Index of reports
> Cases with Liver Disorder (4)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ursodiol where reactions include liver disorder. The selected reports were submitted to the FDA during the sample period of about a year.
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 91 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-02-21
Patient: 91 year old female
Reactions: Jaundice, Bile Duct Stone, Cholangitis Suppurative, Condition Aggravated, Hypoprothrombinaemia, Liver Disorder, Bile Duct Stenosis, Deficiency of Bile Secretion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diovan
Dosage: 80 mg, qd, oral
Administration route: Oral
Indication: Hypertension
End date: 2011-01-11
Maglax (Magnesium Oxide)
Dosage: 990 mg, qd, oral
Administration route: Oral
Indication: Constipation
End date: 2012-01-11
Thiaton (Tiquizium Bromide)
Dosage: 30 mg, qd, oral
Administration route: Oral
Indication: Bile Duct Stone
End date: 2012-01-11
Ursodiol
Dosage: 300 mg, qd, oral
Administration route: Oral
Indication: Bile Duct Stone
End date: 2012-01-11
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
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