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Ursodiol (Ursodiol) - Cholestasis - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Cholestasis (6)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ursodiol where reactions include cholestasis. 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 health professional (non-physician/pharmacist) from Pakistan on 2012-08-01

Patient: 25 year old male

Reactions: Graft Dysfunction, Diarrhoea, Hepatitis C, Urinary Tract Infection, Cholestasis, Pancytopenia, Varices Oesophageal

Drug(s) suspected as cause:
Azathioprine
    Indication: Renal Transplant

Cyclosporine
    Indication: Renal Transplant

Peginterferon Alfa-2B
    Indication: Hepatitis Cholestatic

Prednisolone
    Indication: Renal Transplant

Ribavirin
    Dosage: 400 mg
    Indication: Hepatitis Cholestatic

Ursodiol
    Indication: Liver Function Test Abnormal



Possible Ursodiol side effects in 59 year old male

Reported by a physician from Japan on 2012-02-21

Patient: 59 year old male

Reactions: Jaundice, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Alanine Aminotransferase Increased, Urticaria, Biopsy Liver Abnormal, Cholestasis, Prothrombin Time Prolonged, Lymphocyte Stimulation Test Positive, Rash Pruritic, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Famotidine
    Dosage: 20 mg, qd, oral
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer

Ursodiol
    Dosage: 600 mg, qd, oral
    Administration route: Oral
    Indication: Cholestasis
    Start date: 2011-05-13
    End date: 2011-05-30

Other drugs received by patient: Rabeprazole Sodium; Panabate (Gabexate Mesilate); Wystal (Cefoperazone Sodium, Sulbactam Sodium)



Possible Ursodiol side effects in male

Reported by a physician from Japan on 2012-02-01

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Cholestasis, Prothrombin Time Prolonged, Liver Disorder, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Famotidine
    Dosage: oral
    Administration route: Oral
    Indication: Bile Duct Stone

Ursodiol
    Dosage: oral
    Administration route: Oral
    Indication: Bile Duct Stone



Possible Ursodiol side effects in male

Reported by a physician from Japan on 2012-01-20

Patient: male

Reactions: Jaundice, Bile Duct Stone, Urticaria, Cholestasis, Liver Disorder

Drug(s) suspected as cause:
Fresh Frozen Plasma
    Dosage: 6 units;qd

Pepcid

Ursodiol



Possible Ursodiol side effects in 34 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2011-11-22

Patient: 34 year old female

Reactions: Maternal Drugs Affecting Foetus, Pruritus, Anaemia, Condition Aggravated, Cholestasis, Varices Oesophageal, Premature Labour, Foetal Growth Restriction, Premature Rupture of Membranes, Post Procedural Haemorrhage, Breech Presentation, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ursodiol



Possible Ursodiol side effects in 70 year old female

Reported by a physician from France on 2011-10-24

Patient: 70 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Portal Hypertension, Antimitochondrial Antibody Positive, Biliary Cirrhosis, Cholestasis, Treatment Failure, Disease Progression

Drug(s) suspected as cause:
Ursodiol

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