Is it safe? · Pregnancy Smart
Is Humira (Adalimumab) Safe During Pregnancy?
What does the evidence say about humira during pregnancy?
- MotherToBaby says most studies do not suggest an increased miscarriage chance or birth-defect pattern with adalimumab, while disease activity can complicate interpretation. 1
- A prospective cohort of 257 adalimumab-exposed pregnancies compared with disease-matched controls did not identify increased adverse birth outcomes attributable to adalimumab. 2
- A post-marketing Crohn’s disease registry analysis reported pregnancy outcomes without an additional adverse pattern in its observed pregnancies. 3
- A third-trimester inflammatory bowel disease study compared continuation and discontinuation and reported no higher infant respiratory infection signal with continuation, though the result does not prove equivalence. 4
- Adalimumab crosses the placenta more during the third trimester, so the infant’s care team should know about late exposure when discussing vaccines and infection monitoring. 1
Is humira safe in each trimester?
- First trimester. Discuss ongoing Humira with the prescribing specialist and prenatal clinician early in pregnancy. Disease control and the reason for adalimumab matter when weighing a plan.
- Second trimester. The team can review response, infection history, and the timing of doses. Available studies do not show a consistent increase in major pregnancy problems, but individual decisions remain clinical.
- Third trimester. Late-pregnancy dosing and infant vaccine planning should be coordinated with the prescriber and pediatric team because placental transfer is greater later in pregnancy.
Frequently asked questions
Can you stay on Humira while pregnant?
Some people do continue adalimumab, but the choice depends on disease activity, infection history, dose timing, and specialist advice. Do not stop it without discussing the risk of a flare with the prescribing team.
Does Humira cause birth defects?
Most available studies have not shown a consistent increase in birth defects with adalimumab. The data are observational and cannot answer every dose or disease context, so review your exposure with your clinicians.
When should you stop Humira before delivery?
There is no single stop date for every pregnancy. MotherToBaby notes that most adalimumab is gone from a healthy nonpregnant adult in up to 12 weeks on average, but one case still found medicine in maternal and cord blood 21 weeks after stopping at 16 weeks. Ask the prescriber to set your plan.
Is it safer to stop Humira or risk a disease flare during pregnancy?
The safer plan depends on your disease and its activity. A flare can affect pregnancy, while medication timing has its own considerations. Make the decision jointly with the prescribing specialist and prenatal clinician.
Does Humira cross the placenta?
Yes. MotherToBaby says adalimumab may cross the placenta more in the third trimester than the first. Tell the pediatric clinician about late exposure so vaccine timing and infant follow-up can be individualized.
Can a baby receive live vaccines after Humira exposure?
The U.S. fact sheet says rotavirus is the only live vaccine routinely given in the first year, while inactivated vaccines do not contain live virus. It reports no higher infant infection rate up to 12 months after exposure, but the pediatric clinician should decide vaccine timing.
Does Humira increase miscarriage risk?
Most studies summarized by MotherToBaby do not suggest an increased miscarriage chance. These are observational data, and the underlying inflammatory condition can affect comparisons.
Should I call my doctor after a positive pregnancy test on Humira?
Yes. Contact the prescribing specialist and prenatal clinician with your dose and last injection date. They can coordinate a plan without an abrupt medication change.
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References
Adalimumab (Humira®) - MotherToBaby | Fact Sheets - NCBI Bookshelf
MotherToBaby · https://www.ncbi.nlm.nih.gov/books/NBK582559/
Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study
NIH PMC · https://pmc.ncbi.nlm.nih.gov/articles/PMC6799916/
NIH PMC · https://pmc.ncbi.nlm.nih.gov/articles/PMC9189454/
NIH PMC · https://pmc.ncbi.nlm.nih.gov/articles/PMC11307739/
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