Efavirenz combined with Tenofovir Disoproxil Fumarate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Drug Exposure During Pregnancy Other Serious 10/31/2005 Female 128 lb 1/4/2006 United States
Primary
Secondary
Drug Exposure During Pregnancy Other Serious 12/18/2005 Female 166 lb 1/4/2006 United States
Primary
Secondary
Tearfulness Other Serious 11/11/2005 38 Male 148 lb 1/12/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 4/15/2004 Male 1/12/2006 United Kingdom
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 12/18/2005 Female 166 lb 1/17/2006 United States
Primary
Secondary
White Blood Cell Count Decreased Hospitalization 4/15/2004 Male 1/19/2006 United Kingdom
Primary
Secondary
Concomitant
Hypotension Other Serious 12/18/2005 Female 166 lb 1/24/2006 United States
Primary
Secondary
Mycobacterium Avium Complex Infection Hospitalization 9/24/2004 54 Male 2/22/2006 Consumer United States
Primary
Secondary
Concomitant
Pregnancy Other Serious 10/31/2005 Female 128 lb 3/2/2006 United States
Primary
Secondary
Vaginal Haemorrhage Other Serious 12/18/2005 Female 166 lb 3/2/2006 United States
Primary
Secondary
Spinal Compression Fracture Hospitalization 10/16/2005 Female 3/6/2006 United Kingdom
Primary
Secondary
Hyperlipidaemia Other Serious 10/31/2005 26 Male 205 lb 4/3/2006 United States
Primary
Secondary
Death Death 3/23/2006 46 Male 155 lb 4/24/2006 United States
Primary
Secondary
Concomitant
Neutropenia Death 3/23/2006 46 Male 155 lb 5/2/2006 United States
Primary
Secondary
Concomitant
Syncope Hospitalization 45 Male 7/3/2006 Other Health Professional Switzerland
Primary
Concomitant
Renal Failure Acute Life Threatening 12/23/2005 56 Male 7/19/2006 Consumer United States
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 10/16/2005 Female 7/19/2006 United Kingdom
Primary
Secondary
Meconium In Amniotic Fluid Hospitalization Female 6 lb 8/10/2006 Other Health Professional United States
Primary
Concomitant
Hepatitis Fulminant Other Serious 8/22/2005 33 Male 8/17/2006 Consumer United States
Primary
Secondary
Urine Calcium Decreased Hospitalization 10/16/2005 Female 143 lb 8/22/2006 United Kingdom
Primary
Secondary
Pyrexia Other Serious 52 Male 8/28/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 45 Male 9/5/2006 Switzerland
Primary
Concomitant
Staphylococcal Infection Life Threatening 8/22/2005 33 Male 10/16/2006 Consumer United States
Primary
Secondary
Tuberculosis Hospitalization 10/5/2006 28 Female 10/23/2006 United States
Primary
Secondary
Paralysis Hospitalization 10/23/2006 53 Female 127 lb 11/10/2006 United States
Primary
Secondary
Concomitant
Sputum Culture Positive Life Threatening 10/26/2006 31 Male 132 lb 11/28/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/1/2006 31 Male 132 lb 12/7/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 12/7/2005 55 Male 182 lb 11/30/2006 Pharmacist United States
Primary
Concomitant
Renal Failure Acute Life Threatening 12/23/2005 56 Male 12/20/2006 Consumer Japan
Primary
Secondary
Concomitant
Therapy Non-responder Life Threatening 8/22/2005 33 Male 12/22/2006 Consumer United States
Primary
Secondary
Death Death 1/8/2007 40 Female 136 lb 1/25/2007 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 1/10/2007 Female 119 lb 2/2/2007 United States
Primary
Secondary
Concomitant
Hospitalisation Hospitalization Female 6 lb 2/7/2007 Other Health Professional United States
Primary
Concomitant
Subarachnoid Haemorrhage Death 12/30/2006 36 Female 209 lb 2/16/2007 United States
Primary
Secondary
Concomitant
Death Death 1/8/2007 40 Female 136 lb 2/20/2007 United States
Primary
Secondary
Concomitant
Glucose Tolerance Impaired Other Serious 9/22/2004 Male 2/22/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 31 Female 3/6/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Tearfulness Other Serious 11/11/2005 38 Male 148 lb 3/7/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Kaposi's Sarcoma Life Threatening 11/1/2005 Male 137 lb 3/8/2007 Physician Japan
Primary
Concomitant
Immune Reconstitution Syndrome Hospitalization 7/18/2006 Female 158 lb 3/15/2007 Ireland
Primary
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
Meningitis Aseptic Hospitalization 8/1/2006 Male 156 lb 3/19/2007 Physician United States
Primary
Concomitant
Schistosomiasis Other Serious 1/1/2004 31 Male 3/21/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 46 Male 178 lb 3/21/2007 Consumer Germany
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 3/3/2007 37 Female 162 lb 3/21/2007 United States
Primary
Secondary
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
Oedema Hospitalization 3/1/2006 41 Female 3/24/2007 Other Health Professional France
Primary
Secondary
Concomitant
