URSODIOL Side Effects

7020418-0 | Abscess Intestinal, Anorexia Nervosa, Asperger's Disorder, Convulsion, Crohn's Disease, Device Related Infection, Gastric Ulcer Helicobacter, Gastritis Erosive
on Sep 16, 2010 Female patient from JAPAN , 13 years of age, was diagnosed with crohn's disease (What is crohn's disease?) and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: abscess intestinal, anorexia nervosa, asperger's disorder, convulsion, crohn's disease (What is crohn's disease?), device related infection, gastric ulcer helicobacter, gastritis erosive. Ursodiol dosage: Oral. During the same period patient was treated with REMICADE (150 Mg Intravenous Drip) (View Remicade Review and Remicade Label ), IMURAN (1 Mg/kg, 0.5 Mg/kg Oral) (View Imuran Review and Imuran Label ), PREDNISOLONE (30 Mg, 20 Mg, 25 Mg, 15 Mg, 10 Mg, 5 Mg Oral) (View Prednisolone Review and Prednisolone Label ).

7019827-5 | Condition Aggravated, Interstitial Lung Disease
Patient was taking Ursodiol (View Usage). Patient had the following side effects: condition aggravated, interstitial lung disease on Sep 15, 2010 from JAPAN Additional patient health information: Male patient , 61 years of age, was diagnosed with hepatic function abnormal, hepatitis c (What is hepatitis c?), liver disorder and. Ursodiol dosage: 300mg Oral ; 600mg.

6985145-4 | Interstitial Lung Disease, Musculoskeletal Disorder
Adverse event was reported on Sep 02, 2010 by a Female patient taking Ursodiol (View Usage) (Dosage: 300mg Oral) was diagnosed with hepatic function abnormal and. Location: JAPAN , 83 years of age, After Ursodiol was administered, patient had the following side effects: interstitial lung disease, musculoskeletal disorder. During the same period patient was treated with ASPARA K (L ASPARTATE POTASSIUM) (View Aspara K (l-aspartate Potassium) Review and Aspara K (l-aspartate Potassium) Label ), MAGMITT (MAGNESIUM OXIDE) (View Magmitt (magnesium Oxide) Review and Magmitt (magnesium Oxide) Label ), PRORENAL (LIMAPROST ALFADEX) (View Prorenal (limaprost Alfadex) Review and Prorenal (limaprost Alfadex) Label ), VERAPAMIL HYDROCHLORIDE (View Verapamil Hydrochloride Review and Verapamil Hydrochloride Label ), DIGOXIN (View Digoxin Review and Digoxin Label ), ONEALFA (ALFACALCIDOL) (View Onealfa (alfacalcidol) Review and Onealfa (alfacalcidol) Label ), MUCOSTA (REBAMIPIDE) (View Mucosta (rebamipide) Review and Mucosta (rebamipide) Label ), METHYLCOBAL (MECOBALAMIN) (View Methylcobal (mecobalamin) Review and Methylcobal (mecobalamin) Label ). Patient was hospitalized.

6967525-6 | Bone Disorder, Interstitial Lung Disease, Musculoskeletal Disorder
on Aug 23, 2010 Female patient from JAPAN , 83 years of age, was diagnosed with hepatic function abnormal, neurosis and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: bone disorder, interstitial lung disease, musculoskeletal disorder. Ursodiol dosage: 300 Mg, Oral. During the same period patient was treated with DEPAS (ETIZOLAM) (1.5mg, Oral) (View Depas (etizolam) Review and Depas (etizolam) Label ), ASPARA K (L ASPARTATE POTASSIUM) (View Aspara K (l-aspartate Potassium) Review and Aspara K (l-aspartate Potassium) Label ), MAGMITT (MAGNESIUM OXIDE) (View Magmitt (magnesium Oxide) Review and Magmitt (magnesium Oxide) Label ), PRORENAL (LIMAPROST ALFADEX) (View Prorenal (limaprost Alfadex) Review and Prorenal (limaprost Alfadex) Label ), VERAPAMIL HYDROCHLORIDE (View Verapamil Hydrochloride Review and Verapamil Hydrochloride Label ), DIGOXIN (View Digoxin Review and Digoxin Label ), ONEALFA (ALFACALCIDOL) (View Onealfa (alfacalcidol) Review and Onealfa (alfacalcidol) Label ), MUCOSTA (REBAMIPIDE) (View Mucosta (rebamipide) Review and Mucosta (rebamipide) Label ). Patient was hospitalized.


6929092-2 | Systemic Lupus Erythematosus
on Aug 02, 2010 Female patient from JAPAN , 56 years of age, was diagnosed with autoimmune hepatitis, arthralgia, prophylaxis and was treated with Ursodiol (View Usage). Patient had the following side effects: systemic lupus erythematosus. Ursodiol dosage: 600mg Oral. During the same period patient was treated with ALPROSTADIL (Intravenous Drip) (View Alprostadil Review and Alprostadil Label ), GABAPENTIN (600 Mg Oral) (View Gabapentin Review and Gabapentin Label ), CELECOXIB (400 Mg Oral) (View Celecoxib Review and Celecoxib Label ), LANSOPRAZOLE (15 Mg Oral) (View Lansoprazole Review and Lansoprazole Label ), LIPITOR (View Lipitor Review and Lipitor Label ), LOSARTAN POTASSIUM (View Losartan Potassium Review and Losartan Potassium Label ), DIAZEPAM (View Diazepam Review and Diazepam Label ). Patient was hospitalized.

