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Ursodiol Side Effects

Common Ursodiol Side Effects

The most commonly reported Ursodiol side effects (click to view or check a box to report):

Interstitial Lung Disease (18)
Diarrhoea (14)
Alanine Aminotransferase Increased (11)
Condition Aggravated (10)
Aspartate Aminotransferase Increased (10)
Gamma-glutamyltransferase Increased (8)
Hepatic Function Abnormal (8)
Blood Alkaline Phosphatase Increased (7)
Cholelithiasis (7)
Convulsion (7)
Pyrexia (7)
Nausea (6)
Hypersensitivity (6)
Platelet Count Decreased (6)
Pruritus (6)
Renal Disorder (6)
Rash (6)
Liver Disorder (5)
Urticaria (5)
Sepsis (5)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Ursodiol Side Effects Reported to FDA

The following Ursodiol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Ursodiol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Hepatomegaly, Abdominal Discomfort, Gastrointestinal Sounds Abnormal, Diarrhoea, Gastrooesophageal Reflux Disease, Haemorrhoids
on Jan 21, 2014 Female from US , weighting 191.8 lb, was diagnosed with and was treated with Ursodiol (watson Laboratories). Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: hepatomegaly, abdominal discomfort, gastrointestinal sounds abnormal, diarrhoea, gastrooesophageal reflux disease, haemorrhoids. Ursodiol (watson Laboratories) dosage: 2 Df, Daily.

Liver Transplant, Hallucination, Diabetes Mellitus, Foreign Body, Hypertension, Heart Rate Increased, Gallbladder Disorder, Cholangitis Sclerosing
Patient was taking Ursodiol. Patient felt the following Ursodiol side effects: liver transplant, hallucination, diabetes mellitus, foreign body, hypertension, heart rate increased, gallbladder disorder, cholangitis sclerosing on Feb 24, 2014 from US Additional patient health information: Male , 59 years of age, weighting 170.0 lb, was diagnosed with and. Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Cyclosporine
  • Prograf
  • Gabapentin
  • Sulfameth
  • Trimethoprim
  • Lovastatin
  • Amitriptyline
  • Citalopram


Hypersensitivity, Swollen Tongue, Pharyngeal Oedema, Urticaria, Rash
Adverse event was reported on Oct 28, 2013 by a Female taking Ursodiol (Dosage: N/A) was diagnosed with and. Location: US , 49 years of age, weighting 190.0 lb, After Ursodiol was administered, patient encountered several Ursodiol side effects: hypersensitivity, swollen tongue, pharyngeal oedema, urticaria, rash.
Multiple concurrent drugs taken:
  • Levothyroxine


Pruritus, Product Substitution Issue
on Nov 26, 2012 Male from US , 46 years of age, was diagnosed with and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: pruritus, product substitution issue. Ursodiol dosage: 2 Tablets.


Contusion, Gingival Bleeding, Bleeding Time Prolonged
on Nov 26, 2012 Female from US , 57 years of age, weighting 111.0 lb, was diagnosed with and was treated with Ursodiol Capsules. Patient felt the following Ursodiol side effects: contusion, gingival bleeding, bleeding time prolonged. Ursodiol Capsules dosage: 2 Times A Day.

Anaphylactic Shock, Oropharyngeal Pain, Hepatic Function Abnormal, Influenza A Virus Test Positive, Pneumonia Influenzal
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: anaphylactic shock, oropharyngeal pain, hepatic function abnormal, influenza a virus test positive, pneumonia influenzal on Aug 14, 2013 from JP Additional patient health information: Male , 21 years of age, . Ursodiol dosage: Unk, Oral.
Multiple concurrent drugs taken:
  • Allopurinol (Unk, Oral)
  • Atorvastatin Calcium (Oral)
  • Immunoglobulin
  • Sesden (timepidium Bromide)
Patient was hospitalized.

