Incivo combined with Ribavirin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Aplastic Anaemia Life Threatening 12/5/2011 58 Male 1/27/2012 Physician France
Primary
Secondary
Vertigo Other Serious Male 3/20/2012 Physician Germany
Primary
Concomitant
Oedema Peripheral Other Serious 11/11/2011 53 Male 3/23/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 4/13/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization 4/13/2012 Physician Germany
Primary
Concomitant
Anaemia Other Serious Male 195 lb 4/21/2012 Physician Germany
Primary
Concomitant
Haemorrhoids Other Serious 1/31/2012 65 Female 4/25/2012 Pharmacist Spain
Primary
Secondary
Anaemia Other Serious 4/24/2012 66 Male 176 lb 5/2/2012 Physician Germany
Primary
Concomitant
Rash Hospitalization Female 5/2/2012 Physician Germany
Primary
Concomitant
Cardiac Arrest Death 4/20/2012 43 Male 5/3/2012 Physician United Kingdom
Primary
Concomitant
Drug Eruption Other Serious 3/1/2012 48 Male 5/4/2012 Physician Switzerland
Primary
Concomitant
Craniocerebral Injury Death 4/20/2012 43 Male 5/10/2012 Physician United Kingdom
Primary
Concomitant
Arteriovenous Fistula Other Serious 2/6/2012 54 Female 159 lb 5/11/2012 Other Health Professional France
Primary
Concomitant
Inappropriate Schedule Of Drug Administration Other Serious 3/15/2012 69 Female 5/11/2012 Physician Germany
Primary
Concomitant
Intracranial Pressure Increased Other Serious Female 5/15/2012 Physician Israel
Primary
Concomitant
Craniocerebral Injury Hospitalization 4/20/2012 43 Male 150 lb 5/18/2012 Physician United Kingdom
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 4/24/2012 66 Male 176 lb 5/21/2012 Physician Germany
Primary
Concomitant
Syncope 3/15/2012 69 Female 5/21/2012 Physician Germany
Primary
Concomitant
Cardiac Failure Other Serious 12/15/2011 53 Male 5/29/2012 Physician Germany
Primary
Concomitant
Skin Exfoliation Other Serious 3/6/2012 65 Female 5/29/2012 Other Health Professional Spain
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Other Serious 5/30/2012 Physician Turkey
Primary
Concomitant
Anaemia Hospitalization Female 5/31/2012 Physician Israel
Primary
Secondary
Rash Pruritic Other Serious 3/6/2012 65 Female 5/31/2012 Other Health Professional Spain
Primary
Concomitant
Rash Other Serious 4/1/2012 61 Female 5/31/2012 Physician Germany
Primary
Concomitant
General Physical Health Deterioration Hospitalization 3/11/2012 Female 6/1/2012 Physician Germany
Primary
Concomitant
Rash Other Serious Female 6/4/2012 Physician Israel
Primary
Concomitant
Pulmonary Oedema Other Serious 5/24/2012 Female 6/4/2012 Physician Spain
Primary
Concomitant
Rash Hospitalization 4/10/2012 68 Female 6/4/2012 Physician Germany
Primary
Concomitant
Rash Other Serious 5/1/2012 62 Male 6/6/2012 Physician Spain
Primary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Hospitalization 4/25/2012 51 Male 6/7/2012 Physician Germany
Primary
Concomitant
Anaemia Other Serious 4/15/2012 52 Male 174 lb 6/8/2012 Physician Spain
Primary
Concomitant
Off Label Use Other Serious 50 Male 6/12/2012 Physician France
Primary
Concomitant
Pruritus Hospitalization 5/30/2012 60 Male 182 lb 6/12/2012 Physician Austria
Primary
Concomitant
Eosinophilia Hospitalization 4/1/2012 61 Female 6/13/2012 Physician Germany
Primary
Concomitant
Malaise Death 5/24/2012 Female 6/14/2012 Physician Spain
Primary
Concomitant
Hepatic Neoplasm Malignant Other Serious 6/15/2012 Physician Turkey
Primary
Concomitant
Anaemia Hospitalization Male 6/15/2012 Physician Netherlands
Primary
Concomitant
Rash Other Serious Male 6/16/2012 Physician Portugal
