Tranexamic acid Pregnancy and Breastfeeding Warnings

Brand names: Cyklokapron, Lysteda

Medically reviewed by Drugs.com. Last updated on Oct 19, 2023.

Tranexamic acid Pregnancy Warnings

Benefit should outweigh risk.
-According to some authorities, use is not recommended during pregnancy.

AU TGA pregnancy category: B1

US FDA pregnancy category: Not Assigned

Risk Summary: It is not known whether this drug may cause risk of miscarriage or adverse maternal or fetal outcomes.

Comments:
-There are limited data on use in pregnant women.
-This drug passes through the placenta.
-Women of childbearing potential should use an effective nonhormonal contraceptive method during treatment. Concomitant use of this drug with hormonal contraceptives may increase the risk of thromboembolic adverse reactions.

Animal studies have not shown evidence of an increased occurrence of fetal damage. In humans, there are cases of fetal structural abnormalities that resulted in death of the newborn following the administration of this drug to the mother during conception or the first trimester of pregnancy. Available data in pregnant women in the second and third trimester and at the time of delivery have not clarified this drug's risk of maternal or fetal adverse outcomes.

AU TGA pregnancy category B1: 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.

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

Tranexamic acid Breastfeeding Warnings

Benefit should outweigh risk.
-According to some authorities, use is not recommended while breastfeeding.

Excreted into human milk: Yes

There is insufficient data on the effects of this drug in the nursing infant or on milk production.

Comments:
-Amounts of this drug in breastmilk appear to be low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-According to some authorities, if this drug is required by the mother, it is not a reason to discontinue breastfeeding, however, medical supervision and follow-up of the breastfed infant is recommended until more data is available.

Tranexamic acid is excreted into human milk. A controlled study found no adverse outcomes among infants whose mothers took up to 4 grams daily of this drug while breastfeeding.

See references

Further information

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

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