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Mounjaro, Ozempic, pregnancy and the pill: what do the labels say?

What US, European and UK labels say about Mounjaro, Ozempic, Wegovy and Saxenda: before pregnancy, with the pill, and when breastfeeding.

GLP Guidebook teamPublished 5 Oct 202611 min read20 sourcesWritten from published sources

Written for India. Reading from the US? US versionComing soon

The short answer

US and EU labels warn GLP-1 medicines may harm a baby. They say to stop semaglutide (Ozempic, Wegovy) at least 2 months before a planned pregnancy; the EU tirzepatide (Mounjaro) label says 1 month. The US Mounjaro label warns the pill may work less well, and advises non-pill methods or condoms for 4 weeks after starting and each dose increase.

Key takeaways

  • The US Wegovy and Zepbound labels say weight loss offers no benefit in pregnancy and may harm the baby, and that the medicine is stopped once a pregnancy is known.2,3
  • US and European semaglutide labels say to stop at least 2 months before a planned pregnancy; for tirzepatide, the European label says at least 1 month.3,4,5,6
  • The US Mounjaro label advises a non-pill method, or adding condoms, for 4 weeks after starting and after each dose increase, because the pill may work less well.1
  • In the largest study, 8.3% of 938 babies exposed early to GLP-1 medicines had a major birth defect, against 7.8% after insulin, in mothers with type 2 diabetes.10
  • India's 2025 ESI obesity guideline says contraception is mandatory for women who could get pregnant on weight-loss medicines, and continues for 3 months after stopping.9
On this page
  1. What the labels say
  2. Stopping before a pregnancy
  3. Mounjaro and the pill
  4. If a pregnancy happens
  5. What studies found
  6. "Ozempic babies" and fertility
  7. Breastfeeding
  8. Questions people ask
  9. How we researched this

What do the drug labels say about GLP-1 medicines in pregnancy?

Every label we read warns of possible harm to the baby in pregnancy, mainly on the strength of animal studies.

Before you go further
  • GLP‑1 medicines are prescription-only in India and cannot be bought over the counter.16
  • A government statement on 1 Apr 2026 said only endocrinologists, internal-medicine specialists and cardiologists can prescribe them.16 CDSCO expert-committee minutes attach a similar condition to some approvals (endocrinologist or internal-medicine specialist), but we found no rule covering every brand.17
  • All the risks of these medicines are in Guide 5: Side effects and risks.
  • Check for fakes and recalls in Guide 6.
  • This post describes labels. It promises no result and is not a plan for anyone's treatment.

This post covers two medicines. Semaglutide is sold as Ozempic, Wegovy and Rybelsus; our answer Is semaglutide the same as Ozempic? explains the names. Tirzepatide is Mounjaro, and Cipla sells the same Lilly medicine as Yurpeak.18 More is in What is tirzepatide?

The weight-loss labels are the firmest. Zepbound is the US weight-loss brand of tirzepatide.2 The US Wegovy and Zepbound labels say weight loss offers no benefit in pregnancy and may harm the baby.2,3 Zepbound's label says to stop it once a pregnancy is known.2 Wegovy's says to stop it in women using it for weight.3

The diabetes labels are worded differently. The US Mounjaro and Ozempic labels allow use in pregnancy "only if the potential benefit justifies the potential risk".1,4 That is because badly controlled diabetes is itself a risk in pregnancy.1 With HbA1c (average blood sugar) above 7%, the Mounjaro label puts the risk of a major birth defect at 6% to 10%.1 Above 10%, it has been reported as high as 20% to 25%.1

The European labels are stricter. They say semaglutide "should not be used during pregnancy".6,7 Tirzepatide is "not recommended" in pregnancy, or in women who could get pregnant and are not using contraception.5

The warnings rest on animal studies. In pregnant rats, tirzepatide slowed the babies' growth and caused abnormalities.1 Semaglutide caused early pregnancy losses and abnormalities in rabbits and monkeys.3 In both cases the mothers were also eating less and losing weight. The labels say the harm came alongside that.1,3

India note. CDSCO, India's drug regulator, authorised Mounjaro before its March 2025 launch.19 Our answer Is Mounjaro available in India? covers its status. We found no public copy of the Indian labels for Mounjaro, Wegovy or Ozempic. So this post quotes US and European labels. The Indian obesity guideline (ESI 2025) lists pregnancy and breastfeeding as reasons not to use semaglutide, tirzepatide or liraglutide.9

How long before a planned pregnancy do the labels say to stop?

