Animal studies at doses up to 13 times the human dose showed no evidence of impaired fertility or fetal harm; another study at 25 to 40 times the human dose showed evidence of fetal malformations, which were prevented by simultaneous dietary zinc supplementation. There are no controlled data in human pregnancy.

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 B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is not recommended unless clearly needed.

AU TGA pregnancy category: Exempt
US FDA pregnancy category: B

See references

This drug should be used only if clearly needed.
Safety has not been established.

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

Comments:
-The low molecular weight of this drug (about 374) suggests that it will appear in breast milk.
-Use of this product implies lead poisoning; lead is excreted into breast milk and is toxic to the infant.

See references