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Cough (5)
Darker Urine (4)
Exhausted (4)
URINE COLOUR CHANGES INTO RED (3)
Coughandurinecolorchange (2)
Arthritis (1)
Fever (1)
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Ursodiol Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 186 

Arthralgia, Hypoaesthesia, Musculoskeletal Stiffness, Insomnia, Myalgia (8068742-7)
on Dec 05, 2011 Female from UNITED STATES , 81 years of age, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: arthralgia, hypoaesthesia, musculoskeletal stiffness, insomnia, myalgia. Ursodiol dosage: Unk.
Associated medications used:
  • Prolia (60 Mg, Q6mo)
  • Prolia (60 Mg, Q6mo)
  • Influenza Vaccine (Unk)


Nausea, Myalgia, Vomiting, Arthralgia, Diarrhoea, Joint Swelling (8062546-7)
Patient was taking Ursodiol. Patient felt the following Ursodiol side effects: nausea, myalgia, vomiting, arthralgia, diarrhoea, joint swelling on Jan 11, 2012 from UNITED STATES Additional patient health information: Female , 70 years of age, . Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Pantoprazole
  • Atelvia (35 Mg Once Weekly, Oral)
  • Prednisolone (millipred)
  • Ramipril
  • Actonel (35 Mg Once Weekly, Oral)
  • Tylenol /00020001/ (paracetamol)
  • Vitamin D (50000 Iu Every 2 Weeks)
  • Cellcept /01275102/ (mycophenolate Mofetil)
Patient was hospitalized.

Blood Urine Present (8045208-1)
Adverse event was reported on Jan 11, 2012 by a Male taking Ursodiol (Dosage: 300 Mg 3 Times Daily) was diagnosed with
  • cholelithiasis
and. Location: UNITED STATES , 80 years of age, weighting 150.0 lb, After Ursodiol was administered, patient encountered several Ursodiol side effects: blood urine present.

Obesity (8034641-X)
on Jan 05, 2012 Male from UNITED STATES , 53 years of age, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: obesity. Ursodiol dosage: N/A.
Associated medications used:
  • Hyzaar
  • Omeprazole
Patient was hospitalized.


International Normalised Ratio Increased, Fluid Overload, Blood Potassium Decreased, Protein Total Decreased, Blood Calcium Decreased (8033434-7)
on Jan 06, 2012 Female from UNITED STATES , weighting 147.1 lb, was treated with Ursodiol. Patient felt the following Ursodiol side effects: international normalised ratio increased, fluid overload, blood potassium decreased, protein total decreased, blood calcium decreased. Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Copegus
Patient was hospitalized.

Myocardial Infarction, Oesophageal Haemorrhage, Chest Pain (8031700-2)
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: myocardial infarction, oesophageal haemorrhage, chest pain on Jan 05, 2012 from UNITED STATES Additional patient health information: Male , weighting 185.2 lb, was diagnosed with
  • liver disorder
  • rheumatoid arthritis
and. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Folic Acid
  • Hydrocodone (7.5/325)
  • Vitamin D
  • Humira
  • Prednisone Tab
  • Toprol-xl
  • Tramadol Hcl
  • Calcium Acetate
Patient was hospitalized.

Pancreatitis, Blood Glucose Increased, Off Label Use, Haematemesis (8030323-9)
Adverse event was reported on Jun 22, 2011 by a Female taking Ursodiol (Dosage: N/A) . Location: UNITED STATES , 68 years of age, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: pancreatitis, blood glucose increased, off label use, haematemesis.
Associated medications used:
  • Byetta (5, 2/d, Subcutaneous ; 10 Ug, 2/d, Subcutaneous)
  • Byetta (5, 2/d, Subcutaneous ; 10 Ug, 2/d, Subcutaneous)
  • Pravachol
  • Exenatide 10mcg Pen, Disposable Device (exenatide Pen (10mcg)) Pen,dis
  • Metformin Hcl
  • Glyburide
  • Diovan
Patient was hospitalized.

Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased (8030269-6)
on Dec 27, 2011 Male from JAPAN , 61 years of age, was treated with Ursodiol. Patient felt the following Ursodiol side effects: aspartate aminotransferase increased, gamma-glutamyltransferase increased. Ursodiol dosage: 600 Mg, Qd, Oral.
Multiple prescriptions taken:
  • Humalog (32 Iu Qd Subcutaneous)
  • Lasix (20 Mg, Qd, Oral)
  • Kinedak (epalrestat) (150 Mg, Qd, Oral)


Interstitial Lung Disease (8030253-2)
on Dec 27, 2011 Male from JAPAN , 57 years of age, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: interstitial lung disease. Ursodiol dosage: 400 Mg, Qd, Oral. Patient was hospitalized.

Neutrophil Count Decreased, Lymphocyte Count Decreased, Decreased Appetite, White Blood Cell Count Decreased, Malaise, Hepatitis B, Platelet Count Decreased (8011439-X)
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: neutrophil count decreased, lymphocyte count decreased, decreased appetite, white blood cell count decreased, malaise, hepatitis b, platelet count decreased on Dec 21, 2011 from JAPAN Additional patient health information: Female , weighting 127.9 lb, . Ursodiol dosage: N/A.
Associated medications used:
  • Bendamustine Hcl
  • Ramosetron Hydrochloride
  • Sennoside A
  • Sulfamethoxazole Sodium
  • Insulin Human
  • Entecavir
  • Bendamustine Hcl
  • Insulin Detemir
Patient was hospitalized.

Cardiac Failure Acute (7998919-8)
Adverse event was reported on Dec 14, 2011 by a Female taking Ursodiol (Dosage: N/A) was diagnosed with
  • hepatic function abnormal
  • insomnia
  • gout
  • chronic obstructive pulmonary disease
  • hypertension
and. Location: JAPAN , weighting 123.9 lb, Patient felt the following Ursodiol side effects: cardiac failure acute.
Multiple prescriptions taken:
  • Triazolam
  • Allopurinol
  • L-carbocysteine
  • Candesartan Cilexetil
  • Albuterol Sulfate Autohaler
  • Lansoprazole
  • Rosuvastatin Calcium
  • Theophylline


Stomatitis, Venoocclusive Liver Disease, Weight Increased, Refractoriness To Platelet Transfusion, Abdominal Pain Upper, Disseminated Intravascular Coagulation, Graft Versus Host Disease In Skin, Graft Versus Host Disease In Intestine (7973444-9)
on Nov 25, 2011 Male from JAPAN , 27 years of age, was diagnosed with
  • venoocclusive liver disease
  • prophylaxis
and was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: stomatitis, venoocclusive liver disease, weight increased, refractoriness to platelet transfusion, abdominal pain upper, disseminated intravascular coagulation, graft versus host disease in skin, graft versus host disease in intestine. Ursodiol dosage: N/A.

Bladder Discomfort, Cerebrovascular Accident, Peripheral Arterial Occlusive Disease, Chest Pain, Liver Disorder (7947259-1)
on Nov 17, 2011 Male from UNITED STATES , 63 years of age, weighting 149.9 lb, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: bladder discomfort, cerebrovascular accident, peripheral arterial occlusive disease, chest pain, liver disorder. Ursodiol dosage: N/A.
Associated medications used:
  • Ventolin (As Needed)
  • Lisinopril
  • Aspirin
  • Plavix
  • Flomax
  • Clonazepam
  • Symbicort (160/4.5 Two Puffs Twice A Day)
  • Metoprolol Tartrate


Anaemia, Pruritus, Thrombocytopenia, Condition Aggravated, Cholestasis, Foetal Growth Restriction, Varices Oesophageal, Premature Rupture Of Membranes (7941965-0)
Patient was taking Ursodiol. Patient felt the following Ursodiol side effects: anaemia, pruritus, thrombocytopenia, condition aggravated, cholestasis, foetal growth restriction, varices oesophageal, premature rupture of membranes on Nov 08, 2011 from FRANCE Additional patient health information: Female , 34 years of age, was diagnosed with
  • pruritus
and. Ursodiol dosage: 600 Mg,qd. Patient was hospitalized.