For semaglutide, at least 2 months on US and European labels; for tirzepatide, at least 1 month on the European label.

The gap exists because these medicines stay in the body for weeks. Semaglutide's half-life (the time for half of it to leave the blood) is about 1 week.4 The Ozempic label says it stays in the blood for about 5 weeks after the last dose.4

The US tirzepatide labels give no interval at all.1,2 Tirzepatide's half-life is shorter, about 5 days.1 So the European label's gap is shorter too: at least 1 month before a planned pregnancy.5

MedicineStop before a planned pregnancyThe pillBreastfeeding
Semaglutide (Ozempic, Wegovy, Rybelsus)At least 2 months (US, EU, UK)3,4,6,8No switch advised; EU label: not expected to make it less effective6EU: should not be used. US injection label: no data in humans3,6
Tirzepatide (Mounjaro, Yurpeak)At least 1 month (EU, UK). US label: no interval given1,5,8US and UK: non-pill method or add condoms for 4 weeks after starting and each dose increase. EU: drop not clinically relevant1,5,8EU: "could be considered". US: very little found in milk; weigh benefits1,5
Liraglutide (Saxenda, Victoza)UK: 0 months; stop “just before trying to become pregnant”, as it leaves the body much quicker. US Saxenda: stop when pregnancy is known8,15US Saxenda: peak oestrogen 12% lower, total oestrogen exposure unchanged, peak 1.5 hours later. No switch advised15UK: GLP‑1 medicines should not be taken while breastfeeding8

What each regulator's label or guidance says. US = FDA labels, EU = European Medicines Agency labels, UK = MHRA guidance updated 5 Feb 2026. No Indian label was publicly available. Checked 5 Oct 2026.

India's guideline asks for more time. ESI 2025 says contraception is mandatory for women of child-bearing age who start an anti-obesity medicine.9 It says this must continue for 3 months after the medicine is stopped.9 That is longer than any label interval in the table.

One number online doesn't match the labels. Some websites give "2 months" for Mounjaro. We found no label that gives 2 months for tirzepatide; 2 months is the semaglutide figure.1,5,8 Liraglutide, the older daily medicine, is covered in our Saxenda and Victoza post.

For women with type 2 diabetes, stopping one medicine means another must control blood sugar. The labels' birth-defect figures above show why that switch matters.1 What happens to weight and sugar after stopping is in Guide 9: Stopping and the long term.

Does Mounjaro make the contraceptive pill less reliable?

The US label says it may, because tirzepatide slows stomach emptying, most of all after the first dose.

A slower stomach means a pill taken by mouth is absorbed later and less sharply. In a study on the US label, one 5 mg dose cut the peak level of the pill's oestrogen by 59%.2 Total exposure over the day fell by 20%.2 The progestogen fell by similar amounts, and the peaks came 2.5 to 4.5 hours late.2

So the US Mounjaro label advises a switch to a non-pill method, or adding a barrier method such as condoms.1 That applies for 4 weeks after starting and for 4 weeks after each dose increase.1 It says hormonal methods not taken by mouth should not be affected.1

How long that window can run. Your doctor sets the dose; this example only follows the US label. The label starts at 2.5 mg a week and allows a 2.5 mg step after at least 4 weeks.1 Someone stepped up every 4 weeks to 10 mg makes 3 increases. Each one restarts a 4-week window, so the windows run back to back for about 16 weeks (our arithmetic).

The labels disagree here. The European Mounjaro label reports the same study but calls the drop "not considered clinically relevant".5 It still recommends contraception for women who could get pregnant.5 In 2025 the UK regulator sided with the US advice. It named the coil and the implant as methods "not as affected".8

India's ESI guideline follows the US approach. It says women on the pill "must shift to a non-oral method" or add a barrier method. That applies when tirzepatide is started or increased.9 Its example is a hormone-releasing intrauterine device (a progesterone coil).9

Semaglutide and liraglutide labels carry no pill warning. The European Wegovy label says semaglutide is not expected to make the pill less effective, based on its own study.6 The US Ozempic label gives no switching advice.4 On the US Saxenda label, liraglutide lowered the pill’s peak oestrogen by 12% and left total exposure unchanged. It gives no switching advice.15 How the two main medicines compare is in Mounjaro vs Ozempic.

