Ursodiol Side Effects
Brand Names: Actigall, Urso
Please note - some side effects for Ursodiol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Ursodiol - for the Consumer
Ursodiol
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ursodiol:
Seek medical attention right away if any of these SEVERE side effects occur when using Ursodiol:Constipation; diarrhea; dry skin; gas; headache; indigestion; metallic taste; muscle or joint pain; nausea; skin rash; stomach pain; swelling; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopUrsodiol Side Effects - for the Professional
Ursodiol
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following table summarizes the adverse reactions observed in two placebo-controlled clinical trials.
| Note: Those adverse reactions occurring at the same or higher incidence in the placebo as in the UDCA group have been deleted from this table (this includes diarrhea and thrombocytopenia at 12 months, nausea/vomiting, fever and other toxicity). | ||||
| ADVERSE REACTIONS | VISIT AT 12 MONTHS | VISIT AT 24 MONTHS | ||
|
UDCA n (%) |
Placebo n (%) |
UDCA n (%) |
Placebo n (%) |
|
| Diarrhea | --- | --- | 1 (1.32) | --- |
| Elevated creatinine | --- | --- | 1 (1.32) | --- |
| Elevated blood glucose | 1 (1.18) | --- | 1 (1.32) | --- |
| Leukopenia | --- | --- | 2 (2.63) | --- |
| Peptic ulcer | --- | --- | 1 (1.32) | --- |
| Skin rash | --- | --- | 2 (2.63) | -- |
| Thrombocytopenia | --- | --- | 1 (1.32) | --- |
| UDCA = Ursodeoxycholic acid = Ursodiol | ||||
In a randomized, cross-over study in sixty PBC patients, seven patients (11.6%) reported nine adverse reactions: abdominal pain and asthenia (1 patient), nausea (3 patients), dyspepsia (2 patients) and anorexia and esophagitis (1 patient each). One patient on the twice a day regimen (total dose 1000 mg) withdrew due to nausea. All of these nine adverse reactions except esophagitis were observed with the twice a day regimen at a total daily dose of 1000 mg or greater. However, an adverse reaction may occur at any dose.
Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during postapproval use of Ursodiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Gastrointestinal disorders: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
- General disorders and administration site conditions: malaise, peripheral edema, pyrexia.
- Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema.
- Musculoskeletal and connective tissue disorders: myalgia
- Nervous system disorders: dizziness, headache.
- Respiratory, thoracic and mediastinal disorders: cough.
Skin and subcutaneous tissue disorder: alopecia, pruritus, rash
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have included diarrhea, constipation, dyspepsia, nausea, vomiting and peptic ulcer.
Renal
Renal side effects have included elevated creatinine (1.3%).
Metabolic
Metabolic side effects have included elevated blood glucose (1.3%).
Hematologic
Hematologic side effects have included leukopenia (2.6%) and thrombocytopenia.
.
Dermatologic
Dermatologic side effects have included rash (2.6%).
Musculoskeletal
Musculoskeletal side effects have included back pain (11.8%).
Respiratory
Respiratory side effects have included bronchitis, cough, pharyngitis, rhinitis, and upper respiratory tract infection.
TopMore Ursodiol resources
- ursodiol Advanced Consumer (Micromedex) - Includes Dosage Information
- ursodiol Concise Consumer Information (Cerner Multum)
- Ursodiol Prescribing Information (FDA)
- Ursodiol Monograph (AHFS DI)
- Ursodiol Professional Patient Advice (Wolters Kluwer)
- Ursodiol MedFacts Consumer Leaflet (Wolters Kluwer)
- Actigall Prescribing Information (FDA)
- Urso Prescribing Information (FDA)
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