Primary
Concomitant
General Physical Health Deterioration Hospitalization 3/11/2012 Female 6/18/2012 Physician Germany
Primary
Concomitant
Off Label Use Hospitalization 3/28/2012 64 Male 6/19/2012 Other Health Professional France
Primary
Concomitant
Dyspnoea Other Serious 5/24/2012 Female 6/20/2012 Physician Spain
Primary
Concomitant
Rash Hospitalization 4/17/2012 Female 6/20/2012 Physician Spain
Primary
Concomitant
Rash Macular Hospitalization 5/17/2012 Male 6/21/2012 Physician United Kingdom
Primary
Concomitant
Toxic Skin Eruption Other Serious 5/8/2012 64 Male 6/22/2012 Pharmacist Spain
Primary
Concomitant
Dyspnoea Other Serious 6/8/2012 48 Male 6/25/2012 Physician France
Primary
Concomitant
Off Label Use Other Serious Male 6/27/2012 Physician Portugal
Primary
Concomitant
Toxic Skin Eruption Hospitalization 60 Male 6/27/2012 Physician France
Primary
Concomitant
Cardiac Arrest Hospitalization 4/20/2012 43 Male 150 lb 6/29/2012 Physician United Kingdom
Primary
Concomitant
Pruritus Other Serious 37 Female 165 lb 6/29/2012 Physician France
Primary
Concomitant
Drug Interaction Other Serious Male 6/29/2012 Physician Greece
Primary
Concomitant
Interacting
Haemorrhoids Other Serious 4/20/2012 49 Male 7/4/2012 Other Health Professional United Kingdom
Primary
Concomitant
Off Label Use Other Serious 6/8/2012 Male 129 lb 7/5/2012 Physician Portugal
Primary
Concomitant
Haemorrhoids Other Serious 4/20/2012 49 Male 7/5/2012 Other Health Professional United Kingdom
Primary
Concomitant
Aspartate Aminotransferase Increased Other Serious 45 Male 7/5/2012 Physician France
Primary
Concomitant
Blister Other Serious 6/23/2012 45 Male 150 lb 7/5/2012 Physician France
Primary
Concomitant
Rash Pruritic Other Serious 6/15/2012 37 Male 7/6/2012 Other Health Professional United Kingdom
Primary
Concomitant
Vision Blurred Other Serious 5/23/2012 48 Male 7/6/2012 Other Health Professional United Kingdom
Primary
Concomitant
Haematocrit Decreased Other Serious Male 7/12/2012 Physician Greece
Primary
Concomitant
Interacting
Neutropenia Other Serious 4/23/2012 53 Female 128 lb 7/13/2012 Physician Romania
Primary
Concomitant
Lymphadenopathy Mediastinal Hospitalization 38 Female 7/13/2012 Physician France
Primary
Secondary
Thrombocytopenia Other Serious 7/3/2012 Female 7/13/2012 Physician Brazil
Primary
Concomitant
Anaemia Hospitalization 4/4/2012 54 Male 7/16/2012 Physician Spain
Primary
Concomitant
Haemolytic Anaemia Other Serious 7/16/2012 Physician Denmark
Primary
Concomitant
Haemolytic Anaemia Other Serious Unknown 7/17/2012 Physician Denmark
Primary
Concomitant
Anaemia Hospitalization 5/29/2012 72 Female 198 lb 7/17/2012 Other Health Professional France
Primary
Concomitant
Hypoxic-ischaemic Encephalopathy Death 4/20/2012 43 Male 150 lb 7/17/2012 Physician United Kingdom
Primary
Secondary
Concomitant
Rash Other Serious Female 7/18/2012 Physician France
Primary
Concomitant
Proctalgia Other Serious 6/18/2012 43 Male 7/18/2012 Other Health Professional United Kingdom
Primary
Concomitant
Atrial Fibrillation Other Serious Male 7/18/2012 Physician Greece
Primary
Concomitant
Interacting
Blister Other Serious 6/23/2012 42 Male 150 lb 7/20/2012 Physician France
Primary
Concomitant
Depression Other Serious 6/22/2012 38 Female 165 lb 7/23/2012 Physician France
Primary
Concomitant
Proctalgia Other Serious 7/6/2012 54 Female 7/23/2012 Other Health Professional United Kingdom
Primary
Concomitant
Lymphadenopathy Mediastinal Hospitalization 62 Female 7/23/2012 Physician France
Primary
Secondary
Concomitant
