Incivo combined with Peginterferon Alfa

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Intracranial Pressure Increased Other Serious Female 5/15/2012 Physician Israel
Primary
Concomitant
Rash Other Serious Male 6/16/2012 Physician Portugal
Primary
Concomitant
Off Label Use Other Serious Male 6/27/2012 Physician Portugal
Primary
Concomitant
Fatigue Death 4/18/2012 52 Male 3/1/2013 Physician Es
Primary
Concomitant
Serum Ferritin Abnormal Other Serious 9/13/2012 Physician Nl
Primary
Concomitant
Rash Other Serious 8/25/2012 67 Male 11/1/2012 Consumer Br
Primary
Concomitant
Death Death 8/2012 47 Male 2/27/2013 Physician Es
Primary
Concomitant
Rash Other Serious Male 10/4/2012 Physician Pt
Primary
Concomitant
Renal Failure Other Serious 10/26/2012 65 Female 198 lb 12/28/2012 Consumer De
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 10/30/2012 61 Male 11/16/2012 Physician Es
Primary
Secondary
Thrombocytopenia Other Serious Female 11/20/2012 Consumer Co
Primary
Secondary
Concomitant
Tremor Hospitalization 11/16/2012 67 Female 143 lb 1/21/2013 Consumer Co
Primary
Concomitant
Renal Impairment Other Serious 12/2012 62 Female 2/4/2013 Consumer Es
Primary
Concomitant
Lymphopenia Other Serious Female 187 lb 1/4/2013 Physician Co
Primary
Concomitant
Urinary Tract Infection Other Serious Female 161 lb 1/4/2013 Consumer Co
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 69 Male 2/11/2013 Pharmacist Co
Primary
Concomitant
Cellulitis Hospitalization 2012 Female 1/3/2013 Pharmacist Es
Primary
Secondary
Therapy Responder Other Serious 12/26/2012 65 Female 1/25/2013 Physician Es
Primary
Secondary
Ascites Hospitalization 67 Male 1/22/2013 Physician Il
Primary
Secondary
Rash Erythematous Other Serious 1/15/2013 52 Female 115 lb 4/12/2013 Consumer Co
Primary
Concomitant
Proctalgia Other Serious 2/2013 69 Male 194 lb 4/11/2013 Consumer Co
Primary
Secondary
Concomitant
Rash Other Serious 11/2012 Male 3/7/2013 Physician Es
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/8/2012 Female 154 lb 3/19/2013 Physician Es
Primary
Secondary
Concomitant
Drug Ineffective Other Serious NotSpecified 1/29/2013 Physician Nl
Primary
Secondary
Rash Other Serious 1/22/2013 59 Female 2/14/2013 Other Health Professional Co
Primary
Concomitant
Anorectal Disorder Other Serious Female 157 lb 2/12/2013 Other Health Professional Co
Primary
Concomitant
Rash Other Serious Male 2/13/2013 Consumer Au
Primary
Secondary
Thrombocytopenia Death 2012 65 Male 6/24/2013 Consumer Ie
Primary
Secondary
Neutropenia Other Serious 60 Female 2/21/2013 Physician Tr
Primary
Secondary
Concomitant
Neutropenia Other Serious 65 Male 2/21/2013 Physician Tr
Primary
Secondary
Toxic Epidermal Necrolysis Other Serious 11/2012 51 Male 5/2/2013 Physician Nl
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 1/25/2013 64 Male 4/30/2013 Physician Nl
Primary
Concomitant
Skin Reaction Other Serious NotSpecified 3/1/2013 Physician Es
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 2/10/2013 60 Female 3/7/2013 Physician Es
Primary
Secondary
Rash Other Serious 12/12/2011 55 Female 3/4/2013 Physician Ch
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization Female 3/4/2013 Physician Tr
Primary
Secondary
Off Label Use Other Serious 40 Male 3/13/2013 Physician Gb