Hepatic Function Abnormal, Maternal Exposure During Pregnancy
Adverse event was reported on Jun 15, 2012 by a Female taking Ursodiol (Dosage: 300 Mg, Qd, Oral) . Location: JAPAN , 36 years of age, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: hepatic function abnormal, maternal exposure during pregnancy.
Associated medications used:
  • Maglax (magnesium Oxide)
Patient was hospitalized.

Type 2 Diabetes Mellitus, Fatigue, Polydipsia, Hospitalisation
on Jun 12, 2012 Male from CANADA , 33 years of age, was treated with Ursodiol. Patient felt the following Ursodiol side effects: type 2 diabetes mellitus, fatigue, polydipsia, hospitalisation. Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Calcium
  • Folic Acid
  • Vitamin D
  • Lyrica
  • Prednisone Tab
  • Mycophenolate Mofetil
  • Cymbalta
  • Prednisone Tab (Unk)
Patient was hospitalized.

Feeling Abnormal, Diarrhoea, Fall, Tremor, Muscle Spasms, Cough, Nausea, Muscle Twitching, Urticaria
on Jun 04, 2012 Male from UNITED STATES , 53 years of age, weighting 255.1 lb, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: feeling abnormal, diarrhoea, fall, tremor, muscle spasms, cough, nausea, muscle twitching, urticaria. Ursodiol dosage: 300 Mg Bid Po.

Myositis, Atrial Fibrillation, Blood Creatine Phosphokinase Increased
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: myositis, atrial fibrillation, blood creatine phosphokinase increased on May 29, 2012 from CANADA Additional patient health information: Female , 59 years of age, . Ursodiol dosage: N/A.
Associated medications used:
  • Aspirin
  • Rabeprazole Sodium
  • Multaq
  • Aspirin


Liver Disorder, Prothrombin Time Prolonged, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Rash Pruritic, Urticaria, Alanine Aminotransferase Increased, Lymphocyte Stimulation Test Positive, Biopsy Liver Abnormal
Adverse event was reported on Aug 14, 2013 by a Male taking Ursodiol (Dosage: 600 Mg, Qd, Oral) was diagnosed with and. Location: JP , 59 years of age, Patient felt the following Ursodiol side effects: liver disorder, prothrombin time prolonged, blood alkaline phosphatase increased, blood bilirubin increased, rash pruritic, urticaria, alanine aminotransferase increased, lymphocyte stimulation test positive, biopsy liver abnormal.
Multiple prescriptions taken:
  • Famotidine (20 Mg, Qd, Oral)
  • Wystal (cefoperazone Sodium, Sulbactam Sodium)
  • Panabate (gabexate Mesilate)
  • Rabeprazole Sodium
Patient was hospitalized.

Bacterial Infection, Bite, Arthralgia, Injection Site Swelling, Device Malfunction, Anxiety, Injection Site Haematoma, Cellulitis, Injection Site Erythema
on Apr 27, 2012 Female from UNITED STATES , weighting 217.2 lb, was diagnosed with and was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: bacterial infection, bite, arthralgia, injection site swelling, device malfunction, anxiety, injection site haematoma, cellulitis, injection site erythema. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Omeprazole
  • Multi-vitamins
  • Lorazepam
  • Paroxetine
  • Verapamil
  • Folic Acid
  • Astelin
  • Lisinopril
Patient was hospitalized.

Cerebral Infarction, Interstitial Lung Disease, Hypokalaemia, Oedema Peripheral, Hypoglycaemia, Pancreatitis Chronic, Diarrhoea, Malabsorption
on Aug 14, 2013 Male from JP , 57 years of age, was diagnosed with and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: cerebral infarction, interstitial lung disease, hypokalaemia, oedema peripheral, hypoglycaemia, pancreatitis chronic, diarrhoea, malabsorption. Ursodiol dosage: 400 Mg, Qd, Oral.
Associated medications used:
  • Ozagrel (160 Mg, Qd, Intravenous)
  • Plavix (75 Mg, Qd, Oral)
  • Aspara K /00466902/ (aspartate Potassium)
  • Phelloberin A /01786401/ (berberine Hydrochloride, Geranium Thunbergii, Herb Extract)
  • Cercine
  • Lasix
  • Aldactone
  • Foipan (camostat Mesilate)
Patient was hospitalized.