Insomnia Other Serious 5/28/2012 57 Male 7/23/2012 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Abnormal Hospitalization 3/26/2012 63 Female 7/25/2012 Physician Spain
Primary
Concomitant
Rash Other Serious Male 7/25/2012 Physician Greece
Primary
Concomitant
Interacting
Neutropenia Life Threatening 4/23/2012 53 Female 128 lb 7/26/2012 Physician Romania
Primary
Concomitant
Face Oedema Other Serious 7/1/2012 53 Female 150 lb 7/26/2012 Physician Brazil
Primary
Concomitant
Headache Other Serious 6/26/2012 54 Female 7/27/2012 Other Health Professional United Kingdom
Primary
Concomitant
Blister 6/23/2012 42 Male 150 lb 7/30/2012 Physician France
Primary
Concomitant
Pruritus Other Serious 7/6/2012 54 Female 7/30/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rectal Haemorrhage Other Serious 6/26/2012 54 Female 7/31/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious Male 7/31/2012 Physician Greece
Primary
Concomitant
Interacting
Influenza Other Serious 5/28/2012 57 Male 7/31/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rash Other Serious Male 8/3/2012 Physician Greece
Primary
Concomitant
Nausea Other Serious Female 8/3/2012 Other Health Professional United Kingdom
Primary
Concomitant
Renal Impairment Other Serious 5/8/2012 49 Male 139 lb 8/6/2012 Pharmacist United Kingdom
Primary
Concomitant
Rash Other Serious 5/14/2012 49 Male 8/6/2012 Physician Spain
Primary
Concomitant
Rash Other Serious 7/13/2012 48 Female 8/8/2012 Physician Spain
Primary
Concomitant
Influenza Other Serious 5/28/2012 57 Male 8/9/2012 Other Health Professional United Kingdom
Primary
Concomitant
Proctalgia Other Serious 7/28/2012 Male 8/9/2012 Physician Portugal
Primary
Concomitant
Pruritus Other Serious 9/1/2011 42 Male 165 lb 8/13/2012 Physician Germany
Primary
Concomitant
Flank Pain Other Serious 5/8/2012 49 Male 139 lb 8/13/2012 Pharmacist United Kingdom
Primary
Concomitant
Pruritus Other Serious Male 209 lb 8/13/2012 Physician Germany
Primary
Concomitant
Flank Pain Other Serious 5/1/2012 49 Male 139 lb 8/13/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Rash Hospitalization 6/11/2012 42 Male 168 lb 8/13/2012 Physician Germany
Primary
Concomitant
C-reactive Protein Increased Other Serious 5/8/2012 49 Male 139 lb 8/13/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Lung Infection Hospitalization 2/15/2012 55 Male 176 lb 8/14/2012 Turkey
Primary
Concomitant
Rash Hospitalization 58 Male 8/14/2012 Physician France
Primary
Concomitant
Rash Hospitalization Male 168 lb 8/14/2012 Physician Germany
Primary
Concomitant
Pruritus Other Serious 7/6/2012 54 Female 8/14/2012 United Kingdom
Primary
Concomitant
Retinal Detachment Other Serious 6/16/2012 50 Male 251 lb 10/18/2012 Physician Gb
Primary
Concomitant
Renal Impairment Hospitalization 5/8/2012 49 Male 8/31/2012 Gb
Primary
Secondary
Concomitant
Vision Blurred Other Serious 8/14/2012 60 Male 176 lb 9/4/2012 Physician Ar
Primary
Concomitant
Oedema Peripheral Hospitalization 3/3/2012 47 Male 231 lb 9/21/2012 Physician Gb
Primary
Secondary
Concomitant
Varices Oesophageal Hospitalization 8/10/2012 64 Female 10/17/2012 Consumer Us
Primary
Secondary
Concomitant
Rash Other Serious 8/21/2012 9/28/2012 Other Health Professional Gb
Primary
Concomitant
Toxicity To Various Agents Hospitalization 8/28/2012 41 Female 172 lb 9/12/2012 Physician Au
Primary
Secondary
Concomitant
Rash Other Serious 52 Female 9/13/2012 Consumer Dk
Primary
Concomitant
Rash Pruritic Other Serious 7/10/2012 51 Male 196 lb 10/25/2012 Other Health Professional Gb
Primary
Concomitant