Muscle Haemorrhage, Blood Bilirubin Increased, Dyspnoea Exertional, Jaundice, Infection, Haemolysis (7936895-4)
Adverse event was reported on Nov 15, 2011 by a Male taking Ursodiol (Dosage: 100 Mg, Unk) . Location: JAPAN , 68 years of age, After Ursodiol was administered, patient encountered several Ursodiol side effects: muscle haemorrhage, blood bilirubin increased, dyspnoea exertional, jaundice, infection, haemolysis.
Multiple concurrent drugs taken:
  • Soliris (900 Mg, Q2w)
  • Levofloxacin (500 Mg, Unk)
  • Brotizolam (0.25 Mg, Unk)
  • Warfarin Sodium (Unk)
  • Rabeprazole Sodium (10 Mg, Unk)
Patient was hospitalized.

Autoimmune Hepatitis (7927925-4)
on Nov 07, 2011 Male from SPAIN , 58 years of age, was diagnosed with
  • autoimmune hepatitis
and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: autoimmune hepatitis. Ursodiol dosage: N/A.
Associated medications used:
  • Ezetimibe
  • Metformin Hcl
  • Doxazosin Mesylate
  • Glimepiride
  • Amlodipine
  • Enalapril Maleate
  • Ezetimibe
  • Atorvastatin
Patient was hospitalized.

Renal Impairment, Stomatitis, Hypoalbuminaemia, Diarrhoea, Venoocclusive Liver Disease, Pneumonia Staphylococcal, White Blood Cell Count Decreased, Non-hodgkin's Lymphoma, Thrombotic Microangiopathy (7920008-9)
on Nov 09, 2011 Male from JAPAN , weighting 125.7 lb, was diagnosed with
  • lymphocytic infiltration
  • infection prophylaxis
  • gastritis prophylaxis
and was treated with Ursodiol. Patient felt the following Ursodiol side effects: renal impairment, stomatitis, hypoalbuminaemia, diarrhoea, venoocclusive liver disease, pneumonia staphylococcal, white blood cell count decreased, non-hodgkin's lymphoma, thrombotic microangiopathy. Ursodiol dosage: Unk.
Multiple prescriptions taken:
  • Acyclovir (Unk)
  • Famotidine (Unk)
  • Dalteparin Sodium (Unk)
  • Thymoglobulin (125 Mg, Qd)
  • Rebamipide (Unk)
  • Platelets (Unk)
  • Methylprednisolone Sodium Succinate (Unk)
  • Sulpyrine (Unk)
Patient was hospitalized.

International Normalised Ratio Decreased (7919551-8)
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: international normalised ratio decreased on Nov 16, 2011 from UNITED STATES Additional patient health information: Male , 52 years of age, weighting 170.4 lb, . Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Coumadin (Recent)
  • Remeron
  • Lovenox (Recent)
  • Questran
  • Bupropion Hydrochloride
  • Dexilant
  • M.v.i.
  • Doxycycline
Patient was hospitalized.

Interstitial Lung Disease, Respiratory Distress, Hepatic Function Abnormal, Renal Impairment, Hepatitis B, Dyspnoea Exertional, Infection, Cough, Lung Infiltration (7919126-0)
Adverse event was reported on Oct 31, 2011 by a Male taking Ursodiol (Dosage: N/A) was diagnosed with
  • cholelithiasis
  • haematuria
  • diabetes mellitus
  • insomnia
  • hepatic neoplasm malignant
and. Location: TAIWAN, PROVINCE OF CHINA , weighting 122.1 lb, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: interstitial lung disease, respiratory distress, hepatic function abnormal, renal impairment, hepatitis b, dyspnoea exertional, infection, cough, lung infiltration.
Associated medications used:
  • Tranexamic Acid
  • Humulin R
  • Lorazepam
  • Everolimus (7.5 Mg, Qd)
  • Humulin N
  • Pantoprazole (Unk)
  • Rosuvastatin
  • Albumin (human)
Patient was hospitalized.

Bile Duct Stone (7911124-6)
on Oct 26, 2011 Female from JAPAN , 59 years of age, was diagnosed with
  • bile duct stone
and was treated with Ursodiol. Patient felt the following Ursodiol side effects: bile duct stone. Ursodiol dosage: 300 Mg, Qd, Oral.
Multiple prescriptions taken:
  • Cospanon (flopropione)
Patient was hospitalized.

