Pregnancy SmartShop formulas

Is it safe? · Pregnancy Smart

Is Zepbound Safe During Pregnancy?

Assigned clinical reviewerMatt Stahl· PharmDDraft · pending clinical reviewUpdated

What does the evidence say about zepbound during pregnancy?

  1. The current FDA Zepbound label says weight loss offers no benefit during pregnancy and may cause fetal harm, directs discontinuation when pregnancy is recognized, and states that human tirzepatide data are insufficient to evaluate major birth defects, miscarriage, or other outcomes. 1
  2. In animal studies summarized in the label, fetal growth reduction and abnormalities occurred in rats and fetal growth reduction occurred in rabbits at clinically relevant exposures. These findings coincided with reduced maternal weight and food intake and do not quantify human risk. 1
  3. MotherToBaby estimates that most tirzepatide may take up to about 30 days to leave a healthy adult's body. This is an average clearance estimate, not a tested conception threshold or a formal Zepbound-label waiting period. 2
  4. A prospective cohort compared 168 early-pregnancy exposures to GLP-1 receptor agonists with diabetes and overweight or obesity comparison groups. Major birth-defect estimates were not significantly increased, but confidence intervals were wide and the analysis was not specific to tirzepatide. 3
  5. A 2026 meta-analysis of seven observational cohorts found no statistically significant increase in overall congenital malformations or first-trimester major malformations after GLP-1 receptor agonist exposure. An increased urinary-malformation estimate relied only on unadjusted data. Confounding and limited tirzepatide-specific evidence preclude a Zepbound safety conclusion. 4

Is zepbound safe in each trimester?

  • First trimester. Stop Zepbound when pregnancy is recognized and contact the prescriber promptly. Human tirzepatide evidence is insufficient, and animal findings during organ development cannot quantify the chance of an outcome after an individual early exposure.
  • Second trimester. Do not restart Zepbound for weight loss during pregnancy. Pregnancy weight goals and nutrition should be set with the prenatal team rather than by continuing a weight-reduction medicine without established fetal safety.
  • Third trimester. Zepbound remains inappropriate for pregnancy weight loss late in gestation. Discuss postpartum restart timing, feeding plans, medical indication, and contraception before resuming it.

Frequently asked questions

Can Zepbound be taken during pregnancy?

No. The FDA label says weight loss offers no pregnancy benefit, may cause fetal harm, and Zepbound should be discontinued when pregnancy is recognized. Human tirzepatide data remain insufficient.

What should I do if I find out I am pregnant while taking Zepbound?

Stop Zepbound and contact the prescriber and prenatal clinician promptly. Provide the dose, last injection date, dose-escalation history, and estimated conception timing so they can document the exposure and discuss follow-up.

How long before trying to conceive should Zepbound be stopped?

MotherToBaby estimates that most tirzepatide may take up to about 30 days to leave a healthy adult's body. The current Zepbound label does not state a formal preconception interval, so plan timing with the prescriber.

Is there a Zepbound pregnancy registry?

Yes. The current FDA label lists a pregnancy exposure registry for people exposed to Zepbound during pregnancy. The prescriber can provide current enrollment details and help report the exposure.

Does early Zepbound exposure mean birth defects will occur?

No. An exposure does not determine an individual outcome. Human tirzepatide-specific data are too limited to calculate the chance precisely, and reassuring class-level comparisons have wide uncertainty and cannot establish safety.

Do Zepbound and Mounjaro contain the same medicine?

Yes. Both contain tirzepatide, but their FDA indications differ. Zepbound's pregnancy question centers on weight reduction, which the label says has no benefit during pregnancy, while Mounjaro is used for type 2 diabetes and requires a glucose-management plan.

Can Zepbound make birth-control pills less effective?

Yes. Delayed stomach emptying can reduce oral hormonal contraceptive effectiveness. The label advises a nonoral method or an added barrier method for four weeks after starting Zepbound and for four weeks after each dose increase.

What does the animal research on Zepbound mean?

Animal studies found fetal growth changes and abnormalities at clinically relevant exposures, alongside reduced maternal food intake and weight. They create a safety signal but cannot predict whether or how an individual human pregnancy will be affected.

What is known about Zepbound while breastfeeding?

After one 5 mg tirzepatide dose in 11 lactating adults, 164 of 171 milk samples had no detectable drug; the cumulative detected amount was below 0.02 percent of the maternal dose. This is not a weight-adjusted infant dose estimate. Infant outcomes, milk-production effects, and repeated dosing remain unstudied.

Related in the library

References

  1. ZEPBOUND (tirzepatide) injection, prescribing information

    DailyMed / FDA labeling · https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=487cd7e7-434c-4925-99fa-aa80b1cc776b

  2. Tirzepatide (Mounjaro®, Zepbound®) - MotherToBaby | Fact Sheets - NCBI Bookshelf

    MotherToBaby · https://www.ncbi.nlm.nih.gov/books/NBK605070/?report=printable

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.