URSODIOL

Ursodiol Adverse Events Reported to the FDA Over Time

How are Ursodiol adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Ursodiol, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Ursodiol is flagged as the suspect drug causing the adverse event.

Most Common Ursodiol Adverse Events Reported to the FDA

What are the most common Ursodiol adverse events reported to the FDA?

Interstitial Lung Disease	63 (2.71%)
Hepatic Function Abnormal	60 (2.58%)
Alanine Aminotransferase Increased	52 (2.24%)
Jaundice	45 (1.94%)
Aspartate Aminotransferase Increase...	38 (1.64%)
Pyrexia	38 (1.64%)
Condition Aggravated	35 (1.51%)
Liver Disorder	33 (1.42%)
Platelet Count Decreased	23 (.99%)
Lymphocyte Stimulation Test Positiv...	20 (.86%)
Diarrhoea	18 (.78%)
	Show More
Leukocytoclastic Vasculitis	18 (.78%)
Tubulointerstitial Nephritis	18 (.78%)
Fatigue	17 (.73%)
Pneumonia	17 (.73%)
Anaemia	16 (.69%)
Blood Alkaline Phosphatase Increase...	15 (.65%)
Blood Creatinine Increased	15 (.65%)
Disease Progression	15 (.65%)
Drug Exposure During Pregnancy	15 (.65%)
Rash	15 (.65%)
Autoimmune Hepatitis	14 (.6%)
Headache	14 (.6%)
Pruritus	14 (.6%)
Caesarean Section	13 (.56%)
Cholelithiasis	13 (.56%)
Drug Ineffective	13 (.56%)
Gamma-glutamyltransferase Increased	13 (.56%)
Malaise	13 (.56%)
Premature Baby	13 (.56%)
Toxic Epidermal Necrolysis	13 (.56%)
Blood Beta-d-glucan Increased	12 (.52%)
Blood Bilirubin Increased	12 (.52%)
Eosinophil Count Increased	12 (.52%)
Hepatic Enzyme Increased	12 (.52%)
Musculoskeletal Stiffness	12 (.52%)
Pleural Effusion	12 (.52%)
Cytomegalovirus Viraemia	11 (.47%)
Focal Segmental Glomerulosclerosis	11 (.47%)
Hepatic Neoplasm Malignant	11 (.47%)
Hypoalbuminaemia	11 (.47%)
Pneumocystis Jiroveci Pneumonia	11 (.47%)
Tracheobronchitis	11 (.47%)
White Blood Cell Count Decreased	11 (.47%)
Ascites	10 (.43%)
Maternal Drugs Affecting Foetus	10 (.43%)
Urticaria	10 (.43%)
Abdominal Pain	9 (.39%)
Agranulocytosis	9 (.39%)
Anorexia	9 (.39%)
Cerebral Infarction	9 (.39%)
Cholestasis	9 (.39%)
Convulsion	9 (.39%)
Drug Interaction	9 (.39%)
Dyspnoea	9 (.39%)
Erythema	9 (.39%)
Erythema Multiforme	9 (.39%)
Hypersensitivity	9 (.39%)
International Normalised Ratio Incr...	9 (.39%)
Sepsis	9 (.39%)
Vomiting	9 (.39%)
Allergic Granulomatous Angiitis	8 (.34%)
Asthma	8 (.34%)
Cough	8 (.34%)
Hepatic Failure	8 (.34%)
Hepatitis	8 (.34%)
Hepatitis Acute	8 (.34%)
Hypoxia	8 (.34%)
Nausea	8 (.34%)
Pancytopenia	8 (.34%)
Renal Disorder	8 (.34%)
Rhabdomyolysis	8 (.34%)
Schizophrenia	8 (.34%)
Bile Duct Stone	7 (.3%)
Disease Recurrence	7 (.3%)
Drug Eruption	7 (.3%)
Foetal Distress Syndrome	7 (.3%)
Gastric Ulcer	7 (.3%)
Hepatic Cirrhosis	7 (.3%)
Hepatitis C	7 (.3%)
Hypoaesthesia	7 (.3%)
Liver Transplant	7 (.3%)
Melaena	7 (.3%)
Off Label Use	7 (.3%)
Palpitations	7 (.3%)
Thrombocytopenia	7 (.3%)
Tremor	7 (.3%)
Vasculitis	7 (.3%)
Weight Decreased	7 (.3%)
Blood Immunoglobulin E Increased	6 (.26%)
Diabetes Mellitus	6 (.26%)
Hypokalaemia	6 (.26%)
Hyponatraemia	6 (.26%)
Liver Function Test Abnormal	6 (.26%)
Renal Failure Acute	6 (.26%)
Renal Impairment	6 (.26%)
Stevens-johnson Syndrome	6 (.26%)
Suicide Attempt	6 (.26%)
Toxic Skin Eruption	6 (.26%)
Blood Pressure Decreased	5 (.22%)
Death	5 (.22%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Ursodiol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ursodiol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Ursodiol

What are the most common Ursodiol adverse events reported to the FDA?

