It is not known whether this drug crosses the placental barrier or reaches fetal tissues. However, many injectable contrast agents cross the placental barrier in humans and appear to enter fetal tissues. Intravenously administration does not induce adverse effects on fertility and general reproductive performance in rats. No teratogenic effects attributable to this drug have been observed in teratology studies performed in animals. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are no adequate and well controlled studies in pregnant women.

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: Not assigned
US FDA pregnancy category: B

Comments: X-ray examination of women should be conducted during the pre-ovulation phase of the menstrual cycle and should be avoided during pregnancy.

See references

Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

Animal experiences revealed that this drug is nontoxic in animals after oral administration. Due to the low level of absorption of this drug from the gastrointestinal tract, it is unlikely that a fetus could be exposed to significant levels. Harm to the nursing infant is unlikely to occur.

See references