GLP-1 Pregnancy, Breastfeeding and Fertility: What Each FDA Label Says

Section 8 of a U.S. prescribing information document, Use in Specific Populations, is where the FDA-approved label addresses pregnancy (8.1), lactation (8.2) and females and males of reproductive potential (8.3). This page reads those three subsections, plus the fertility paragraph in Section 13.1, on seven current labels: Ozempic (semaglutide injection, Novo Nordisk, revised 5/2026), Wegovy (semaglutide injection and tablets, Novo Nordisk, revised 6/2026), Rybelsus and Ozempic tablets (oral semaglutide, Novo Nordisk, revised 1/2026), Mounjaro (tirzepatide, Eli Lilly, revised 8/2026), Zepbound (tirzepatide, Eli Lilly, revised 8/2026), Saxenda (liraglutide, Novo Nordisk, revised 6/2026) and Victoza (liraglutide, Novo Nordisk, revised 10/2025). Each was read on DailyMed, the National Library of Medicine's mirror of current FDA labeling, accessed 14 September 2026.

The headline is that the labels do not say one thing. The three semaglutide labels carry a specific pre-pregnancy interval: discontinue at least 2 months before a planned pregnancy. The two tirzepatide labels carry no interval and instead use Section 8.3 to address oral hormonal contraceptives. The two liraglutide labels have no Section 8.3 at all. Two labels, Wegovy and Zepbound, name a pregnancy exposure registry; five do not. On lactation, the tirzepatide labels print a human milk study, the semaglutide injection and liraglutide labels say there are no human data, and the oral semaglutide labels say breastfeeding is not recommended because of the SNAC absorption enhancer.

What every label shares is the hedge. Each says that animal studies suggest there may be risks to the fetus, none claims human data sufficient to establish or exclude a drug-associated risk, and each leaves the decision to the prescriber with the patient's history in front of them. This page is a transcription of that text. It does not say what anyone should do, and the instructions quoted below are the labels' instructions to prescribers, not this site's. For the same labels' pharmacokinetic sections — the half-life figures behind the 2-month interval — see Ozempic, Wegovy, Zepbound and Saxenda. Pages that touch pregnancy from the condition side, GLP-1 for PCOS and GLP-1 and menopause, point back here for the label text rather than repeating it.

Ozempic Section 8.3, Females and Males of Reproductive Potential, is one sentence: discontinue OZEMPIC in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide, with a cross-reference to 8.1. The Highlights box at the top of the label repeats it word for word. The Rybelsus and Ozempic tablets label uses the same sentence with its own product names: discontinue RYBELSUS or OZEMPIC tablets in women at least 2 months before a planned pregnancy due to the long washout period for semaglutide (Ozempic revised 5/2026; Rybelsus and Ozempic tablets revised 1/2026, via DailyMed, accessed 14 September 2026).

Wegovy Section 8.3 says the same thing in different words and gives a reason: because of the potential for fetal harm, discontinue WEGOVY in patients at least 2 months before they plan to become pregnant to account for the long half-life of semaglutide. The Wegovy Highlights adds a qualifier the full section does not, tying the interval to patients receiving WEGOVY for cardiovascular risk reduction or weight reduction, or for MASH where the potential risk outweighs the potential benefit — a reflection of the label's newer indication for metabolic dysfunction-associated steatohepatitis, discussed below. The Wegovy Medication Guide, written for patients, tells them to stop using WEGOVY 2 months before they plan to become pregnant (Wegovy revised 6/2026, via DailyMed, accessed 14 September 2026). Outside the United States the interval is the same: section 4.6 of the EMA Summary of Product Characteristics for Wegovy states that semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life, and that if a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued (EMA product information updated 26 August 2026).

That is where the interval ends. The Mounjaro and Zepbound labels do not print any number of weeks or months before a planned pregnancy; their Section 8.3 is about contraception, quoted in the fertility section below, and their Section 17 counseling text says only to advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant. The Saxenda and Victoza labels have no Section 8.3 — the table of contents on each runs 8.1 Pregnancy, 8.2 Lactation, 8.4 Pediatric Use — and neither prints a pre-pregnancy interval anywhere (Mounjaro and Zepbound revised 8/2026; Saxenda revised 6/2026; Victoza revised 10/2025, via DailyMed, accessed 14 September 2026). The labels do not explain why they differ; the pharmacokinetic reason usually offered — semaglutide's roughly one-week half-life against tirzepatide's roughly five days and liraglutide's roughly 13 hours — is a reading of Section 12.3, not a statement any label makes in Section 8. Whether an interval applies to a particular person, and what happens during it, is a prescriber's question.

The Section 8.1 risk summaries sort the seven labels by indication rather than by molecule. The weight-management labels all carry the same core sentence: weight loss offers no benefit to a pregnant patient and may cause fetal harm. Wegovy 8.1 continues: when a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue WEGOVY in pregnant patients who are using it for weight reduction. Zepbound 8.1: advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue ZEPBOUND when a pregnancy is recognized. Saxenda 8.1: when a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue SAXENDA. All three add, under Clinical Considerations, that appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy (via DailyMed, accessed 14 September 2026).

