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Index of reports
> Cases with Acute Respiratory Distress Syndrome ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to PEG-Intron (Peginterferon Alfa-2B) where reactions include acute respiratory distress syndrome. The selected reports were submitted to the FDA during the sample period of about a year.
Possible PEG-Intron side effects in
Reported by a individual with unspecified qualification from France on 2012-08-10
Patient:
Reactions: Interstitial Lung Disease, Sepsis, Acute Respiratory Distress Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 50 ?g, qw
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-05-01
Placebo
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-06-01
Blinded Post Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Blinded PRE Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Blinded Post Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Blinded Post Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-06-01
Ribavirin
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Placebo
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Ribavirin
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-06-01
Peginterferon Alfa-2B
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-06-01
Blinded PRE Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-26
End date: 2011-06-01
Blinded PRE Trial Therapy
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Peginterferon Alfa-2B
Dosage: 1000 mg, qd
Administration route: Oral
Start date: 2010-01-26
End date: 2011-06-01
Other drugs received by patient: Prilosec; Dihydroergotamine Mesylate; Cyanocobalamin; Neorecormon; Propranolol Hydrochloride
Possible PEG-Intron side effects in
Reported by a physician from United States on 2012-07-24
Patient:
Reactions: Acute Respiratory Distress Syndrome
Drug(s) suspected as cause:
PEG-Intron
Dosage: unk, qw
Indication: Hepatitis C
Start date: 2012-01-01
PEG-Intron
Dosage: unk, qw
Start date: 2012-02-01
Other drugs received by patient: Rebetol; Procrit
Possible PEG-Intron side effects in 65 year old male
Reported by a physician from Japan on 2012-06-04
Patient: 65 year old male, weighing 67.0 kg (147.4 pounds)
Reactions: White Blood Cell Count Decreased, Drug Eruption, Pruritus, Nausea, Headache, Rash, Haemoglobin Decreased, Malaise, Fatigue, Acute Respiratory Distress Syndrome
Drug(s) suspected as cause:
PEG-Intron
Dosage: 1.5 mcg/kg;qw;sc
Indication: Hepatitis C
Start date: 2012-02-16
Telavic (Antivirals Nos)
Dosage: 2250 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-16
End date: 2012-04-26
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-03-16
End date: 2012-04-04
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-16
End date: 2012-03-15
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-04-05
Other drugs received by patient: Lendormin; Amlodipine; Prednisolone; Glimerpride; Lansoprazole; Rikkunshi-TO; Olopatadine HCL; Primperan TAB; Citicoline; Nizoral Cream
Possible PEG-Intron side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-05-31
Patient: 59 year old female
Reactions: Jaundice, White Blood Cell Count Decreased, Dyspnoea, Haematuria, Anaemia, Transfusion Reaction, Oesophageal Varices Haemorrhage, Activated Partial Thromboplastin Time Shortened, Acute Respiratory Distress Syndrome, Platelet Count Decreased, Oedema, Bradycardia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 100 mcg;qw;sc
Indication: Hepatitis C
Start date: 2012-03-28
End date: 2012-05-16
Ribavirin
Dosage: 200 mg;tid;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-03-28
End date: 2012-05-16
Victrelis
Dosage: 800 mg;tid
Indication: Hepatitis C
Start date: 2012-05-02
End date: 2012-05-16
Other drugs received by patient: Spironolactone; Levothyroxine Sodium; Propranolol
Possible PEG-Intron side effects in 65 year old male
Reported by a physician from Japan on 2012-05-30
Patient: 65 year old male, weighing 67.0 kg (147.4 pounds)
Reactions: White Blood Cell Count Decreased, Drug Eruption, Pruritus, Nausea, Rash, Headache, Haemoglobin Decreased, Fatigue, Malaise, Acute Respiratory Distress Syndrome
Drug(s) suspected as cause:
Telavic (Antivirals Nos)
Dosage: 2250 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-16
End date: 2012-04-26
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-03-16
End date: 2012-04-04
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-04-05
Rebetol
Dosage: 800 mg;qd;po 600 mg;qd;po 400 mg;qd;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2012-02-16
End date: 2012-03-15
PEG-Intron
Dosage: 1.5 mcg/kg;qw;sc
Indication: Hepatitis C
Start date: 2012-02-16
Other drugs received by patient: Lendormin; Nizoral Cream; Olopatadine HCL; Primperan TAB; Glimepiride; Prednisolone; Amlodipine; Citicoline; Lansoprazole; Rikkunshi-TO
Possible PEG-Intron side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-05-30
Patient: 59 year old female
Reactions: Anaemia, Haematuria, Acute Respiratory Distress Syndrome, Bradycardia, Oesophageal Varices Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-09
End date: 2012-05-16
Ribavirin
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-02
End date: 2012-05-16
Victrelis
Dosage: 800 mg;tid;
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-02
End date: 2012-05-16
Possible PEG-Intron side effects in 5 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-09
Patient: 5 year old male, weighing 32.5 kg (71.5 pounds)
Reactions: Renal Tubular Disorder, Dyskinesia, Disseminated Intravascular Coagulation, Petechiae, Hepatic Failure, Mental Status Changes, Coma, Headache, Pyrexia, Lactic Acidosis, Urine Output Increased, Generalised Oedema, Malaise, Acute Respiratory Distress Syndrome, Pulmonary Oedema, Electrolyte Imbalance, Vomiting, International Normalised Ratio Increased, Respiratory Distress, Tremor, Nephrogenic Diabetes Insipidus, Convulsion, Renal Failure, Product Packaging Issue, Mitochondrial Toxicity, Depressed Level of Consciousness, Rash Maculo-Papular, Multi-Organ Disorder, Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Acetaminophen
Dosage: 445 mg;once;rtl
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-07
Acetaminophen
Dosage: 400 mg;once ; 400 mg;once
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-07
Acetaminophen
Dosage: 400 mg;once ; 400 mg;once
Indication: Product Used FOR Unknown Indication
Start date: 2010-01-07
PEG-Intron
Dosage: 64 mcg;sc
Indication: Hepatitis C
Start date: 2010-01-07
End date: 2010-01-07
Rebetol
Dosage: 240 mg;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2010-01-07
End date: 2010-01-07
Possible PEG-Intron side effects in 40 year old male
Reported by a physician from Taiwan, Province of China on 2012-02-07
Patient: 40 year old male
Reactions: Incorrect Route of Drug Administration, Acute Respiratory Distress Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
PEG-Intron
Dosage: 100 mcg;qw;im ; 100 mcg;qw;im ; 100 mcg;qw;im
Indication: Hepatitis C
Start date: 2011-12-21
End date: 2011-12-21
PEG-Intron
Dosage: 100 mcg;qw;im ; 100 mcg;qw;im ; 100 mcg;qw;im
Indication: Hepatitis C
Start date: 2011-12-08
End date: 2011-12-08
PEG-Intron
Dosage: 100 mcg;qw;im ; 100 mcg;qw;im ; 100 mcg;qw;im
Indication: Hepatitis C
Start date: 2011-12-15
End date: 2011-12-15
Rebetol
Dosage: 200 mg;bid;po
Administration route: Oral
Indication: Hepatitis C
Start date: 2011-12-08
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