Fenofibrate combined with Metformin Hydrochloride

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Polymyalgia Rheumatica Hospitalization 5/15/2000 Male 1/3/2006 Australia
Primary
Concomitant
Varices Oesophageal Hospitalization 5/22/2000 Male 1/3/2006 Australia
Primary
Concomitant
Sleep Disorder Other Serious 5/25/2000 Male 1/3/2006 Australia
Primary
Concomitant
Cholangitis Hospitalization 1/24/2000 Female 1/3/2006 Australia
Primary
Concomitant
Congenital Cystic Kidney Disease Hospitalization 7/23/2000 Male 1/3/2006 Finland
Primary
Concomitant
Testicular Disorder Other Serious 5/25/2001 Male 1/3/2006 France
Primary
Concomitant
Eye Pain Hospitalization 12/23/1999 Female 1/3/2006 New Zealand
Primary
Concomitant
Sudden Death Death 6/8/2001 Male 1/3/2006 Australia
Primary
Concomitant
Pain Hospitalization 11/8/2000 Female 1/3/2006 France
Primary
Concomitant
Syncope Hospitalization 9/27/2000 Female 1/3/2006 France
Primary
Concomitant
Pericarditis Hospitalization 12/6/2000 Female 1/3/2006 France
Primary
Concomitant
Thrombosis Hospitalization 1/20/2001 Male 1/3/2006 France
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 10/5/2001 Female 1/3/2006 France
Primary
Concomitant
Urinary Retention Hospitalization 8/10/2000 Male 1/3/2006 France
Primary
Concomitant
Exostosis Hospitalization 7/14/2002 Female 1/4/2006 France
Primary
Concomitant
Tendon Rupture Other Serious 11/13/2002 Male 1/4/2006 France
Primary
Concomitant
Pulmonary Embolism Other Serious 9/15/2003 Male 1/4/2006 Australia
Primary
Concomitant
Tendon Rupture Hospitalization 1/25/2002 Male 1/4/2006 France
Primary
Concomitant
Sudden Death Other Serious 9/4/2001 Male 1/4/2006 France
Primary
Concomitant
Skin Ulcer Hospitalization 2/13/2002 Female 1/4/2006 France
Primary
Concomitant
Chest Pain Hospitalization 3/25/2001 Male 1/4/2006 Australia
Primary
Concomitant
Sleep Disorder Hospitalization 8/12/2002 Female 1/4/2006 Australia
Primary
Concomitant
Renal Failure Life Threatening 9/2/2003 Male 1/4/2006 Finland
Primary
Concomitant
Tendon Rupture Other Serious 5/29/2001 Male 1/4/2006 Finland
Primary
Concomitant
Vertigo Hospitalization 11/16/2002 Male 1/4/2006 France
Primary
Concomitant
Intestinal Stenosis Hospitalization 5/27/2004 Male 1/4/2006 France
Primary
Concomitant
Pulmonary Embolism Life Threatening 4/22/2003 Female 1/4/2006 France
Primary
Concomitant
Renal Failure Acute Hospitalization 3/20/2003 Female 1/4/2006 Australia
Primary
Concomitant
Thrombophlebitis Superficial Hospitalization 2/12/2002 Female 1/4/2006 Finland
Primary
Concomitant
Pulmonary Embolism Life Threatening 2/16/2002 Male 1/4/2006 Finland
Primary
Concomitant
Palpitations Hospitalization 4/29/2002 Male 1/4/2006 France
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 7/1/2001 Male 1/4/2006 Australia
Primary
Concomitant
Pulmonary Fibrosis Hospitalization 7/14/2004 Male 1/4/2006 France
Primary
Concomitant
Cholelithiasis Hospitalization 11/14/2002 Male 1/4/2006 France
Primary
Concomitant
Tendon Rupture Hospitalization 1/6/2003 Male 1/4/2006 France
Primary
Concomitant
Tendon Disorder Hospitalization 2/15/2002 Male 1/4/2006 France
Primary
Concomitant
Parotitis Hospitalization 7/13/2001 Male 1/4/2006 Australia
Primary
Concomitant
Pulmonary Embolism Hospitalization 5/22/2002 Male 1/4/2006 Australia
Primary
Concomitant
Thrombosis Hospitalization 11/25/2002 Female 1/4/2006 France
Primary
Concomitant
Pain Other Serious 7/8/2002 Male 1/4/2006 France
Primary
Concomitant
Pituitary Tumour Benign Hospitalization 12/13/2001 Female 1/4/2006 Australia
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 2/12/2002 Male 1/4/2006 Australia
Primary
Concomitant
Tendon Disorder Hospitalization 6/18/2003 Male 1/4/2006 Australia