No Therapeutic Response Other Serious 46 Male 178 lb 3/29/2007 Consumer Germany
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 1/1/2005 52 Male 4/2/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatitis Hospitalization 3/3/2007 37 Female 162 lb 4/4/2007 United States
Primary
Secondary
Sudden Death Death 12/30/2006 36 Female 209 lb 4/23/2007 United States
Primary
Secondary
Concomitant
Hepatitis Hospitalization 2/27/2007 37 Female 162 lb 4/30/2007 United States
Primary
Secondary
White Blood Cell Count Increased Hospitalization 4/12/2007 32 Male 115 lb 5/9/2007 United States
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 65 Male 5/18/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Tuberculosis Gastrointestinal Hospitalization 10/5/2006 28 Female 6/7/2007 United States
Primary
Secondary
Concomitant
Hepatic Cirrhosis Hospitalization 4/25/2005 39 Male 6/21/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 2/23/2006 Male 167 lb 6/29/2007 Brazil
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/9/2007 27 Female 7/9/2007 United States
Primary
Secondary
Concomitant
Multi-organ Failure Death 3/23/2007 Male 7/10/2007 Physician Mexico
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 4/12/2007 32 Male 115 lb 8/2/2007 United States
Primary
Secondary
Concomitant
Rash Erythematous Hospitalization 5/11/2007 62 Male 8/13/2007 Other Health Professional United States
Primary
Secondary
Hepatitis Hospitalization 2/27/2007 37 Female 162 lb 8/13/2007 United States
Primary
Secondary
Paraplegia Hospitalization 10/23/2006 53 Female 127 lb 8/13/2007 United States
Primary
Secondary
Concomitant
Sudden Death Death 1/8/2007 40 Female 136 lb 8/15/2007 United States
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Death 11/13/2006 50 Male 101 lb 8/20/2007 United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/9/2007 27 Female 60 lb 8/22/2007 United States
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 9/27/2006 Male 8/22/2007 Japan
Primary
Secondary
Concomitant
Rib Fracture Hospitalization 6/21/2007 Male 8/30/2007 Brazil
Primary
Concomitant
Pregnancy Other Serious Female 115 lb 9/4/2007 Dominican Republic
Primary
Concomitant
Sudden Death Death 1/8/2007 40 Female 136 lb 9/18/2007 United States
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Death 12/30/2006 36 Female 209 lb 9/18/2007 United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/9/2007 27 Female 60 lb 9/18/2007 United States
Primary
Secondary
Concomitant
Lymphoma Life Threatening 2/7/2005 61 Male 9/20/2007 Physician Japan
Primary
Secondary
Concomitant
Treatment Failure Other Serious 34 Male 9/18/2007 Physician Brazil
Primary
Secondary
Paraplegia Hospitalization 10/23/2006 53 Female 127 lb 9/25/2007 United States
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 2/23/2006 Male 167 lb 9/27/2007 Brazil
Primary
Secondary
Concomitant
Pancytopenia Other Serious 5/26/1999 Male 11/1/2007 Physician United States
Primary
Secondary
Concomitant
Visceral Leishmaniasis Other Serious 10/1/1996 46 Male 11/1/2007
Primary
Secondary
Concomitant
Muscular Weakness Other Serious 25 Female 11/12/2007 Other Health Professional Brazil
Primary
Secondary
Type 2 Diabetes Mellitus Other Serious 1/1/1999 40 Male 11/19/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Liver Disorder Other Serious 36 Male 11/19/2007 Consumer United States
Primary
Secondary
Paraplegia Hospitalization 10/23/2006 53 Female 127 lb 11/19/2007 United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/9/2007 27 Female 60 lb 11/26/2007 United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 25 Male 11/30/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Premature Rupture Of Membranes Other Serious Female 12/5/2007 Other Health Professional Netherlands
Primary
Secondary
Cardiomyopathy Other Serious Male 12/5/2007 Other Health Professional Netherlands
Primary
Secondary
Cardiomyopathy Other Serious Female 12/5/2007 Other Health Professional Netherlands
Primary
Secondary
Vomiting Hospitalization 4/14/2003 Male 12/10/2007
Primary
Secondary
Concomitant
Schistosomiasis Other Serious 1/1/2004 31 Male 12/11/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 25 Male 12/12/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Other Serious Female 2 lb 12/14/2007 Other Health Professional Netherlands
Primary
Secondary
Low Cardiac Output Syndrome Other Serious Male 2 lb 12/14/2007 Other Health Professional Netherlands
Primary
Secondary
Nervous System Disorder Other Serious 3/1/2003 32 Male 12/19/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Hyperbilirubinaemia Hospitalization 11/16/2007 34 Female 117 lb 12/20/2007 United States
Primary
Secondary
Concomitant