Hepatic And Hepatobiliary	236 (10.16%)
Hepatobiliary	142 (6.12%)
Hematology Investigations	120 (5.17%)
Epidermal And Dermal Conditions	114 (4.91%)
Lower Respiratory Tract Disorders	86 (3.7%)
Infections - Pathogen Unspecified	60 (2.58%)
Respiratory	57 (2.45%)
Therapeutic And Nontherapeutic Effe...	41 (1.77%)
Body Temperature Conditions	40 (1.72%)
Gastrointestinal Signs	40 (1.72%)
Neurological	38 (1.64%)
	Show More
Nephropathies	35 (1.51%)
Viral Infectious	35 (1.51%)
Anemias Nonhemolytic And Marrow Dep...	33 (1.42%)
Renal Disorders	33 (1.42%)
Chemical Injury And Poisoning	25 (1.08%)
Gastrointestinal Motility And Defec...	23 (.99%)
Renal And Urinary Tract Investigati...	23 (.99%)
Bile Duct	22 (.95%)
Enzyme	22 (.95%)
Central Nervous System Vascular	21 (.9%)
Gallbladder	21 (.9%)
Musculoskeletal And Connective Tiss...	21 (.9%)
Skin Vascular Abnormalities	21 (.9%)
White Blood Cell	21 (.9%)
Gastrointestinal Hemorrhages	18 (.78%)
Hepatobiliary Neoplasms Malignant A...	18 (.78%)
Microbiology And Serology	18 (.78%)
Neonatal And Perinatal Conditions	18 (.78%)
Appetite And General Nutritional	17 (.73%)
Bacterial Infectious	17 (.73%)
Electrolyte And Fluid Balance Condi...	17 (.73%)
Muscle	17 (.73%)
Physical Examination Topics	17 (.73%)
Urinary Tract Signs	17 (.73%)
Allergic Conditions	16 (.69%)
Fungal Infectious	15 (.65%)
Immunology And Allergy	15 (.65%)
Medication Errors	15 (.65%)
Fetal Complications	14 (.6%)
Glucose Metabolism Disorders	14 (.6%)
Headaches	14 (.6%)
Protein And Amino Acid Metabolism	14 (.6%)
Cardiac And Vascular Investigations	13 (.56%)
Obstetric And Gynecological Therape...	13 (.56%)
Upper Respiratory Tract Disorders	13 (.56%)
Gastrointestinal Inflammatory Condi...	12 (.52%)
Gastrointestinal Ulceration And Per...	12 (.52%)
Movement Disorders	12 (.52%)
Pleural	12 (.52%)
Fatal Outcomes	11 (.47%)
Angiedema And Urticaria	10 (.43%)
Maternal Complications Of Labour An...	10 (.43%)
Oral Soft Tissue Conditions	10 (.43%)
Peritoneal And Retroperitoneal Cond...	10 (.43%)
Therapeutic Procedures And Supporti...	10 (.43%)
Thyroid Gland	10 (.43%)
Bronchial Disorders	9 (.39%)
Cardiac Arrhythmias	9 (.39%)
Lifestyle Issues	9 (.39%)
Lipid Metabolism	9 (.39%)
Platelet	9 (.39%)
Seizures	9 (.39%)
Vascular Inflammations	9 (.39%)
Coagulopathies And Bleeding Diathes...	8 (.34%)
Neuromuscular	8 (.34%)
Protein And Chemistry Analyses	8 (.34%)
Schizophrenia And Other Psychotic	8 (.34%)
Spleen, Lymphatic And Reticulendoth...	8 (.34%)
Water, Electrolyte And Mineral	8 (.34%)
Cardiac Disorder Signs	7 (.3%)
Exocrine Pancreas Conditions	7 (.3%)
Gastrointestinal Vascular Condition...	7 (.3%)
Hepatobiliary Therapeutic Procedure...	7 (.3%)
Metabolic, Nutritional And Blood Ga...	7 (.3%)
Musculoskeletal And Connective Tiss...	7 (.3%)
Procedural And Device Related Injur...	7 (.3%)
Bone, Calcium, Magnesium And Phosph...	6 (.26%)
Encephalopathies	6 (.26%)
Immune	6 (.26%)
Joint	6 (.26%)
Skin Appendage Conditions	6 (.26%)
Suicidal And Self-injurious Behavio...	6 (.26%)
Tendon, Ligament And Cartilage	6 (.26%)
Abortions And Stillbirth	5 (.22%)
Acid-base	5 (.22%)
Gastrointestinal Stenosis And Obstr...	5 (.22%)
Heart Failures	5 (.22%)
Psychiatric	5 (.22%)
Vascular	5 (.22%)
Vascular Hypertensive	5 (.22%)
Anxiety Disorders	4 (.17%)
Cardiac And Vascular Disorders Cong...	4 (.17%)
Connective Tissue Disorders	4 (.17%)
Cranial Nerve Disorders	4 (.17%)
Decreased And Nonspecific Blood Pre...	4 (.17%)
Dental And Gingival Conditions	4 (.17%)
Gastrointestinal Neoplasms Malignan...	4 (.17%)
Hematological	4 (.17%)
Leukemias	4 (.17%)
Metastases	4 (.17%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Ursodiol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Ursodiol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.