Ursodiol Side Effects

Some side effects of ursodiol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ursodiol: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ursodiol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Other less serious side effects are more likely to occur, such as:

• fever, chills, body aches, flu symptoms;

• stomach pain, nausea, diarrhea, constipation;

• dizziness, tired feeling;

• back pain;

• runny or stuffy nose, cold symptoms; or

• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to ursodiol: oral capsule, oral tablet

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.
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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.

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