Primary
Concomitant
Respiratory Tract Infection Hospitalization 6/13/2003 Male 1/4/2006
Primary
Concomitant
Aortic Aneurysm Rupture Death 11/21/2003 Male 1/4/2006 France
Primary
Concomitant
Bone Marrow Failure Other Serious 9/13/2004 Male 1/4/2006 Australia
Primary
Concomitant
Bladder Cancer Other Serious 8/25/2004 Female 1/4/2006 Australia
Primary
Concomitant
Myalgia Hospitalization 7/20/2002 Male 1/4/2006 France
Primary
Concomitant
Weight Decreased Hospitalization 3/1/2005 79 Male 216 lb 2/23/2006 Physician Italy
Primary
Concomitant
Toxic Skin Eruption Hospitalization 11/23/2005 58 Female 3/22/2006 Other Health Professional France
Primary
Concomitant
Thrombosis Other Serious 66 Male 3/20/2006 Pharmacist Germany
Primary
Concomitant
Toxic Skin Eruption Hospitalization 11/23/2005 58 Female 4/7/2006 Other Health Professional France
Primary
Concomitant
Weight Decreased Hospitalization 12/25/2005 66 Male 5/19/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Thrombosis Other Serious 12/20/2005 66 Male 5/16/2006 Pharmacist Germany
Primary
Concomitant
Myopathy Hospitalization 75 Male 5/25/2006 Consumer France
Primary
Concomitant
Interacting
Swelling 4/24/2006 Male 418 lb 6/30/2006 Pharmacist United States
Primary
Concomitant
Thrombosis Other Serious 66 Male 7/28/2006 Pharmacist Germany
Primary
Concomitant
Granulocytopenia Required Intervention 11/28/2005 39 Male 6/16/2006 United States
Primary
Concomitant
Granulocytopenia Required Intervention 9/13/2005 58 Male 1/9/2006 Consumer United States
Primary
Concomitant
High Density Lipoprotein Decreased Other Serious 55 Male 159 lb 10/6/2006 Canada
Primary
Concomitant
Renal Failure Acute Life Threatening 6/10/2006 79 Female 196 lb 11/1/2006 Other Health Professional France
Primary
Secondary
Concomitant
Hypercalcaemia Other Serious 10/24/2006 Male 11/21/2006 Physician France
Primary
Concomitant
Renal Impairment Hospitalization 5/6/2005 60 Female 11/27/2006 Other Health Professional United States
Primary
Secondary
Concomitant
High Density Lipoprotein Decreased Other Serious 63 Female 1/31/2007 Physician United Kingdom
Primary
Secondary
Concomitant
High Density Lipoprotein Decreased Other Serious 54 Male 2/19/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
High Density Lipoprotein Decreased Other Serious 59 Male 2/21/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Multiple Myeloma Other Serious 10/24/2006 Male 4/6/2007 Physician France
Primary
Concomitant
Meningitis Death 11/10/2006 66 Female 11/20/2007 Physician Germany
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 11/24/2007 Female 112 lb 5/27/2008 Other Health Professional France
Primary
Secondary
Concomitant
Interacting
Rhabdomyolysis Hospitalization 11/24/2007 Female 112 lb 5/29/2008 Other Health Professional France
Primary
Secondary
Concomitant
Interacting
Rash Pruritic 12/10/2007 Male 251 lb 8/27/2008 Consumer United States
Primary
Concomitant
Rash Generalised 11/28/2007 Male 208 lb 8/27/2008 Consumer United States
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 12/25/2005 66 Male 9/19/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Liver Injury Hospitalization 3/1/2008 64 Male 198 lb 9/24/2008 Other Health Professional Germany
Primary
Concomitant
Rash Hospitalization 9/5/2008 59 Female 10/10/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 5/5/2008 Male 159 lb 10/20/2008 Consumer United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Required Intervention 65 Male 4/30/2009 Malaysia
Primary
Concomitant
Vision Blurred Female 170 lb 6/12/2009 Physician United States
Primary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 12/1/2008 61 Female 6/24/2009 Other Health Professional France
