Ribavirin combined with Telaprevir

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Syncope Hospitalization 5/3/2008 Female 134 lb 6/16/2008 Physician Germany
Primary
Secondary
Platelet Count Decreased Hospitalization 7/15/2008 Male 83 lb 8/4/2008 Physician Germany
Primary
Secondary
Pericarditis Hospitalization 1/12/2009 Male 2/3/2009 Physician United States
Primary
Secondary
Concomitant
Pericarditis Hospitalization 1/12/2009 Male 2/26/2009 Physician United States
Primary
Secondary
Concomitant
Appendicectomy Hospitalization 10/10/2008 Female 137 lb 3/16/2009 Physician France
Primary
Secondary
Appendicitis Hospitalization 10/10/2008 Female 137 lb 3/26/2009 Physician France
Primary
Secondary
Pericarditis Hospitalization 1/12/2009 Male 5/1/2009 Physician United States
Primary
Secondary
Concomitant
Appendicitis Hospitalization 10/10/2008 Female 137 lb 6/10/2009 Other Health Professional Ireland
Primary
Secondary
Appendicitis Hospitalization 10/10/2008 Female 137 lb 6/12/2009 Other Health Professional Ireland
Primary
Secondary
Myocardial Infarction Hospitalization 9/28/2010 69 Male 163 lb 11/22/2010 Other Health Professional Belgium
Primary
Secondary
Brain Injury Other Serious 6/27/2009 Male 2/7/2011 Lawyer United States
Primary
Secondary
Emotional Distress Other Serious 6/27/2009 Male 2/11/2011 Lawyer United States
Primary
Secondary
Cholecystitis Other Serious 2/14/2011 Other Health Professional France
Primary
Secondary
Angina Unstable Other Serious 1/19/2011 53 Male 2/18/2011 Physician United States
Primary
Secondary
Concomitant
Angina Unstable Other Serious 1/19/2011 53 Male 2/22/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/28/2011 67 Female 156 lb 3/9/2011 Physician Belgium
Primary
Secondary
Concomitant
Convulsion Hospitalization 3/2/2011 66 Female 133 lb 3/14/2011 Other Health Professional Belgium
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 3/2/2011 66 Female 133 lb 3/16/2011 Physician Belgium
Primary
Secondary
Concomitant
Convulsion Life Threatening 3/2/2011 66 Female 293 lb 3/22/2011 Physician United States
Primary
Secondary
Concomitant
Convulsion Hospitalization 3/2/2011 66 Female 133 lb 3/24/2011 Physician Belgium
Primary
Secondary
Concomitant
Convulsion Hospitalization 3/2/2011 66 Female 293 lb 3/30/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/28/2011 67 Female 156 lb 3/31/2011 Physician Belgium
Primary
Secondary
Concomitant
Anaemia Hospitalization 2/28/2011 67 Female 156 lb 4/15/2011 Physician Belgium
Primary
Secondary
Concomitant
Depression Other Serious 3/23/2011 36 Female 119 lb 4/15/2011 Physician United Kingdom
Primary
Secondary
Convulsion Hospitalization 3/2/2011 66 Female 133 lb 4/20/2011 Physician Belgium
Primary
Secondary
Concomitant
Depression Other Serious 3/23/2011 36 Female 132 lb 4/25/2011 Physician United Kingdom
Primary
Secondary
Dyspnoea Exertional Hospitalization 4/19/2011 48 Female 214 lb 4/27/2011 Physician United States
Primary
Secondary
Death Death 3/26/2011 65 Male 171 lb 4/28/2011 Physician Switzerland
Primary
Secondary
Renal Failure Acute Death 3/26/2011 64 Male 171 lb 5/4/2011 Physician Switzerland
Primary
Secondary
Dyspnoea Hospitalization 4/22/2011 58 Female 117 lb 5/6/2011 Physician United States
Primary
Secondary
Dyspnoea Exertional Hospitalization 4/19/2011 48 Female 214 lb 5/9/2011 Physician United States
Primary
Secondary
Anaemia Hospitalization 4/22/2011 58 Female 117 lb 5/17/2011 Physician United States
Primary
Secondary
Syncope Hospitalization 4/19/2011 48 Female 214 lb 5/19/2011 Physician United States
Primary
Secondary
Mental Status Changes Hospitalization 5/11/2011 60 Male 194 lb 5/20/2011 Physician United States
Primary
Secondary
Concomitant
Dehydration Hospitalization 2/28/2011 67 Female 156 lb 6/6/2011 Physician United States
Primary
Secondary
Concomitant
Septic Shock Death 5/17/2011 59 Male 172 lb 6/7/2011 Physician France
Primary
Secondary