Sickness is a separate route. Vomiting and diarrhoea are among the most common side effects of GLP‑1 medicines, the UK regulator says.8 UK NHS guidance on the combined pill covers both. It says vomiting less than 3 hours after a pill means taking another one straight away.20 For diarrhoea lasting more than 24 hours, it says to use condoms as well until 7 days after it stops.20

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What do the labels say if a pregnancy happens while on one?

The weight-loss labels say to stop the medicine once a pregnancy is known, and two US labels name pregnancy registries.

The Zepbound, Wegovy and Saxenda labels all say weight loss offers no benefit in pregnancy.2,3,15 Each says the medicine is stopped when a pregnancy is recognised, at least when used for weight.2,3,15 The UK regulator says anyone who might be pregnant should speak to a healthcare professional "straight away".8

The Wegovy and Zepbound labels each name a pregnancy exposure registry, a study that follows pregnancies exposed to the medicine.2,3 We found no registry line on the US Mounjaro or Ozempic labels.1,4 Both registries list US phone numbers.2,3 We found no Indian equivalent.

The labels also state the normal background risk. In the US general population, 2% to 4% of recognised pregnancies have a major birth defect. Between 15% and 20% end in miscarriage.1,2,3 Those are the numbers any study of exposed pregnancies is compared against.

What have studies of exposed pregnancies found so far?

Two studies, of 938 babies and 168 pregnancies, found no large rise in birth defects. A Danish study of 529 pregnancies found more preterm births, only with diabetes.

The largest study (2024) used health records from 4 Nordic countries, the US and Israel. It covered women with type 2 diabetes. Exposure meant a prescription from 90 days before pregnancy to the end of the first trimester.10 Of 938 babies exposed to a GLP‑1 medicine, 8.3% had a major birth defect. After insulin, the figure was 7.8%.10

After adjusting for differences between the mothers, the relative risk was 0.95, with a range of 0.72 to 1.26.10 The authors said this did not show a large added risk, but "confirmation from other studies is needed".10 For comparison, 3.7% of all babies in the records had a major birth defect.10

A European and Israeli study (2024) followed 168 pregnancies exposed in the first trimester.11 Major birth defects were 2.6%, against 2.3% in women with diabetes and 3.9% in women with overweight or obesity.11 It found no rise in pregnancy loss, but said larger studies are needed.11

A Danish study (2026) looked at 529 pregnancies exposed to liraglutide or semaglutide around conception.12 It measured pregnancy complications such as preterm birth, not birth defects.12 After matching, only preterm birth stayed higher, and only in women taking them for diabetes.12 Among women using them for weight, no link with preterm birth was seen.12 The authors say the design "cannot establish causality".12

The limits are large. None of the three studies was done in India.10,11,12 The 168-pregnancy study calls its own sample limited.11 A 2025 review found the only trial evidence comes from pregnancies that happened by accident during drug trials.13 It called registries for exposed pregnancies "a high priority".13 For tirzepatide, the US label says human data are still too few to judge the risk.1

Can these medicines make pregnancy more likely?

"Ozempic babies" names reported surprise pregnancies; researchers think weight loss restoring ovulation is the likeliest reason.

Two Australian researchers described "a rise in stories" of women on drugs like Ozempic reporting unexpected pregnancies.14 These are personal accounts from women on the medicines. They wrote that weight loss and better metabolic health are "the most likely reasons".14

The link runs through ovulation (an egg being released each month). They wrote that women with a BMI above 27 are 3 times as likely to be unable to conceive. They ovulate less often.14 Losing weight can make periods more regular.14 They added that it is "uncertain" whether Ozempic itself causes pill failure.14

The European labels say the effect of semaglutide and tirzepatide on human fertility is unknown.5,6 PCOS (polycystic ovary syndrome) causes hormone imbalances that make periods irregular.14 It gets its own post: PCOS and GLP‑1 medicines. ESI 2025 says contraception counselling is "essential" before any anti-obesity medicine starts.9

