PatientsVille.com Logo

Ursodiol Side Effects

PatientsVille

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.

Ursodiol Side Effects Reported to FDA



Ursodiol Side Effect Report#9832706
Hepatomegaly, Abdominal Discomfort, Gastrointestinal Sounds Abnormal, Diarrhoea, Gastrooesophageal Reflux Disease, Haemorrhoids
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: biliary cirrhosis primary, who was treated with Ursodiol (watson Laboratories) (dosage: 2 Df, Daily, start time:
Sep 18, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hepatomegaly, Abdominal Discomfort, Gastrointestinal Sounds Abnormal, Diarrhoea, Gastrooesophageal Reflux Disease, Haemorrhoids after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol (watson Laboratories) treatment in female patients, resulting in Hepatomegaly side effect.
Ursodiol Side Effect Report#9675056
Liver Transplant, Hallucination, Diabetes Mellitus, Foreign Body, Hypertension, Heart Rate Increased, Gallbladder Disorder, Cholangitis Sclerosing
This report suggests a potential Ursodiol Liver Transplant side effect(s) that can have serious consequences. A 59-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome and used Ursodiol (dosage: NA) starting 2000. After starting Ursodiol the patient began experiencing various side effects, including: Liver Transplant, Hallucination, Diabetes Mellitus, Foreign Body, Hypertension, Heart Rate Increased, Gallbladder Disorder, Cholangitis SclerosingAdditional drugs used concurrently:
  • Cyclosporine
  • Prograf
  • Gabapentin
  • Sulfameth
  • Trimethoprim
  • Lovastatin
  • Amitriptyline
  • Citalopram
Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Liver Transplant, may still occur.
Ursodiol Side Effect Report#9653350
Hypersensitivity, Swollen Tongue, Pharyngeal Oedema, Urticaria, Rash
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: biliary cirrhosis. On 201303 this consumer started treatment with Ursodiol (dosage: NA). The following drugs were being taken at the same time:
  • Levothyroxine
When using Ursodiol, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Swollen Tongue, Pharyngeal Oedema, Urticaria, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hypersensitivity, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8932469
Pruritus, Product Substitution Issue
This Pruritus side effect was reported by a physician from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: sclerosing cholangitis,cirrhosis liver.The patient was prescribed Ursodiol (drug dosage: 2 Tablets), which was initiated on
Nov 29, 2005. Concurrently used drugs: NA..After starting to take Ursodiol the consumer reported adverse symptoms, such as: Pruritus, Product Substitution IssueThese side effects may potentially be related to Ursodiol.
Ursodiol Side Effect Report#8929206
Contusion, Gingival Bleeding, Bleeding Time Prolonged
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: gallbladder disorder,prophylaxis, who was treated with Ursodiol Capsules (dosage: 2 Times A Day, start time:
Oct 21, 2012), combined with: NA. and developed a serious reaction and side effect(s): Contusion, Gingival Bleeding, Bleeding Time Prolonged after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol Capsules treatment in female patients, resulting in Contusion side effect.
Ursodiol Side Effect Report#8739735
Anaphylactic Shock, Oropharyngeal Pain, Hepatic Function Abnormal, Influenza A Virus Test Positive, Pneumonia Influenzal
This report suggests a potential Ursodiol Anaphylactic Shock side effect(s) that can have serious consequences. A 21-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: NA and used Ursodiol (dosage: Unk, Oral) starting NS. After starting Ursodiol the patient began experiencing various side effects, including: Anaphylactic Shock, Oropharyngeal Pain, Hepatic Function Abnormal, Influenza A Virus Test Positive, Pneumonia InfluenzalAdditional drugs used concurrently:
  • Allopurinol (Unk, Oral)
  • Atorvastatin Calcium (Oral)
  • Immunoglobulin
  • Sesden (timepidium Bromide)
The patient was hospitalized. Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anaphylactic Shock, may still occur.
Ursodiol Side Effect Report#8487495-1
Hepatic Function Abnormal, Maternal Exposure During Pregnancy
This Hepatic Function Abnormal problem was reported by a health professional from Japan. A 36-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 19, 2012 this consumer started treatment with Ursodiol (dosage: 300 Mg, Qd, Oral). The following drugs were being taken at the same time:
  • Maglax (magnesium Oxide)