Concomitant
Myoclonus Hospitalization 5/11/2011 60 Male 194 lb 6/29/2011 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Exertional Hospitalization 4/19/2011 7/5/2011 Physician Belgium
Primary
Secondary
Asthenia Hospitalization 6/23/2011 51 Female 461 lb 7/6/2011 Physician United States
Primary
Secondary
Concomitant
Asthenia Hospitalization 6/23/2011 51 Female 461 lb 7/11/2011 Physician United States
Primary
Secondary
Concomitant
Syncope Hospitalization 4/19/2011 7/18/2011 Physician Belgium
Primary
Secondary
Dehydration Other Serious 7/19/2011 Physician United States
Primary
Secondary
Transient Ischaemic Attack Hospitalization 6/23/2011 51 Female 208 lb 7/22/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Disability 7/12/2011 56 Male 143 lb 7/25/2011 Physician Poland
Primary
Secondary
Hemiparesis Hospitalization 6/23/2011 51 Female 208 lb 7/29/2011 Physician United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Hospitalization 7/5/2011 36 Female 205 lb 8/2/2011 Physician Germany
Primary
Secondary
Syncope Hospitalization 6/30/2011 62 Male 287 lb 8/8/2011 Physician United States
Primary
Secondary
Sepsis Other Serious Female 8/9/2011 Other Health Professional United States
Primary
Secondary
Anaemia Hospitalization 6/30/2011 62 Male 287 lb 8/17/2011 Physician United States
Primary
Secondary
Pulmonary Embolism Hospitalization Female 8/11/2011 Other Health Professional United States
Primary
Secondary
Transfusion Hospitalization Female 8/12/2011 Other Health Professional United States
Primary
Secondary
Anaemia Other Serious Female 8/18/2011 Other Health Professional United States
Primary
Secondary
Drug Abuse Other Serious Male 8/23/2011 Other Health Professional United States
Primary
Secondary
Vaginal Haemorrhage Hospitalization 7/5/2011 36 Female 205 lb 8/30/2011 Physician Germany
Primary
Secondary
Concomitant
Hemiparesis Hospitalization 6/23/2011 51 Female 208 lb 9/1/2011 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Staphylococcal Death 5/17/2011 59 Male 172 lb 9/2/2011 Physician France
Primary
Secondary
Concomitant
Bone Infarction Other Serious 56 Male 167 lb 9/8/2011 Consumer United States
Primary
Secondary
Concomitant
Hemiparesis Hospitalization 6/23/2011 51 Female 208 lb 9/12/2011 Physician United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Hospitalization 7/5/2011 36 Female 205 lb 9/13/2011 Physician Germany
Primary
Secondary
Concomitant
Supraventricular Tachycardia Hospitalization 8/31/2011 64 Male 154 lb 9/14/2011 Physician Italy
Primary
Secondary
Concomitant
Disease Recurrence Other Serious Female 9/12/2011 Other Health Professional United States
Primary
Secondary
Systemic Lupus Erythematosus Other Serious Female 9/13/2011 Other Health Professional United States
Primary
Secondary
Haemoglobin Decreased Hospitalization 8/31/2011 64 Male 154 lb 9/20/2011 Physician Italy
Primary
Secondary
Concomitant
Substance Use Hospitalization 9/8/2011 42 Male 227 lb 9/20/2011 Physician Germany
Primary
Secondary
Dilatation Ventricular Hospitalization 4/21/2011 48 Female 200 lb 9/21/2011 Physician Belgium
Primary
Secondary
Death Life Threatening 8/31/2011 Male 9/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Hospitalization 7/5/2011 36 Female 205 lb 9/22/2011 Physician Germany
Primary
Secondary
Concomitant
Supraventricular Tachycardia Hospitalization 8/31/2011 64 Male 154 lb 9/23/2011 Physician Italy
Primary
Secondary
Concomitant
Anaemia Disability 7/12/2011 56 Male 143 lb 9/23/2011 Physician Poland
Primary
Secondary
Influenza Like Illness Hospitalization Male 9/23/2011 Pharmacist United States
Primary
Secondary
Blood Urine Present Hospitalization 9/1/2011 68 Female 9/29/2011 Physician United States
Primary
Secondary
Concomitant
Diarrhoea Haemorrhagic Other Serious Male 10/4/2011 Other Health Professional United States
Primary
Secondary
Choking Sensation Other Serious Female 10/15/2011 Consumer United States
