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Ursodiol Pregnancy and Breastfeeding Warnings

Ursodiol is also known as: Actigall, Urso, Urso DS, Urso Forte

Medically reviewed by Drugs.com. Last updated on Nov 14, 2018.

Ursodiol Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: This drug may cause fetal harm.

Comments:
-Some authorities state that use is contraindicated in patients who are pregnant or may become pregnant.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Patients receiving treatment for dissolution of gallstones should use effective non-hormonal contraception, while those being treated for other conditions should use effective non-hormonal or low-estrogen oral contraceptives during treatment.
-Some experts recommend excluding pregnancy in patients of childbearing potential prior to starting treatment.

Animal studies have revealed evidence of embryolethality, embryotoxicity, and teratogenicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Ursodiol Breastfeeding Warnings

Use is not recommended, and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown/Data not available
Excreted into animal milk: Yes

Comments:
-Some authorities state that use is contraindicated in patients who are breastfeeding.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Urso (ursodiol)" Scandipharm Inc, Birmingham, AL.
  4. "Product Information. Actigall capsules (ursodiol)." Novartis Pharmaceutical, Research Triangle Pk, NC.

References for breastfeeding information

  1. "Product Information. Actigall capsules (ursodiol)." Novartis Pharmaceutical, Research Triangle Pk, NC.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Urso (ursodiol)" Scandipharm Inc, Birmingham, AL.
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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