6929091-0 | Cerebral Artery Stenosis, Transient Ischaemic Attack
Patient was taking Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: cerebral artery stenosis, transient ischaemic attack on Aug 05, 2010 from JAPAN Additional patient health information: Male patient , 67 years of age, was diagnosed with hepatitis c (What is hepatitis c?), liver disorder and. Ursodiol dosage: 600mg Oral. Patient was hospitalized.

6924314-6 | Dysuria, Eye Pruritus, Mood Swings
Adverse event was reported on Aug 11, 2010 by a Female patient taking Ursodiol (View Usage) (Dosage: 3x Day) was diagnosed with biliary cirrhosis primary and. Location: UNITED STATES , 63 years of age, weighting 117.0 lb, Patient experienced the following unwanted or unexpected effects: dysuria, eye pruritus, mood swings.

6915562-X | Chromaturia, Jaundice
on Jul 28, 2010 Female patient from JAPAN , 70 years of age, was diagnosed with hepatitis c (What is hepatitis c?) and was treated with Ursodiol (View Usage). Patient had the following side effects: chromaturia, jaundice (What is jaundice?). Ursodiol dosage: 1200 Mg. During the same period patient was treated with LOSARTAN POTASSIUM (View Losartan Potassium Review and Losartan Potassium Label ), ALDACTONE (View Aldactone Review and Aldactone Label ), LIVACT (ISOLEUCINE, LEUCINE, VALINE) (View Livact (isoleucine, Leucine, Valine) Review and Livact (isoleucine, Leucine, Valine) Label ).

6896953-2 | Chromaturia, Jaundice
on Jul 14, 2010 Female patient from JAPAN , 70 years of age, was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: chromaturia, jaundice (What is jaundice?). Ursodiol dosage: 1200 Mg. During the same period patient was treated with LOSARTAN POTASSIUM (View Losartan Potassium Review and Losartan Potassium Label ), SPIRONOLACTONE (View Spironolactone Review and Spironolactone Label ), ISOLEUCINE/LEUCINE/VALINE (View Isoleucine/leucine/valine Review and Isoleucine/leucine/valine Label ).

6896928-3 | Asthma, Atrial Fibrillation, Portal Vein Thrombosis, Splenic Vein Thrombosis
Patient was taking Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: asthma (What is asthma?), atrial fibrillation (What is atrial fibrillation?), portal vein thrombosis, splenic vein thrombosis on Jul 23, 2010 from JAPAN Additional patient health information: Female patient , 46 years of age, was diagnosed with hepatitis c (What is hepatitis c?) and. Ursodiol dosage: 600mg Qd Oral. During the same period patient was treated with PROTECADIN (LAFUTIDINE) (View Protecadin (lafutidine) Review and Protecadin (lafutidine) Label ), CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label ), AMOXICILLIN (View Amoxicillin Review and Amoxicillin Label ), PARIET (SODIUM RABEPRAZOLE) (View Pariet (sodium Rabeprazole) Review and Pariet (sodium Rabeprazole) Label ), ISOTONIC SODIUM CHLORIDE SOLUTION (ISOTONIC SODIUM CHLORIDE SOLUTION) (View Isotonic Sodium Chloride Solution (isotonic Sodium Chloride Solution) Review and Isotonic Sodium Chloride Solution (isotonic Sodium Chloride Solution) Label ), DIAGNOGREEN (INDOCYANINE GREEN) (View Diagnogreen (indocyanine Green) Review and Diagnogreen (indocyanine Green) Label ), LAXOBERON (SODIUM PICOSULFATE) (View Laxoberon (sodium Picosulfate) Review and Laxoberon (sodium Picosulfate) Label ), LAC B (BIFIDOBACTERIUM) (View Lac-b (bifidobacterium) Review and Lac-b (bifidobacterium) Label ).

6863121-X | Toxic Epidermal Necrolysis
Adverse event was reported on Jul 09, 2010 by a Male patient taking Ursodiol (View Usage) (Dosage: ) was diagnosed with hepatic cirrhosis and. Location: JAPAN , 66 years of age, weighting 119.0 lb, Patient had the following side effects: toxic epidermal necrolysis. During the same period patient was treated with LASIX (View Lasix Review and Lasix Label ), EVAMYL (View Evamyl Review and Evamyl Label ), EURODIN (View Eurodin Review and Eurodin Label ), SERENACE (View Serenace Review and Serenace Label ), TAGAMET (View Tagamet Review and Tagamet Label ), OPALMON (View Opalmon Review and Opalmon Label ), ALDACTONE (View Aldactone Review and Aldactone Label ), LOXONIN (View Loxonin Review and Loxonin Label ). Patient was hospitalized.

6861316-2 | Interstitial Lung Disease
on Jul 07, 2010 Male patient from JAPAN , 62 years of age, was diagnosed with hepatic function abnormal, hepatitis c (What is hepatitis c?), liver disorder and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: interstitial lung disease. Ursodiol dosage: 300mg Oral, 600mg Oral.