Weight Decreased Hospitalization 6/2012 62 Male 119 lb 10/4/2012 Consumer Br
Primary
Concomitant
Serum Ferritin Abnormal Other Serious 9/13/2012 Physician Nl
Primary
Concomitant
Rash Other Serious 9/28/2012 Other Health Professional Gb
Primary
Concomitant
Drug Reaction With Eosinophilia And Systemic Symptoms Other Serious 5/3/2012 Male 10/23/2012 Physician Es
Primary
Secondary
Concomitant
Tachycardia Hospitalization 54 Female 9/21/2012 Other Health Professional Br
Primary
Concomitant
Rectal Haemorrhage Other Serious 6/21/2012 57 Male 167 lb 10/17/2012 Physician Gb
Primary
Concomitant
Porphyria Other Serious 6/23/2012 42 Male 150 lb 10/1/2012 Consumer Fr
Primary
Secondary
Vasculitis Other Serious 5/2012 Male 9/17/2012 Physician Es
Primary
Secondary
Concomitant
Skin Irritation Other Serious Female 165 lb 10/2/2012 Physician Au
Primary
Concomitant
Platelet Count Decreased Other Serious 7/23/2012 57 Male 202 lb 9/21/2012 Other Health Professional Gb
Primary
Secondary
Pericarditis Other Serious Male 12/26/2012 Consumer Gr
Primary
Concomitant
Adverse Drug Reaction Other Serious 71 Male 141 lb 9/25/2012 Physician De
Primary
Secondary
Pneumonia Bacterial Hospitalization 51 Male 176 lb 10/2/2012 Physician De
Primary
Secondary
Rash Other Serious 4/15/2012 53 Male 174 lb 9/25/2012 Physician Es
Primary
Secondary
Skin Reaction Hospitalization 10/17/2012 Consumer De
Primary
Secondary
Leukocytoclastic Vasculitis Other Serious 8/3/2012 55 Male 265 lb 10/8/2012 Physician Es
Primary
Secondary
Concomitant
Rash Other Serious 9/12/2012 Male 12/4/2012 Other Health Professional Gr
Primary
Concomitant
Thrombocytopenia Hospitalization 6/2/2012 63 Male 212 lb 9/28/2012 Physician Nl
Primary
Secondary
Rash Other Serious Female 9/28/2012 Physician Pt
Primary
Concomitant
Depression Other Serious 66 Male 9/28/2012 Other Health Professional Dk
Primary
Secondary
Rash Other Serious 8/25/2012 67 Male 11/1/2012 Consumer Br
Primary
Concomitant
Nausea Other Serious 8/9/2012 39 Male 10/30/2012 Other Health Professional Gb
Primary
Concomitant
Rash Hospitalization Female 10/2/2012 Consumer De
Primary
Concomitant
Rash Maculo-papular Hospitalization 8/2012 Male 10/4/2012 Other Health Professional Fr
Primary
Secondary
Rash Other Serious Male 10/4/2012 Physician Pt
Primary
Concomitant
Vascular Purpura Other Serious 58 Male 10/5/2012 Other Health Professional Fr
Primary
Concomitant
Cellulitis Other Serious 61 Male 10/8/2012 Physician Gb
Primary
Concomitant
Urosepsis Hospitalization Female 165 lb 10/25/2012 Physician Es
Primary
Concomitant
Rash Other Serious Male 10/8/2012 Consumer Gr
Primary
Concomitant
Interacting
Rash Other Serious Female 11/2/2012 Consumer De
Primary
Concomitant
Sepsis Hospitalization 40 Male 10/10/2012 Physician Fi
Primary
Secondary
Renal Failure Acute Hospitalization 9/28/2012 Male 10/10/2012 Other Health Professional Au
Primary
Concomitant
Liver Function Test Abnormal Other Serious 10/10/2012 Other Health Professional Gb
Primary
Concomitant
Malaise Other Serious Male 10/12/2012 Other Health Professional Gb
Primary
Concomitant
Vision Blurred Other Serious Male 11/13/2012 Physician Gb
Primary
Secondary
Panniculitis Other Serious 10/12/2012 Other Health Professional Gb
Primary
Concomitant
Medication Error Other Serious Female 11/1/2012 Consumer Gr
Primary
Concomitant
Skin Reaction Other Serious 9/19/2012 42 Male 155 lb 10/16/2012 Other Health Professional Gb
Primary
Concomitant
Vomiting Other Serious 10/17/2012 Other Health Professional Gb
Primary
Concomitant
Toxic Skin Eruption Other Serious 9/2012 Male 10/22/2012 Consumer Es
Primary
Concomitant

Drug Data