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 69 Male 4/24/2013 Physician Tr
Primary
Secondary
Rash Hospitalization 11/23/2012 Female 6/5/2013 Physician Es
Primary
Secondary
Thrombocytopenia Other Serious 2/21/2013 59 Male 3/7/2013 Physician Tr
Primary
Secondary
Thrombocytopenia Other Serious 2/21/2013 55 Male 3/7/2013 Physician Tr
Primary
Secondary
Loss Of Consciousness Hospitalization 1/28/2013 67 Female 119 lb 2/5/2013 Other Health Professional Co
Primary
Concomitant
Abdominal Pain Hospitalization 1/22/2013 Male 192 lb 2/6/2013 Other Health Professional Co
Primary
Concomitant
Syncope Other Serious 2/8/2013 64 Male 3/20/2013 Physician Es
Primary
Secondary
Concomitant
Nausea Other Serious Male 2/15/2013 Other Health Professional Co
Primary
Concomitant
Thrombocytopenia Other Serious 1/30/2013 37 Female 157 lb 4/12/2013 Other Health Professional Co
Primary
Concomitant
Leukopenia Other Serious 3/6/2013 50 Male 5/29/2013 Physician Tr
Primary
Secondary
Rash Papular Hospitalization Male 3/21/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 67 Female 3/21/2013 Physician Tr
Primary
Secondary
Vomiting Hospitalization Male 3/22/2013 Physician Tr
Primary
Secondary
Depression Hospitalization 70 Female 3/18/2013 Physician Tr
Primary
Secondary
Depression Hospitalization 70 Female 3/18/2013 Physician Tr
Primary
Secondary
Urticaria Other Serious 3/10/2013 54 Male 4/1/2013 Physician Es
Primary
Secondary
Pancytopenia Hospitalization 64 Female 3/20/2013 Consumer De
Primary
Secondary
Cholecystitis Acute Hospitalization 3/12/2013 60 Male 3/21/2013 Physician At
Primary
Secondary
Lower Gastrointestinal Haemorrhage Hospitalization 3/19/2013 54 Female 60 lb 3/25/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 1/21/2013 74 Female 143 lb 5/22/2013 Other Health Professional Co
Primary
Secondary
Concomitant
Rash Other Serious Male 4/8/2013 Physician Es
Primary
Concomitant
Mental Disorder Other Serious 4/1/2013 59 Female 4/9/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 61 Female 4/11/2013 Consumer Ch
Primary
Secondary
Vomiting Other Serious 1/23/2013 66 Male 4/12/2013 Consumer Co
Primary
Concomitant
Tremor Hospitalization 2/25/2013 47 Male 187 lb 4/30/2013 Pharmacist Es
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization Male 4/16/2013 Consumer Fr
Primary
Secondary
No Adverse Event NotSpecified 6/28/2013 Consumer De
Primary
Concomitant
Rash Hospitalization Female 4/17/2013 Consumer De
Primary
Secondary
Infection Hospitalization Male 4/18/2013 Consumer Fr
Primary
Secondary
Rash Other Serious 4/11/2013 62 Female 4/19/2013 Physician Tr
Primary
Secondary
Pancreatitis Acute Hospitalization 3/2013 63 Male 12/16/2013 Physician Tr
Primary
Secondary
Sepsis Hospitalization Male 4/29/2013 Physician Il
Primary
Concomitant
Death Death 2/11/2013 44 Female 4/23/2013 Physician Be
Primary
Secondary
Rash Other Serious Male 4/26/2013 Other Health Professional Gb
Primary
Secondary
Weight Decreased Other Serious 30 Male 160 lb 4/26/2013 Consumer Es
Primary
Secondary
Concomitant
Rash Other Serious 2013 45 Male 5/2/2013 Consumer Fr
Primary
Concomitant
Rib Fracture Hospitalization Male 4/30/2013 Pharmacist Gb
Primary
Concomitant
Platelet Count Decreased Hospitalization NotSpecified 5/2/2013 Physician Tr
Primary
Secondary
