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Iopamidol Pregnancy and Breastfeeding Warnings

Brand names: Iopamidol-370, Isovue-128, Isovue-200, Isovue-250, Isovue-300, Isovue-370, Isovue-M-200, Isovue-M-300

Medically reviewed by Drugs.com. Last updated on Mar 31, 2025.

Iopamidol Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: Not assigned
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: Intravenous administration of 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.

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

Iopamidol Breastfeeding Warnings

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

Does Iopamidol interact with my other drugs?

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See also

References for pregnancy information

  1. Zhanel GG, Mayer M, Laing N, Adam HJ (2006) "Mutant Prevention Concentrations of Levofloxacin Alone and in Combination with Azithromycin, Ceftazidime, Colistin (Polymyxin E), Meropenem, Piperacillin-Tazobactam, and Tobramycin against Pseudomonas aeruginosa." Antimicrob Agents Chemother, 50, p. 2228-30
  2. (2007) "Product Information. Isovue-M-200 (iopamidol)." Bracco Diagnostics Inc
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2024) "Product Information. Isovue-300 (iopamidol)." Bracco Diagnostics Inc
  5. (2022) "Product Information. Isovue-M-300 (iopamidol)." Bracco Diagnostics Inc
  6. (2025) "Product Information. Iopamidol (iopamidol)." Slate Run Pharmaceuticals, LLC

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2007) "Product Information. Isovue-M-200 (iopamidol)." Bracco Diagnostics 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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