Weight Decreased, Respiratory Tract Infection (7880940-1)
on Oct 21, 2011 Female from NETHERLANDS , 18 years of age, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: weight decreased, respiratory tract infection. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Vitamin Tab
  • Antibiotics
  • Gammagard Liquid (X Per 35 Dagen)
  • Gammagard Liquid (X Per 35 Dagen)
  • Gammagard Liquid (X Per 35 Dagen)
Patient was hospitalized.

Mania (7878228-8)
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: mania on Oct 17, 2011 from CANADA Additional patient health information: Male , 28 years of age, . Ursodiol dosage: 1500 Mg, Bid.
Associated medications used:
  • Sulfasalazine (1000 Mg, Tid)
  • Metronidazole (500 Mg, Bid)
  • Ciprofloxacin (400 Mg, Bid)
  • Cefazolin (1 G, Tid)
  • Ciprofloxacin (500 Mg, Bid)
  • Gravol Tab (25-50 Mg Q4h)
  • Sulfasalazine (300 Mg, Tid)
  • Folic Acid (1 Mg, Qd)


Pancreas Divisum, Nausea, Psoriasis, Abdominal Pain Upper, Weight Decreased, Musculoskeletal Stiffness (7876386-2)
Adverse event was reported on Oct 25, 2011 by a Female taking Ursodiol (Dosage: N/A) was diagnosed with
  • biliary tract disorder
  • blood cholesterol increased
  • depression
  • skin disorder
  • insomnia
  • anxiety
  • psoriatic arthropathy
  • urge incontinence
  • gastrooesophageal reflux disease
and. Location: UNITED STATES , weighting 160.1 lb, Patient felt the following Ursodiol side effects: pancreas divisum, nausea, psoriasis, abdominal pain upper, weight decreased, musculoskeletal stiffness.
Multiple prescriptions taken:
  • Pravastatin (At Bedtime)
  • Sertraline Hydrochloride
  • Betamethasone
  • Ambien
  • Lorazepam (4 Mg As Needed (rarely Takes))
  • Humira
  • Vesicare
  • Omeprazole (At Bedtime)


Antimitochondrial Antibody Positive, Portal Hypertension, Cholestasis, Biliary Cirrhosis, Disease Progression, Treatment Failure (7850881-4)
on Oct 10, 2011 Female from FRANCE , 70 years of age, weighting 143.3 lb, was diagnosed with
  • biliary cirrhosis primary
and was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: antimitochondrial antibody positive, portal hypertension, cholestasis, biliary cirrhosis, disease progression, treatment failure. Ursodiol dosage: 500 Mg. Bid. Oral.

Pyrexia, Depressed Level Of Consciousness, Infectious Peritonitis, Hepatic Encephalopathy (7785879-8)
on Sep 26, 2011 Male from UNITED STATES , 63 years of age, weighting 145.5 lb, was diagnosed with
  • prophylaxis
  • hepatic encephalopathy
  • vitamin supplementation
  • hypoalbuminaemia
and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: pyrexia, depressed level of consciousness, infectious peritonitis, hepatic encephalopathy. Ursodiol dosage: 200 Mg, Tid.
Associated medications used:
  • Aminoleban (500 Ml, Qd)
  • Neurobion (1 Df, Qd)
  • Falkamin (4.15 G, Bid)
  • Syakuyakukanzoto (2.5 Mg, Tid)
  • Ceftriaxone (1 G, Bid)
  • Sorafenib (raf Kinase Inhibitor) (400 Mg, Qd)
  • Lactitol (6 Mg, Tid)
  • Basen
Patient was hospitalized.

Showing 1-25 of 186 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Ursodiol Information

Alternative URSODIOL Names:ACTIGALL URSO URSO 250 URSO FORTE

Active Ingredient: URSODIOL

Ursodiol Dosage, Warnings, Usage.

Side Effects reported to FDA: 186. View Ursodiol Adverse Reports

Ursodiol safety alerts: No

Reported deaths: 32

Reported hospitalizations: 84

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