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Allopurinol / lesinurad Pregnancy and Breastfeeding Warnings

Allopurinol / lesinurad is also known as: Duzallo

Allopurinol / lesinurad Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

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

Animal studies have failed to reveal evidence of teratogenicity and fetotoxicity at allopurinol and lesinurad doses reaching maternal toxicity. Allopurinol has been teratogenic and produced fetal deaths in animals with intraperitoneal administration. 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

Allopurinol / lesinurad Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes (allopurinol); Unknown (lesinurad)
Excreted into animal milk: Yes (lesinurad)

-The effects of allopurinol in the nursing infant are unknown.
-The WHO considers allopurinol compatible with breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Duzallo (allopurinol-lesinurad)." Ironwood Pharmaceuticals, Inc (2017):

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network." (2013):
  2. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs." (2014):
  3. "Product Information. Duzallo (allopurinol-lesinurad)." Ironwood Pharmaceuticals, Inc (2017):

Further information

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