Actigall

Last updated on RxList: 1/21/2021
Actigall Side Effects Center

What Is Actigall?

Actigall (ursodiol) is a bile acid used for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Actigall is also used for the prevention of gallstone formation in obese patients experiencing rapid weight loss. Actigall is available in generic form.

What Are Side Effects of Actigall?

Common side effects of Actigall include stomach upset or pain, indigestion, nausea, diarrhea, constipation, dizziness, back pain, hair loss, cough, headache, cold symptoms (stuffy nose, sneezing, sore throat), itching or rash, upper respiratory tract infection, urinary tract infection, muscle or joint pain, or insomnia.

Dosage for Actigall

The recommended dose for Actigall treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.

What Drugs, Substances, or Supplements Interact with Actigall?

Actigall may interact with cholestyramine and colestipol, aluminum-based antacids, estrogens, oral contraceptives, clofibrate, and other lipid-lowering drugs. Tell your doctor all medications and supplements you use.

Actigall During Pregnancy and Breastfeeding

Actigall is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Actigall (ursodiol) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Actigall Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects may include:

  • headache, dizziness;
  • mild stomach pain or discomfort;
  • nausea, diarrhea, constipation;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • hair loss; or
  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Actigall (Ursodiol, USP Capsules)

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Actigall Professional Information

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)

Read the entire FDA prescribing information for Actigall (Ursodiol, USP Capsules)

© Actigall Patient Information is supplied by Cerner Multum, Inc. and Actigall Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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