6832134-6 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatine Phosphokinase Increased, Cardiac Failure, Chromaturia, Coma, Convulsion, Haemodialysis, Myoglobin Blood Increased
on Jun 20, 2010 Male patient from JAPAN , 74 years of age, was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, cardiac failure, chromaturia, coma, convulsion, haemodialysis, myoglobin blood increased. Ursodiol dosage: 300 Mg, Oral. During the same period patient was treated with DEPAS (ETIZOLAM) (Oral) (View Depas (etizolam) Review and Depas (etizolam) Label ), PABRON (BROMHEXINE HYDROCHLORIDE ETC) (View Pabron (bromhexine Hydrochloride Etc) Review and Pabron (bromhexine Hydrochloride Etc) Label ), BEZATOL SR (BEZAFIBRATE) (View Bezatol Sr (bezafibrate) Review and Bezatol Sr (bezafibrate) Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ). Patient was hospitalized.

6785167-2 | Blood Creatine Phosphokinase Increased, Cardiac Failure, Coma, Convulsion, Haemodialysis
Patient was taking Ursodiol (View Usage). Patient had the following side effects: blood creatine phosphokinase increased, cardiac failure, coma, convulsion, haemodialysis on Jun 09, 2010 from JAPAN Additional patient health information: Male patient , 74 years of age, . Ursodiol dosage: 300mg, Oral. During the same period patient was treated with DEPAS (ETILOZAM) (Oral) (View Depas (etilozam) Review and Depas (etilozam) Label ), PABRON (BROMHEXINE HYDROCHLORIDE ETC) (View Pabron (bromhexine Hydrochloride Etc) Review and Pabron (bromhexine Hydrochloride Etc) Label ), BEZATOL SR (BEZAFIBRATE) (View Bezatol Sr (bezafibrate) Review and Bezatol Sr (bezafibrate) Label ), FAMOTIDINE (View Famotidine Review and Famotidine Label ). Patient was hospitalized.

6785102-7 | International Normalised Ratio Increased
Adverse event was reported on Jun 14, 2010 by a Female patient taking Ursodiol (View Usage) (Dosage: 300 Mg Oral) was diagnosed with biliary tract infection viral, cardiac valve prosthesis user and. Location: ITALY , 42 years of age, After Ursodiol was administered, patient had the following side effects: international normalised ratio increased. During the same period patient was treated with COUMADIN (31.25 Mg Weekly Oral) (View Coumadin Review and Coumadin Label ), CEFIXIME (400 Mg Oral) (View Cefixime Review and Cefixime Label ), BISOPROLOL FUMARATE (View Bisoprolol Fumarate Review and Bisoprolol Fumarate Label ), LASIX (View Lasix Review and Lasix Label ), OMEPRAZEN (OMEPRAZOLE) (View Omeprazen (omeprazole) Review and Omeprazen (omeprazole) Label ).

6784320-1 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Thyroiditis Subacute
on Jun 10, 2010 Female patient from JAPAN , 49 years of age, was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, thyroiditis subacute. Ursodiol dosage: 600 Mg, Oral.

6761435-5 | Agranulocytosis, Autoimmune Hepatitis, Escherichia Urinary Tract Infection, Hypocalcaemia, Urinary Tract Infection Enterococcal
on May 28, 2010 Female patient from FRANCE , 59 years of age, was diagnosed with hepatitis cholestatic, prothrombin time, hypocalcaemia and was treated with Ursodiol (View Usage). Patient had the following side effects: agranulocytosis, autoimmune hepatitis, escherichia urinary tract infection, hypocalcaemia, urinary tract infection enterococcal. Ursodiol dosage: 250mg Tid, Oral; 1-6 Days. During the same period patient was treated with VITAMIN K1 (20mg Qd, Oral; 2- 6 Dfays) (View Vitamin K1 Review and Vitamin K1 Label ), CACIT D3 (CALCIUM CARBONATE/ CHOLECALCIFEROL) (1 Df Qd, Oral; 3-6 Days) (View Cacit D3 (calcium Carbonate/ Cholecalciferol) Review and Cacit D3 (calcium Carbonate/ Cholecalciferol) Label ), LEVOTHYROXINE SODIUM (View Levothyroxine Sodium Review and Levothyroxine Sodium Label ).

6755691-7 | Renal Disorder
Patient was taking Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: renal disorder on May 25, 2010 from JAPAN Additional patient health information: Male patient , 84 years of age, was diagnosed with cholelithiasis, reflux oesophagitis, gingivitis and. Ursodiol dosage: 300 Mg, Oral. During the same period patient was treated with OMEPRAZOLE (20 Mg, Oral) (View Omeprazole Review and Omeprazole Label ), ACETAMINOPHEN (300 Mg, Oral) (View Acetaminophen Review and Acetaminophen Label ), FLOMOX (CEFCAPENE PIVOXIL HYDROCHLORIDE) (300 Mg, Oral) (View Flomox (cefcapene Pivoxil Hydrochloride) Review and Flomox (cefcapene Pivoxil Hydrochloride) Label ).

6755562-6 | Pemphigoid
Adverse event was reported on May 20, 2010 by a Female patient taking Ursodiol (View Usage) (Dosage: 100 Mg Oral) was diagnosed with hepatic function abnormal, reflux oesophagitis and. Location: JAPAN , 81 years of age, Patient experienced the following unwanted or unexpected effects: pemphigoid. During the same period patient was treated with GASMOTIN (MOSAPRIDE CITRATE) (15 Mg Oral) (View Gasmotin (mosapride Citrate) Review and Gasmotin (mosapride Citrate) Label ), PARIET (SODIUM RABEPRAZOLE) (10mg Oral) (View Pariet (sodium Rabeprazole) Review and Pariet (sodium Rabeprazole) Label ). Patient was hospitalized.

