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

 
 



Index of reports > Death (8)

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

Possible Ursodiol side effects in 66 year old male

Reported by a physician from France on 2012-08-10

Patient: 66 year old male

Reactions: Multi-Organ Failure, Thrombotic Microangiopathy

Adverse event resulted in: death

Drug(s) suspected as cause:
Solu-Medrol
    Indication: Immunosuppression

Heparin Calcium
    Indication: Prophylaxis
    End date: 2012-03-21

Plitican
    Indication: Prophylaxis
    Start date: 2012-03-14
    End date: 2012-03-19

Sulfamethoxazole and Trimethoprim
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-04-05

Sandimmune
    Indication: Prophylaxis
    Start date: 2012-01-23

Vfend
    Indication: Prophylaxis

Ursodiol
    Administration route: Oral
    Indication: Cholestasis

Nicardipine HCL
    Administration route: Oral
    Indication: Hypertension
    End date: 2012-04-15

Omeprazole
    Indication: Prophylaxis

Zolpidem Tartrate
    Administration route: Oral
    Indication: Insomnia
    End date: 2012-03-18

Folic Acid
    Indication: Vitamin B12 Deficiency
    End date: 2012-04-05

Phenoxymethyl Penicillin
    Dosage: 2 m iu daily
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2012-03-22

Tiorfan
    Administration route: Oral
    Indication: Prophylaxis Against Diarrhoea
    End date: 2012-04-25

Levothyroxine Sodium
    Indication: Hypothyroidism

Valganciclovir
    Indication: Prophylaxis
    Start date: 2012-03-10
    End date: 2012-03-16

Albumin (Human)
    End date: 2012-03-06

Effexor
    Start date: 2012-03-13
    End date: 2012-03-22

Clorazepate Dipotassium
    Dosage: unknown dose daily
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-13
    End date: 2012-03-16

Other drugs received by patient: Idarubicin HCL; Vidaza; Cytarabine



Possible Ursodiol side effects in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-09

Patient: 51 year old male

Reactions: Hepatitis Cholestatic, Drug Ineffective, Neoplasm Malignant, Vertigo, Gait Disturbance

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Prednisolone
    Indication: Liver Injury

Ursodiol
    Indication: Liver Injury

Silymarin
    Indication: Liver Injury



Possible Ursodiol side effects in 40 year old

Reported by a consumer/non-health professional from Brazil on 2012-03-14

Patient: 40 year old

Reactions: Multi-Organ Failure, Hypotension, Drug Administration Error, Hepatitis, Hepatic Cirrhosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ursodiol
    Dosage: 300 mg, per oral
    Administration route: Oral
    Indication: Hepatitis
    Start date: 2012-01-01

Amlodipine Besylate and Olmesartan Medoxomil
    Dosage: 40/10; 20/5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-01-01

Amlodipine Besylate and Olmesartan Medoxomil
    Dosage: 40/10; 20/5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-01-01

Other drugs received by patient: Propranolol; Iron (Iii) Glucinate / Vitamin B12 / Vitamin B5vitamin B3vitamin B1 / Vitami; Spironolactone



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 male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-01-10

Patient: male

Reactions: Hepatic Failure, Metastases To Lymph Nodes, Hepatic Neoplasm Malignant Recurrent, Mixed Hepatocellular Cholangiocarcinoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Ursodiol



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 47 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-07

Patient: 47 year old male

Reactions: Lymphocyte Stimulation Test Positive, Hepatitis

Adverse event resulted in: death

Drug(s) suspected as cause:
Ursodiol
    Dosage: 600 mg, qd, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-03-31
    End date: 2011-01-01

Lebenin (Lactobacillus Acidophilus, Lactobacillus Bifidus, Lyophilized
    Dosage: 3 df, qd, oral
    Administration route: Oral
    Indication: Gastrointestinal Disorder
    Start date: 2011-03-31
    End date: 2011-06-12

Other drugs received by patient: Aminoleban EN (Alanine, Aminoacetic Acid, Arginine Hydrochloride, Isol; Spironolactone; Rabeprazole Sodium; Livact / 00847901 / (Isoleucine, Leucine, Valine)

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