Pregnancy and breastfeeding information on a medicine label

Updated 2026-10-10 · Reviewed for accuracy by the EKO Labs team. Educational only; not medical advice.

If you are pregnant, breastfeeding or planning a pregnancy, the most useful information about a prescription medicine is in section 8 of its FDA prescribing informationPrescribing information (label) the official FDA document for a medicine, with its uses, warnings and side effects., called “Use in Specific Populations.” This guide explains how that section is organized, what each part means, and what current GLP-1GLP-1 (glucagon-like peptide-1) a hormone the gut releases after eating. It helps release insulin, slows stomach emptying and signals fullness. labels say, so you can have a better conversation with your doctor or pharmacist. It is general information, not medical advice.

Do not stop or start a prescription medicine on your own because of something you read here. If you are pregnant or think you may be, tell your prescriber. In an emergency, call 911.

Where to find it

The full prescribing information for most prescription medicines is free on DailyMed (dailymed.nlm.nih.gov) and Drugs@FDA. Look for section 8. Subsections 8.1 to 8.3 cover pregnancy, breastfeeding, and pregnancy testing, birth control and fertility. The “Highlights” box at the top of the label gives a short summary.

No more A, B, C, D and X letters

Older labels used pregnancy letter categories (A, B, C, D and X). FDA’s Pregnancy and Lactation Labeling Rule (PLLR), in effect since June 30, 2015, removed these letters. Labels now use written summaries based on the available human, animal and pharmacology data. New prescription drug labels use this format right away, and labels of prescription drugs approved on or after June 30, 2001 are being changed over gradually. Over-the-counter medicine labels are not affected. If an older document still shows a letter category, ask your pharmacist for the current label.

8.1 Pregnancy

Under federal rules (21 CFR 201.57(c)(9)(i)), this subsection uses up to four subheadings, in this order:

• Pregnancy Exposure Registry: if a scientifically acceptable registry exists, the label says so and gives contact information. Registries collect information about pregnancies exposed to a medicine; taking part is voluntary.
• Risk Summary: what is known about the risk of birth defects, miscarriage and other developmental outcomes, from human data first, then animal data, then how the drug works. It must say when there are no human data, and it must give the U.S. background rates of major birth defects and miscarriage that happen regardless of any medicine. If the drug is contraindicated in pregnancy, that is stated first.
• Clinical Considerations: risks of the illness itself during pregnancy, dose changes during pregnancy and after birth, possible effects on the mother, the fetus or the newborn, and labor and delivery.
• Data: details of the human and animal studies behind the summary.

8.2 Lactation (breastfeeding)

This subsection, formerly called “Nursing Mothers,” has a Risk Summary, Clinical Considerations and Data. The Risk Summary must say whether the drug is present in human milk, what is known about its effects on the breastfed child and on milk production, or that there are no data. When only animal data exist, it may only say whether the drug was found in animal milk. Unless breastfeeding is contraindicated, the label states that the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any possible effects on the child.

8.3 Females and males of reproductive potential

When needed, this subsection covers pregnancy testing, contraception and infertility, for example how long before a planned pregnancy a medicine should be stopped, or whether a medicine can make birth-control pills work less well.

Example: what current GLP-1 labels say

We checked the FDA prescribing information (through openFDA, October 2026) for Ozempic and Wegovy (semaglutide) and for Mounjaro and Zepbound (tirzepatide). In short:

• Pregnancy data are limited. All four labels say human data in pregnancy are limited or insufficient to establish a drug-related risk, and that animal studies suggest possible risks to the fetus.
• Weight-management labels (Wegovy and Zepbound) say weight loss offers no benefit during pregnancy and may cause fetal harm, and that the medicine should be stopped when a pregnancy is recognized. Both list a pregnancy exposure registry.
• Diabetes labels (Ozempic and Mounjaro) say the medicine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and note that poorly controlled diabetes itself carries risks in pregnancy.
• Planning a pregnancy: the Ozempic and Wegovy labels say to stop semaglutide at least 2 months before a planned pregnancy, because it stays in the body for a long time.
• Birth-control pills: the Mounjaro and Zepbound labels say tirzepatide may make oral hormonal contraceptives less effective (because it slows stomach emptying) and advise switching to a non-oral method or adding a barrier method for 4 weeks after starting and for 4 weeks after each dose increase.
• Breastfeeding: the semaglutide labels say there are no data on semaglutide in human milk (it was found in the milk of rats). The tirzepatide labels describe a small single-dose study in which tirzepatide in breast milk was mostly undetectable or low, and say there are no data on effects on the breastfed infant or on milk production.

Compounded medicines are not FDA-approvedFDA-approved the FDA reviewed the medicine's safety and effectiveness for a specific use. and have no FDA-approved labeling, so they have no section 8. Ask your prescriber how the information for the FDA-approved product applies to you. Labels are updated over time, so always check the current version.

Other places to get help

• Your prescriber, OB-GYN, midwife or pharmacist, who can look at your whole health picture.
• MotherToBaby, an information service about medicines and other exposures during pregnancy and breastfeeding: 1-866-626-6847.
• If a label lists a pregnancy exposure registry, its contact information is in section 8.1.

Questions to ask your doctor or pharmacist

• What does section 8 of this medicine’s label say about pregnancy and breastfeeding?
• If I want to become pregnant, when should we talk about stopping or changing this medicine?
• Can this medicine affect my birth control, and do I need a backup method?
• Is there a pregnancy registry for this medicine?
• Is my medicine FDA-approved or compounded?

Sources: 21 CFR 201.57(c)(9)(i)–(iii) (eCFR, current text, October 2026); FDA, “Pregnancy and Lactation Labeling (Drugs) Final Rule”; FDA prescribing information for Ozempic, Wegovy, Mounjaro and Zepbound, sections 8.1–8.3 (openFDA, consulted October 2026); MotherToBaby (mothertobaby.org). This guide is general information, not medical advice.