6746303-7 | Renal Disorder
on May 19, 2010 Male patient from JAPAN , 84 years of age, was diagnosed with cholelithiasis, reflux oesophagitis, gingivitis and was treated with Ursodiol (View Usage). Patient had the following side effects: renal disorder. Ursodiol dosage: 300 Mg Oral. During the same period patient was treated with OMEPRAZOLE (20 Mg Oral) (View Omeprazole Review and Omeprazole Label ), ACETAMINOPHEN (300 Mg, Oral) (View Acetaminophen Review and Acetaminophen Label ), FLOMOX (CEFCAPENE PIVOXIL HYDROCHLORIDE) (300 Mg, Oral) (View Flomox (cefcapene Pivoxil Hydrochloride) Review and Flomox (cefcapene Pivoxil Hydrochloride) Label ).

6700833-2 | Asthma, Atrial Fibrillation, Portal Vein Thrombosis, Splenic Vein Thrombosis
on Apr 19, 2010 Female patient from JAPAN , 46 years of age, was diagnosed with liver disorder and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: asthma (What is asthma?), atrial fibrillation (What is atrial fibrillation?), portal vein thrombosis, splenic vein thrombosis. Ursodiol dosage: 600mg Qd Oral. During the same period patient was treated with PROTECADIN (LAFUTIDINE) (View Protecadin (lafutidine) Review and Protecadin (lafutidine) Label ), CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label ), AMOXICILLIN (View Amoxicillin Review and Amoxicillin Label ), PARIET (SODIUM RABEPRAZOLE) (View Pariet (sodium Rabeprazole) Review and Pariet (sodium Rabeprazole) Label ), ISOTONIC SODIUM CHLORIDE SOLUTION (ISOTONIC SODIUM CHLORIDE SOLUTION) (View Isotonic Sodium Chloride Solution (isotonic Sodium Chloride Solution) Review and Isotonic Sodium Chloride Solution (isotonic Sodium Chloride Solution) Label ), DIAGNOGREEN (INDOCYANINE GREEN) (View Diagnogreen (indocyanine Green) Review and Diagnogreen (indocyanine Green) Label ), LAXOBERON (SODIUM PICOSULFATE) (View Laxoberon (sodium Picosulfate) Review and Laxoberon (sodium Picosulfate) Label ), LAC B (BIFIDOBACTERIUM) (View Lac-b (bifidobacterium) Review and Lac-b (bifidobacterium) Label ).

6700819-8 | Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Thyroiditis Subacute
Patient was taking Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, aspartate aminotransferase increased, thyroiditis subacute on Apr 20, 2010 from JAPAN Additional patient health information: Female patient , 49 years of age, was diagnosed with liver disorder and. Ursodiol dosage: 600mg Oral.

6700818-6 | Coagulation Factor Vii Level Decreased, Coagulation Factor X Level Decreased, Diarrhoea, Dyspepsia, Prothrombin Level Decreased, Vitamin K Deficiency
Adverse event was reported on Apr 19, 2010 by a Male patient taking Ursodiol (View Usage) (Dosage: 200 Mg, Oral) . Location: FRANCE , 58 years of age, Patient had the following side effects: coagulation factor vii level decreased, coagulation factor x level decreased, diarrhoea, dyspepsia, prothrombin level decreased, vitamin k deficiency. During the same period patient was treated with SOMATULINE LP 120MG (LANREOTIDE) (120 Mg, Intramuscular) (View Somatuline Lp 120mg (lanreotide) Review and Somatuline Lp 120mg (lanreotide) Label ), CREON (25,000 Iu) (View Creon Review and Creon Label ). Patient was hospitalized.

6623553-1 | Biliary Dilatation, Biliary Tract Infection
on Feb 26, 2010 Male patient from JAPAN , 76 years of age, was diagnosed with cholangitis sclerosing and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: biliary dilatation, biliary tract infection. Ursodiol dosage: 900mg. During the same period patient was treated with IMURAN (50mg, Oral) (View Imuran Review and Imuran Label ), PREDNISOLONE (40mg, Oral) (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6615864-0 | Hepatic Neoplasm Malignant, Malignant Neoplasm Progression
on Feb 17, 2010 Male patient from JAPAN , 77 years of age, was diagnosed with hepatitis c (What is hepatitis c?) and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: hepatic neoplasm malignant, malignant neoplasm progression. Ursodiol dosage: 300mg; 600mg. During the same period patient was treated with NEO MINOPHAGEN C (View Neo-minophagen C Review and Neo-minophagen C Label ).

6571267-9 | Anaemia
Patient was taking Ursodiol (View Usage). Patient had the following side effects: anaemia on Jan 25, 2010 from JAPAN Additional patient health information: Male patient , 75 years of age, was diagnosed with hepatic function abnormal, hepatitis c (What is hepatitis c?), liver disorder and. Ursodiol dosage: 900 Mg Oral, 600mg Oral.

