Actigall Side Effects

Generic Name: ursodiol

Note: This page contains information about the side effects of ursodiol. Some of the dosage forms included on this document may not apply to the brand name Actigall.

Not all side effects for Actigall may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

In addition to its needed effects, some unwanted effects may be caused by ursodiol (the active ingredient contained in Actigall). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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
  • 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 of the side effects that can occur with ursodiol may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
  • 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
  • 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

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

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

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

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

Genitourinary

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

Dermatologic

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

Hypersensitivity

Common (1% to 10%): Allergy (5.2%)
Postmarketing reports: Drug hypersensitivity (including facial edema, urticaria, angioedema, laryngeal edema)

Hematologic

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

Metabolic

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

Renal

Common (1% to 10%): Elevated creatinine (1.3%)

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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