Ursodiol

Side effects and indications

Whenever possible, frequency information about the side effects was extracted from the labels. Aggregated frequency information for the drug and, if available, placebo is shown. To the right, you can click on shaded boxes to be taken to mentions of the side effect on the label. (In some cases, the side effect cannot be highlighted due to conversion problems.) Information about indications was extracted from the indications and usage sections of the labels.

Show MedDRA Preferred Terms

Side effect Data for drug Placebo Labels (show all 11)
1 2 3 4 5 6 7 8 9 10
Constipation def postmarketing, 9.68% - 54.8% 8.8% - 45.3% x x x x x x
Diarrhoea def postmarketing, 25.2% - 52.3% 20.9% - 42.8% x x x x x x x x x x
Headache def postmarketing, 18.1% - 51.6% 21.4% - 49.1% x x x x x x x
Abdominal pain def postmarketing, 6.2% - 43.2% 12% - 44% x x x x x x x x x x
Pain def postmarketing, 3.2% - 43.2% 4.6% - 44% x x x x x x x x x x
Nausea def postmarketing, 14.2% - 36.1% 13.2% - 27% x x x x x x x x x x
Dizziness def postmarketing, 16.5% - 34.2% 12.9% - 26.4% x x x x x x x
Vomiting def postmarketing, 9.68% - 28.4% 6.9% - 27.7% x x x x x x x x
Infection def 6.45% - 25.8% 4.4% - 25.8% x x x x x x
Back pain def 7.1% - 24.5% 6.46% - 13.2% x x x x x x
Viral infection def 9% - 19.4% 8.9% - 25.8% x x x x
Dyspepsia def postmarketing, 16.8% 11.3% x x x x x x x x x x
Fatigue def 4.5% - 16.1% 5% - 20.8% x x x x
Respiratory tract infection def 12.4% - 15.5% 10.8% - 13.2% x x
Upper respiratory tract infection def 12.4% - 15.5% 10.8% - 13.2% x x
Influenza def 6.5% - 13.5% 5.8% - 11.9% x x x x x
Musculoskeletal pain def 5.9% - 12.3% 4.6% - 9.43% x x x x
Dysmenorrhoea def 5.59% - 11.6% 5.8% - 11.9% x x x x
Sinusitis def 5.28% - 11% 5.5% - 11.3% x x x x x
Alopecia def postmarketing, 5.28% - 11% 2.46% - 5.03% x x x x x x
Flatulence def postmarketing, 4.66% - 9.68% 7.38% - 15.1% x x x x x x
Pharyngitis def 3.1% - 8.4% 3.1% - 11.9% x x x x x x
Arthralgia def 7.7% - 7.74% 15.1% x x x x x
Cough def postmarketing, 7.1% 4.4% x x x x x x
Bronchitis def 6.45% - 6.5% 3.77% - 3.8% x x x x x x
Urinary tract infection def 6.45% - 6.5% 4.4% x x x x x x
Arthritis def 5.8% - 5.81% 2.5% - 2.52% x x x x x
Myalgia def postmarketing, 5.8% - 5.81% 5.66% - 5.7% x x x x x x
Cholecystitis def 5.16% - 5.2% 4.4% x x x x
Hypersensitivity def postmarketing, 5.16% - 5.2% 4.4% x x x x x
Rhinitis def 5.16% - 5.2% 6.9% - 6.92% x x x x x x
Gastrointestinal disorder def postmarketing, 3.87% - 3.9% 5% - 5.03% x x x x x x
Chest pain def 3.2% - 3.23% 6.29% - 6.3% x x x x x x x x x
Insomnia def 1.9% - 1.94% 5% - 5.03% x x x x x
Angioedema def postmarketing x
Connective tissue disorder def postmarketing x
Drug hypersensitivity def postmarketing x
Oedema def postmarketing x x x x x x
Rash def postmarketing x x x x x x
Body temperature increased def postmarketing x x x x
Immune system disorder def postmarketing x x
Laryngeal oedema def postmarketing x
Mediastinal disorder def postmarketing x x
Nervous system disorder def postmarketing x x
Pruritus def postmarketing x x x x x x
Urticaria def postmarketing x x
Oedema peripheral def postmarketing x x x x x x
Malaise def postmarketing x x
Abdominal discomfort postmarketing x
Discomfort def postmarketing x
Face oedema def postmarketing x
Drug interaction def postmarketing x
Dissecting aortic aneurysm, thoracic postmarketing x x
Amblyopia def x
Amnesia def x
Amyloidosis def x
Anaemia def x x x x
Haemolytic anaemia def x
Angina pectoris def x
Anorexia def x x x x x x
Arrhythmia def x x
Asthenia def x x x x x x
Asthma def x
Atrial fibrillation def x
Bone disorder def x
Breast disorder def x
Cardiovascular disorder def x x
Cellulitis def x
Neck pain def x
Confusional state def x
Conjunctivitis def x
Cystitis def x
Cyst def x x x x
Deafness def x
Dysphagia def x x
Dehydration def x
Diabetes mellitus def x x x x
Diplopia def x
Duodenal ulcer def x
Dyspnoea def x x
Dysuria def x
Ear disorder def x
Ecchymosis def x
Effusion def x
Epistaxis def x