When using Ursodiol, the patient experienced the following unwanted symptoms/side effects: Hepatic Function Abnormal, Maternal Exposure During PregnancyThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Function Abnormal, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8452311-0
Type 2 Diabetes Mellitus, Fatigue, Polydipsia, Hospitalisation
This Type 2 Diabetes Mellitus side effect was reported by a physician from Canada. A 33-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ursodiol (drug dosage: NA), which was initiated on
Oct 05, 2011. Concurrently used drugs:
  • Calcium
  • Folic Acid
  • Vitamin D
  • Lyrica
  • Prednisone Tab
  • Mycophenolate Mofetil
  • Cymbalta
  • Prednisone Tab (Unk)
.After starting to take Ursodiol the consumer reported adverse symptoms, such as: Type 2 Diabetes Mellitus, Fatigue, Polydipsia, HospitalisationThese side effects may potentially be related to Ursodiol. The patient was hospitalized.
Ursodiol Side Effect Report#8421199-6
Feeling Abnormal, Diarrhoea, Fall, Tremor, Muscle Spasms, Cough, Nausea, Muscle Twitching, Urticaria
This is a report of a 53-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Ursodiol (dosage: 300 Mg Bid Po, start time:
Jan 27, 2012), combined with: NA. and developed a serious reaction and side effect(s): Feeling Abnormal, Diarrhoea, Fall, Tremor, Muscle Spasms, Cough, Nausea, Muscle Twitching, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol treatment in male patients, resulting in Feeling Abnormal side effect.
Ursodiol Side Effect Report#8410607-2
Myositis, Atrial Fibrillation, Blood Creatine Phosphokinase Increased
This report suggests a potential Ursodiol Myositis side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from Canada was diagnosed with the following symptoms/conditions: NA and used Ursodiol (dosage: NA) starting
Dec 14, 2010. After starting Ursodiol the patient began experiencing various side effects, including: Myositis, Atrial Fibrillation, Blood Creatine Phosphokinase IncreasedAdditional drugs used concurrently:
  • Aspirin
  • Rabeprazole Sodium
  • Multaq
  • Aspirin
Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myositis, may still occur.
Ursodiol Side Effect Report#8402783
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
This Liver Disorder problem was reported by a physician from JP. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: cholestasis,prophylaxis against gastrointestinal ulcer. On
May 13, 2011 this consumer started treatment with Ursodiol (dosage: 600 Mg, Qd, Oral). The following drugs were being taken at the same time:
  • Famotidine (20 Mg, Qd, Oral)
  • Wystal (cefoperazone Sodium, Sulbactam Sodium)
  • Panabate (gabexate Mesilate)
  • Rabeprazole Sodium
When using Ursodiol, the patient experienced the following unwanted symptoms/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 AbnormalThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Liver Disorder, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8338014-1
Bacterial Infection, Bite, Arthralgia, Injection Site Swelling, Device Malfunction, Anxiety, Injection Site Haematoma, Cellulitis, Injection Site Erythema
This Bacterial Infection side effect was reported by a physician from United States. A female patient (weight:NA) experienced the following symptoms/conditions: gallbladder disorder,gastrooesophageal reflux disease,vitamin supplementation.The patient was prescribed Ursodiol (drug dosage: NA), which was initiated on
May 01, 2011. Concurrently used drugs:
  • Omeprazole
  • Multi-vitamins
  • Lorazepam
  • Paroxetine
  • Verapamil
  • Folic Acid
  • Astelin
  • Lisinopril
.After starting to take Ursodiol the consumer reported adverse symptoms, such as: Bacterial Infection, Bite, Arthralgia, Injection Site Swelling, Device Malfunction, Anxiety, Injection Site Haematoma, Cellulitis, Injection Site ErythemaThese side effects may potentially be related to Ursodiol. The patient was hospitalized.
Ursodiol Side Effect Report#8336418
Cerebral Infarction, Interstitial Lung Disease, Hypokalaemia, Oedema Peripheral, Hypoglycaemia, Pancreatitis Chronic, Diarrhoea, Malabsorption
This is a report of a 57-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: alcoholic liver disease,cerebral infarction, who was treated with Ursodiol (dosage: 400 Mg, Qd, Oral, start time:
Nov 07, 2011), combined with:
  • 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)
and developed a serious reaction and side effect(s): Cerebral Infarction, Interstitial Lung Disease, Hypokalaemia, Oedema Peripheral, Hypoglycaemia, Pancreatitis Chronic, Diarrhoea, Malabsorption after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol treatment in male patients, resulting in Cerebral Infarction side effect. The patient was hospitalized.