Primary
Secondary
Nephrolithiasis Other Serious Female 10/21/2011 Other Health Professional United States
Primary
Secondary
Death Death 10/28/2011 Physician United States
Primary
Secondary
Concomitant
Death Death 10/12/2011 58 Male 10/31/2011 Other Health Professional United States
Primary
Concomitant
Swelling Face Death 11/1/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 43 Female 10/28/2011 Other Health Professional United States
Primary
Secondary
Sepsis Life Threatening 8/17/2011 57 Male 156 lb 11/11/2011 Consumer United States
Primary
Secondary
Concomitant
Dysarthria Other Serious Male 11/11/2011 Consumer United States
Primary
Secondary
Hypertensive Nephropathy Other Serious Male 11/14/2011 Physician United States
Primary
Secondary
Anaphylactic Reaction Death 9/10/2011 58 Male 271 lb 11/14/2011 Physician United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 7/18/2011 67 Female 11/14/2011 Consumer United States
Primary
Secondary
Concomitant
Proctalgia Other Serious Male 11/9/2011 Other Health Professional United States
Primary
Secondary
Death Death 10/12/2011 58 Male 271 lb 11/21/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Ascites Other Serious 11/4/2011 55 Male 11/15/2011 Other Health Professional United States
Primary
Secondary
Proctalgia Other Serious Male 11/17/2011 Other Health Professional United States
Primary
Secondary
Lethargy Other Serious Female 11/24/2011 Consumer United States
Primary
Secondary
Renal Failure Other Serious 11/29/2011 Other Health Professional United States
Primary
Concomitant
Angina Pectoris Required Intervention 11/22/2011 56 Male 188 lb 11/22/2011 Pharmacist United States
Primary
Secondary
Oral Pain Other Serious Female 11/24/2011 Other Health Professional United States
Primary
Secondary
Acute Respiratory Distress Syndrome Death 11/28/2011 61 Male 179 lb 12/5/2011 Physician United States
Primary
Concomitant
Asthenia Other Serious Male 12/13/2011 Consumer United States
Primary
Secondary
Pruritus Other Serious Female 12/5/2011 Other Health Professional United States
Primary
Secondary
Yellow Skin Other Serious Male 12/14/2011 Consumer United States
Primary
Secondary
Blood Bilirubin Increased Other Serious Male 12/9/2011 Other Health Professional United States
Primary
Secondary
Pharyngeal Oedema Other Serious Female 12/15/2011 Consumer United States
Primary
Secondary
Dysphonia Other Serious Female 12/19/2011 Consumer United States
Primary
Secondary
Weight Decreased Other Serious 58 Female 12/16/2011 Other Health Professional United States
Primary
Secondary
Encephalopathy Hospitalization Male 12/22/2011 Other Health Professional United States
Primary
Secondary
Swelling Face Death 9/10/2011 58 Male 271 lb 12/29/2011 Physician United States
Primary
Secondary
Concomitant
Sepsis Life Threatening 8/17/2011 57 Male 156 lb 12/29/2011 Physician United States
Primary
Secondary
Concomitant
Sleep Disorder Other Serious Female 12/28/2011 Other Health Professional United States
Primary
Secondary
Pulmonary Thrombosis Other Serious Female 12/23/2011 Other Health Professional United States
Primary
Secondary
Feeling Abnormal Hospitalization Male 1/12/2012 Consumer United States
Primary
Secondary
Wrist Fracture Hospitalization 12/24/2011 57 Female 1/13/2012 Consumer United States
Primary
Secondary
Urticaria Required Intervention 11/23/2011 60 Male 165 lb 1/10/2012 Pharmacist United States
Primary
Secondary
Oral Candidiasis Hospitalization 12/26/2011 59 Male 137 lb 1/13/2012 Physician Australia
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 12/14/2011 54 Male 210 lb 1/16/2012 Other Health Professional United Kingdom
Primary
Concomitant
Exsanguination Death Female 1/17/2012 Other Health Professional United States
Primary
Concomitant
Viith Nerve Paralysis Hospitalization 1/11/2012 57 Male 179 lb 1/18/2012 Pharmacist United States
Primary
Concomitant