Eructation def x
Oesophagitis def x x x x x
Eye disorder def x x
Fibrocystic breast disease def x
Fibrosis def x
Pathological fracture def x
Gastritis def x
Gastrointestinal haemorrhage def x
Granuloma def x
Block heart def x
Cardiac disorder def x
Cardiomegaly def x
Cardiac failure def x
Cardiac failure congestive def x
Haematuria def x
Haemorrhage def x
Herpes NOS def x
Herpes simplex def x
Hypertension def x x x x x
Pulmonary hypertension def x
Hypertrophy def x
Salivary gland enlargement x
Hypotension def x
Orthostatic hypotension def x
Incontinence def x
Infarction def x
Cramps of lower extremities x
Leukopenia def x x x x x
Breast mass def x
Lung disorder def x
Melaena def x x x x
Menorrhagia def x
Miliaria def x
Cramp muscle def x
Myocardial infarction def x
Neoplasm def x x x x
Nervousness def x
Nodule def x
Nocturia def x
Otitis def x
Otitis media def x
Palpitations def x
Pancreatitis def x
Paraesthesia def x x
Peptic ulcer def x x x x x
Pericardial effusion def x
Pericarditis def x
Pleural disorder def x
Pleural effusion def x
Pneumonia def x x x x
Polyp def x
Psoriasis def x
Pulmonary fibrosis def x
Lung nodule x
Renal failure def x
Respiratory disorder def x x
Retinal disorder def x
Seizures def x
Skin disorder def x x
Skin ulcer def x
Gastric disorder def x
Gastric ulcer def x
Cerebrovascular accident def x
Sweating def x
Syncope def x
Tachycardia def x
Thrombocytopenia def x x x x x x
Tinnitus def x
Ulcer def x x x x x x
Pollakiuria def x
Urinary incontinence def x
Urinary tract disorder def x
Vaginal inflammation def x
Angiopathy def x
Vasodilation def x
Plantar warts x
Vertigo def x
Visual impairment def x
Common wart def x
Weight increased def x
Dry mouth def x
Chills def x
Cataract def x
Hepatic function abnormal x x x
Migraine def x x
Atrioventricular block complete def x
Creatinine increased def x x x x
Generalised oedema x
Skin hypertrophy x
Biliary colic def x
Bone pain def x
Retrosternal pain x
Skin discolouration def x
Interstitial pneumonia x x x
Cardiac fibrillation x
Tenderness def x
Lung infiltration x
Hepatic enzyme increased x
Hepatobiliary disease def x
Ulcer haemorrhage x
Renal impairment def x
Photosensitivity def x
Laboratory test abnormal x
Lymphadenopathy def x
Distress gastrointestinal x
Blood glucose increased x x x x
Acne def x
Infestation NOS x
Sore nose x
Glucose increased x
Cardiomyopathy def x
Flu symptoms x
Breast neoplasm def x x x x
Insufficiency renal def x
Somnolence def x
Indication Labels
Biliary cirrhosis def x x x x x
Biliary cirrhosis primary def x x x x x
Cholecystolithiasis def x x x x
Cholestasis def x
Cytolysis def x
Decompensated cirrhosis x x x
Disease progression def x
Elderly def x
Hepatic cirrhosis def x x x x x
Hepatocellular injury x
Liver disorder def x x x
Myeloproliferative disorder def x
Premenstrual syndrome def x
Thrombocytosis def x
Thrombosis def x
Weight decreased def x x x x

Information

More information: STITCH, PubChem and possibly Wikipedia

ATC Codes: A05AA01, A05AA02

Legend

Color scheme: standard – alternative

100%    
75%    
50%    
10%    
frequent (1% to 100%)    
infrequent (0.1% to 1%)    
rare (<0.1%)    
postmarketing    
0%    
no frequency information    
not found on label    

Labels

Labels were obtained from different sources and potentially contain different sets of side effects. If you click on the label name, a HTML version of the label will be shown with proteins, chemicals and side efffects highlighted using Reflect.

  1. ursodiol : 26 side effects (FDA XML label)
  2. URSODIOL / PHL-URSODIOL C : 29 side effects (Health Canada)
  3. URSODIOL / PMS-URSODIOL C : 29 side effects (Health Canada)
  4. URSODIOL : 32 side effects (FDA XML label)
  5. URSODIOL : 32 side effects (FDA XML label)
  6. URSODIOL : 34 side effects (FDA XML label)
  7. URSODIOL : 34 side effects (FDA XML label)
  8. URSODIOL : 40 side effects (FDA XML label)
  9. URSODIOL / URSO : 99 side effects (Health Canada)
  10. URSODIOL / DOM-URSODIOL C : 123 side effects (Health Canada)