Ursodiol Side Effects
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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Ursodiol:Constipation; diarrhea; dry skin; gas; headache; indigestion; metallic taste; muscle or joint pain; nausea; skin rash; stomach pain; swelling; tiredness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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:
| 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) |
| 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) |
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:
| 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) |
| 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) |
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:
|
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) |
|
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) |
More resources:
Ursodiol - Includes detailed dosage instructions.
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