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Ursodiol (Ursodiol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ursodiol and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (65)
Death (8)
Life Threatening Events (1)
Disability (2)

Reports by Reaction Type

Interstitial Lung Disease (7)Cholestasis (6)Jaundice (5)Nausea (5)Maternal Exposure During Pregnancy (5)Dysmorphism (4)Hepatic Function Abnormal (4)Maternal Drugs Affecting Foetus (4)Bile Duct Stone (4)Foetal Exposure During Pregnancy (4)Liver Disorder (4)Hepatic Fibrosis (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Ursodiol. For a complete list or a specific selection of reports, please use the links above.

Possible Ursodiol side effects in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-24

Patient: 51 year old male

Reactions: Retinal Haemorrhage, Rash

Drug(s) suspected as cause:
Rebetol
    Dosage: 1000 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-02-15

PEG-Intron
    Dosage: 1.5 a?g/kg, unk
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-04-12

Ursodiol
    Dosage: 900 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2010-10-05
    End date: 2012-03-07

Rebetol
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2012-02-23
    End date: 2012-03-14

Rebetol
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-03-15
    End date: 2012-05-23

PEG-Intron
    Dosage: 1 a?g/kg, unk
    Start date: 2012-05-17
    End date: 2012-07-05

PEG-Intron
    Dosage: 0.75 a?g/kg, unk
    Start date: 2012-04-13
    End date: 2012-05-10

Ursodiol
    Dosage: 2250 mg, qd
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-01-24
    End date: 2012-03-28

Ursodiol
    Dosage: 1500 mg, qd
    Administration route: Oral
    Start date: 2012-03-29
    End date: 2012-04-05

Rebetol
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2012-02-16
    End date: 2012-02-22

Rebetol
    Dosage: 600 mg, qd
    Administration route: Oral
    Start date: 2012-05-24
    End date: 2012-07-11

Other drugs received by patient: Youcobal / 00091803 /; Depas; Omeprazole; Calblock; Candesartan Cilexetil; Hyalein; Allopurinol; Halcion; Candesartan Cilexetil; Allopurinol; BIO-Three; Flomox; Rabeprazole Sodium; Rohypnol; Lendormin; Polaramine; Neophagen C; Livostin; Adenosine



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

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient:

Reactions: Hydronephrosis, Palpitations, Forced Expiratory Volume Decreased, Maternal Exposure During Pregnancy, Blood Creatinine Increased

Drug(s) suspected as cause:
Prednisolone

Sulfamethoxazole and Trimethoprim

Sulfonmethane

Ursodiol

Darbepoetin Alfa

Leucovorin Calcium

Azasite

Allopurinol

Calcium Carbonate

Zocor
    Administration route: Oral

Cotazym Capsules
    Administration route: Oral

Colistin

Tacrolimus
    Dosage: 1.5-2 mg

Lansoprazole



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:
Cyclosporine
    Indication: Renal Transplant

Peginterferon Alfa-2B
    Indication: Hepatitis Cholestatic

Ribavirin
    Dosage: 400 mg
    Indication: Hepatitis Cholestatic

Azathioprine
    Indication: Renal Transplant

Ursodiol
    Indication: Liver Function Test Abnormal

Prednisolone
    Indication: Renal Transplant



Possible Ursodiol side effects in 40 year old male

Reported by a physician from Pakistan on 2012-08-01

Patient: 40 year old male

Reactions: Enterococcal Bacteraemia, Hepatitis Cholestatic, Complications of Transplanted Kidney, Hepatitis C, Transplant Rejection, Pancytopenia

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

Interferon Alpha 2A
    Indication: Hepatitis Cholestatic

Azathioprine
    Indication: Renal Transplant

Ribavirin
    Dosage: 400 mg
    Indication: Hepatitis Cholestatic

Ursodiol
    Indication: Liver Function Test Abnormal

Cyclosporine
    Indication: Renal Transplant



Possible Ursodiol side effects in 54 year old female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: 54 year old female, weighing 98.9 kg (217.5 pounds)

Reactions: Pruritus, Nausea, Liver Function Test Abnormal

Drug(s) suspected as cause:
Ursodiol



Possible Ursodiol side effects in 85 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-12

Patient: 85 year old male

Reactions: Rash, Dermatitis Exfoliative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ursodiol

