ACTIGALL SIDE EFFECTS
- Generic Name: ursodiol, usp capsules
- Brand Name: Actigall
Last updated on MDtodate: 10/03/2022
SIDE EFFECTS
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 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 | ||||
| Actigall 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) |
SRC: NLM .