Ursodiol Side Effect Report#8317135-3
Deep Vein Thrombosis
This report suggests a potential Ursodiol Deep Vein Thrombosis side effect(s) that can have serious consequences. A 73-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Ursodiol (dosage: NA) starting
May 13, 2011. After starting Ursodiol the patient began experiencing various side effects, including: Deep Vein ThrombosisAdditional drugs used concurrently:
  • 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
Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Deep Vein Thrombosis, may still occur.
Ursodiol Side Effect Report#8303981-9
Sepsis, Bacteraemia, Small Intestinal Obstruction, Multi-organ Failure, Fungaemia, Escherichia Urinary Tract Infection, Urinary Tract Infection Enterococcal
This Sepsis problem was reported by a physician from United States. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 28, 2006 this consumer started treatment with Ursodiol (dosage: 300 Mg, Tid). The following drugs were being taken at the same time:
  • 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)
When using Ursodiol, the patient experienced the following unwanted symptoms/side effects: Sepsis, Bacteraemia, Small Intestinal Obstruction, Multi-organ Failure, Fungaemia, Escherichia Urinary Tract Infection, Urinary Tract Infection EnterococcalAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sepsis, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8297880-9
Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease
This Death side effect was reported by a physician from Japan. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Ursodiol (drug dosage: Unk), which was initiated on
Mar 02, 2010. Concurrently used drugs:
  • 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)
.After starting to take Ursodiol the consumer reported adverse symptoms, such as: Chronic Graft Versus Host Disease, Acute Graft Versus Host DiseaseThese side effects may potentially be related to Ursodiol.
Ursodiol Side Effect Report#8249480-4
Hypoaesthesia, Hypokalaemia, Malabsorption, Hypoglycaemia, Pancreatitis Chronic, Interstitial Lung Disease, Oedema Peripheral, Respiratory Rate Increased, Pyrexia
This is a report of a 57-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Ursodiol (dosage: 400 Mg, Qd, Oral, start time:
Nov 07, 2011), combined with:
  • Ozagrel /01030902/ (ozagrel Sodium) (160 Mg, Qd, Intravenous)
  • Plavix (75 Mg, Qd, Oral)
and developed a serious reaction and side effect(s): Hypoaesthesia, Hypokalaemia, Malabsorption, Hypoglycaemia, Pancreatitis Chronic, Interstitial Lung Disease, Oedema Peripheral, Respiratory Rate Increased, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol treatment in male patients, resulting in Hypoaesthesia side effect. The patient was hospitalized.
Ursodiol Side Effect Report#8243720-3
Suicidal Ideation, Hypersomnia, Delusion
This report suggests a potential Ursodiol Suicidal Ideation side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hepatic steatosis and used Ursodiol (dosage: NA) starting
Apr 14, 2011. After starting Ursodiol the patient began experiencing various side effects, including: Suicidal Ideation, Hypersomnia, DelusionAdditional drugs used concurrently:
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Emsam
  • Levothyroxine Sodium
  • Nifedipine
Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Ursodiol Side Effect Report#8219893-5
Hepatic Enzyme Increased, Cushingoid
This Hepatic Enzyme Increased problem was reported by a health professional from Turkey. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Ursodiol (dosage: NA). The following drugs were being taken at the same time:
  • Budesonide
  • Azathioprine
  • Budesonide
When using Ursodiol, the patient experienced the following unwanted symptoms/side effects: Hepatic Enzyme Increased, CushingoidAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Enzyme Increased, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8217829-4
Hepatic Cirrhosis, Hepatitis, Hypotension, Multi-organ Failure
This Hepatic Cirrhosis side effect was reported by a consumer or non-health professional from Brazil. A 40-year-old patient (weight:NA) experienced the following symptoms/conditions: hepatitis.The patient was prescribed Ursodiol (drug dosage: 300 Mg, Per Oral), which was initiated on
Jan 01, 2012. Concurrently used drugs:
  • 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
