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Index of reports
> Cases with Hepatic Cirrhosis ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Copegus (Ribavirin) where reactions include hepatic cirrhosis. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Copegus side effects in 49 year old male
Reported by a physician from Germany on 2012-08-03
Patient: 49 year old male, weighing 84.0 kg (184.8 pounds)
Reactions: Hepatic Failure, Ascites, Hepatic Cirrhosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2011-10-20
Copegus
Administration route: Oral
Telaprevir
Dosage: last dos prior to sae; 12/jan/2012
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-20
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-20
Possible Copegus side effects in female
Reported by a individual with unspecified qualification from Tunisia on 2012-06-21
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2009-04-29
End date: 2009-05-01
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2009-04-29
End date: 2009-05-01
Possible Copegus side effects in 45 year old male
Reported by a physician from France on 2012-06-05
Patient: 45 year old male
Reactions: Abdominal Pain Lower, Cholecystitis Acute, Hepatic Neoplasm Malignant, Abasia, Erythema, Hepatic Encephalopathy, Fatigue, Memory Impairment, Hepatic Cirrhosis, Toxic Skin Eruption, Scar
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Victrelis
Dosage: 800 mg;tid
Indication: Hepatitis C
Start date: 2011-06-14
Viraferonpeg
Dosage: 80 mcg;qw
Indication: Hepatitis C
Start date: 2011-05-17
Copegus
Dosage: 800 mg;qd
Indication: Hepatitis C
Start date: 2011-05-17
Other drugs received by patient: Neupogen; Zovirax; Neorecormon
Possible Copegus side effects in 60 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-04
Patient: 60 year old female
Reactions: Haemoglobin Decreased, Weight Increased, Dyspnoea, Oedema Peripheral, Tachycardia, Blood Thyroid Stimulating Hormone Increased, Bronchitis, Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Indication: Hepatitis C
Start date: 2011-04-01
End date: 2011-07-01
Copegus
Indication: Hepatitis C
Start date: 2006-01-01
End date: 2008-01-01
Victrelis
Dosage: 800 mg;tid;
Indication: Hepatitis C
Start date: 2012-02-09
Pegasys
Indication: Hepatitis C
Start date: 2006-01-01
End date: 2008-01-01
Pegasys
Indication: Hepatitis C
Start date: 2011-04-01
End date: 2011-07-01
Pegasys
Indication: Hepatitis C
Start date: 2012-01-02
Other drugs received by patient: Cefpodoxime Proxetil; Bronchokod; Deturgylone
Possible Copegus side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-24
Patient: male, weighing 110.0 kg (242.0 pounds)
Reactions: Hepatic Failure, Multi-Organ Failure, Pneumonia Klebsiella, Sepsis, Acute Respiratory Distress Syndrome, Septic Shock, Renal Failure Acute, Hepatic Cirrhosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Telaprevir
Administration route: Oral
Indication: Hepatitis C
Pegasys
Indication: Hepatitis C
Start date: 2011-10-21
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-10
Other drugs received by patient: Diovan; Erythromycin; Acetaminophen; Hydrocortisone; Guaifenesin; Spironolactone; Thymol; Metoprolol Succinate; Furosemide; Omeprazole; Clindamycin; Clotrimazole
Possible Copegus side effects in male
Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-04-30
Patient: male, weighing 86.0 kg (189.2 pounds)
Reactions: Pneumonia, Toxic Encephalopathy, Anaemia, Coagulopathy, Renal Failure Acute, Ascites, Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Dosage: frequency: daily
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-08-09
End date: 2010-11-05
Pegasys
Indication: Hepatitis C
Start date: 2010-08-09
End date: 2010-11-05
Other drugs received by patient: Enterol; Inderal Retard; Lasix; Enterol; Dexpanthenol; Aldactone; Lactulose
Possible Copegus side effects in 49 year old male
Reported by a physician from Germany on 2012-04-26
Patient: 49 year old male, weighing 84.0 kg (184.8 pounds)
Reactions: Hepatic Cirrhosis, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2011-10-20
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-10-20
Possible Copegus side effects in male
Reported by a individual with unspecified qualification from United States on 2012-04-12
Patient: male
Reactions: Cataract, Glaucoma, Retinal Detachment, Hepatic Fibrosis, Pain, Feeling Cold, Eye Haemorrhage, Post-Traumatic Stress Disorder, Blood Potassium Decreased, Imprisonment, Depression, Hepatic Cirrhosis, Influenza
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Indication: Hepatitis C
Start date: 2001-02-02
End date: 2002-04-05
Copegus
Start date: 2012-02-03
Boceprevir
Indication: Hepatitis C
Start date: 2012-03-02
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2012-02-03
Possible Copegus side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-05
Patient: 44 year old female, weighing 62.5 kg (137.5 pounds)
Reactions: Toxicity To Various Agents, Hepatic Cirrhosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Copegus
Dosage: 4000 mg, bid
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-02-09
Amitriptyline HCL
Dosage: 25 mg, unk
Administration route: Oral
Indication: Pain
Pegasys
Dosage: 180 ug, qw
Indication: Hepatitis C
Start date: 2011-02-09
Methadone HCL
Administration route: Oral
Indication: Drug Dependence
Diazepam
Other drugs received by patient: Diclofenac Sodium; Albuterol
Possible Copegus side effects in male
Reported by a individual with unspecified qualification from Poland on 2012-01-10
Patient: male, weighing 71.0 kg (156.2 pounds)
Reactions: Insomnia, Asthenia, Hepatic Cirrhosis, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-02-23
End date: 2011-12-30
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2011-02-23
End date: 2011-12-30
Other drugs received by patient: Pentoxyverine
Possible Copegus side effects in male
Reported by a individual with unspecified qualification from Poland on 2012-01-05
Patient: male, weighing 71.0 kg (156.2 pounds)
Reactions: Insomnia, Asthenia, Ascites, Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-02-23
End date: 2011-12-30
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2011-02-23
End date: 2011-12-30
Other drugs received by patient: Pentoxyverine
Possible Copegus side effects in female
Reported by a individual with unspecified qualification from United States on 2011-11-23
Patient: female
Reactions: Hepatic Cirrhosis
Drug(s) suspected as cause:
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2010-06-20
Copegus
Indication: Hepatitis C
Start date: 2010-06-20
Possible Copegus side effects in female
Reported by a individual with unspecified qualification from Germany on 2011-10-18
Patient: female, weighing 79.0 kg (173.8 pounds)
Reactions: Waist Circumference Increased, Anaemia, Hepatic Cirrhosis, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Copegus
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-10-01
End date: 2011-03-04
PEG-Interferon Alfa 2A
Indication: Hepatitis C
Start date: 2010-10-01
End date: 2011-03-04
Other drugs received by patient: Torsemide; Calcimagon-D3; Pantoprazole
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