6540456-1 | Biliary Tract Infection
Adverse event was reported on Jan 06, 2010 by a Male patient taking Ursodiol (View Usage) (Dosage: 900mg) was diagnosed with cholangitis sclerosing, eosinophilia and. Location: JAPAN , 76 years of age, After Ursodiol was administered, patient had the following side effects: biliary tract infection. During the same period patient was treated with AZANIN (AZATHIOPRINE) (50mg) (View Azanin (azathioprine) Review and Azanin (azathioprine) Label ), PREDNISOLONE (40mg Daily Oral) (View Prednisolone Review and Prednisolone Label ). Patient was hospitalized.

6536837-2 | Caesarean Section, Chorioamnionitis, Funisitis, Heart Rate Increased, Premature Labour
on Dec 22, 2009 Female patient from UNITED STATES , 20 years of age, was diagnosed with cholestasis and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: caesarean section, chorioamnionitis, funisitis, heart rate increased, premature labour. Ursodiol dosage: .

6523171-X | Hepatic Failure, Pulmonary Hypertension
on Dec 11, 2009 Female patient from JAPAN , 49 years of age, was diagnosed with hepatitis c (What is hepatitis c?), liver disorder and was treated with Ursodiol (View Usage). Patient had the following side effects: hepatic failure, pulmonary hypertension (What is pulmonary hypertension?). Ursodiol dosage: 600 Mg Oral. During the same period patient was treated with RIVOTRIL (CLONAZEPAM) (1 Mg Oral ; 1.5 Mg Oral) (View Rivotril (clonazepam) Review and Rivotril (clonazepam) Label ), PAXIL (10 Mg Oral) (View Paxil Review and Paxil Label ), DESYREL (50 Mg Oral) (View Desyrel Review and Desyrel Label ), AMOBAN (ZOPICLONE) (7.5 Mg Oral) (View Amoban (zopiclone) Review and Amoban (zopiclone) Label ), LASIX (View Lasix Review and Lasix Label ), ALDACTONE (View Aldactone Review and Aldactone Label ).

6461126-4 | Condition Aggravated, Platelet Count Decreased, Schizophrenia
Patient was taking Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: condition aggravated, platelet count decreased, schizophrenia on Nov 17, 2009 from JAPAN Additional patient health information: Female patient , 47 years of age, was diagnosed with hepatitis c (What is hepatitis c?) and. Ursodiol dosage: 300mg, Oral. During the same period patient was treated with HIBON (RIBOFLAVIN TETRABUTYRATE) (40 Mg, Oral) (View Hibon (riboflavin Tetrabutyrate) Review and Hibon (riboflavin Tetrabutyrate) Label ), LANIRAPID (METILDIGOXIN) (0.1 Mg, Oral) (View Lanirapid (metildigoxin) Review and Lanirapid (metildigoxin) Label ), LASIX (20 Mg, Oral) (View Lasix Review and Lasix Label ), SLOW K (600 Mg, Oral) (View Slow-k Review and Slow-k Label ), JUVELA N (TOCOPHEROL NICOTINATE) (600 Df, Oral) (View Juvela N (tocopherol Nicotinate) Review and Juvela N (tocopherol Nicotinate) Label ), WARFARIN (WARFARIN POTASSIUM) (2.5 Mg, Oral) (View Warfarin (warfarin Potassium) Review and Warfarin (warfarin Potassium) Label ). Patient was hospitalized.

6426695-9 | Acute Respiratory Failure, Adult T-cell Lymphoma/leukaemia, Cholelithiasis, Constipation, Cytomegalovirus Infection, Gait Disturbance, Herpes Dermatitis, Herpes Simplex
Adverse event was reported on Oct 23, 2009 by a Male patient taking Ursodiol (View Usage) (Dosage: 300mg Oral ; 600mg Oral ; 600mg Oral) was diagnosed with liver disorder and. Location: JAPAN , 61 years of age, Patient experienced the following unwanted or unexpected effects: acute respiratory failure, adult t-cell lymphoma/leukaemia, cholelithiasis, constipation (What is constipation?), cytomegalovirus infection (What is cytomegalovirus infection?), gait disturbance, herpes dermatitis, herpes simplex (What is herpes simplex?). During the same period patient was treated with RENIVACE (View Renivace Review and Renivace Label ), ADALAT CC (View Adalat Cc Review and Adalat Cc Label ), ALLELOCK (View Allelock Review and Allelock Label ), MUCOSTA (View Mucosta Review and Mucosta Label ), HIRUDOID (View Hirudoid Review and Hirudoid Label ), MYSER (View Myser Review and Myser Label ).

6408608-9 | Hyperphosphatasaemia, Lymphoma, Renal Disorder, Renal Failure Acute, Tubulointerstitial Nephritis, Vasculitis
on Oct 08, 2009 Female patient from JAPAN , 52 years of age, was diagnosed with cholestasis and was treated with Ursodiol (View Usage). Patient had the following side effects: hyperphosphatasaemia, lymphoma (What is lymphoma?), renal disorder, renal failure acute, tubulointerstitial nephritis, vasculitis (What is vasculitis?). Ursodiol dosage: 300mg Oral. During the same period patient was treated with LOXONIN (LOXOPROFEN SODIUM) (View Loxonin (loxoprofen Sodium) Review and Loxonin (loxoprofen Sodium) Label ), CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label ), SIGMART (NICORANDIL) (View Sigmart (nicorandil) Review and Sigmart (nicorandil) Label ). Patient was hospitalized.