Other drugs received by patient: Clobetasol Propionate; Allegra



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 35 year old female

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

Patient: 35 year old female

Reactions: White Blood Cell Count Abnormal, Platelet Count Abnormal, Maternal Exposure During Pregnancy, Aplasia Pure RED Cell

Drug(s) suspected as cause:
Ursodiol
    Dosage: 600 mg, qd, oral
    Administration route: Oral
    Indication: Cholestasis
    Start date: 2012-04-05
    End date: 2012-05-10

Ursodiol
    Dosage: 600 mg, qd, oral
    Administration route: Oral
    Indication: Cholestasis
    Start date: 2012-01-18
    End date: 2012-02-09

Other drugs received by patient: Prednisolone; Omeprazole; Magmitt (Magnesium Oxide); Ferrous Citrate; Pursennid (Sennoside A+B Calcium)



Possible Ursodiol side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-02

Patient: 57 year old male

Reactions: Malabsorption, Drug Effect Decreased, Hypoglycaemia, Hypokalaemia, Diarrhoea, Interstitial Lung Disease, Cerebral Infarction, Oedema Peripheral, Pancreatitis Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ursodiol
    Dosage: 400 mg, qd, oral
    Administration route: Oral
    Indication: Alcoholic Liver Disease
    Start date: 2011-10-21
    End date: 2011-11-11

Plavix
    Dosage: 75 mg, qd, oral
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2011-11-07
    End date: 2011-11-11

Ozagrel / 01030902 / (Ozagrel Sodium) Unknown
    Dosage: 160 mg, qd, intravenous
    Indication: Cerebral Infarction
    Start date: 2011-11-07
    End date: 2011-11-11

Other drugs received by patient: Diazepam; Aldactone; Foipan (Camostat Mesilate); Lansoprazole; Aspara K / 00466902 / (Aspartate Potassium); Lasix; Berizym / 00517401 / (Enzymes Nos); Elental-P (Nutrients Nos); Phelloberin A / 01786401 / (Berberine Hydrochloride, Geranium Thunbergii



Possible Ursodiol side effects in 36 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-27

Patient: 36 year old female

Reactions: Hepatic Function Abnormal, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ursodiol

Other drugs received by patient: Maglax (Magnesium Oxide)



Possible Ursodiol side effects in 53 year old male

Reported by a pharmacist from United States on 2012-06-04

Patient: 53 year old male, weighing 115.7 kg (254.5 pounds)

Reactions: Nausea, Urticaria, Fall, Muscle Twitching, Tremor, Diarrhoea, Feeling Abnormal, Muscle Spasms, Cough

Drug(s) suspected as cause:
Ursodiol



Possible Ursodiol side effects in 33 year old female

Reported by a health professional (non-physician/pharmacist) from Ireland on 2012-05-29

Patient: 33 year old female

Reactions: Hydronephrosis, Palpitations, Maternal Exposure During Pregnancy, Forced Expiratory Volume Decreased, Blood Creatinine Increased

Drug(s) suspected as cause:
Tacrolimus
    Indication: Product Used FOR Unknown Indication

Prednisolone
    Indication: Product Used FOR Unknown Indication

Pancrelipase
    Indication: Product Used FOR Unknown Indication

Calcium Carbonate
    Indication: Product Used FOR Unknown Indication

Tacrolimus

Darbepoetin Alfa
    Indication: Product Used FOR Unknown Indication

Sulfamethoxazole and Trimethoprim
    Indication: Product Used FOR Unknown Indication

Lansoprazole
    Indication: Product Used FOR Unknown Indication

Leucovorin Calcium
    Indication: Product Used FOR Unknown Indication

Tacrolimus
    Dosage: 1.5-2 mg

Prednisolone

Azithromycin
    Indication: Product Used FOR Unknown Indication

Ursodiol
    Indication: Product Used FOR Unknown Indication

Colistin Sulfomethate
    Indication: Product Used FOR Unknown Indication

Simvastatin
    Indication: Product Used FOR Unknown Indication

Allopurinol
    Indication: Product Used FOR Unknown Indication



Possible Ursodiol side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-18

Patient:

Reactions: Atrial Septal Defect, Brain Malformation, Premature Baby

Drug(s) suspected as cause:
Cyclosporine
    Indication: Foetal Exposure During Pregnancy

Ursodiol
    Indication: Foetal Exposure During Pregnancy

Mycophenolate Mofetil
    Indication: Foetal Exposure During Pregnancy

Prednisone
    Indication: Foetal Exposure During Pregnancy



Possible Ursodiol side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-14

Patient:

