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Sodium polystyrene sulfonate Pregnancy and Breastfeeding Warnings

Brand names: Kalexate, Kayexalate, Kionex

Medically reviewed by Drugs.com. Last updated on Jul 25, 2025.

Sodium polystyrene sulfonate Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
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.

Animal studies have not been conducted with this drug. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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

Sodium polystyrene sulfonate Breastfeeding Warnings

Caution is recommended; benefit to the mother should outweigh risk to the infant.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

No information exists regarding excretion into human breastmilk. When this drug was added to expressed breastmilk and/or formula, potassium, calcium, and creatinine levels in infants decreased; infants did not have clinically noticeable side effects. Secretion into breastmilk is predicted to be unlikely as this drug is not orally absorbed.

See references

Does Sodium polystyrene sulfonate interact with my other drugs?

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See also

References for pregnancy information

  1. (2001) "Product Information. Kayexalate (sodium polystyrene sulfonate)." Sanofi Winthrop Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2017) "Product Information. Kayexalate (sodium polystyrene sulfonate)." Covis Pharmaceuticals
  5. (2024) "Product Information. Kionex (sodium polystyrene sulfonate)." ANI Pharmaceuticals, Inc.

References for breastfeeding information

  1. (2001) "Product Information. Kayexalate (sodium polystyrene sulfonate)." Sanofi Winthrop Pharmaceuticals
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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

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