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Ursodiol (Ursodiol) - Hepatic Fibrosis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Hepatic Fibrosis (4)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ursodiol where reactions include hepatic fibrosis. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Ursodiol side effects in 25 year old male

Reported by a physician from Japan on 2012-01-19

Patient: 25 year old male

Reactions: Cholangitis Sclerosing, Hepatic Fibrosis, Metastases To Liver, Colitis Ulcerative, Condition Aggravated, Bile Duct Cancer, Metastases To Lymph Nodes, Dilatation Intrahepatic Duct Acquired, Bile Duct Stenosis, Cholecystitis, Metastases To Lung

Adverse event resulted in: death

Drug(s) suspected as cause:
Prednisolone
    Dosage: 5 mg qd
    Indication: Colitis Ulcerative

Ursodiol
    Dosage: 600 mg, qd
    Indication: Cholangitis



Possible Ursodiol side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-05

Patient:

Reactions: Portal Hypertension, Renal Impairment, Hepatic Neoplasm Malignant, Hepatic Fibrosis, Hepatic Atrophy, Portal Vein Thrombosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Ursodiol



Possible Ursodiol side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-05

Patient:

Reactions: Portal Hypertension, Gastrointestinal Haemorrhage, Shock Haemorrhagic, Hepatic Failure, Gastric Ulcer, Cerebral Haemorrhage, Haemodynamic Instability, Hepatitis Cholestatic, Oesophagitis, Truncus Coeliacus Thrombosis, Metabolic Acidosis, Cholecystitis Infective, Neurological Decompensation, Hepatic Fibrosis, Pancytopenia, Ascites, Renal Failure, Respiratory Failure, Sepsis, Oliguria, Cytomegalovirus Infection, Bone Marrow Toxicity, Infectious Peritonitis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ursodiol
    Dosage: oral
    Administration route: Oral
    Indication: Cholestasis
    Start date: 2011-07-01
    End date: 2011-08-23

Azathioprine
    Dosage: 125 mg, qd, oral
    Administration route: Oral
    Indication: Autoimmune Hepatitis
    Start date: 2011-07-01
    End date: 2011-08-23

Other drugs received by patient: Prednisone



Possible Ursodiol side effects in 58 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2011-11-09

Patient: 58 year old male

Reactions: Antinuclear Antibody Positive, Smooth Muscle Antibody Positive, Autoimmune Hepatitis, Hepatic Fibrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ezetimibe
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-01

Ezetimibe
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Ursodiol
    Indication: Autoimmune Hepatitis
    Start date: 2009-01-01

Atorvastatin Calcium
    Dosage: 40 mg, qd,
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-01-01
    End date: 2007-12-01

Enalapril Maleate
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Glimepiride
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-01-01
    End date: 2007-12-01

Doxazosin Mesylate
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-01

Enalapril Maleate and Hydrochlorothiazide
    Dosage: 20 + 12.5 mg, qd,
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-01-01
    End date: 2007-12-01

Metformin HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-01

Amlodipine
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-07-01

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