Primary
Concomitant
Erythema Male 8/22/2009 United States
Primary
Concomitant
Blood Glucose Increased 6/1/2008 Male 210 lb 8/25/2009 Consumer United States
Primary
Concomitant
Death Death 8/8/2009 68 9/4/2009 Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 3/14/2009 61 Female 10/1/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Stress Hospitalization 61 Female 180 lb 9/28/2009 United States
Primary
Concomitant
Skin Ulcer Life Threatening 72 Male 9/30/2009 United Kingdom
Primary
Concomitant
Condition Aggravated Death 8/8/2009 68 10/16/2009 Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/20/2009 83 Male 10/22/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Weight Decreased Other Serious 8/20/2009 83 Male 10/27/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Hyperhidrosis Other Serious 6/1/2008 55 Male 12/21/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hyperhidrosis Other Serious 6/1/2008 55 Male 12/29/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Angioedema Required Intervention 59 Female 12/22/2009 Physician Thailand
Primary
Concomitant
Hypoglycaemic Seizure Other Serious 10/2/2008 59 Male 1/12/2010 Consumer Canada
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 10/16/2009 Male 179 lb 1/13/2010 Physician Poland
Primary
Secondary
Concomitant
Hyperhidrosis Other Serious 6/1/2008 55 Male 1/7/2010 Physician Denmark
Primary
Secondary
Concomitant
Wheezing Hospitalization 12/14/2009 Female 1/19/2010 United States
Primary
Concomitant
Hyperhidrosis Other Serious 6/1/2008 55 Male 1/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 9/1/2009 61 Female 2/12/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Product Substitution Issue Other Serious 1/1/2010 62 Male 216 lb 3/10/2010 United States
Primary
Concomitant
Thyroid Disorder Other Serious Male 4/21/2010 Other Health Professional United States
Primary
Secondary
Thyroid Disorder Other Serious Male 4/22/2010 Other Health Professional United States
Primary
Secondary
Thyroid Disorder Other Serious Male 5/10/2010 Other Health Professional United States
Primary
Secondary
Thyroid Disorder Other Serious Male 5/10/2010 Other Health Professional United States
Primary
Secondary
Pancreatitis Acute Hospitalization 4/12/2010 63 Male 5/13/2010 Physician Italy
Primary
Concomitant
Hepatic Steatosis 1/15/2010 62 Female 164 lb 5/17/2010 United States
Primary
Concomitant
Blood Glucose Increased 5/1/2010 57 Male 280 lb 5/17/2010 United States
Primary
Concomitant
Ventricular Tachycardia Other Serious 76 Male 5/18/2010 United States
Primary
Concomitant
Myalgia Other Serious 72 Female 213 lb 5/27/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Liver Injury Hospitalization 3/1/2008 64 Male 198 lb 6/17/2010 Other Health Professional Germany
Primary
Concomitant
Vomiting 11/1/2007 62 Female 190 lb 7/17/2010 Consumer United States
Primary
Concomitant
Liver Injury Hospitalization 3/1/2008 64 Male 198 lb 8/4/2010 Other Health Professional Germany
Primary
Concomitant
Renal Disorder Other Serious 10/16/2009 55 Male 179 lb 9/29/2010 Physician Poland
Primary
Concomitant
Renal Failure Acute Required Intervention 59 Female 9/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2010 72 Female 172 lb 12/20/2010 Consumer Brazil
Primary
Concomitant
Renal Impairment Other Serious 12/3/2008 62 Male 1/12/2011 Consumer Japan
Primary
Concomitant
Renal Function Test Abnormal Other Serious 12/3/2008 62 Male 1/31/2011 Consumer Japan
Primary
Concomitant
Blood Potassium Decreased Death 1/1/2009 45 Female 1/27/2011 Physician United States
Primary
Secondary
