Peginterferon Alfa-2B combined with Telaprevir

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Heart Rate Increased Hospitalization 11/5/2011 54 Female 12/1/2011 Consumer United States
Primary
Secondary
Hepatic Enzyme Increased Hospitalization 1/31/2012 54 Female 154 lb 2/12/2012 Physician Turkey
Primary
Concomitant
Off Label Use Hospitalization 60 Female 2/14/2012 Other Health Professional United States
Primary
Concomitant
Anaemia Hospitalization 73 Female 2/15/2012 Other Health Professional United States
Primary
Concomitant
Rash Hospitalization 3/19/2012 68 Female 135 lb 4/3/2012 Other Health Professional Italy
Primary
Concomitant
Dermatitis Exfoliative Hospitalization 4/12/2012 66 Female 126 lb 4/24/2012 Physician Italy
Primary
Concomitant
Liver Injury Hospitalization 4/2/2012 46 Male 4/26/2012 Other Health Professional United Kingdom
Primary
Concomitant
Rash Hospitalization 4/23/2012 59 Female 121 lb 5/3/2012 Physician Italy
Primary
Concomitant
Vomiting Disability 4/26/2012 63 Female 5/15/2012 Physician Italy
Primary
Concomitant
Rash Hospitalization 3/19/2012 68 Female 135 lb 5/15/2012 Other Health Professional Italy
Primary
Concomitant
Thrombocytopenia Hospitalization 4/27/2012 45 Male 168 lb 5/16/2012 Physician Italy
Primary
Concomitant
Transfusion Hospitalization 4/10/2012 55 Female 5/16/2012 United States
Primary
Secondary
Concomitant
Erythema Other Serious 4/26/2012 63 Female 5/25/2012 Physician Italy
Primary
Concomitant
Rash Hospitalization 4/23/2012 59 Female 121 lb 5/25/2012 Physician Italy
Primary
Concomitant
Rash Hospitalization 3/19/2012 68 Female 135 lb 5/25/2012 Other Health Professional Italy
Primary
Concomitant
Anaemia Megaloblastic Hospitalization 4/30/2012 72 Male 170 lb 5/29/2012 Physician Italy
Primary
Concomitant
Anaemia Megaloblastic Hospitalization 4/30/2012 72 Male 170 lb 6/8/2012 Physician Italy
Primary
Concomitant
Dermatitis Exfoliative Hospitalization 4/12/2012 66 Female 126 lb 6/11/2012 Physician Italy
Primary
Concomitant
Skin Reaction Other Serious Male 6/13/2012 Physician Spain
Primary
Concomitant
Pain Other Serious 4/26/2012 63 Female 6/13/2012 Physician Italy
Primary
Concomitant
Anaemia Hospitalization 4/27/2012 45 Male 168 lb 6/13/2012 Physician Italy
Primary
Concomitant
Dermatitis Exfoliative Hospitalization 4/12/2012 66 Female 126 lb 6/27/2012 Italy
Primary
Concomitant
Rash Hospitalization 6/14/2012 53 Male 161 lb 6/29/2012 Physician Italy
Primary
Concomitant
Abdominal Pain Upper Hospitalization 6/21/2012 42 Female 154 lb 7/3/2012 Physician Italy
Primary
Concomitant
Decreased Appetite Hospitalization 4/12/2012 7/11/2012 Japan
Primary
Secondary
Concomitant
Rash Papular Hospitalization 5/18/2012 7/11/2012 Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 3/6/2012 7/11/2012 Japan
Primary
Secondary
Concomitant
Erythema Other Serious 6/1/2012 7/11/2012 Japan
Primary
Secondary
Concomitant
Skin Disorder Other Serious 6/7/2012 7/12/2012 Japan
Primary
Secondary
Rash Hospitalization 4/23/2012 59 Female 106 lb 7/13/2012 Physician Italy
Primary
Concomitant
Dizziness Hospitalization 6/21/2012 42 Female 154 lb 7/17/2012 Physician Italy
Primary
Concomitant
Vomiting Disability 4/26/2012 63 Female 7/18/2012 Physician Italy
Primary
Concomitant
Photosensitivity Reaction Other Serious 3/14/2012 54 Male 7/18/2012 Other Health Professional United Kingdom
Primary
Concomitant
Depressed Mood Hospitalization 7/18/2012 Consumer United States
Primary
Secondary
Dyspnoea Hospitalization 7/18/2012 Physician United States
Primary
Secondary
Rash Hospitalization 1/21/2012 7/19/2012 Physician Japan
