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Index of reports
> Cases with Multi-Organ Failure ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ribavirin where reactions include multi-organ failure. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Ribavirin side effects in female
Reported by a physician from United States on 2012-08-10
Patient: female, weighing 115.0 kg (253.0 pounds)
Reactions: Multi-Organ Failure, Emphysematous Cystitis, Urinary Tract Infection, Sepsis, Ascites
Adverse event resulted in: death
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2010-12-23
End date: 2011-01-13
Pegasys
Start date: 2010-11-05
Ribavirin
Indication: Hepatitis C
Start date: 2010-11-05
Other drugs received by patient: Lisinopril; Glipizide; Fluoxetine HCL; Spironolactone; Propranolol; Omeprazole; Glipizide; Fosamax
Possible Ribavirin side effects in
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-02
Patient:
Reactions: Confusional State, Anaemia, Ketoacidosis, Ascites, Loss of Consciousness, Haemoglobin Decreased, Multi-Organ Failure, Renal Failure, Platelet Count Decreased, Septic Shock, Blood Glucose Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Ribavirin
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Victrelis
Dosage: 800 mg, q8h
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-05
End date: 2012-03-13
Pegasys
Dosage: 180 ?g, qw
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Other drugs received by patient: Glyburide; Metformin Hydrochloride; Eprex; Nadolol; Diazepam; Spironolactone; Lasix
Possible Ribavirin side effects in male
Reported by a physician from France on 2012-06-12
Patient: male, weighing 78.0 kg (171.6 pounds)
Reactions: Multi-Organ Failure, Renal Failure, Vomiting, Food Intolerance, Nausea, Urinary Tract Infection, Gastroenteritis Staphylococcal, Acidosis, Septic Shock, Abdominal Pain Upper
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-04-22
End date: 2011-05-15
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2011-04-22
End date: 2011-05-15
Duragesic-100
Indication: Pain
Telaprevir
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-04-22
End date: 2011-05-15
Other drugs received by patient: Levothyroxine Sodium; Acetaminophen; Aluminum Hydroxide and Magnesium Trisilicate; Diamicron; Temazepam; Metformin HCL; Dicetel
Possible Ribavirin side effects in female
Reported by a physician from United States on 2012-05-25
Patient: female, weighing 115.0 kg (253.0 pounds)
Reactions: Death, Multi-Organ Failure, Emphysematous Cystitis, Urinary Tract Infection, Sepsis, Ascites
Adverse event resulted in: death
Drug(s) suspected as cause:
Pegasys
Start date: 2010-11-05
Ribavirin
Indication: Hepatitis C
Start date: 2010-11-05
Pegasys
Indication: Hepatitis C
Start date: 2010-12-23
End date: 2011-01-13
Other drugs received by patient: Lisinopril; Glipizide; Propranolol; Spironolactone; Glipizide; Fluoxetine; Fosamax
Possible Ribavirin side effects in male
Reported by a physician from China on 2012-05-22
Patient: male
Reactions: Multi-Organ Failure, Meningitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Azithromycin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Cefuroxime
Dosage: .8g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Blinded Vaccine
Administration route: Oral
Indication: Prophylaxis
Start date: 2010-12-03
End date: 2010-12-03
Ribavirin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Possible Ribavirin side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-05-09
Patient: 59 year old male
Reactions: Anaemia, Ketoacidosis, Ascites, Loss of Consciousness, Multi-Organ Failure, Renal Failure, Platelet Count Decreased, Septic Shock, Blood Glucose Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Victrelis
Dosage: 800 mg;q8h;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-05
End date: 2012-03-13
Pegasys
Dosage: 180 mcg;qw;sc
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Ribavirin
Dosage: 1000 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Other drugs received by patient: Glyburide; Eprex; Nadol; Metformin HCL; Diazepam; Lasix
Possible Ribavirin side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-08
Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Janumet
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2012-04-10
Telaprevir
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Other drugs received by patient: Epoetin Beta
Possible Ribavirin side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-05-01
Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Janumet
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2012-04-10
Telaprevir
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Other drugs received by patient: Epoetin Beta
Possible Ribavirin side effects in 56 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-30
Patient: 56 year old male, weighing 49.0 kg (107.8 pounds)
Reactions: Multi-Organ Failure, Rhabdomyolysis, Lactic Acidosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Peginterferon Alfa-2A
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Janumet
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
End date: 2012-04-10
Telaprevir
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-24
End date: 2012-04-10
Other drugs received by patient: Epoetin Beta
Possible Ribavirin side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-11
Patient: 59 year old male
Reactions: Confusional State, Anaemia, Condition Aggravated, Ketoacidosis, Somnolence, Ascites, Loss of Consciousness, Multi-Organ Failure, Renal Failure, Platelet Count Decreased, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Ribavirin
Dosage: 1000 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Pegasys
Dosage: 180 mcg;qw;sc
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Victrelis
Dosage: 800 mg;q8h;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-05
End date: 2012-03-13
Other drugs received by patient: Glyburide; Nadol; Lasix; Diazepam; Eprex; Metformin HCL
Possible Ribavirin side effects in 64 year old male
Reported by a physician from Spain on 2012-04-11
Patient: 64 year old male, weighing 63.0 kg (138.6 pounds)
Reactions: Hepatic Function Abnormal, Disseminated Intravascular Coagulation, Disorientation, Somnolence, Multi-Organ Failure, Asterixis, Hepatic Encephalopathy, Ventricular Tachyarrhythmia, Acute Respiratory Failure, Metabolic Acidosis, Dyspnoea, Hypotension, Anaemia, General Physical Health Deterioration, Lobar Pneumonia, Haemodialysis, Ascites, Renal Failure, Treatment Failure, Cardiac Arrest, Purulent Discharge
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 100 mcg;qw;sc
Indication: Hepatitis C
Start date: 2012-01-13
End date: 2012-03-18
Ribavirin
Dosage: 800 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-01-13
End date: 2012-03-18
Victrelis
Dosage: 800 mg;q8h;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-10
End date: 2012-03-18
Other drugs received by patient: Propranolol; Amiloride Hydrochloride
Possible Ribavirin side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-10
Patient: male, weighing 65.0 kg (143.0 pounds)
Reactions: Anaemia, Ketoacidosis, Loss of Consciousness, Ascites, Haemoglobin Decreased, Multi-Organ Failure, Renal Failure, Platelet Count Decreased, Septic Shock, Blood Glucose Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pegasys
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Victrelis
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-12
End date: 2012-03-13
Other drugs received by patient: Nadolol; Lasix; Metformin HCL; Eprex; Glyburide; Spironolactone; Diazepam
Possible Ribavirin side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-04-06
Patient: 57 year old female
Reactions: Pulmonary Necrosis, Metabolic Acidosis, Continuous Haemodiafiltration, Hepatic Failure, Treatment Noncompliance, Lung Abscess, Ascites, Multi-Organ Failure, Renal Failure, Dialysis, Respiratory Failure, Pneumonia Staphylococcal, Skin Infection, Septic Shock, Immunosuppression
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 100 mcg;qw;sc
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2011-01-30
Boceprevir (Sch-503034)
Dosage: 800 mg;tid
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Ribavirin
Dosage: 400 mg;bid;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Possible Ribavirin side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-04
Patient: male
Reactions: Multi-Organ Failure, Septic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Victrelis
Indication: Product Used FOR Unknown Indication
Ribavirin
Indication: Product Used FOR Unknown Indication
Pegasys
Indication: Product Used FOR Unknown Indication
Possible Ribavirin side effects in 59 year old male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-04
Patient: 59 year old male
Reactions: Anaemia, Ketoacidosis, Loss of Consciousness, Ascites, Multi-Organ Failure, Renal Failure, Platelet Count Decreased, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Victrelis
