It’s not definitely known whether Stelara can harm an unborn baby because human studies are not large enough to prove safety or risks linked to using the drug while pregnant.

Doctors and scientists have only limited information from clinical trials and other studies, as well as reports from people who took Stelara while pregnant. Because of that, Stelara’s latest prescribing information label doesn’t say whether the drug does or does not cause problems for the unborn baby.

Animal studies don’t clearly show that Stelara causes health problems, but the results of animal studies don’t always apply to humans. In tests with pregnant monkeys, researchers didn’t observe any direct effects of Stelara on the developing baby, despite exposing the animals to doses higher than a human would receive.

While the prescribing information doesn’t list any specific risks of taking Stelara while pregnant, it does not rule them out either. It simply states there is not enough evidence to link Stelara with specific pregnancy outcomes.

One additional note from the prescribing information worth mentioning is that proteins similar to Stelara can pass through the placenta, especially later in pregnancy. This means, if you take Stelara while pregnant, the drug could reach the baby.

People who take Stelara and plan to get pregnant or are already pregnant can benefit from discussing specifics with their doctor. A healthcare professional can answer questions about your situation and provide alternative treatment plans.

If you use Stelara while pregnant, consider enrolling in a pregnancy registry. A pregnancy registry collects information about the effects of certain drugs when used during pregnancy. You can enroll in the Stelara registry by calling 866-626-6847 or visiting this website.

Stelara can end up in breast milk. Limited published data suggest that small amounts of ustekinumab (the active ingredient in Stelara) are present in human milk. Experts do not yet know how this may affect a lactating infant, though.

Because lactation has proven developmental and health benefits for children, it’s important to weigh the pros and cons before suspending or skipping it if you take Stelara.

Consider discussing Stelara with your child’s pediatrician and your prescribing doctor.You can benefit from discussing all breastfeeding decisions with a healthcare professional while on Stelara.

Some of the questions you may want to reflect on while considering Stelara include:

  • What is known versus unknown about Stelara’s effects during pregnancy and lactation?
  • Should I consider enrolling in the pregnancy registry to help gather more data about Stelara during pregnancy?
  • How much Stelara crossing the placenta affect the baby, and can that be monitored during pregnancy?
  • Am I clear on all the benefits of breastfeeding as well as the reasons why I take Stelara?
  • Are there alternative treatments to Stelara that have more research on effects on unborn or lactating children?

Disclaimer: While Healthline strives for factual, comprehensive, and current information, this article is not a substitute for a licensed healthcare professional’s expertise. Always consult a doctor before taking or discontinuing any medication. Drug information is subject to change and may not cover all uses, directions, precautions, warnings, interactions, reactions, or adverse effects. The lack of a warning does not guarantee a drug’s safety, effectiveness, or appropriateness for all patients or specific uses. Learn more about our approach to content integrity.