Pyrexia Other Serious 10/1/2011 60 Female 1/18/2012 Consumer United States
Primary
Secondary
Portal Hypertension Other Serious Male 1/19/2012 Consumer United States
Primary
Secondary
Rash Other Serious 12/20/2011 47 Female 139 lb 1/19/2012 Other Health Professional United Kingdom
Primary
Concomitant
Fungal Infection Other Serious Female 442 lb 1/17/2012 Other Health Professional United States
Primary
Secondary
Fatigue Life Threatening 11/12/2011 56 Female 172 lb 1/25/2012 Consumer United States
Primary
Secondary
Concomitant
Dyspnoea 12/7/2011 60 Male 172 lb 1/21/2012 Pharmacist United States
Primary
Secondary
Anaemia Other Serious 10/9/2011 56 Female 1/27/2012 Physician Poland
Primary
Concomitant
Hepatic Failure Death 1/20/2012 67 Female 1/27/2012 Physician United States
Primary
Concomitant
Asthenia Hospitalization 11/18/2011 55 Female 137 lb 1/27/2012 Other Health Professional United States
Primary
Concomitant
Interacting
Anaemia Other Serious 10/9/2011 56 Female 1/31/2012 Physician Poland
Primary
Concomitant
Rash Other Serious 2/3/2012 Other Health Professional United Kingdom
Primary
Concomitant
Platelet Count Decreased Other Serious 1/28/2012 61 Male 2/7/2012 Consumer United States
Primary
Secondary
Oral Candidiasis Hospitalization 12/26/2011 59 Male 148 lb 2/10/2012 Physician Australia
Primary
Concomitant
Hepatic Enzyme Increased Hospitalization 1/31/2012 54 Female 154 lb 2/12/2012 Physician Turkey
Primary
Concomitant
Dyspnoea Other Serious Female 2/7/2012 Other Health Professional United States
Primary
Secondary
Diarrhoea Other Serious Female 2/7/2012 Other Health Professional United States
Primary
Secondary
Off Label Use Hospitalization 60 Female 2/14/2012 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Other Serious 57 Female 2/15/2012 Other Health Professional United States
Primary
Concomitant
Anaemia Hospitalization 73 Female 2/15/2012 Other Health Professional United States
Primary
Concomitant
Viral Load Increased Other Serious Male 2/17/2012 Consumer United States
Primary
Secondary
Dehydration Hospitalization Female 2/20/2012 Consumer United States
Primary
Secondary
Mental Disorder Other Serious Female 2/14/2012 Other Health Professional United States
Primary
Secondary
Hepatic Cirrhosis Other Serious 12/14/2011 54 Male 210 lb 2/21/2012 Other Health Professional United Kingdom
Primary
Concomitant
Pruritus Other Serious 2/13/2012 66 Male 168 lb 2/21/2012 Physician Brazil
Primary
Concomitant
Anaemia Other Serious 1/24/2012 64 Female 121 lb 2/22/2012 Physician Spain
Primary
Concomitant
Drug Dose Omission 9/21/2011 51 Male 2/23/2012 Physician United States
Primary
Secondary
Concomitant
Angina Pectoris Other Serious 10/9/2011 56 Female 2/27/2012 Physician Poland
Primary
Concomitant
Skin Disorder Other Serious 2/14/2012 24 Female 148 lb 2/28/2012 Germany
Primary
Secondary
Concomitant
Dry Skin Other Serious Female 2/24/2012 Other Health Professional United States
Primary
Secondary
Bicytopenia Hospitalization 2/17/2012 46 Female 110 lb 2/29/2012 Physician Germany
Primary
Concomitant
Pneumonia Streptococcal Hospitalization Male 3/1/2012 Other Health Professional United States
Primary
Secondary
Blood Blister Other Serious 1/24/2012 52 Male 2/28/2012 Other Health Professional United States
Primary
Secondary
Tonsillitis Hospitalization 2/8/2012 64 Male 3/2/2012 Physician Germany
Primary
Concomitant
Haemoptysis Male 3/2/2012 Consumer United States
Primary
Secondary
Eczema Hospitalization 2/13/2012 64 Female 127 lb 3/2/2012 Physician Belgium
Primary
Concomitant
Death Death 59 Female 3/5/2012 Physician United States
Primary
Secondary
Oesophageal Varices Haemorrhage Other Serious Male 3/1/2012 Other Health Professional United States
Primary
Secondary
Anaemia Other Serious 1/24/2012 64 Female 121 lb 3/6/2012 Physician Spain
Primary
Concomitant
Decreased Appetite 9/21/2011 51 Male 3/8/2012 Physician United States
Primary
Secondary
Concomitant

Drug Data