Drug Information
Side Effects > Ursodiol

Ursodiol Side Effects

Brand Names: Urso, Actigall

Please note - some side effects for Ursodiol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Ursodiol - for the consumer


Ursodiol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ursodiol:

Constipation; diarrhea; dry skin; gas; headache; indigestion; metallic taste; muscle or joint pain; nausea; skin rash; stomach pain; swelling; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur when using Ursodiol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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For the professional


Ursodiol

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

GALLSTONE DISSOLUTION
Ursodiol Placebo
8-10 mg/kg/day
(N=155) (N=159)
N (%) N (%)
Body as a Whole
Allergy 8 (5.2) 7 (4.4)
Chest Pain 5 (3.2) 10 (6.3)
Fatigue 7 (4.5) 8 (5.0)
Infection Viral 30 (19.4) 41 (25.8)
Digestive System
Abdominal Pain 67 (43.2) 70 (44.0)
Cholecystitis 8 (5.2) 7 (4.4)
Constipation 15 (9.7) 14 (8.8)
Diarrhea 42 (27.1) 34 (21.4)
Dyspepsia 26 (16.8) 18 (11.3)
Flatulence 12 (7.7) 12 (7.5)
Gastrointestinal
Disorder 6 (3.9) 8 (5.0)
Nausea 22 (14.2) 27 (17.0)
Vomiting 15 (9.7) 11 (6.9)
Musculoskeletal System
Arthralgia 12 (7.7) 24 (15.1)
Arthritis 9 (5.8) 4 (2.5)
Back Pain 11 (7.1) 18 (11.3)
Myalgia 9 (5.8) 9 (5.7)
Nervous System
Headache 28 (18.1) 34 (21.4)
Insomnia 3 (1.9) 8 (5.0)
Respiratory System
Bronchitis 10 (6.5) 6 (3.8)
Coughing 11 (7.1) 7 (4.4)
Pharyngitis 13 (8.4) 5 (3.1)
Rhinitis 8 (5.2) 11 (6.9)
Sinusitis 17 (11.0) 18 (11.3)
Upper Respiratory
Tract Infection 24 (15.5) 21 (13.2)
Urogenital System
Urinary Tract
Infection 10 (6.5) 7 (4.4)
GALLSTONE PREVENTION
Ursodiol Placebo
600 mg
(N=322) (N=325)
N (%) N (%)
Body as a Whole
Fatigue 25 (7.8) 33 (10.2)
Infection Viral 29 (9.0) 29 (8.9)
Influenza-like
Symptoms 21 (6.5) 19 (5.8)
Digestive System
Abdominal Pain 20 (6.2) 39 (12.0)
Constipation 85 (26.4) 72 (22.2)
Diarrhea 81 (25.2) 68 (20.9)
Flatulence 15 (4.7) 24 (7.4)
Nausea 56 (17.4) 43 (13.2)
Vomiting 44 (13.7) 44 (13.5)
Musculoskeletal System
Back Pain 38 (11.8) 21 (6.5)
Musculoskeletal
Pain 19 (5.9) 15 (4.6)
Nervous System
Dizziness 53 (16.5) 42 (12.9)
Headache 80 (24.8) 78 (24.0)
Respiratory System
Pharyngitis 10 (3.1) 19 (5.8)
Sinusitis 17 (5.3) 18 (5.5)
Upper Respiratory
Tract Infection 40 (12.4) 35 (10.8)
Skin and Appendages
Alopecia 17 (5.3) 8 (2.5)
Urogenital System
Dysmenorrhea 18 (5.6) 19 (5.8)