Weight Decreased Other Serious 4/15/2009 Female 3/9/2011 Other Health Professional Australia
Primary
Concomitant
Antinuclear Antibody Increased Other Serious 4/15/2009 Female 3/14/2011 Other Health Professional Australia
Primary
Concomitant
Liver Function Test Abnormal Other Serious 4/15/2009 Female 3/16/2011 Other Health Professional Australia
Primary
Concomitant
Cerumen Impaction Other Serious 2/16/2011 77 Female 3/9/2011 Other Health Professional Denmark
Primary
Concomitant
Weight Decreased Other Serious 4/15/2009 Female 3/24/2011 Other Health Professional Australia
Primary
Concomitant
Liver Injury Other Serious 4/15/2009 Female 3/30/2011 Consumer Germany
Primary
Concomitant
Exostosis Other Serious 2/16/2011 77 Female 3/24/2011 Other Health Professional Denmark
Primary
Concomitant
Hypotension Other Serious 8/1/2010 45 Female 236 lb 5/3/2011 Consumer United States
Primary
Secondary
Concomitant
Apolipoprotein A-i Decreased Other Serious 56 Female 6/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 61 Female 6/10/2011 Other Health Professional Germany
Primary
Concomitant
Tremor Other Serious Female 250 lb 7/20/2011 Consumer United States
Primary
Concomitant
Microangiopathic Haemolytic Anaemia Hospitalization 8/3/2010 57 Male 222 lb 8/26/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 61 Female 9/15/2011 Other Health Professional Germany
Primary
Concomitant
Organising Pneumonia Hospitalization 9/29/2010 64 Male 9/15/2011 Other Health Professional France
Primary
Concomitant
Respiratory Arrest Other Serious 7/27/2011 57 Female 201 lb 10/6/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Constipation 9/1/2011 68 Female 10/6/2011 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Death 8/3/2010 57 Male 223 lb 10/10/2011 Consumer United States
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 8/3/2010 57 Male 222 lb 10/3/2011 Consumer United States
Primary
Secondary
Concomitant
Injection Site Necrosis Other Serious 8/1/2011 47 Female 315 lb 10/12/2011 Physician United States
Primary
Concomitant
Microangiopathic Haemolytic Anaemia Hospitalization 8/3/2010 57 Male 223 lb 10/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Orthostatic Hypotension Hospitalization 4/21/2011 65 Male 236 lb 10/17/2011 Physician United States
Primary
Concomitant
Myocardial Infarction Death 9/2/2011 68 Male 192 lb 10/26/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Angioedema Other Serious 6/28/2011 57 Female 262 lb 11/23/2011 Physician France
Primary
Concomitant
Impaired Gastric Emptying Other Serious 1/1/1998 36 Female 172 lb 1/1/2012 Physician United States
Primary
Secondary
Concomitant
Exostosis Other Serious 1/1/1998 36 Female 172 lb 1/5/2012 Physician United States
Primary
Secondary
Concomitant
Colorectal Cancer Metastatic Other Serious 10/1/2011 61 Female 2/9/2012 Physician France
Primary
Concomitant
Colorectal Cancer Metastatic Other Serious 10/1/2011 61 Female 2/10/2012 Physician France
Primary
Concomitant
Colorectal Cancer Metastatic Hospitalization 10/1/2011 61 Female 3/5/2012 Physician France
Primary
Concomitant
Cardiac Arrest Hospitalization 2/26/2011 69 Female 3/14/2012 Other Health Professional France
Primary
Secondary
Hiatus Hernia Other Serious 2/26/2011 69 Female 3/16/2012 Other Health Professional France
Primary
Secondary
Cardiac Arrest Death 2/27/2011 69 Female 3/16/2012 Physician France
Primary
Secondary
Renal Failure Acute Death 2/27/2011 69 Female 3/19/2012 Physician France
Primary
Secondary
Polyp Hospitalization 2/26/2011 69 Female 3/20/2012 Other Health Professional France
Primary
Secondary
Renal Failure Acute Hospitalization 2/27/2011 69 Female 3/23/2012 Other Health Professional France
Primary
Secondary

Drug Data