Deep Vein Thrombosis
Patient was taking Ursodiol. Patient felt the following Ursodiol side effects: deep vein thrombosis on Apr 13, 2012 from UNITED STATES Additional patient health information: Male , 73 years of age, . Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Fenofibrate
  • Lisinopril
  • Ipratropium (ipratropium Bromide)
  • Busulfan (58 Mg Milligram(s), Daily Dose, Intravenous, 190 Mg Milligram(s), Daily Dose, Intravenous)
  • Busulfan (58 Mg Milligram(s), Daily Dose, Intravenous, 190 Mg Milligram(s), Daily Dose, Intravenous)
  • Bortezomib (2.5 Mg Milligram(s), Daily Dose, Intravenous)
  • Acyclovir
  • Omeprazole


Sepsis, Bacteraemia, Small Intestinal Obstruction, Multi-organ Failure, Fungaemia, Escherichia Urinary Tract Infection, Urinary Tract Infection Enterococcal
Adverse event was reported on Apr 17, 2012 by a Male taking Ursodiol (Dosage: 300 Mg, Tid) . Location: UNITED STATES , weighting 218.3 lb, After Ursodiol was administered, patient encountered several Ursodiol side effects: sepsis, bacteraemia, small intestinal obstruction, multi-organ failure, fungaemia, escherichia urinary tract infection, urinary tract infection enterococcal.
Multiple concurrent drugs taken:
  • Norepinephrine Bitartrate (Unk)
  • Daptomycin (700 Mg, Uid/qd)
  • Methylprednisolone (25 Mg, Uid/qd)
  • Lansoprazole (30 Mg, Uid/qd)
  • Doripenem (250 Mg, Uid/qd)
  • Ribavirin (200 Mg, Bid)
  • Calcium Chloride (Unk)
  • Prograf (1 Mg, Tid)


Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease
on Apr 10, 2012 Male from JAPAN , weighting 127.9 lb, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: chronic graft versus host disease, acute graft versus host disease. Ursodiol dosage: Unk.
Associated medications used:
  • Cyclophosphamide (Unk)
  • Cilastatin W (Unk)
  • Thymoglobulin (120 Mg, Qd)
  • Fludarabine Phosphate (Unk)
  • Itraconazole (Unk)
  • Rabeprazole Sodium (Unk)
  • Valacyclovir Hydrochloride (Unk)
  • Thymoglobulin (117.5 Mg, Unk)


Hypoaesthesia, Hypokalaemia, Malabsorption, Hypoglycaemia, Pancreatitis Chronic, Interstitial Lung Disease, Oedema Peripheral, Respiratory Rate Increased, Pyrexia
on Mar 14, 2012 Male from JAPAN , 57 years of age, was treated with Ursodiol. Patient felt the following Ursodiol side effects: hypoaesthesia, hypokalaemia, malabsorption, hypoglycaemia, pancreatitis chronic, interstitial lung disease, oedema peripheral, respiratory rate increased, pyrexia. Ursodiol dosage: 400 Mg, Qd, Oral.
Multiple prescriptions taken:
  • Ozagrel /01030902/ (ozagrel Sodium) (160 Mg, Qd, Intravenous)
  • Plavix (75 Mg, Qd, Oral)
Patient was hospitalized.

Suicidal Ideation, Hypersomnia, Delusion
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: suicidal ideation, hypersomnia, delusion on Apr 18, 2011 from UNITED STATES Additional patient health information: Male , 57 years of age, was diagnosed with and. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Levothyroxine Sodium
  • Nifedipine


Hepatic Enzyme Increased, Cushingoid
Adverse event was reported on Mar 08, 2012 by a Female taking Ursodiol (Dosage: N/A) . Location: TURKEY , 51 years of age, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: hepatic enzyme increased, cushingoid.
Associated medications used:
  • Budesonide
  • Azathioprine
  • Budesonide


