Animal studies showed no adverse effects on embryofetal development. There are no controlled data in human pregnancy. It is considered unlikely that supplementation that does not lead to hyperkalemia would adversely affect the fetus. 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 Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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 should be used during pregnancy only if clearly needed. Use under physician supervision.

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

Comments:
-Pregnancy is associated with gastrointestinal hypomotility; solid forms of oral potassium should be given only if clearly needed.
-Close monitoring of serum potassium is recommended.
-Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm.

See references

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant. Use under the supervision of a physician.

Excreted into human milk: Yes

Comments:
-As long as body potassium is not excessive, potassium supplementation should have little or no effect on the level in human milk.
-Normal potassium ion levels in human breast milk is about 13 mEq/L.
-There is no information regarding this drug on the effects on a breastfed infant or effects on milk production.
-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.

See references