Dosage: 800 mg, q8h, po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-05
End date: 2012-03-13
Ribavirin
Dosage: 1000 mg, qd, po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Pegasys
Dosage: 180 mcg, qw, sc
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Other drugs received by patient: Eprex; Diazepam; Lasix; Nadol; Glyburide
Possible Ribavirin side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-28
Patient: male
Reactions: Anaemia, Ketoacidosis, Loss of Consciousness, Ascites, Haemoglobin Decreased, Multi-Organ Failure, Platelet Count Decreased, Blood Glucose Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Victrelis
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-12
End date: 2012-03-13
Pegasys
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Ribavirin
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-11-07
End date: 2012-03-13
Other drugs received by patient: Eprex; Nadolol; Diazepam
Possible Ribavirin side effects in male
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-03-27
Patient: male
Reactions: Multi-Organ Failure, Septic Shock
Adverse event resulted in: death
Drug(s) suspected as cause:
Victrelis
Indication: Product Used FOR Unknown Indication
Pegasys
Indication: Product Used FOR Unknown Indication
Ribavirin
Indication: Product Used FOR Unknown Indication
Possible Ribavirin side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-16
Patient: 57 year old female
Reactions: Hepatic Failure, Treatment Noncompliance, Oral Herpes, Lung Abscess, Multi-Organ Failure, Pneumonia Staphylococcal, Immunosuppression, Metabolic Acidosis, Pulmonary Necrosis, International Normalised Ratio Increased, Ascites, Haemodialysis, Renal Failure, Staphylococcal Infection, Respiratory Failure, Septic Shock, Infection Susceptibility Increased
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Boceprevir (Sch-503034)
Dosage: 800 mg; tid
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Ribavirin
Dosage: 400 mg; bid; po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
PEG-Intron
Dosage: 100 mcg; qw; sc
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Possible Ribavirin side effects in 57 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-03-12
Patient: 57 year old female
Reactions: Pneumonia, Metabolic Acidosis, Necrosis, Hepatic Failure, Multi-Organ Failure, Renal Failure, Dialysis, Abscess, Pneumonia Staphylococcal, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 100 mcg;qw;sc
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Boceprevir (Sch-503034)
Dosage: 800 mg;tid
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Ribavirin
Dosage: 400mg;bid;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-01-19
End date: 2012-01-30
Possible Ribavirin side effects in male
Reported by a physician from China on 2012-01-04
Patient: male
Reactions: Multi-Organ Failure, Meningitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Cefuroxime
Dosage: .8g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Blinded Vaccine
Administration route: Oral
Indication: Prophylaxis
Start date: 2010-12-03
End date: 2010-12-03
Ribavirin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Azithromycin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Possible Ribavirin side effects in male
Reported by a physician from China on 2011-12-28
Patient: male
Reactions: Mydriasis, Sudden Death, Multi-Organ Failure, Overdose, Cyanosis, Pulse Absent, Nervous System Disorder, Meningitis Bacterial, Respiratory Arrest, Meningitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Azithromycin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Blinded Vaccine
Administration route: Oral
Indication: Prophylaxis
Start date: 2010-12-03
End date: 2010-12-03
Cefuroxime
Dosage: .8g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Ribavirin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Possible Ribavirin side effects in male
Reported by a physician from China on 2011-12-22
Patient: male
Reactions: Multi-Organ Failure, Meningitis
Adverse event resulted in: death
Drug(s) suspected as cause:
Ribavirin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Blinded Vaccine
Administration route: Oral
Indication: Prophylaxis
Start date: 2010-12-03
End date: 2010-12-03
Azithromycin
Dosage: .1g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
Cefuroxime
Dosage: .8g per day
Indication: Meningitis
Start date: 2011-07-11
End date: 2011-07-11
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