Neutrophil Count Decreased Other Serious 70 Female 5/2/2013 Physician Tr
Primary
Secondary
Thrombocytopenia Other Serious NotSpecified 5/6/2013 Consumer Fr
Primary
Secondary
Urinary Tract Infection Other Serious NotSpecified 5/6/2013 Consumer Fr
Primary
Secondary
Concomitant
Renal Failure Other Serious Female 5/7/2013 Physician Il
Primary
Secondary
Weight Decreased Other Serious 66 Male 5/14/2013 Physician Tr
Primary
Secondary
Concomitant
Rash Other Serious Male 5/14/2013 Physician Gb
Primary
Secondary
Concomitant
Drug Ineffective Other Serious 1/2013 Male 143 lb 5/23/2013 Physician At
Primary
Secondary
Concomitant
Vomiting Hospitalization 70 Female 5/20/2013 Physician Tr
Primary
Secondary
Depression Other Serious 62 Male 5/20/2013 Physician Tr
Primary
Secondary
Vaginal Haemorrhage Other Serious Female 5/21/2013 Physician Tr
Primary
Secondary
Vaginal Haemorrhage Other Serious NotSpecified 5/30/2013 Physician Tr
Primary
Secondary
Rash Other Serious NotSpecified 5/22/2013 Physician Tr
Primary
Secondary
Pain In Extremity Other Serious 63 Male 5/23/2013 Physician Tr
Primary
Secondary
Concomitant
Viral Load Increased Hospitalization NotSpecified 12/9/2013 Other Health Professional De
Primary
Secondary
Pruritus Other Serious 5/2013 Female 12/17/2013 Physician Gr
Primary
Concomitant
Appendicectomy Other Serious Male 5/31/2013 Physician Il
Primary
Secondary
Leukopenia Other Serious 67 Female 6/6/2013 Physician Tr
Primary
Secondary
Rash Other Serious 69 Female 7/24/2013 Physician Tr
Primary
Secondary
Neutropenia Other Serious 47 Female 5/30/2013 Physician Tr
Primary
Secondary
Rash Other Serious 60 Female 10/2/2013 Consumer Gr
Primary
Concomitant
Sepsis Hospitalization 5/2013 73 Female 6/7/2013 Physician Tr
Primary
Secondary
Urinary Tract Infection Other Serious 3/26/2013 56 Female 199 lb 6/11/2013 Other Health Professional Au
Primary
Secondary
Optic Neuritis Other Serious 45 Female 6/6/2013 Physician Tr
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening Female 220 lb 7/17/2013 Other Health Professional Au
Primary
Secondary
Weight Increased Other Serious 5/25/2013 60 Male 172 lb 6/10/2013 Other Health Professional Au
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 1/1/2012 69 Female 146 lb 11/22/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Rash Hospitalization 5/14/2013 55 Female 6/18/2013 Physician Tr
Primary
Secondary
Concomitant
Weight Decreased Other Serious 2013 60 Male 7/9/2013 Physician Tr
Primary
Secondary
Rash Other Serious Male 6/14/2013 Other Health Professional Gb
Primary
Secondary
Hepatic Cirrhosis Hospitalization Male 6/14/2013 Other Health Professional Gb
Primary
Secondary
Rash Other Serious 60 Male 6/17/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Nausea Hospitalization 34 Female 12/23/2013 Physician Tr
Primary
Secondary
Rash Maculo-papular Hospitalization Female 6/19/2013 Physician Tr
Primary
Secondary
Renal Tubular Disorder Other Serious NotSpecified 6/21/2013 Physician Tr
Primary
Secondary
Hyperglycaemia Other Serious 6/19/2013 48 Female 12/17/2013 Physician Tr
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 53 Female 6/26/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 61 Female 7/2/2013 Physician Tr
Primary
Secondary
Thrombocytopenia Other Serious NotSpecified 7/3/2013 Other Health Professional Fr
