Urso Side Effects

Generic name: ursodiol

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Note: This document provides detailed information about Urso Side Effects associated with ursodiol. Some dosage forms listed on this page may not apply specifically 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 side effects

• 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 side effects

• 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 side effects

• 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 side effects

• diarrhea

Rare side effects

• 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 adverse events

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]

Further information

Urso side effects can vary depending on the individual. 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.

Medical Disclaimer