6408602-8 | Erythema Multiforme, Escherichia Sepsis
on Oct 08, 2009 Male patient from JAPAN , 71 years of age, was diagnosed with liver disorder, alcoholism (What is alcoholism?), erythema multiforme and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: erythema multiforme, escherichia sepsis. Ursodiol dosage: 300mg Oral. During the same period patient was treated with CYANAMIDE (CYANAMIDE) (15ml Oral) (View Cyanamide (cyanamide) Review and Cyanamide (cyanamide) Label ), VERAPAMIL HYDROCHLORIDE (120mg Oral) (View Verapamil Hydrochloride Review and Verapamil Hydrochloride Label ), PREDNISOLONE (20mg Increased To 30mg) (View Prednisolone Review and Prednisolone Label ), LANIRAPID (METILDIGOXIN) (View Lanirapid (metildigoxin) Review and Lanirapid (metildigoxin) Label ). Patient was hospitalized.

6400757-4 | Renal Disorder, Renal Failure Acute
Patient was taking Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: renal disorder, renal failure acute on Sep 24, 2009 from JAPAN Additional patient health information: Female patient , 52 years of age, was diagnosed with cholestasis and. Ursodiol dosage: 300mg, Oral. During the same period patient was treated with LOXONIN (LOXOPROFEN SODIUM) (View Loxonin (loxoprofen Sodium) Review and Loxonin (loxoprofen Sodium) Label ), CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label ), SIGMART (NICORANDIL) (View Sigmart (nicorandil) Review and Sigmart (nicorandil) Label ).

6380646-4 | Gamma-glutamyltransferase Increased, Hyperphosphatasaemia, Pyrexia, Renal Disorder
Adverse event was reported on Sep 14, 2009 by a Female patient taking Ursodiol (View Usage) (Dosage: 300mg, Oral) was diagnosed with cholestasis and. Location: JAPAN , 52 years of age, Patient had the following side effects: gamma-glutamyltransferase increased, hyperphosphatasaemia, pyrexia, renal disorder. During the same period patient was treated with LOXONIN (LOXOPROFEN SODIUM) (View Loxonin (loxoprofen Sodium) Review and Loxonin (loxoprofen Sodium) Label ), CLARITHROMYCIN (View Clarithromycin Review and Clarithromycin Label ), SIGMART (NICORANDIL) (View Sigmart (nicorandil) Review and Sigmart (nicorandil) Label ).

6372028-6 | Aphthous Stomatitis, Blood Culture Positive, Erythema Multiforme, Escherichia Infection, Oropharyngeal Pain, Pyrexia, Sepsis
on Sep 03, 2009 Male patient from JAPAN , 71 years of age, was diagnosed with liver disorder, alcoholism (What is alcoholism?), cardiac disorder, erythema multiforme and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: aphthous stomatitis, blood culture positive, erythema multiforme, escherichia infection, oropharyngeal pain, pyrexia, sepsis (What is sepsis?). Ursodiol dosage: 300mg Oral. During the same period patient was treated with CYANAMIDE (CYANAMIDE) (15ml Oral) (View Cyanamide (cyanamide) Review and Cyanamide (cyanamide) Label ), VERAPAMIL HYDROCHLORIDE (120 Mg Oral) (View Verapamil Hydrochloride Review and Verapamil Hydrochloride Label ), PREDNISOLONE (20mg Increased To 30mg) (View Prednisolone Review and Prednisolone Label ), LANIRAPID (METILDIGOXIN) (View Lanirapid (metildigoxin) Review and Lanirapid (metildigoxin) Label ). Patient was hospitalized.

6318628-0 | Condition Aggravated, Platelet Count Decreased, Schizophrenia
on Aug 07, 2009 Female patient from JAPAN , 47 years of age, was diagnosed with hepatitis c (What is hepatitis c?), liver disorder, concomitant disease aggravated and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: condition aggravated, platelet count decreased, schizophrenia. Ursodiol dosage: 300mg , Oral. During the same period patient was treated with HIBON (RIBOFLAVIN TETRABUTYRATE) (3.40 Mg,oral) (View Hibon (riboflavin Tetrabutyrate) Review and Hibon (riboflavin Tetrabutyrate) Label ), LANIRAPID (METILDIGOXIN) (0.1 Mg, Oral) (View Lanirapid (metildigoxin) Review and Lanirapid (metildigoxin) Label ), LASIX (20 Mg, Oral) (View Lasix Review and Lasix Label ), SLOW K (600 Mg, Oral) (View Slow-k Review and Slow-k Label ), JUVELA N (TOCOPHEROL NICOTINATE) (600 Mg, Oral) (View Juvela N (tocopherol Nicotinate) Review and Juvela N (tocopherol Nicotinate) Label ). Patient was hospitalized.

6303788-8 | Adult T-cell Lymphoma/leukaemia, Alopecia, Cholelithiasis, Chronic Hepatitis, Constipation, Gait Disturbance, Hepatic Cirrhosis
Patient was taking Ursodiol (View Usage). Patient had the following side effects: adult t-cell lymphoma/leukaemia, alopecia, cholelithiasis, chronic hepatitis, constipation (What is constipation?), gait disturbance, hepatic cirrhosis on Jul 24, 2009 from JAPAN Additional patient health information: Male patient , 61 years of age, was diagnosed with hepatitis c virus test, liver disorder and. Ursodiol dosage: 300 Mg Oral ; 600mg Oral. During the same period patient was treated with ENALAPRIL MALEATE (View Enalapril Maleate Review and Enalapril Maleate Label ), ADALAT CC (View Adalat Cc Review and Adalat Cc Label ), ALLELOCK (OLOPATADINE) (View Allelock (olopatadine) Review and Allelock (olopatadine) Label ).

