Animal studies have not shown evidence of an increased occurrence of fetal damage. However, tranexamic acid is known to cross the placenta and appears in cord blood at concentrations approximately equal to maternal concentration.

There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

AU TGA pregnancy category: B1
Drugs which have been taken by only a limited number or 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.

This drug is only recommended for use during pregnancy when benefit outweighs the risk.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: It is not known if the use of this drug during pregnancy can cause adverse maternal or fetal outcomes.

Comments:
-According to some authorities, the oral formulation should be used in pregnancy only when benefit outweighs risk and the IV injection is not recommended during the first trimester of pregnancy.

See references

Tranexamic acid should be used during lactation only if clearly needed.

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

Comments:
The effects in the nursing infant are unknown.
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.

Tranexamic acid is excreted into human milk. There are no data on the effects of tranexamic acid on the breastfed child or the effects on milk production.

See references