Actigall Side Effects
Generic Name: ursodiol
Please note - some side effects for Actigall 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).
Side Effects of Actigall - for the Consumer
Actigall
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 Actigall:
Seek medical attention right away if any of these SEVERE side effects occur when using Actigall: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).
Actigall Side Effects - for the Professional
Actigall
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) |
| Actigall | 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) |
Side Effects by Body System
Gastrointestinal
Gastrointestinal side effects have included diarrhea, constipation, dyspepsia, nausea, vomiting and peptic ulcer.
Renal
Renal side effects have included elevated creatinine (1.3%).
Metabolic
Metabolic side effects have included elevated blood glucose (1.3%).
Hematologic
Hematologic side effects have included leukopenia (2.6%).
Dermatologic
Dermatologic side effects have included rash (2.6%).
Musculoskeletal
Musculoskeletal side effects have included back pain (11.8%).
Respiratory
Respiratory side effects have included bronchitis, cough, pharyngitis, rhinitis, and upper respiratory tract infection.
TopMore resources:
Actigall - Includes detailed dosage instructions.
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