious 6/4/2008 Female 6/16/2008 Belgium
Primary
Concomitant
Rhabdomyolysis Other Serious 9/1/2003 Male 6/19/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/19/2008 Female 6/19/2008 Belgium
Primary
Concomitant
Pyrexia Other Serious 4/24/2007 30 Male 137 lb 6/20/2008 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 12/28/1999 Male 6/27/2008 Physician Japan
Primary
Secondary
Concomitant
Drug Toxicity Hospitalization 12/1/2007 Female 181 lb 6/27/2008 Netherlands
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/21/2008 34 Female 120 lb 6/27/2008 United States
Primary
Concomitant
Vomiting Other Serious 5/19/2008 Female 6/27/2008 Belgium
Primary
Concomitant

Drug Data