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Ioversol Pregnancy and Breastfeeding Warnings

Brand names: Optiray 160, Optiray 240, Optiray 300, Optiray 320, Optiray 350

Medically reviewed by Drugs.com. Last updated on Aug 14, 2025.

Ioversol Pregnancy Warnings

Safety has not been established during pregnancy.

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

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comment: This drug has been shown to cross the placenta and has been detected in small amounts in the digestive tract of exposed infants after birth.

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

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. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Ioversol Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

Many injectable contrast agents are excreted unchanged in breast milk to an amount of
approximately 1 % of the given dose.

See references

Does Ioversol interact with my other drugs?

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See also

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2006) "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc
  3. Cerner Multum, Inc. "Australian Product Information."

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2006) "Product Information. Optiray 350 (ioversol)." Mallinckrodt Medical Inc
  3. Cerner Multum, Inc. "Australian Product Information."

Further information

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

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