PatientsVille.com Logo

PatientsVille

Ursodiol Side Effects

Report Ursodiol Side Effects

If you experienced any harmful or unwanted effects of Ursodiol, please share your experience. This could help to raise awareness about Ursodiol side effects, identify uknown risks and inform health professionals and patients taking Ursodiol.

Examples: headache, dizziness


The most commonly reported Ursodiol side effects are:
Cough (6 reports)
Darker Urine (4 reports)
Exhausted (4 reports)
URINE COLOUR CHANGES INTO RED (3 reports)
Coughandurinecolorchange (3 reports)
Fever (1 reports)
Hives (1 reports)
Irregular Heart Beat (1 reports)
Low Vitamin D (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Ursodiol side effects . You can also compare Ursodiol side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

Page 1 of 8 

Bile Duct Stone
on Jan 27, 2012 Female from JAPAN , 56 years of age, was diagnosed with and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: bile duct stone. Ursodiol dosage: 300 Mg, Qd, Oral, 600 Mg, Qd, Oral.
Associated medications used: Patient was hospitalized.

Insomnia, Blood Uric Acid Increased, Rhabdomyolysis, Thrombocytopenia
Patient was taking Ursodiol. Patient felt the following Ursodiol side effects: insomnia, blood uric acid increased, rhabdomyolysis, thrombocytopenia on Jan 27, 2012 from JAPAN Additional patient health information: Male , 74 years of age, . Ursodiol dosage: Oral. Patient was hospitalized.

Graft Versus Host Disease, Thrombotic Microangiopathy, Pneumonia Aspiration, Multi-organ Failure
Adverse event was reported on Jan 30, 2012 by a Male taking Ursodiol (Dosage: Unk) was diagnosed with
  • prophylaxis
  • infection prophylaxis
  • graft versus host disease
and. Location: JAPAN , weighting 196.2 lb, After Ursodiol was administered, patient encountered several Ursodiol side effects: graft versus host disease, thrombotic microangiopathy, pneumonia aspiration, multi-organ failure.
Multiple concurrent drugs taken:
  • Sulfamethoprim (Unk)
  • Thymoglobulin (75 Mg, Qd)
  • Carperitide (Unk)
  • Brotizolam (Unk)
  • Micafungin Sodium (Unk)
  • Acyclovir (Unk)
  • Acyclovir (Unk)
  • Heparin (Unk)


Aspartate Aminotransferase Increased, Hepatitis C
on Jan 17, 2012 Male from JAPAN , 61 years of age, was diagnosed with and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: aspartate aminotransferase increased, hepatitis c. Ursodiol dosage: 600 Mg, Qd, Oral.
Associated medications used:


Injection Site Pain
on Oct 07, 2011 Male from UNITED STATES , 41 years of age, was treated with Ursodiol. Patient felt the following Ursodiol side effects: injection site pain. Ursodiol dosage: N/A.
Multiple prescriptions taken:
  • Welchol
  • Metformin Hcl
  • Lisinopril
  • Humira


Diarrhoea
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: diarrhoea on Oct 07, 2011 from UNITED STATES Additional patient health information: Female , 76 years of age, . Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Vitamin D
  • Humira
  • Plaquenil
  • Calcium
  • Acetaminophen
  • Eye Gtts
  • Eye Gtts
  • Norco


Hypersensitivity
Adverse event was reported on Jan 23, 2012 by a Female taking Ursodiol (Dosage: Unk) . Location: UNITED STATES , weighting 138.0 lb, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: hypersensitivity.
Associated medications used:

Pancytopenia, Aplastic Anaemia
on Jan 05, 2012 Male from UNITED STATES , 15 years of age, was diagnosed with and was treated with Ursodiol. Patient felt the following Ursodiol side effects: pancytopenia, aplastic anaemia. Ursodiol dosage: 300 Mg, Bid,oral. Patient was hospitalized.

Arthralgia, Hypoaesthesia, Musculoskeletal Stiffness, Insomnia, Myalgia
on Dec 05, 2011 Female from UNITED STATES , 81 years of age, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: arthralgia, hypoaesthesia, musculoskeletal stiffness, insomnia, myalgia. Ursodiol dosage: Unk.
Multiple concurrent drugs taken:

Nausea, Myalgia, Vomiting, Arthralgia, Diarrhoea, Joint Swelling
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected 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.
Associated medications used:
  • 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
Adverse event was reported on Jan 11, 2012 by a Male taking Ursodiol (Dosage: 300 Mg 3 Times Daily) was diagnosed with and. Location: UNITED STATES , 80 years of age, weighting 150.0 lb, Patient felt the following Ursodiol side effects: blood urine present.

Obesity
on Jan 05, 2012 Male from UNITED STATES , 53 years of age, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: obesity. Ursodiol dosage: N/A.
Multiple concurrent drugs taken: Patient was hospitalized.

International Normalised Ratio Increased, Fluid Overload, Blood Potassium Decreased, Protein Total Decreased, Blood Calcium Decreased
on Jan 06, 2012 Female from UNITED STATES , weighting 147.1 lb, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: international normalised ratio increased, fluid overload, blood potassium decreased, protein total decreased, blood calcium decreased. Ursodiol dosage: N/A.
Associated medications used: Patient was hospitalized.