The benefit-versus-risk sentence appears on five labels. Ozempic 8.1, Rybelsus 8.1, Mounjaro 8.1 and Victoza 8.1 each state that the product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and Saxenda 8.1 carries both sentences: the benefit-versus-risk sentence and, in the next line, the instruction to discontinue when a pregnancy is recognized. The four diabetes labels each describe the disease-associated risk the benefit is weighed against: poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications, and increases the fetal risk for major birth defects, stillbirth and macrosomia-related morbidity. The Ozempic, Rybelsus, Mounjaro and Victoza labels also print a diabetes-specific background rate: an estimated 6% to 10% risk of major birth defects in women with pre-gestational diabetes and a peri-conceptional HbA1c above 7, reported as high as 20% to 25% with an HbA1c above 10 (via DailyMed, accessed 14 September 2026).

Wegovy sits in both camps since its MASH indication. Its 8.1 says WEGOVY for the treatment of MASH with advanced liver fibrosis should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, that there may be risks to the mother and fetus related to MASH — the label names gestational diabetes, hypertensive complications, preterm birth and postpartum hemorrhage — and that whether WEGOVY treatment during pregnancy reduces these risks is unknown (Wegovy revised 6/2026, via DailyMed, accessed 14 September 2026).

On the human evidence, Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound each state that available data are limited or insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes; Saxenda and Victoza print no such sentence. Saxenda says the background risk for the indicated populations is unknown; Victoza prints the diabetes-specific rates quoted above instead. On every label, the animal reproduction studies are the stated reason for caution. The semaglutide labels describe embryofetal mortality, structural abnormalities and altered growth in pregnant rats, and early pregnancy losses and structural abnormalities in rabbits and cynomolgus monkeys, all coinciding with marked maternal weight loss. The tirzepatide labels describe fetal growth reductions and fetal abnormalities in rats and rabbits alongside pharmacological effects on maternal weight and food consumption. The Saxenda label describes early embryonic deaths in rats and decreased fetal weight with major fetal abnormalities in rabbits. The oral semaglutide labels add that salcaprozate sodium, SNAC, the tablets' absorption enhancer, crosses the placenta in rats (Section 8.1 of each label, via DailyMed, accessed 14 September 2026).

Section 8.2 is where the molecules separate most clearly. The Ozempic label states there are no data on the presence of semaglutide in human milk, the effects on the breastfed infant, or the effects on milk production; that semaglutide was present in the milk of lactating rats at levels 3- to 12-fold lower than in maternal plasma; and that, because of species-specific differences in lactation physiology, the clinical relevance of these data are not clear. Wegovy 8.2 for the subcutaneous injection says the same — no data on subcutaneously administered semaglutide or its metabolites in human milk — and adds that WEGOVY subcutaneous injection does not contain the SNAC metabolites. Both close with the standard sentence that the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for the product and any potential adverse effects on the breastfed infant (via DailyMed, accessed 14 September 2026).

The oral semaglutide products are the exception. Rybelsus 8.2 and the Wegovy tablets paragraph of Wegovy 8.2 report a clinical lactation study in which semaglutide concentrations in human milk were below the lower limit of quantification — but SNAC and/or its metabolites are present in human milk, the activity of enzymes involved in SNAC clearance may be lower in infants than in adults, and higher SNAC plasma levels may occur in neonates and infants. Because of the unknown potential for serious adverse reactions in the breastfed infant due to possible SNAC accumulation, and because alternative semaglutide formulations without SNAC can be used during lactation, both labels direct prescribers to advise patients that breastfeeding is not recommended during treatment with the tablets. The Highlights of the Rybelsus label say simply: breastfeeding not recommended; the Wegovy Highlights say breastfeeding not recommended during treatment with WEGOVY tablets (Rybelsus and Ozempic tablets revised 1/2026; Wegovy revised 6/2026, via DailyMed, accessed 14 September 2026). The EMA Summary of Product Characteristics for Wegovy is stricter than the FDA injection label's no-data wording: section 4.6 states that semaglutide should not be used during breast-feeding for the injection, because semaglutide was excreted in the milk of lactating rats and a risk to newborns or infants cannot be excluded, and separately that Wegovy should not be used during breast-feeding for the tablets, because salcaprozate sodium and some of its metabolites were present in breast milk (SmPC section 4.6, updated 26 August 2026).

The tirzepatide labels are the only ones with a human milk figure for the active molecule. Mounjaro 8.2 and Zepbound 8.2 report a single-dose clinical lactation study in 11 healthy lactating adults: tirzepatide was undetectable in 164 of 171 breast milk samples assayed, the cumulative amount detected in the remaining 7 samples over the 28-day sampling window was equivalent to less than 0.02% of the maternal administered dose, the last measurable concentrations occurred 5 days post-dose, and the milk AUC could not be calculated because of insufficient quantifiable concentrations. Both labels then say there are no available data on the effects of tirzepatide on the breastfed infant or on milk production, and print the same benefits-of-breastfeeding sentence (Mounjaro and Zepbound revised 8/2026, via DailyMed, accessed 14 September 2026).

