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

Applies to ursodiol: oral capsule, oral tablet.

Serious side effects of Urso

Along with its needed effects, ursodiol (the active ingredient contained in Urso) 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 Urso

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]