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Ursodiol Side Effects

Medically reviewed by Last updated on Dec 4, 2022.


Commonly reported side effects of ursodiol include: back pain. Other side effects include: arthralgia, alopecia, arthritis, and pharyngitis. Continue reading for a comprehensive list of adverse effects.

Applies to ursodiol: oral capsule, oral tablet.

Serious side effects of Ursodiol

Along with its needed effects, ursodiol 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

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

  • Chest tightness
  • 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
  • swelling of hands, ankles, feet, or lower legs
  • unpleasant breath odor
  • yellow eyes or skin

Other side effects of Ursodiol

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

Less common


Incidence not known

  • Acid or sour stomach
  • belching bloating or swelling of face, arms, hands, lower legs, or feet
  • difficulty with moving
  • loss or thinning of the hair
  • 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.


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


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[Ref]

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.[Ref]

Nervous system

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


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[Ref]


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

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


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

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


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[Ref]


Common (1% to 10%): Leukopenia, thrombocytopenia[Ref]


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


Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, fever, other toxicity

Postmarketing reports: Malaise, pyrexia[Ref]


Common (1% to 10%): Allergy

Frequency not reported: Allergic reactions

Postmarketing reports: Angioedema, drug hypersensitivity[Ref]

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


Common (1% to 10%): Insomnia

Frequency not reported: Sleep disturbance[Ref]


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

Frequency not reported: Anorexia[Ref]


Common (1% to 10%): Chest pain

Postmarketing reports: Peripheral edema[Ref]


Common (1% to 10%): Elevated creatinine[Ref]


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[Ref]

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


1. "Product Information. Actigall (ursodiol)." Novartis Pharmaceuticals (2022):

2. "Product Information. Urso (ursodiol)." Scandipharm Inc (2001):

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.