Primary
Secondary
Concomitant
Drug Rash With Eosinophilia And Systemic Symptoms Other Serious Male 7/25/2012 Physician Spain
Primary
Concomitant
Erythema Other Serious 5/10/2012 7/26/2012 Consumer Japan
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 6/21/2012 42 Female 154 lb 7/27/2012 Physician Italy
Primary
Concomitant
Dermatitis Exfoliative Hospitalization 3/31/2012 66 Female 126 lb 8/2/2012 Italy
Primary
Concomitant
Skin Disorder Other Serious 6/7/2012 8/6/2012 Japan
Primary
Secondary
Erythema Other Serious 6/1/2012 8/8/2012 Japan
Primary
Secondary
Concomitant
Haemoglobin Decreased Other Serious 3/6/2012 8/9/2012 Japan
Primary
Secondary
Concomitant
Rash Papular Hospitalization 5/18/2012 8/9/2012 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 1/21/2012 8/9/2012 Physician Japan
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/8/2012 49 Male 139 lb 8/20/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 5/8/2012 49 Male 139 lb 8/22/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 1/1/2012 8/16/2012 Other Health Professional United States
Primary
Secondary
Blood Creatinine Increased Other Serious 3/25/2012 8/22/2012 Physician Japan
Primary
Secondary
Concomitant
Dysuria Hospitalization 5/8/2012 49 Male 139 lb 8/27/2012 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 2/13/2012 55 Female 11/29/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Rash Other Serious 5/24/2012 49 Female 192 lb 9/7/2012 Other Health Professional Gb
Primary
Concomitant
Urine Output Decreased Hospitalization Female 9/12/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Vomiting Hospitalization Female 9/13/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Vomiting Other Serious 7/2012 55 Female 12/6/2012 Other Health Professional Gb
Primary
Secondary
Platelet Count Decreased Other Serious 4/23/2012 51 Male 141 lb 10/1/2012 Consumer Jp
Primary
Secondary
Concomitant
Malaise Other Serious 6/14/2012 47 Male 10/1/2012 Consumer Gb
Primary
Secondary
Suicidal Ideation Other Serious 6/19/2012 43 Male 10/7/2013 Other Health Professional Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 7/24/2012 60 Female 11/6/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Malaise Other Serious 6/14/2012 47 Male 10/8/2012 Other Health Professional Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 50 Female 10/8/2012 Consumer Gb
Primary
Secondary
Suicidal Ideation Other Serious 6/19/2012 44 Male 2/28/2013 Other Health Professional Gb
Primary
Secondary
Tremor Other Serious Male 12/27/2012 Other Health Professional Gb
Primary
Secondary
Skin Exfoliation Other Serious 8/15/2012 61 Male 11/6/2012 Other Health Professional Gb
Primary
Secondary
Tremor Other Serious 2012 48 Male 12/12/2012 Other Health Professional Gb
Primary
Secondary
Renal Failure Acute Other Serious 65 Male 10/30/2012 Physician Country Not Specified
Primary
Secondary
Hepatitis C Other Serious 41 Male 11/30/2012 Physician Country Not Specified
Primary
Secondary
Rash Generalised Other Serious 2012 47 Male 12/9/2012 Consumer Gb
Primary
Secondary
Anaemia Other Serious NotSpecified 1/17/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Drug Ineffective Death NotSpecified 1/8/2013 Other Health Professional Us
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 10/26/2012 Other Health Professional Us
Primary
Secondary
Pruritus Other Serious 8/20/2012 54 Male 10/29/2012 Other Health Professional Gb
Primary
Secondary
Weight Decreased Other Serious 9/17/2012 43 Male 2/13/2013 Physician Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 2012 54 Male 10/30/2012 Consumer Gb