The liraglutide labels have the least. Saxenda 8.2 and Victoza 8.2 state there are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or effects on milk production, and both give the same figure, from animal data: in lactating rats, liraglutide was present unchanged in milk at approximately 50% of maternal plasma concentrations (Data, 8.2 of each label; Saxenda revised 6/2026; Victoza revised 10/2025, via DailyMed, accessed 14 September 2026). None of these paragraphs is a recommendation; the labels leave the weighing to the prescriber and, in practice, the pharmacist and the infant's clinician.

No GLP-1 label reports a human fertility study. What each carries is a rat fertility study in Section 13.1, Carcinogenesis, Mutagenesis, Impairment of Fertility. The semaglutide labels — Ozempic, Wegovy, Rybelsus — describe a combined fertility and embryo-fetal development study in which males were dosed for 4 weeks before mating and females for 2 weeks before mating and through organogenesis: no effects were observed on male fertility; in females, an increase in estrus-cycle length was observed at all dose levels, together with a small reduction in numbers of corpora lutea at clinically relevant exposures, and the labels state these effects were likely an adaptive response secondary to the pharmacological effect of semaglutide on food consumption and body weight (via DailyMed, accessed 14 September 2026).

The tirzepatide labels, Mounjaro and Zepbound, describe fertility and early embryonic development studies in rats: no effects of tirzepatide were observed on sperm morphology, mating, fertility and conception; in female rats, an increase in the number of females with prolonged diestrus and a decrease in the mean number of corpora lutea, resulting in a decrease in the mean number of implantation sites and viable embryos, was observed at all dose levels, and these effects were considered secondary to the pharmacological effects of tirzepatide on food consumption and body weight. The liraglutide labels, Saxenda and Victoza, report that no direct adverse effects on male fertility were observed at doses up to the highest tested, and that in female rats an increase in early embryonic deaths occurred at that highest dose, alongside reduced body weight gain and food consumption (Section 13.1 of each label, via DailyMed, accessed 14 September 2026). The EMA text for Wegovy summarises the human position in one sentence: the effect of semaglutide on fertility in humans is unknown (SmPC section 4.6).

The tirzepatide labels use Section 8.3 for a different reproductive-potential issue. Mounjaro 8.3 and Zepbound 8.3, both titled Contraception, state that use of the product may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying; that this delay is largest after the first dose and diminishes over time; and that prescribers should advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation, cross-referencing Section 7.2 on drug interactions. The Highlights of both labels repeat it. No semaglutide or liraglutide label has an equivalent paragraph in Section 8.3; the Wegovy and Rybelsus labels address oral medications in Section 7 in general terms instead (Mounjaro and Zepbound revised 8/2026, via DailyMed, accessed 14 September 2026). Contraceptive method, like everything else on this page, is a conversation with the prescriber and pharmacist, and the label text above is what they will be reading.

A pregnancy exposure registry is an observational study that follows pregnancies exposed to a medication so that the insufficient-data sentence in Section 8.1 can eventually be replaced with something better. Two of the seven labels name one. Wegovy 8.1 opens with a Pregnancy Exposure Registry paragraph: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to WEGOVY during pregnancy, and pregnant women exposed to WEGOVY and healthcare providers are encouraged to contact Novo Nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com; the Section 17 counseling text and the Medication Guide repeat the contact details. Zepbound 8.1 opens the same way: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ZEPBOUND (tirzepatide) during pregnancy, and pregnant patients and healthcare providers are encouraged to register by calling 1-844-524-0039, emailing MILEregistry@thermofisher.com, or visiting pregnancyregistry.lilly.com/zepbound (Wegovy revised 6/2026; Zepbound revised 8/2026, via DailyMed, accessed 14 September 2026).

The Ozempic, Rybelsus, Mounjaro, Saxenda and Victoza labels do not mention a registry. That is a statement about the label text on the access date, not about whether a registry exists — Mounjaro and Zepbound are the same molecule from the same manufacturer, and only the Zepbound label names the Lilly registry. Whether a registry applies to a given product is a question for the prescriber or the manufacturer's medical information line, not something to infer from a sibling label.

None of this page is actionable on its own. What it does make obvious is how much of Section 8 turns on dates: the date of the last dose relative to a planned conception, the date a pregnancy was recognized relative to the doses before it, the date of initiation and of each dose escalation relative to a contraceptive change, the date breastfeeding started or stopped. Those are the facts a prescriber, an obstetric clinician or a registry coordinator will ask for, and memory reconstructs them badly. GLP-1 Tracker, a free iPhone app that stores what you enter on your device, does the narrow job of holding each dose with its date and site, your weight, and a dated note when something changes, so the sequence is accurate when someone asks; it does not interpret Section 8 or decide anything about a pregnancy. A dated list of doses is also the first item on how to prepare a GLP-1 summary for your doctor, and the questions this page raises belong on the list in questions to ask at your GLP-1 follow-up.