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Urso Forte Side Effects

Generic Name: ursodiol

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 Urso Forte.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

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

  • 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

Rare

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

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%): Flatulence (up to 7.7%), cholecystitis (5.2%), gastrointestinal disorder (3.9%), esophagitis (1.7%), peptic ulcer (1.3%)

Postmarketing reports: Abdominal discomfort, abdominal pain, diarrhea, constipation, dyspepsia, nausea, vomiting[Ref]

Nervous system

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

Common (1% to 10%): Insomnia (1.9%)

Postmarketing reports: Dizziness, headache[Ref]

Other

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

Common (1% to 10%): Fatigue (up to 7.8%), influenza-like symptoms (6.5%), chest pain (3.2%), asthenia (1.7%)

Postmarketing reports: Malaise, peripheral edema, pyrexia[Ref]

Respiratory

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

Common (1% to 10%): Pharyngitis (up to 8.4%), coughing (7.1%), bronchitis (6.5%), rhinitis (5.2%)

Postmarketing reports: Cough[Ref]

Musculoskeletal

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

Common (1% to 10%): Arthralgia (7.7%), musculoskeletal pain (5.9%), arthritis (5.8%), myalgia (5.8%)

Postmarketing reports: Myalgia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection (6.5%), dysmenorrhea (5.6%)[Ref]

Dermatologic

Common (1% to 10%): Alopecia (5.3%), skin rash (2.6%)

Postmarketing reports: Alopecia, pruritus, rash[Ref]

Hypersensitivity

Common (1% to 10%): Allergy (5.2%)

Postmarketing reports: Drug hypersensitivity (including facial edema, urticaria, angioedema, laryngeal edema)[Ref]

Hematologic

Common (1% to 10%): Leukopenia (2.6%), thrombocytopenia (1.3%)[Ref]

Metabolic

Common (1% to 10%): Anorexia (1.7%), elevated blood glucose (up to 1.3%)[Ref]

Renal

Common (1% to 10%): Elevated creatinine (1.3%)[Ref]

Hepatic

Postmarketing reports: Jaundice (or aggravation of preexisting jaundice), increased ALT, increased AST, increased blood alkaline phosphatase, increased blood bilirubin, increased gamma-glutamyltransferase, increased hepatic enzymes, abnormal liver function test, increased transaminases[Ref]

References

1. "Product Information. Urso (ursodiol)" Scandipharm Inc, Birmingham, AL.

2. "Product Information. Actigall capsules (ursodiol)." Novartis Pharmaceutical, Research Triangle Pk, NC.

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.

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