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Ustekinumab Pregnancy and Breastfeeding Warnings

Ustekinumab is also known as: Stelara

Medically reviewed by Last updated on Dec 1, 2020.

Ustekinumab Pregnancy Warnings

Developmental toxicity studies in animals found no evidence of harm to the fetus due to this drug. There are no controlled data in human pregnancy.

There is a pregnancy registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy. Patients should be encouraged to enroll by calling 1-877-311-8972. More information can be found at

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.

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

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

Risk Summary: Limited data on the use of this drug in pregnant women are insufficient to inform a drug associated risk. In animal studies, no adverse developmental effects were observed at exposures greater than 100 times the human exposure at the maximum recommended human dose (MRHD).

-Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.

See references

Ustekinumab Breastfeeding Warnings

Caution is recommended.

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

The effects in the nursing infant are unknown.

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references

References for pregnancy information

  1. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Stelara (ustekinumab)." Centocor Inc, Malvern, PA.
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

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