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 6/19/2012 44 Male 2/20/2013 Other Health Professional Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 9/16/2012 54 Male 10/26/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Pruritus Other Serious 2012 53 Male 11/1/2012 Consumer Country Not Specified
Primary
Secondary
Weight Decreased Other Serious 9/17/2012 42 Male 119 lb 2/14/2013 Consumer Gb
Primary
Secondary
Rash Other Serious 9/24/2012 50 Female 11/30/2012 Other Health Professional Gb
Primary
Secondary
Nausea Other Serious 3/20/2012 52 Female 11/5/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Vomiting Other Serious 9/10/2012 44 Female 1/24/2013 Other Health Professional Gb
Primary
Secondary
Oral Pain Other Serious 4/11/2012 56 Female 11/5/2012 Consumer Gb
Primary
Secondary
Platelet Count Decreased Other Serious 3/12/2012 62 Male 11/6/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Haemorrhoids Other Serious 50 Female 11/6/2012 Consumer Gb
Primary
Secondary
Vomiting Other Serious 9/10/2012 45 Female 1/17/2013 Other Health Professional Gb
Primary
Secondary
Rash Generalised Other Serious 7/25/2012 48 Female 11/7/2012 Other Health Professional Gb
Primary
Secondary
Rash Hospitalization 6/7/2012 57 Male 11/7/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 10/19/2012 55 Male 11/7/2012 Other Health Professional Jp
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 9/1/2012 66 Male 11/8/2012 Gb
Primary
Secondary
Rash Other Serious 9/5/2012 44 Male 11/12/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Viral Mutation Identified Other Serious 2012 55 Female 11/12/2012 Consumer Gb
Primary
Secondary
Skin Irritation Other Serious 10/14/2012 51 Female 11/10/2012 Consumer Gb
Primary
Secondary
Rash Other Serious 10/2/2012 49 Male 11/16/2012 Consumer Gb
Primary
Secondary
Vision Blurred Other Serious Male 11/22/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Oral Pain Other Serious 4/11/2012 56 Female 11/16/2012 Physician Gb
Primary
Secondary
Swollen Tongue Other Serious 9/5/2012 48 Female 2/14/2013 Other Health Professional Gb
Primary
Secondary
Pruritus Other Serious 9/2012 50 Female 12/6/2012 Other Health Professional Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 2012 58 Female 12/6/2012 Consumer Gb
Primary
Secondary
Rash Other Serious 9/24/2012 44 Male 12/6/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Rash Other Serious 2012 44 Male 12/6/2012 Consumer Gb
Primary
Secondary
Rash Other Serious 44 Male 12/6/2012 Consumer Gb
Primary
Secondary
Rash Hospitalization 11/2012 46 Female 12/7/2012 Other Health Professional Dk
Primary
Secondary
Renal Impairment Other Serious 10/10/2012 49 Female 12/6/2012 Consumer Gb
Primary
Secondary
Weight Decreased Other Serious 9/12/2012 49 Male 1/16/2013 Consumer Gb
Primary
Secondary
Pruritus Other Serious 10/20/2012 53 Male 12/10/2012 Consumer Gb
Primary
Secondary
Insomnia Other Serious 10/12/2012 44 Male 12/7/2012 Consumer Gb
Primary
Secondary
Kidney Infection Hospitalization 10/23/2012 39 Female 12/10/2012 Consumer Gb
Primary
Secondary
Vision Blurred Other Serious Male 12/10/2012 Other Health Professional Gb
Primary
Secondary
Rectal Tenesmus Other Serious 2012 57 Male 12/10/2012 Consumer Gb
Primary
Secondary
Weight Decreased Other Serious 9/12/2012 Male 12/11/2012 Physician Gb
Primary
Secondary
Concomitant
Erythema Other Serious 5/13/2012 60 Male 143 lb 12/12/2012 Consumer Jp
Primary
Secondary
Concomitant
Palpitations Other Serious 10/20/2012 51 Female 12/19/2012 Physician Gb
Primary
Secondary