6282502-9 | Anaemia
Adverse event was reported on Jul 09, 2009 by a Male patient taking Ursodiol (View Usage) (Dosage: 900 Mg, Oral; 600mg, Oral) was diagnosed with hepatitis c (What is hepatitis c?), liver disorder and. Location: JAPAN , 75 years of age, After Ursodiol was administered, patient had the following side effects: anaemia.

6266986-8 | Lymphoedema
on Jun 28, 2009 Male patient from UNITED KINGDOM , 62 years of age, was diagnosed with liver transplant (What is liver transplant?) and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: lymphoedema. Ursodiol dosage: Oral. During the same period patient was treated with BISOPROLOL FUMARATE (View Bisoprolol Fumarate Review and Bisoprolol Fumarate Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), CALCICHEW (CALCIUM CARBONATE) (View Calcichew (calcium Carbonate) Review and Calcichew (calcium Carbonate) Label ), URSODEOXYCHOLIC ACID (URSODIOL) (View Ursodeoxycholic Acid (ursodiol) Review and Ursodeoxycholic Acid (ursodiol) Label ).

6249107-7 | Bile Duct Cancer, Bile Duct Stenosis, Gallstone Ileus
on Jun 12, 2009 Male patient from JAPAN , 73 years of age, was diagnosed with cholelithiasis and was treated with Ursodiol (View Usage). Patient had the following side effects: bile duct cancer, bile duct stenosis, gallstone ileus. Ursodiol dosage: 300 Mg, Oral. During the same period patient was treated with FAMOTIDINE (View Famotidine Review and Famotidine Label ), SELBEX (TEPRENONE) (View Selbex (teprenone) Review and Selbex (teprenone) Label ), AMLODIPINE BESYLATE (View Amlodipine Besylate Review and Amlodipine Besylate Label ), MAGLAX (MAGNESIUM OXIDE) (View Maglax (magnesium Oxide) Review and Maglax (magnesium Oxide) Label ).

6234250-9 | Autoimmune Hepatitis, Carotid Artery Aneurysm, Cerebral Infarction, Disease Recurrence, Embolic Stroke, Hepatic Necrosis, Lung Disorder, Lymphocytic Infiltration, Muscular Weakness
Patient was taking Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: autoimmune hepatitis, carotid artery aneurysm, cerebral infarction, disease recurrence, embolic stroke, hepatic necrosis, lung disorder, lymphocytic infiltration, muscular weakness on Jun 05, 2009 from JAPAN Additional patient health information: Female patient , 54 years of age, was diagnosed with ascites, hepatic cirrhosis and. Ursodiol dosage: 600 Mg/day Oral. During the same period patient was treated with MEDWAY (HUMAN SERUM ALBUMIN GENETICAL RECOMBINATION) (50 Mg/day, Dr) (View Medway (human Serum Albumin - Genetical Recombination) Review and Medway (human Serum Albumin - Genetical Recombination) Label ), LANSOPRAZOLE (View Lansoprazole Review and Lansoprazole Label ), PREDNISOLONE (View Prednisolone Review and Prednisolone Label ), BENET (SODIUM RISEDRONATE HYDRATE) (View Benet (sodium Risedronate Hydrate) Review and Benet (sodium Risedronate Hydrate) Label ), ALOSENN (SENNA LEAF SENNA POD) (View Alosenn (senna Leaf-senna Pod) Review and Alosenn (senna Leaf-senna Pod) Label ), NELBON (NITRAZEPAM) (View Nelbon (nitrazepam) Review and Nelbon (nitrazepam) Label ), MAGNESIUM OXIDE (View Magnesium Oxide Review and Magnesium Oxide Label ), RIZE (CLOTIAZEPAM) (View Rize (clotiazepam) Review and Rize (clotiazepam) Label ). Patient was hospitalized.

6167828-1 | Anaemia, Off Label Use
Adverse event was reported on Apr 13, 2009 by a Male patient taking Ursodiol (View Usage) (Dosage: 900 Mg Oral) was diagnosed with hepatitis c virus test, liver disorder and. Location: JAPAN , 75 years of age, Patient experienced the following unwanted or unexpected effects: anaemia, off label use.

6104807-4 | Choking
on Mar 04, 2009 Female patient from UNITED STATES , weighting 160.0 lb, was diagnosed with biliary cirrhosis primary and was treated with Ursodiol (View Usage). Patient had the following side effects: choking (What is choking?). Ursodiol dosage: 5 Po Qam.

6053364-X | International Normalised Ratio Decreased
on Jan 09, 2009 Male patient from FRANCE , 55 years of age, was diagnosed with dilatation intrahepatic duct congenital and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: international normalised ratio decreased. Ursodiol dosage: 500 Mg/day. During the same period patient was treated with PREVISCAN (FLUINDIONE) (View Previscan (fluindione) Review and Previscan (fluindione) Label ), COUMADIN (View Coumadin Review and Coumadin Label ), FOSITEC (FOSINOPRIL) (View Fositec (fosinopril) Review and Fositec (fosinopril) Label ), BISOPROLOL FUMARATE (View Bisoprolol Fumarate Review and Bisoprolol Fumarate Label ), PREXIUM (PERINDOPRIL) (View Prexium (perindopril) Review and Prexium (perindopril) Label ), DIAMICRON (GLICLAZIDE) (View Diamicron (gliclazide) Review and Diamicron (gliclazide) Label ), IMOVANE (ZOPICLONE) (View Imovane (zopiclone) Review and Imovane (zopiclone) Label ), THERALENE (TRIMEPRAZINE) (View Theralene (trimeprazine) Review and Theralene (trimeprazine) Label ).