Primary
Secondary
Pneumonia Other Serious 5/6/2013 63 Male 7/12/2013 Physician Nl
Primary
Secondary
Concomitant
Sepsis Hospitalization Female 7/9/2013 Physician Be
Primary
Secondary
Rash Generalised Other Serious 75 Male 7/12/2013 Consumer Fr
Primary
Secondary
Concomitant
Rash Other Serious 55 Male 7/18/2013 Physician Tr
Primary
Secondary
Vomiting Other Serious 6/12/2013 62 Male 7/31/2013 Physician Tr
Primary
Secondary
Off Label Use Other Serious Male 11/27/2013 Physician Ch
Primary
Secondary
Upper Gastrointestinal Haemorrhage Other Serious NotSpecified 7/31/2013 Physician Tr
Primary
Secondary
Rash Other Serious 65 Female 7/31/2013 Physician Tr
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization Female 8/23/2013 Physician Il
Primary
Secondary
Concomitant
Pyrexia Other Serious 41 Female 8/9/2013 Consumer Il
Primary
Secondary
Thrombocytopenia Other Serious 2013 Male 8/12/2013 Physician Au
Primary
Concomitant
Rash Other Serious 8/2/2013 28 Male 8/19/2013 Physician Tr
Primary
Secondary
Rash Other Serious NotSpecified 8/13/2013 Other Health Professional Gb
Primary
Secondary
Rash Hospitalization 8/1/2013 62 Male 192 lb 8/28/2013 Other Health Professional Au
Primary
Secondary
Jaundice Other Serious 52 Female 9/4/2013 Physician Br
Primary
Concomitant
Overdose Death 2013 40 Male 8/23/2013 Physician Gb
Primary
Secondary
Hypokalaemia Other Serious Male 8/21/2013 Physician Tr
Primary
Secondary
Anaemia Other Serious Male 193 lb 9/6/2013 Other Health Professional Gb
Primary
Secondary
Toxicity To Various Agents Other Serious NotSpecified 8/30/2013 Physician Fr
Primary
Secondary
Dermatitis Bullous Hospitalization 8/2013 49 Male 8/30/2013 Physician De
Primary
Secondary
Thrombocytopenia Hospitalization 6/20/2013 48 Female 143 lb 9/16/2013 Consumer De
Primary
Secondary
Concomitant
Vomiting Other Serious 64 Female 9/5/2013 Consumer Is
Primary
Concomitant
Drug Reaction With Eosinophilia And Systemic Symptoms Hospitalization 7/2013 58 Male 209 lb 9/6/2013 Physician Tr
Primary
Concomitant
Drug Reaction With Eosinophilia And Systemic Symptoms Hospitalization Male 9/11/2013 Physician Tr
Primary
Secondary
Rash Generalised Other Serious Male 9/11/2013 Physician Gb
Primary
Concomitant
Nausea Other Serious 68 Male 9/11/2013 Consumer Il
Primary
Secondary
Xerosis Other Serious 11/2011 78 Male 9/12/2013 Other Health Professional Fr
Primary
Secondary
Respiratory Failure Other Serious 64 Male 10/4/2013 Physician Tr
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 62 Female 9/24/2013 Physician Tr
Primary
Secondary
Rash Male 9/27/2013 Physician Pt
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 7/22/2013 45 Female 10/2/2013 Other Health Professional Au
Primary
Secondary
Rash Other Serious 55 Male 10/7/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Off Label Use Other Serious NotSpecified 10/8/2013 Pharmacist Es
Primary
Secondary
Rash Other Serious NotSpecified 10/23/2013 Other Health Professional Gb
Primary
Secondary
Rash Generalised Other Serious 48 Female 10/30/2013 Consumer Il
Primary
Secondary
Vomiting Other Serious 10/15/2013 57 Male 179 lb 12/17/2013 Consumer De
Primary
Secondary
Vomiting Hospitalization 2/5/2013 48 Male 187 lb 6/21/2013 Consumer Co
Primary
Concomitant

Drug Data