Hepatic Cirrhosis, Hepatitis, Hypotension, Multi-organ Failure
on Mar 01, 2012 Patient from BRAZIL , 40 years of age, was diagnosed with and was treated with Ursodiol. Patient felt the following Ursodiol side effects: hepatic cirrhosis, hepatitis, hypotension, multi-organ failure. Ursodiol dosage: 300 Mg, Per Oral.
Multiple prescriptions taken:
  • Propranolol
  • Iron (iii) Glucinate/vitamin B12/vitamin B5vitamin B3vitamin B1/vitami
  • Amlodipine Besylate And Olmesartan Medoxomil (40/10; 20/5 Mg (1 In 1 D), Per Oral)
  • Amlodipine Besylate And Olmesartan Medoxomil (40/10; 20/5 Mg (1 In 1 D), Per Oral)
  • Spironolactone
Patient was hospitalized.

Colitis Ulcerative
on Mar 02, 2012 Female from UNITED STATES , weighting 71.65 lb, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: colitis ulcerative. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Remicade
  • Probiotic
  • Remicade
  • Prednisone
  • Remicade
  • Multiple Vitamin
Patient was hospitalized.

Haemolytic Anaemia, Cerebral Haemorrhage, Acute Graft Versus Host Disease, Idiopathic Thrombocytopenic Purpura
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: haemolytic anaemia, cerebral haemorrhage, acute graft versus host disease, idiopathic thrombocytopenic purpura on Feb 28, 2012 from JAPAN Additional patient health information: Male , weighting 33.07 lb, was diagnosed with and. Ursodiol dosage: 75 Mg, Bid.
Associated medications used:
  • Cefazolin (Unk)
  • Prednisolone Sodium Succinate Inj (2 Mg, Qd)
  • Micafungin Sodium (25 Mg, Qd)
  • Prednisolone (1.5 Mg, Bid)
  • Prednisolone (16 Mg, Bid)
  • Prednisolone (8 Mg, Bid)
  • Midazolam (10 Mg, Qd)
  • Ambroxol (6 Mg, Bid)


Pneumoperitoneum, Ascites, Intestinal Dilatation, Infectious Peritonitis, Necrotising Colitis
Adverse event was reported on Feb 28, 2012 by a Female taking Ursodiol (Dosage: N/A) . Location: MALAYSIA , weighting 2.65 lb, Patient felt the following Ursodiol side effects: pneumoperitoneum, ascites, intestinal dilatation, infectious peritonitis, necrotising colitis.
Multiple prescriptions taken:
  • Phenylephrine Hcl ((1 Gtt Befpre Procedure Ophthalmic))
  • Mydriacyl ((1 Gtt Before Procedure Ophthalmic))
  • Metoclopramide
  • Sodium Phosphate


Bile Duct Cancer
on Feb 27, 2012 Male from ROMANIA , weighting 132.3 lb, was diagnosed with and was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: bile duct cancer. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Propranolol
  • Azathioprine
  • Spironolactone
  • Propranolol
  • Infliximab, Recombinant
  • Furosemide
  • Prednisone Tab


Toxicity To Various Agents
on Feb 13, 2012 Male from BELGIUM , weighting 22.71 lb, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: toxicity to various agents. Ursodiol dosage: Unk.
Associated medications used:
  • Nexium (Unk)
  • Tranexamic Acid (Unk)
  • Ganciclovir (Unk)
  • Temocillin (Unk)
  • Ranitidine (Unk)
  • Alizapride (Unk)
  • Tacrolimus (1.6 Mg, Bid)
  • Sandostatin (Unk)


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Why Your Notes are Important

Your notes could be helpful in several ways:

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  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

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    Scale: 1 = very mild to 10 = very bad


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    Discuss Ursodiol Side Effects

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative URSODIOL Names:ACTIGALL URSO URSO 250 URSO FORTE

    Active Ingredient: URSODIOL

    Ursodiol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 194

    Ursodiol safety alerts: No

    Reported deaths: 32

    Reported hospitalizations: 92

    Latest Ursodiol clinical trials