What is Actigall (ursodiol)?
Actigall (ursodiol) is a naturally-occurring bile acid made by the liver in humans and is secreted in small quantities into bile and is used to dissolve and prevent cholesterol gallstones and to treat primary biliary cirrhosis, a disease of the liver.
Actigall blocks the enzyme in the liver that produces cholesterol and thereby decreases production of cholesterol by the liver and the amount of cholesterol in bile. It also reduces the absorption of cholesterol from the intestine. By decreasing the concentration of cholesterol in bile, Actigall prevents the formation and promotes the dissolution of cholesterol-containing gallstones. The mechanism by which it acts in primary biliary cirrhosis is not clear.
Common side effects of Actigall include:
Serious side effects of Actigall include serious allergic reactions and reduced concentration of white blood cells.
Drug interactions of Actigall include aluminum containing antacids, which reduce the absorption of Actigall and therefore reduce its action, such as:
The following drugs may counteract the effects of Actigall by increasing cholesterol secretion by the liver and the risk for gallstone formation:
- estrogens,
- oral contraceptives,
- clofibrate, and
- potentially other cholesterol-reducing drugs.
There are no adequate studies of Actigall in pregnant women. It is unknown if Actigall is secreted in breast milk. Consult your doctor before breastfeeding.
Actigall (ursodiol) side effects list for healthcare professionals
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) |
What drugs interact with Actigall (ursodiol)?
Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of Actigall by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with Actigall in the same manner as the bile acid sequestering agents. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion, and encourage cholesterol gallstone formation and hence may counteract the effectiveness of Actigall.
Summary
Actigall (ursodiol) is a naturally-occurring bile acid made by the liver in humans and is secreted in small quantities into bile and is used to dissolve and prevent cholesterol gallstones and to treat primary biliary cirrhosis, a disease of the liver. Common side effects of Actigall include rash, itching, nausea, vomiting, stomach pain, back pain, constipation, diarrhea, and hair loss. Serious side effects of Actigall include serious allergic reactions and reduced concentration of white blood cells. Drug interactions of Actigall include aluminum containing antacids, cholestyramine and colestipol; estrogens; oral contraceptives; clofibrate; and potentially other cholesterol reducing drugs. There are no adequate studies of Actigall in pregnant women. It is unknown if Actigall is secreted in breast milk. Consult your doctor before breastfeeding.
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Related Disease Conditions
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Cirrhosis (Liver)
Cirrhosis of the liver refers to a disease in which normal liver cells are replaced by scar tissue caused by alcohol and viral hepatitis B and C. This disease leads to abnormalities in the liver's ability to handle toxins and blood flow, causing internal bleeding, kidney failure, mental confusion, coma, body fluid accumulation, and frequent infections. Symptoms include yellowing of the skin (jaundice), itching, and fatigue. The prognosis is good for some people with cirrhosis of the liver, and the survival can be up to 12 years; however the life expectancy is about 6 months to 2 years for people with severe cirrhosis with major complications.
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Gallstones
Gallstones are stones that form when substances in the bile harden. Gallstones (formed in the gallbladder) can be as small as a grain of sand or as large as a golf ball. There can be just one large stone, hundreds of tiny stones, or any combination. The majority of gallstones do not cause signs or symptoms; however, when they do occur the primary sign is biliary colic. Symptoms of biliary colic are constant pain for 15 minutes to 4-5 hours, and it may vary in intensity; nausea, severe pain that does not worsen with movement; and pain beneath the sternum. Treatment of gallstones depends upon the patient and the clinical situation.
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Primary Biliary Cirrhosis (PBC)
Primary Biliary Cirrhosis (PBS) is a liver disease in which bile building up in the organ damages bile ducts. Ultimately, this can cause liver failure. A number of drugs are available to treat this disease of unknown cause, but the only ultimate cure is a liver transplant.
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Primary Biliary Cirrhosis (PBC) Treatment
Primary biliary cirrhosis (PBC) is thought to be an autoimmune disorder that involves the deterioration of the liver's small bile ducts. These ducts are crucial to transport bile to the small intestine, digesting fats and removing wastes. Symptoms of PBC are edema, itching, elevated cholesterol, malabsorption of fat, liver cancer, gallstones, urinary tract infections (UTIs), and hypothyroidism. Treatments include ursodeoxycholic acid (UDCA); colchicine (Colcrys); and immunosuppressive medications, such as corticosteroids; obeticholic acid (Ocaliva); and medications that treat PBC symptoms. For PBC that is associated with cirrhosis of the liver, liver transplantation may be indicated in extreme cases.
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Is There a Cure for Cirrhosis of the Liver?
Liver cirrhosis results from disease- or chemical-induced injury to the liver over a sustained period. The injury kills liver cells, and your body attempts to rebuild the damage. In the process, the existing cells are inflamed and scar tissue results, compromising the structure of the liver and hampering its function.
Treatment & Diagnosis
- Gallstones FAQs
- Chronic Viral Hepatitis, Alcoholism, Cirrhosis Linked to Liver Cancer
- Ashcroft Surgery for Gallstone Pancreatitis
- Gallstones' Bark Is Bigger Than Its Bite
- Can you pass gallstones?
- Can Gallbladder Pain Continue after Gallbladder Surgery?
- Can MRI Find Pancreatic Duct Stones?
- Can Gallbladder Problems Cause Blood Clots?
Medications & Supplements

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