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Ursodiol Capsules

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

Gallstone Dissolution
Ursodiol Placebo
8-10 mg/kg/day
(N=155) (N=159)
N (%) N (%)
Body as a Whole
Allergy 8 (5.2) 7 (4.4)
Chest Pain 5 (3.2) 10 (6.3)
Fatigue 7 (4.5) 8 (5.0)
Infection Viral 30 (19.4) 41 (25.8)
Digestive System
Abdominal Pain 67 (43.2) 70 (44.0)
Cholecystitis 8 (5.2) 7 (4.4)
Constipation 15 (9.7) 14 (8.8)
Diarrhea 42 (27.1) 34 (21.4)
Dyspepsia 26 (16.8) 18 (11.3)
Flatulence 12 (7.7) 12 (7.5)
Gastrointestinal Disorder 6 (3.9) 8 (5.0)
Nausea 22 (14.2) 27 (17.0)
Vomiting 15 (9.7) 11 (6.9)
Musculoskeletal System
Arthralgia 12 (7.7) 24 (15.1)
Arthritis 9 (5.8) 4 (2.5)
Back Pain 11 (7.1) 18 (11.3)
Myalgia 9 (5.8) 9 (5.7)
Nervous System
Headache 28 (18.1) 34 (21.4)
Insomnia 3 (1.9) 8 (5.0)
Respiratory System
Bronchitis 10 (6.5) 6 (3.8)
Coughing 11 (7.1) 7 (4.4)
Pharyngitis 13 (8.4) 5 (3.1)
Rhinitis 8 (5.2) 11 (6.9)
Sinusitis 17 (11.0) 18 (11.3)
Upper Respiratory Tract Infection 24 (15.5) 21 (13.2)
Urogenital System
Urinary Tract Infection 10 (6.5) 7 (4.4)
Gallstone Prevention
Ursodiol Placebo
600 mg
(N=322) (N=325)
N (%) N (%)
Body as a Whole
Fatigue 25 (7.8) 33 (10.2)
Infection Viral 29 (9.0) 29 (8.9)
Influenza-like Symptoms 21 (6.5) 19 (5.8)
Digestive System
Abdominal Pain 20 (6.2) 39 (12.0)
Constipation 85 (26.4) 72 (22.2)
Diarrhea 81 (25.2) 68 (20.9)
Flatulence 15 (4.7) 24 (7.4)
Nausea 56 (17.4) 43 (13.2)
Vomiting 44 (13.7) 44 (13.5)
Musculoskeletal System
Back Pain 38 (11.8) 21 (6.5)
Musculoskeletal Pain 19 (5.9) 15 (4.6)
Nervous System
Dizziness 53 (16.5) 42 (12.9)
Headache 80 (24.8) 78 (24.0)
Respiratory System
Pharyngitis 10 (3.1) 19 (5.8)
Sinusitis 17 (5.3) 18 (5.5)
Upper Respiratory Tract Infection 40 (12.4) 35 (10.8)
Skin and Appendages
Alopecia 17 (5.3) 8 (2.5)
Urogenital System
Dysmenorrhea 18 (5.6) 19 (5.8)

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Ursodiol Capsules 300mg

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

GALLSTONE DISSOLUTION
Urosodiol
8-10 mg/kg/day
(N=155)
Placebo

(N=159)
N (%) N (%)
Body as a Whole
   Allergy 8 (5.2) 7 (4.4)
   Chest Pain 5 (3.2) 10 (6.3)
   Fatigue 7 (4.5) 8 (5.0)
   Infection Viral 30 (19.4) 41 (25.8)
Digestive System
   Abdominal Pain 67 (43.2) 70 (44.0)
   Cholecystitis 8 (5.2) 7 (4.4)
   Constipation 15 (9.7) 14 (8.8)
   Diarrhea 42 (27.1) 34 (21.4)
   Dyspepsia 26 (16.8) 18 (11.3)
   Flatulence 12 (7.7) 12 (7.5)
   Gastrointestinal Disorder 6 (3.9) 8 (5.0)
   Nausea 22 (14.2) 27 (17.0)
   Vomiting 15 (9.7) 11 (6.9)
Musculoskeletal System
   Arthralgia 12 (7.7) 24 (15.1)
   Arthritis 9 (5.8) 4 (2.5)
   Back Pain 11 (7.1) 18 (11.3)
   Myalgia 9 (5.8) 9 (5.7)
Nervous System
   Headache 28 (18.1) 34 (21.4)
   Insomnia 3 (1.9) 8 (5.0)
Respiratory System
   Bronchitis 10 (6.5) 6 (3.8)
   Coughing 11 (7.1) 7 (4.4)
   Pharyngitis 13 (8.4) 5 (3.1)
   Rhinitis 8 (5.2) 11 (6.9)
   Sinusitis 17 (11.0) 18 (11.3)
   Upper Respiratory Tract
   Infection
24 (15.5) 21 (13.2)
Urogenital System
   Urinary Tract Infection 10 (6.5) 7 (4.4)
GALLSTONE PREVENTION
Urosodiol
600 mg
(N=322)
Placebo

(N=325)
N (%) N (%)
Body as a Whole
   Fatigue 25 (7.8) 33 (10.2)
   Infection Viral 29 (9.0) 29 (8.9)
   Influenza-like Symptoms 21 (6.5) 19 (5.8)
Digestive System
   Abdominal Pain 20 (6.2) 39 (12.0)
   Constipation 85 (26.4) 72 (22.2)
   Diarrhea 81 (25.2) 68 (20.9)
   Flatulence 15 (4.7) 24 (7.4)
   Nausea 56 (17.4) 43 (13.2)
   Vomiting 44 (13.7) 44 (13.5)
Musculoskeletal System
   Back Pain 38 (11.8) 21 (6.5)
   Musculoskeletal Pain 19 (5.9) 15 (4.6)
Nervous System
   Dizziness 53 (16.5) 42 (12.9)
   Headache 80 (24.8) 78 (24.0)
Respiratory System
   Pharyngitis 10 (3.1) 19 (5.8)
   Sinusitis 17 (5.3) 18 (5.5)
   Upper Respiratory Tract
   Infection
40 (12.4) 35 (10.8)
Skin and Appendages
   Alopecia 17 (5.3) 8 (2.5)
Urogenital System
   Dysmenorrhea 18 (5.6) 19 (5.8)

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More resources:

Cerner Multum ursodiol

PDR Ursodiol

MedFacts Ursodiol

Micromedex Ursodiol - Includes detailed dosage instructions.

FDA Ursodiol

FDA Urso

Facts & Comparisons Ursodiol

FDA Actigall

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.


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