Weight Decreased Other Serious 9/12/2012 49 Male 12/19/2012 Other Health Professional Gb
Primary
Secondary
Rash Other Serious 11/20/2012 55 Male 181 lb 12/21/2012 Other Health Professional Au
Primary
Concomitant
Platelet Count Decreased Other Serious 11/4/2012 47 Male 12/27/2012 Consumer Gb
Primary
Secondary
Skin Fissures Other Serious 46 Male 12/27/2012 Consumer Gb
Primary
Secondary
Skin Fissures Other Serious Male 12/28/2012 Other Health Professional Gb
Primary
Secondary
Dizziness Other Serious 10/15/2012 34 Male 12/27/2012 Consumer Gb
Primary
Secondary
Rectal Haemorrhage Other Serious 50 Male 12/28/2012 Consumer Gb
Primary
Secondary
Nasopharyngitis Other Serious 10/1/2012 30 Female 12/28/2012 Consumer Gb
Primary
Secondary
Stevens-johnson Syndrome Life Threatening 9/10/2012 54 Female 12/28/2012 Consumer Gb
Primary
Secondary
Palpitations Other Serious 10/20/2012 51 Female 12/28/2012 Consumer Gb
Primary
Secondary
Pruritus Other Serious 2012 52 Male 1/2/2013 Physician Gb
Primary
Secondary
Concomitant
Sleep Disorder Other Serious 8/29/2012 51 Female 1/11/2013 Other Health Professional Gb
Primary
Secondary
Sleep Disorder Other Serious 8/29/2012 51 Female 1/11/2013 Consumer Gb
Primary
Secondary
Renal Impairment Other Serious 2004 69 Female 1/10/2013 Other Health Professional Jp
Primary
Secondary
Rash Other Serious 10/3/2012 47 Male 1/18/2013 Physician Gb
Primary
Secondary
Rash Other Serious 10/3/2012 46 Male 1/15/2013 Other Health Professional Gb
Primary
Secondary
Rash Other Serious 10/9/2012 57 Male 1/16/2013 Consumer Gb
Primary
Secondary
Pancreatitis Other Serious 11/10/2012 33 Male 1/17/2013 Consumer Gb
Primary
Secondary
Vomiting Other Serious 9/10/2012 44 Female 1/18/2013 Other Health Professional Country Not Specified
Primary
Secondary
Steatorrhoea Other Serious 9/2012 47 Female 1/18/2013 Consumer Gb
Primary
Secondary
Rash Generalised Other Serious 2012 60 Male 1/20/2013 Consumer Gb
Primary
Secondary
Loss Of Consciousness Other Serious 10/22/2012 55 Male 1/22/2013 Consumer Gb
Primary
Secondary
Steatorrhoea Other Serious 9/20/2012 47 Female 1/23/2013 Physician Gb
Primary
Secondary
Rash Other Serious 11/3/2012 41 Male 2/14/2013 Other Health Professional Gb
Primary
Secondary
Haemoglobin Decreased Hospitalization 11/20/2012 62 Male 2/15/2013 Other Health Professional Gb
Primary
Secondary
Vomiting Other Serious 8/7/2012 Male 2/15/2013 Physician Gb
Primary
Secondary
Pain In Extremity Other Serious 11/21/2012 Female 1/29/2013 Physician Gb
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 11/21/2012 39 Female 1/30/2013 Physician Us
Primary
Secondary
Vomiting Other Serious 2012 52 Female 1/30/2013 Consumer Country Not Specified
Primary
Secondary
Concomitant
Rash Other Serious 2012 48 Male 1/30/2013 Consumer Gb
Primary
Secondary
Tooth Abscess Other Serious 11/7/2012 Male 2/22/2013 Other Health Professional Gb
Primary
Secondary
Tooth Abscess Other Serious 11/7/2012 51 Male 2/15/2013 Other Health Professional Gb
Primary
Secondary
Hepatic Pain Other Serious 10/9/2012 29 Male 2/25/2013 Physician Gb
Primary
Secondary
Hepatic Pain Other Serious 2012 29 Male 2/21/2013 Consumer Gb
Primary
Secondary
Urinary Incontinence Other Serious 5/30/2012 38 Male 2/21/2013 Other Health Professional Gb
Primary
Secondary
Concomitant
Vomiting Other Serious 11/27/2012 27 Female 2/22/2013 Consumer Gb
Primary
Secondary
Pyrexia Hospitalization 12/2012 Male 2/22/2013 Other Health Professional Au
Primary
Secondary
Sinus Headache Other Serious 8/7/2012 38 Male 1/15/2013 Other Health Professional Gb
Primary
Secondary
Concomitant

Drug Data