5756342-0 | Arthralgia, Back Pain, Constipation, Dizziness
Patient was taking Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, back pain (What is back pain?), constipation (What is constipation?), dizziness (What is dizziness?) on May 28, 2008 from UNITED STATES Additional patient health information: Male patient , 39 years of age, weighting 270.0 lb, was diagnosed with obesity (What is obesity?), surgery (What is surgery?) and. Ursodiol dosage: 1tablet 2time Daily Po.

5699369-X | Blood Pressure Increased, Caesarean Section, Disseminated Intravascular Coagulation, Eclampsia, Foetal Distress Syndrome, Haemoglobin Decreased, Headache, Nausea
Adverse event was reported on Mar 28, 2008 by a Female patient taking Ursodiol (View Usage) (Dosage: 250 Mg/ Day , Oral) was diagnosed with cholestasis of pregnancy and. Location: TURKEY , 20 years of age, Patient had the following side effects: blood pressure increased, caesarean section, disseminated intravascular coagulation, eclampsia, foetal distress syndrome, haemoglobin decreased, headache (What is headache?), nausea (What is nausea?). During the same period patient was treated with ZYRTEC (CETIRIZINE HYDROCHLORIDE), 10 MG/DAY (View Zyrtec (cetirizine Hydrochloride), 10 Mg/day Review and Zyrtec (cetirizine Hydrochloride), 10 Mg/day Label ), GLYCEROL TRINITRATE (View Glycerol Trinitrate Review and Glycerol Trinitrate Label ), MAGNESIUM SULPHATE, 2G/H CONTINUOUS INFUSION (View Magnesium Sulphate, 2g/h Continuous Infusion Review and Magnesium Sulphate, 2g/h Continuous Infusion Label ), ALDOMET (View Aldomet Review and Aldomet Label ). Patient was hospitalized.

5647963-4 | Anaemia, Blood Chloride Increased, Blood Sodium Increased, Dehydration, Overdose, Urinary Tract Infection
on Feb 20, 2008 Female patient from UNITED STATES , 97 years of age, weighting 95.02 lb, was diagnosed with cholelithiasis and was treated with Ursodiol (View Usage). After Ursodiol was administered, patient had the following side effects: anaemia, blood chloride increased, blood sodium increased, dehydration, overdose, urinary tract infection (What is urinary tract infection?). Ursodiol dosage: 1200 Mg, Bid, Oral; 600 Mg, Bid, Oral. Patient was hospitalized.

5589345-X | Coagulopathy, Growth Retardation, Intestinal Haemorrhage, Liver Transplant, Pulmonary Haemorrhage
on Dec 28, 2007 Male patient from JAPAN , child 2 years of age, was diagnosed with cholestasis and was treated with Ursodiol (View Usage). Patient experienced the following unwanted or unexpected effects: coagulopathy, growth retardation, intestinal haemorrhage, liver transplant (What is liver transplant?), pulmonary haemorrhage. Ursodiol dosage: 20 Mg/kg Po. Patient was hospitalized.

5578467-5 | Condition Aggravated, Hepatic Cirrhosis, Hepatitis B, Histiocytosis Haematophagic, No Therapeutic Response, Platelet Count Decreased, Renal Disorder, White Blood Cell Count Decreased
Patient was taking Ursodiol (View Usage). Patient had the following side effects: condition aggravated, hepatic cirrhosis, hepatitis b (What is hepatitis b?), histiocytosis haematophagic, no therapeutic response, platelet count decreased, renal disorder, white blood cell count decreased on Dec 19, 2007 from JAPAN Additional patient health information: Male patient , 60 years of age, was diagnosed with liver disorder, jaundice (What is jaundice?), pruritus, hepatitis b (What is hepatitis b?), gastrointestinal haemorrhage, ascites and. Ursodiol dosage: 600 Mg Po. During the same period patient was treated with CHOLEBINE TABLETS (COLESTILAN) (3000 Mg Po) (View Cholebine Tablets (colestilan) Review and Cholebine Tablets (colestilan) Label ), HEPSERA (ADEFOVIR PIVOXIL) (10 Mg Po) (View Hepsera (adefovir Pivoxil) Review and Hepsera (adefovir Pivoxil) Label ), ZEFIX (LAMIVUDINE) (100 Mg Po) (View Zefix (lamivudine) Review and Zefix (lamivudine) Label ), NEO MINOPHAGEN C (GLYCYRRHIZIN) (5b-2b Iv) (View Neo-minophagen C (glycyrrhizin) Review and Neo-minophagen C (glycyrrhizin) Label ), GASTER (FAMOTIDNE) (40 Mg Po) (View Gaster (famotidne) Review and Gaster (famotidne) Label ), ALDACTONE (25 Mg Po) (View Aldactone Review and Aldactone Label ), LASIX (40 Mg Po) (View Lasix Review and Lasix Label ).