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Actigall

Generic Name: Ursodiol (ur soe DYE ol)
Brand Name: Actigall, Urso 250, Urso Forte
Easy-to-read patient leaflet for Actigall. Includes indications, proper use, special instructions, precautions, and possible side effects.

Average Savings for ursodiol (generic): 13.96%
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Drug Information:
This is not a list of all drugs or health problems that interact with Actigall (Ursodiol). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Actigall (Ursodiol) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Use Actigall (Ursodiol) as ordered by your doctor. Read all information given to you. Follow all instructions closely. Learn more

Actigall Side Effects

Actigall Side Effects

Note: This document contains side effect information about ursodiol. Some of the dosage forms listed on this page may not apply to the brand name Actigall.

In Summary

Common side effects of Actigall include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

Along with its needed effects, ursodiol (the active ingredient contained in Actigall) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ursodiol:

More common

  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • dizziness
  • fast heartbeat
  • frequent urge to urinate
  • indigestion
  • lower back or side pain
  • severe nausea
  • skin rash or itching over the entire body
  • stomach pain
  • vomiting
  • weakness

Less common

  • Black, tarry stools
  • chest pain
  • chills or fever
  • cough
  • pinpoint red spots on the skin
  • severe or continuing stomach pain
  • sore throat or swollen glands
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Incidence not known

  • Clay-colored stools
  • dark urine
  • difficulty with swallowing
  • headache
  • hives or welts
  • hoarseness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea
  • redness of the skin
  • slow or irregular breathing
  • tightness in the chest
  • unpleasant breath odor
  • yellow eyes or skin

Some side effects of ursodiol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Back pain
  • body aches or pain
  • congestion
  • constipation
  • general feeling of discomfort or illness
  • heartburn
  • loss of voice
  • muscle aches
  • muscle or bone pain
  • pain, swelling, or redness in the joints
  • runny nose
  • sweating
  • trouble sleeping

Less common

  • Diarrhea

Rare

  • Worsening psoriasis

Incidence not known

  • Acid or sour stomach
  • belching bloating or swelling of face, arms, hands, lower legs, or feet
  • difficulty with moving
  • rapid weight gain
  • stomach discomfort or upset
  • tingling of the hands or feet
  • unusual weight gain or loss

For Healthcare Professionals

Applies to ursodiol: oral capsule, oral tablet

General

The most commonly reported side effects included abdominal pain, diarrhea, constipation, and headache.

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 43.2%), diarrhea (up to 27.1%), constipation (up to 26.4%), nausea (up to 17.4%), dyspepsia (up to 16.8%), vomiting (up to 13.7%)

Common (1% to 10%): Cholecystitis, flatulence, gastrointestinal disorder, pasty stools, peptic ulcer

Very rare (less than 0.01%): Calcification of gallstones, severe upper right abdominal pain

Frequency not reported: Esophagitis

Postmarketing reports: Abdominal discomfort

Calcification of gallstones may result in surgery, as bile acid therapy alone may not be able to dissolve the calcifications.

Severe upper right abdominal pain occurred in patients with primary biliary cirrhosis.

Nervous system

Very common (10% or more): Headache (up to 24.8%), dizziness (up to 16.5%)

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15.5%), sinusitis (up to 11%)

Common (1% to 10%): Bronchitis, coughing, pharyngitis, rhinitis

Postmarketing reports: Cough, laryngeal edema

Immunologic

Very common (10% or more): Viral infection (up to 19.4%)

Common (1% to 10%): Influenza-like symptoms

Musculoskeletal

Very common (10% or more): Back pain (up to 11.8%)

Common (1% to 10%): Arthralgia, arthritis, musculoskeletal pain, myalgia

Dermatologic

Common (1% to 10%): Alopecia, skin rash/rash

Very rare (less than 0.01%): Urticaria

Frequency not reported: Increased pruritus/pruritus

Postmarketing reports: Facial edema

Hematologic

Common (1% to 10%): Leukopenia, thrombocytopenia

Genitourinary

Common (1% to 10%): Dysmenorrhea, urinary tract infection

Other

Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, fever, other toxicity

Postmarketing reports: Malaise, pyrexia

Hypersensitivity

Drug hypersensitivity reactions included angioedema, facial edema, laryngeal edema, and urticaria.

Common (1% to 10%): Allergy

Frequency not reported: Allergic reactions

Postmarketing reports: Angioedema, drug hypersensitivity

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Sleep disturbance

Metabolic

Common (1% to 10%): Elevated blood glucose

Frequency not reported: Anorexia

Cardiovascular

Common (1% to 10%): Chest pain

Postmarketing reports: Peripheral edema

Renal

Common (1% to 10%): Elevated creatinine

Hepatic

Very rare (less than 0.01%): Decompensation of hepatic cirrhosis

Frequency not reported: Increased cholestasis

Postmarketing reports: Aggravation of pre-existing jaundice/jaundice, ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, GGT increased, hepatic enzyme increased, liver function tests abnormal, transaminases increased

Decompensation of hepatic cirrhosis occurred in patients with advanced stages of primary biliary cirrhosis. The condition partially regressed after treatment was discontinued.

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Actigall (www.drugs.com/actigall.html).