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.
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.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopActigall 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:
| 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 |
||||
| 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 - for Healthcare Professionals
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%) and thrombocytopenia.
.
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 Actigall resources
- Actigall Prescribing Information (FDA)
- Actigall MedFacts Consumer Leaflet (Wolters Kluwer)
- Actigall Concise Consumer Information (Cerner Multum)
- Actigall Advanced Consumer (Micromedex) - Includes Dosage Information
- Ursodiol Prescribing Information (FDA)
- Ursodiol Monograph (AHFS DI)
- Ursodiol Professional Patient Advice (Wolters Kluwer)
- Urso Prescribing Information (FDA)
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