RisksThe risks, in brief
  • Stomach effects are common. In the US Zepbound weight trials, 25% to 29% had nausea, against 8% on a dummy injection.2
  • Pancreatitis. The warning sign on the label is persistent or severe stomach pain, sometimes spreading to the back.1
  • Gallbladder problems. Reported in 0.6% on Mounjaro, against 0% on placebo, in the diabetes trials.1
  • Dehydration from vomiting or diarrhoea can injure the kidneys.1
  • Thyroid warning. Ruled out by the US label for anyone with a personal or family history of medullary thyroid cancer (MTC) or MEN 2; tell your doctor if this applies.1
  • Not in pregnancy. The weight-loss labels say the medicine is stopped once a pregnancy is known.2,3
Full detail in Guide 5: Side effects and risks →
Get help now: call 112. Severe stomach pain that won't go away, or that spreads to the back, is the label's warning sign for pancreatitis.1

Can you breastfeed while taking a GLP-1 medicine?

The labels split: European semaglutide labels say no, and the European tirzepatide label says it "could be considered".

The UK regulator says no for all GLP‑1 medicines.8 For tirzepatide, a study gave one 5 mg dose to 11 breastfeeding women. The medicine was undetectable in 164 of 171 milk samples.1 The rest added up to less than 0.02% of the dose.1 The US label says there are no data on the effect on the baby or on milk supply.1

On that basis, the European Mounjaro label says tirzepatide "could be considered" during breastfeeding.5 The US label asks prescribers to weigh breastfeeding's benefits against the mother's need and any risk to the baby.1

For semaglutide, the European labels say it "should not be used during breast-feeding", as it passed into milk in rats.6,7 The US Wegovy label has no human milk data for the injection.3 It says breastfeeding is not recommended on Wegovy tablets, because of an added ingredient (SNAC) that reaches milk.3

The UK regulator says GLP‑1 medicines "should not be taken by people who are breastfeeding".8 India's ESI guideline lists breastfeeding as a reason not to use them.9

Questions people ask

Can you take Mounjaro while pregnant?

The European label says tirzepatide is not recommended in pregnancy.5 The US Zepbound label says weight loss offers no benefit in pregnancy. It says the medicine is stopped once a pregnancy is known.2 India's ESI guideline lists pregnancy as a reason not to use it.9

How long after stopping Mounjaro can you try to get pregnant?

The European label and the UK regulator say to stop at least 1 month before a planned pregnancy.5,8 The US label gives no interval.1 India's ESI guideline says contraception continues for 3 months after stopping.9

Does Ozempic stop the pill from working?

The European Wegovy label says semaglutide is not expected to make the pill less effective.6 The pill warning on US labels is for tirzepatide (Mounjaro), not semaglutide.1,4 Separately, UK NHS pill guidance covers vomiting within 3 hours of a pill and diarrhoea lasting over 24 hours.20

Does Mounjaro affect the coil or the implant?

The US label says hormonal methods not taken by mouth should not be affected.1 The UK regulator names the coil and the implant as methods not as affected by GLP‑1 medicines.8

What happens if you get pregnant on Ozempic or Mounjaro?

The weight-loss labels say the medicine is stopped once a pregnancy is known.2,3 In the largest study, 8.3% of 938 exposed babies had a major birth defect. After insulin, it was 7.8%. The mothers had type 2 diabetes.10 The authors said more studies are needed.10

Are "Ozempic babies" real?

They are surprise pregnancies reported by women taking these medicines.14 Two Australian researchers think weight loss restoring ovulation is the likeliest reason.14 The European labels say the effect on human fertility is unknown.5,6

How we researched this

On 5 Oct 2026 we read the pregnancy and contraception sections of 5 US labels: Mounjaro, Zepbound, Wegovy, Ozempic and Saxenda. We also read 3 European labels, the UK regulator's guidance, the NHS combined-pill sickness page and India's ESI 2025 obesity guideline. Zepbound is the US weight-loss brand of tirzepatide; it is quoted where its label says more than Mounjaro's.

We found no public copy of the Indian labels. So every label figure here is US or European, and says so. We read the summaries of three observational studies and one review. We left out a UK count of pregnancy reports found only second-hand. We also left out a 2026 pooled analysis with badly matched groups.