Myocardial Infarction, Oesophageal Haemorrhage, Chest Pain
Patient was taking Ursodiol. Patient felt the following 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 and. Ursodiol dosage: N/A.
Multiple prescriptions 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
Adverse event was reported on Jun 22, 2011 by a Female taking Ursodiol (Dosage: N/A) . Location: UNITED STATES , 68 years of age, After Ursodiol was administered, patient encountered several Ursodiol side effects: pancreatitis, blood glucose increased, off label use, haematemesis.
Multiple concurrent drugs taken:
  • Byetta (5, 2/d, Subcutaneous ; 10 Ug, 2/d, Subcutaneous)
Patient was hospitalized.

Aspartate Aminotransferase Increased, Gamma-glutamyltransferase Increased
on Dec 27, 2011 Male from JAPAN , 61 years of age, was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: aspartate aminotransferase increased, gamma-glutamyltransferase increased. Ursodiol dosage: 600 Mg, Qd, Oral.
Associated medications used:
  • Humalog (32 Iu Qd Subcutaneous)
  • Lasix (20 Mg, Qd, Oral)
  • Kinedak (epalrestat) (150 Mg, Qd, Oral)


Interstitial Lung Disease
on Dec 27, 2011 Male from JAPAN , 57 years of age, was treated with Ursodiol. Patient felt the following 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
Patient was taking Ursodiol. After Ursodiol was administered, patient encountered several 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.
Multiple concurrent drugs taken:
  • Bendamustine Hcl
  • Ramosetron Hydrochloride
  • Sennoside A
  • Sulfamethoxazole Sodium
  • Insulin Human
  • Entecavir
Patient was hospitalized.

Cardiac Failure Acute
Adverse event was reported on Dec 14, 2011 by a Female taking Ursodiol (Dosage: N/A) was diagnosed with and. Location: JAPAN , weighting 123.9 lb, Directly after, patient experienced the unwanted or unexpected Ursodiol side effects: cardiac failure acute.
Associated medications used:
  • 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
on Nov 25, 2011 Male from JAPAN , 27 years of age, was diagnosed with and was treated with Ursodiol. Patient felt the following 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
on Nov 17, 2011 Male from UNITED STATES , 63 years of age, weighting 149.9 lb, was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: bladder discomfort, cerebrovascular accident, peripheral arterial occlusive disease, chest pain, liver disorder. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • 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
Patient was taking Ursodiol. Directly after, patient experienced the unwanted or unexpected 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 and. Ursodiol dosage: 600 Mg,qd. Patient was hospitalized.

Muscle Haemorrhage, Blood Bilirubin Increased, Dyspnoea Exertional, Jaundice, Infection, Haemolysis
Adverse event was reported on Nov 15, 2011 by a Male taking Ursodiol (Dosage: 100 Mg, Unk) . Location: JAPAN , 68 years of age, Patient felt the following Ursodiol side effects: muscle haemorrhage, blood bilirubin increased, dyspnoea exertional, jaundice, infection, haemolysis.
Multiple prescriptions 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
on Nov 07, 2011 Male from SPAIN , 58 years of age, was diagnosed with and was treated with Ursodiol. After Ursodiol was administered, patient encountered several Ursodiol side effects: autoimmune hepatitis. Ursodiol dosage: N/A.
Multiple concurrent drugs taken:
  • Ezetimibe
  • Metformin Hcl
  • Doxazosin Mesylate
  • Glimepiride
  • Amlodipine
  • Enalapril Maleate
Patient was hospitalized.

Renal Impairment, Stomatitis, Hypoalbuminaemia, Diarrhoea, Venoocclusive Liver Disease, Pneumonia Staphylococcal, White Blood Cell Count Decreased, Non-hodgkin's Lymphoma, Thrombotic Microangiopathy
on Nov 09, 2011 Male from JAPAN , weighting 125.7 lb, was diagnosed with and was treated with Ursodiol. Directly after, patient experienced the unwanted or unexpected 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.
Associated medications used:
  • Acyclovir (Unk)
  • Famotidine (Unk)
  • Dalteparin Sodium (Unk)
  • Thymoglobulin (125 Mg, Qd)
  • Rebamipide (Unk)
  • Platelets (Unk)
  • Methylprednisolone Sodium Succinate (Unk)
  • Sulpyrine (Unk)
Patient was hospitalized.

Page 1 of 8 

Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

Track Your Side Effects - It's Easy and Free. >> Start Today

Already a User? Log In

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.

Tips for Taking Medicines Properly

Before Taking Ursodiol

Find Out How to Take Ursodiol

Discuss Ursodiol Side Effects

Did You Have a Ursodiol Side Effect?

Yes, Severe
Yes, Moderate
Yes, Minor
No

How Effective is Ursodiol for You?

Exceeded Expectations
Effective
Somewhat Effective
Not Effective


JustAnswer.com

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