Reactions: Atrial Septal Defect, Brain Malformation, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Ursodiol

Cyclosporine

Myfortic
    Dosage: (maternal dose: 1 g/day)

Prednisone TAB

Cellcept
    Dosage: (maternal dose: 1 g/day)



Possible Ursodiol side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-14

Patient:

Reactions: Atrial Septal Defect, Premature Baby, Brain Malformation, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Cellcept
    Dosage: (maternal dose: 1 g/day)

Ursodiol

Cyclosporine

Myfortic
    Dosage: (maternal dose: 1 g/day)

Prednisone



Possible Ursodiol side effects in female

Reported by a individual with unspecified qualification from France on 2012-04-26

Patient: female

Reactions: Maternal Drugs Affecting Foetus, Dysmorphism, Caesarean Section, NO Adverse Event

Drug(s) suspected as cause:
Aspirin
    Dosage: 250 mg, qd, transplacental
    Indication: Foetal Exposure During Pregnancy

Josacine / 00273602 / (Josamycin Propionate)
    Indication: Foetal Exposure During Pregnancy

Cellcept
    Dosage: 250 mg, bid, transplacental
    Indication: Foetal Exposure During Pregnancy

Innohep 1000 (Tinzaparin Sodium) Solution FOR Injection, 10000iu / .5ml
    Dosage: 0.5 mg, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Prograf
    Dosage: 2.5 g, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Pentasa
    Indication: Foetal Exposure During Pregnancy

Ursodiol
    Dosage: 200 mg, qid, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Calcium Carbonate
    Dosage: 1 df, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Prednisolone
    Indication: Foetal Exposure During Pregnancy



Possible Ursodiol side effects in female

Reported by a physician from France on 2012-04-06

Patient: female

Reactions: Dysmorphism

Drug(s) suspected as cause:
Innohep
    Dosage: reported as 10000iu, anti-xa/0.5ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2000-01-01
    End date: 2009-05-15

Calcium Carbonate
    Indication: Product Used FOR Unknown Indication

Ursodiol
    Dosage: 200 mh 4 times daily
    Indication: Product Used FOR Unknown Indication

Mycophenolate Mofetil (Cellcept)
    Dosage: therapy was stopped at 6 week of amenorrhea
    Indication: Liver Transplant

Aspegic 250
    Dosage: started before pregnancy. form powder for oral solution.
    Indication: Product Used FOR Unknown Indication

Prograf
    Dosage: started before pregnancy, frequency: daily
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Pentasa



Possible Ursodiol side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-05

Patient: female

Reactions: Congenital Nose Malformation, Maternal Drugs Affecting Foetus, Caesarean Section, Dysmorphism, Haematoma

Drug(s) suspected as cause:
Ursodiol
    Dosage: 200 mg, qid, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Calcium Carbonate
    Dosage: 1 df, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Innohep
    Dosage: 0.5 mg, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Josacine / 00273602 / (Josamycin Propionate)
    Dosage: transplacental
    Indication: Foetal Exposure During Pregnancy

Pentasa
    Dosage: transplacental
    Indication: Foetal Exposure During Pregnancy

Prograf
    Dosage: 2.5 g, qd, transplacental
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Aspirin
    Dosage: 250 mg, qd, transplacental
    Indication: Foetal Exposure During Pregnancy

Prednisolone
    Dosage: transplacental
    Indication: Foetal Exposure During Pregnancy

Cellcept
    Dosage: 250 mg, bid, transplacental
    Indication: Foetal Exposure During Pregnancy



Possible Ursodiol side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-02

Patient: female

Reactions: Dysmorphism

Drug(s) suspected as cause:
Calcium Carbonate
    Dosage: 1 df, daily
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Innohep
    Dosage: 0.5 ml, unknown/d
    Indication: Foetal Exposure During Pregnancy
    Start date: 2000-01-01
    End date: 2009-05-15

Aspegic 1000
    Dosage: 250 meq/ml, daily
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-01

Ursodiol
    Dosage: 200 mg, qid
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Prograf
    Dosage: 2.5 g , daily
    Indication: Foetal Exposure During Pregnancy
    End date: 2009-05-15

Mycophenolate Mofetil (Cellcept)
    Dosage: 500 mg, daily
    Indication: Foetal Exposure During Pregnancy

Other drugs received by patient: Josamycin; Pentasa



Possible Ursodiol side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-30

Patient: female, weighing 72.6 kg (159.6 pounds)

