Ursodiol Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.

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

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

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

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
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: compounding powder, oral capsule, oral tablet.

General

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

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^[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]

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^[Ref]

Immunologic

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

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

Musculoskeletal

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

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

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^[Ref]

Hematologic

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

Genitourinary

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

Other

Common (1% to 10%): Fatigue

Frequency not reported: Asthenia, fever, other toxicity

Postmarketing reports: Malaise, pyrexia^[Ref]

Hypersensitivity

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]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Sleep disturbance^[Ref]

Metabolic

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

Frequency not reported: Anorexia^[Ref]

Cardiovascular

Common (1% to 10%): Chest pain

Postmarketing reports: Peripheral edema^[Ref]

Renal

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

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^[Ref]

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