Before you move on

  • Every label we read warns that GLP‑1 medicines may harm a baby in pregnancy.
  • Labels give 2 months for semaglutide and 1 month for tirzepatide (EU) before a planned pregnancy. ESI says 3 months of contraception.
  • The pill warning is for tirzepatide: 4 weeks after starting and after each dose step, on the US label.
  • Two studies found no large rise in birth defects so far; the authors want more data, and none of the studies is Indian.
Side effects and risksI'm considering it for my weightDoctor questions toolWho can prescribe in India

More from the India blog

INIndiaMounjaro vs Ozempic: how do they differ in India? INIndiaWegovy vs Ozempic: same medicine, different brand? INIndiaLiraglutide, Saxenda and Victoza: the older GLP-1 in India
About GLP Guidebook

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Sources

  1. Eli Lilly. Mounjaro (tirzepatide) prescribing information, US label, revised 08/2026: §2.1, §5, §7.2, §8.1–8.3, §12.3. pi.lilly.com/us/mounjaro-uspi.pdf
  2. Eli Lilly. Zepbound (tirzepatide) prescribing information, US label, revised 08/2026: Table 1, §8.1–8.3, §12.3. pi.lilly.com/us/zepbound-uspi.pdf
  3. Novo Nordisk. Wegovy (semaglutide) prescribing information, US label, revised 06/2026: §8.1–8.3. novo-pi.com/wegovy.pdf
  4. Novo Nordisk. Ozempic (semaglutide) prescribing information, US label, revised 05/2026: §8.1–8.3, §12.3. novo-pi.com/ozempic.pdf
  5. European Medicines Agency. Mounjaro product information (EU label, SmPC) §4.5–4.6, downloaded 5 Oct 2026. ema.europa.eu (PDF)
  6. European Medicines Agency. Wegovy product information (EU label, SmPC) §4.5–4.6, downloaded 5 Oct 2026. ema.europa.eu (PDF)
  7. European Medicines Agency. Ozempic product information (EU label, SmPC) §4.6, downloaded 5 Oct 2026. ema.europa.eu (PDF)
  8. MHRA (UK medicines regulator). GLP‑1 medicines for weight loss and diabetes: what you need to know. Published 5 Jun 2025, updated 5 Feb 2026. gov.uk
  9. Madhu SV, et al. Endocrine Society of India (ESI) clinical practice guidelines for obesity 2025. Indian J Endocrinol Metab. 2025;29(4):355–365. DOI · Full text
  10. Cesta CE, et al. Safety of GLP‑1 receptor agonists and other second-line antidiabetics in early pregnancy. JAMA Intern Med. 2024;184(2):144–152. DOI · PMID 38079178
  11. Dao K, et al. Use of GLP1 receptor agonists in early pregnancy and reproductive safety: a multicentre, observational, prospective cohort study based on the databases of six Teratology Information Services. BMJ Open. 2024;14:e083550. DOI · PMID 38663923
  12. Hviid KVR, et al. Periconceptional GLP‑1 receptor agonist exposure and obstetric outcomes: a Danish nationwide cohort study. Hum Reprod Open. 2026. DOI · PMID 41852577
  13. Parker CH, et al. GLP‑1 receptor agonists' use during pregnancy: safety data from regulatory clinical trials. Diabetes Obes Metab. 2025. DOI · PMID 40329607
  14. Hammarberg K, Norman R. What are "Ozempic babies"? Can the drug really increase your chance of pregnancy? The Conversation, 17 Apr 2024. theconversation.com
  15. Novo Nordisk. Saxenda (liraglutide) prescribing information, US label, revised 02/2026: §8.1, §12.3. novo-pi.com/saxenda.pdf
  16. PIB Research (Government of India). GLP‑1 Drugs: Use, Risks, and Regulation. 1 Apr 2026. static.pib.gov.in (PDF)
  17. CDSCO. Recommendations of the Subject Expert Committee (Endocrinology & Metabolism), 20–21 Apr 2023, tirzepatide item. cdsco.gov.in (PDF) · archived copy
  18. Cipla. Press release: Cipla launches Yurpeak (tirzepatide). 10 Dec 2025. cipla.com (PDF)
  19. Business Standard. Eli Lilly launches Mounjaro in India. 20 Mar 2025. business-standard.com
  20. NHS (UK). What to do if you’re sick or have diarrhoea when taking the combined pill. Page last reviewed 15 Feb 2024. nhs.uk

Last checked 5 Oct 2026 · Next review due 5 Oct 2027 · Report an error

How this post was made. Written by the GLP Guidebook team from the sources above. It's general information, not medical advice. Talk to a qualified doctor before starting, stopping or changing any medicine, or before planning a pregnancy on one. How we write