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Sirolimus
    Dosage: 2 mg, qd
    Administration route: Oral
    Indication: Liver Transplant

Mycophenolate Mofetil
    Dosage: 1000 mg, bid
    Administration route: Oral
    Indication: Liver Transplant
    End date: 2011-06-16

Multi-Vitamins
    Dosage: unk df, unk

Insulin
    Dosage: administered via insulin pump
    Indication: Diabetes Mellitus

Ursodiol
    Dosage: unk df, unk

Tacrolimus
    Dosage: 2 mg, bid
    Administration route: Oral
    Indication: Liver Transplant



Possible Ursodiol side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-28

Patient: 57 year old male

Reactions: Malabsorption, Respiratory Rate Increased, Hypoglycaemia, Pyrexia, Hypoaesthesia, Hypokalaemia, Cerebral Infarction, Interstitial Lung Disease, Diarrhoea, Oedema Peripheral, Pancreatitis Chronic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ursodiol
    Dosage: 400 mg, qd, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-10-21
    End date: 2011-11-11

Ozagrel / 01030902 / (Ozagrel Sodium)
    Dosage: 160 mg, qd, intravenous
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-07
    End date: 2011-11-12

Plavix
    Dosage: 75 mg, qd, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-11-07
    End date: 2011-11-11



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 64 year old female

Reported by a physician from United States on 2012-03-09

Patient: 64 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Impaired Driving Ability, Dysgraphia, Tremor

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Prograf
    Dosage: 1 mg, qd, oral
    Administration route: Oral
    Indication: Transplant
    Start date: 2007-01-01

Cellcept
    Dosage: 500 mg, tid, oral
    Administration route: Oral
    Indication: Transplant
    Start date: 2007-01-01

Prednisone
    Dosage: 5 mg, qd, oral
    Administration route: Oral
    Indication: Transplant
    Start date: 2007-01-01

Ursodiol
    Dosage: 500 mg, bid,oral
    Administration route: Oral
    Indication: Biliary Cirrhosis Primary
    Start date: 2007-01-01

Other drugs received by patient: Amlodipine



Possible Ursodiol side effects in 69 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-03-09

Patient: 69 year old female

Reactions: Rhabdomyolysis, Hypothyroidism, Thyroxine Free Decreased

Drug(s) suspected as cause:
Sermion / 00396401 / (Nicergoline) Unknown, 5MG
    Dosage: 15 mg, oral
    Administration route: Oral
    Indication: Cerebral Infarction
    Start date: 2011-04-06
    End date: 2011-05-25

Ursodiol
    Dosage: 300 mg, qd, oral
    Administration route: Oral
    Indication: Cholelithiasis
    Start date: 2011-10-12



Possible Ursodiol side effects in 62 year old female

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: 62 year old female, weighing 95.3 kg (209.6 pounds)

Reactions: Nausea, Rhinorrhoea

Drug(s) suspected as cause:
Ursodiol

Other drugs received by patient: Vitamin D; Nasonex; Spironolactone; Spiriva; Advair Diskus 100 / 50; Vitamin E; Loratadine; Ventolin; Furosemide; Duoneb



Possible Ursodiol side effects in female

Reported by a pharmacist from United States on 2012-02-27

Patient: female

Reactions: Drug Ineffective, Liver Function Test Abnormal

Drug(s) suspected as cause:
Ursodiol
    Administration route: Oral
    Start date: 2011-01-01

Ursodiol
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Levothyroxine Sodium; Trazodone HCL; Lisinopril; Bupropion HCL; Diltiazem HCL; Bumetanide; Ropinirole



Possible Ursodiol side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-27

Patient: female

Reactions: Fatigue, Influenza Like Illness

Drug(s) suspected as cause:
Ursodiol
    Administration route: Oral
    Indication: Biliary Cirrhosis Primary
    Start date: 2010-01-01

Ursodiol
    Administration route: Oral



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:
Maglax (Magnesium Oxide)
    Dosage: 990 mg, qd, oral
    Administration route: Oral
    Indication: Constipation
    End date: 2012-01-11

Ursodiol
    Dosage: 300 mg, qd, oral
    Administration route: Oral
    Indication: Bile Duct Stone
    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

Diovan
    Dosage: 80 mg, qd, oral
    Administration route: Oral
    Indication: Hypertension
    End date: 2011-01-11



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

Famotidine
    Dosage: 20 mg, qd, oral
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer

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

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