Myalgia Other Serious 5/22/2006 53 Male 12/26/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 25 Male 12/28/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Hospitalization 12/29/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Hospitalization 25 Male 1/4/2008 United Kingdom
Primary
Secondary
Concomitant
Weight Increased Hospitalization 54 Male 12/28/2007 Japan
Primary
Secondary
Vanishing Bile Duct Syndrome Hospitalization 25 Male 1/9/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Hospitalization 25 Male 1/10/2008 United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Hospitalization 25 Male 1/11/2008 Other Health Professional United Kingdom
Primary
Secondary
Vanishing Bile Duct Syndrome Hospitalization 25 Male 1/16/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Death 25 Male 1/11/2008 United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 25 Male 1/17/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Death 25 Male 1/16/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 25 Male 1/23/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/14/2003 Male 1/24/2008
Primary
Secondary
Concomitant
Hyperbilirubinaemia Hospitalization 11/16/2007 34 Female 117 lb 1/25/2008 United States
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Other Serious 25 Male 1/28/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Other Serious 25 Male 1/29/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Life Threatening 4/14/2003 Male 1/30/2008
Primary
Secondary
Concomitant
Nervous System Disorder Other Serious 3/1/2003 32 Male 2/4/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Life Threatening 25 Male 1/29/2008 Other Health Professional United Kingdom
Primary
Secondary
Vomiting Life Threatening 25 Male 1/29/2008 United Kingdom
Primary
Secondary
Vomiting Other Serious 25 Male 2/7/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hodgkin's Disease Other Serious 2/4/2008 50 Male 2/7/2008 Consumer United Kingdom
Primary
Secondary
Completed Suicide Death 1/4/2008 33 Male 111 lb 2/7/2008 United States
Primary
Secondary
Vanishing Bile Duct Syndrome Other Serious 25 Male 2/8/2008 United Kingdom
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Death 35 Male 2/25/2008 Other Health Professional Switzerland
Primary
Secondary
Hodgkin's Disease Other Serious 45 Male 2/25/2008 Other Health Professional Switzerland
Primary
Secondary
Hodgkin's Disease Other Serious 40 Male 2/25/2008 Other Health Professional Switzerland
Primary
Secondary
Vomiting Other Serious 25 Male 2/27/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Hospitalization 2/28/2008 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Histiocytosis Haematophagic Hospitalization 2/28/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/1/2001 54 Male 3/12/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 10/24/2003 36 Male 3/14/2008 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 2/23/2006 Male 167 lb 3/20/2008 Brazil
Primary
Secondary
Concomitant
Vanishing Bile Duct Syndrome Hospitalization 1/1/2007 25 Male 3/19/2008 United Kingdom
Primary
Secondary
Concomitant
Histoplasmosis Hospitalization 4/15/2008 Male 141 lb 4/24/2008 Brazil
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 9/10/2001 Male 4/25/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious Unknown 4/22/2008 Consumer United States
Primary
Secondary
Nausea Other Serious Unknown 4/22/2008 Consumer United States
Primary
Secondary
Pain Other Serious Unknown 4/22/2008 Physician United States
Primary
Secondary
Hepatic Steatosis Other Serious 46 Male 4/29/2008 United States
Primary
Secondary
Abortion Spontaneous Other Serious Female 115 lb 5/7/2008 Dominican Republic
Primary
Concomitant
Abortion Spontaneous Other Serious Female 115 lb 5/12/2008 Dominican Republic
Primary
Concomitant
Abortion Spontaneous Other Serious Female 115 lb 5/15/2008 Dominican Republic
Primary
Concomitant
Pancytopenia Other Serious 5/26/1999 Male 6/3/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/1/2001 54 Male 6/3/2008 Physician Japan
Primary
Secondary
Concomitant
Skin Neoplasm Excision Hospitalization 5/27/2008 Male 6/11/2008 Australia
Primary
Concomitant
Skin Neoplasm Excision Hospitalization 5/27/2008 Male 6/20/2008 Australia
Primary
Concomitant
Squamous Cell Carcinoma Hospitalization 6/12/2008 Male 159 lb 6/25/2008 Australia
Primary
Concomitant
Weight Decreased Other Serious 12/28/1999 Male 6/27/2008 Physician Japan
Primary
Secondary
Concomitant
Splenomegaly Hospitalization 4/15/2008 40 Male 141 lb 7/1/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 43 7/7/2008 France
Primary
Secondary
Stillbirth Other Serious 11/22/2007 34 Female 7/14/2008 Consumer United States
Primary
Secondary
Weight Increased Hospitalization 1/1/2001 54 Male 7/21/2008 Physician Japan
Primary
Secondary
Concomitant

Drug Data