.After starting to take Ursodiol the consumer reported adverse symptoms, such as: Hepatic Cirrhosis, Hepatitis, Hypotension, Multi-organ FailureThese side effects may potentially be related to Ursodiol. The patient was hospitalized.
Ursodiol Side Effect Report#8204826-8
Colitis Ulcerative
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Ursodiol (dosage: NA, start time:
Jan 16, 2012), combined with:
  • Remicade
  • Probiotic
  • Remicade
  • Prednisone
  • Remicade
  • Multiple Vitamin
and developed a serious reaction and side effect(s): Colitis Ulcerative after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol treatment in female patients, resulting in Colitis Ulcerative side effect. The patient was hospitalized.
Ursodiol Side Effect Report#8197126-6
Haemolytic Anaemia, Cerebral Haemorrhage, Acute Graft Versus Host Disease, Idiopathic Thrombocytopenic Purpura
This report suggests a potential Ursodiol Haemolytic Anaemia side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: prophylaxis and used Ursodiol (dosage: 75 Mg, Bid) starting
May 23, 2009. After starting Ursodiol the patient began experiencing various side effects, including: Haemolytic Anaemia, Cerebral Haemorrhage, Acute Graft Versus Host Disease, Idiopathic Thrombocytopenic PurpuraAdditional drugs used concurrently:
  • 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)
Although Ursodiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemolytic Anaemia, may still occur.
Ursodiol Side Effect Report#8196192-1
Pneumoperitoneum, Ascites, Intestinal Dilatation, Infectious Peritonitis, Necrotising Colitis
This Pneumoperitoneum problem was reported by a pharmacist from Malaysia. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 17, 2011 this consumer started treatment with Ursodiol (dosage: NA). The following drugs were being taken at the same time:
  • Phenylephrine Hcl ((1 Gtt Befpre Procedure Ophthalmic))
  • Mydriacyl ((1 Gtt Before Procedure Ophthalmic))
  • Metoclopramide
  • Sodium Phosphate
When using Ursodiol, the patient experienced the following unwanted symptoms/side effects: Pneumoperitoneum, Ascites, Intestinal Dilatation, Infectious Peritonitis, Necrotising ColitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumoperitoneum, may become evident only after a product is in use by the general population.
Ursodiol Side Effect Report#8188698-6
Bile Duct Cancer
This Bile Duct Cancer side effect was reported by a physician from Romania. A male patient (weight:NA) experienced the following symptoms/conditions: cholangitis sclerosing,hepatic cirrhosis,crohn's disease.The patient was prescribed Ursodiol (drug dosage: NA), which was initiated on
Jan 01, 1986. Concurrently used drugs:
  • Propranolol
  • Azathioprine
  • Spironolactone
  • Propranolol
  • Infliximab, Recombinant
  • Furosemide
  • Prednisone Tab
.After starting to take Ursodiol the consumer reported adverse symptoms, such as: Bile Duct CancerThese side effects may potentially be related to Ursodiol.
Ursodiol Side Effect Report#8143723-3
Toxicity To Various Agents
This is a report of a male patient (weight: NA) from Belgium, suffering from the following health symptoms/conditions: NA, who was treated with Ursodiol (dosage: Unk, start time:
Jan 07, 2012), combined with:
  • Nexium (Unk)
  • Tranexamic Acid (Unk)
  • Ganciclovir (Unk)
  • Temocillin (Unk)
  • Ranitidine (Unk)
  • Alizapride (Unk)
  • Tacrolimus (1.6 Mg, Bid)
  • Sandostatin (Unk)
and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Ursodiol treatment in male patients, resulting in Toxicity To Various Agents side effect.


1 of 8 


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.


Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • 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 Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.

    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 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.

    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

    Ursodiol Safety Alerts, Active Ingredients, Usage Information

    NDC0115-1524
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameURSODIOL
    NameURSODIOL
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20111223
    LabelerGlobal Pharmaceuticals, Division of Impax Laboratories, Inc.
    Active Ingredient(s)URSODIOL
    Strength(s)250
    Unit(s)mg/1
    Pharma ClassBile Acid [EPC],Bile Acids and Salts [Chemical/Ingredient]

    Ursodiol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 194

    Ursodiol safety alerts: No

    Reported deaths: 32

    Reported hospitalizations: 92

    Latest Ursodiol clinical trials