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In-depth article

Botulinum toxin, pregnancy and breastfeeding: what do the labels say?

During pregnancy and breastfeeding, the labels of the botulinum toxins used in aesthetic medicine advise against injection, because there are not enough data in pregnant women or on transfer into breast milk. Here is exactly what they say, what is known about an injection given before you knew you were pregnant, and when to talk to a doctor.

An ongoing pregnancy, plans for a baby, breastfeeding: the question comes up often in consultation. It is part of the precautions to take before and after a botulinum toxin injection, and this article looks at it in detail, relying only on the official labels of the medicines and on the few published data.

What the labels say about pregnancy

Summaries of product characteristics (SmPCs) are the official product information written for doctors. For the botulinum toxins approved for aesthetic use, their section on pregnancy points in the same direction for all those we reviewed, with more or less strict wording depending on the product:

  • for one type A toxin, the product is not recommended during pregnancy or in women of childbearing potential who do not use contraception1; another uses very similar wording4;
  • for a third, the product should not be used during pregnancy unless clearly necessary2;
  • for a fourth, the product should not be used during pregnancy3;
  • for the short-acting botulinum toxin (serotype E), use during pregnancy and in women of childbearing potential not using contraception is not recommended5.

The short-acting toxin is approved in the European Union5. As of 9 October 2026, it is also approved in Canada (since 22 June 2026)7. In practice, the aesthetic treatment of wrinkles is never urgent. The simplest position, and the one that follows from the labels, is to postpone any injection until after pregnancy.

Why such caution?

The caution comes first from a lack of data. One label states that there are no adequate studies of type A botulinum toxin in pregnant women, that animal studies have shown reproductive toxicity, and that the potential risk in humans is unknown1. For the short-acting toxin, data in pregnant women are limited and animal studies are insufficient to draw conclusions on reproductive toxicity5.

So this is not proof of danger, but an absence of proof of safety. What is known comes mainly from following pregnancies exposed without the mother knowing, such as the analysis presented below6.

An injection received before you knew you were pregnant

This is the most common situation, and it causes a lot of worry. First step: tell the doctor or midwife who is following the pregnancy, as well as the doctor who gave the injection. The package leaflet of the short-acting toxin asks you to tell your doctor if you become pregnant after your treatment5. Write down the date of the injection, the area treated and, if possible, the name and batch number of the product, which the labels ask to be clearly recorded5.

The only published figures come from the safety database of a type A toxin manufacturer, analysed over 29 years6. Of 913 reported pregnancies, 397 had a known outcome and could be analysed; the indication was aesthetic in about a third of the cases where it was known, and exposure had taken place before conception or in the first trimester in nearly 95% of the cases where the timing was known6. Among the 152 live births from pregnancies reported before their outcome, a single major birth defect was reported, or 0.7%, a rate the authors consider consistent with that of the general population6.

These figures have important limitations, which the authors partly acknowledge: coming from a post-marketing safety database, the data are subject to reporting bias, they are scarce for exposure in the second or third trimester, and most of the authors are employees of the manufacturer6. They do not allow anyone to conclude that an injection during pregnancy is risk-free; they can, however, inform your discussion with the doctor following you, who alone can assess your situation.

Planning a pregnancy and contraception

The labels also cover women of childbearing potential who do not use contraception: injection is not recommended for them1,4,5. If you are planning a pregnancy, tell the doctor before the session.

No label sets a waiting period between an injection and conception. As a guide, remember that the effect is temporary: it gradually fades as the nerve recovers its ability to control the muscle. The timings for each family of toxins are set out on our page about how long the effect of botulinum toxin lasts.

What about breastfeeding?

Here too, the labels agree. It is not known whether botulinum toxin passes into breast milk1,2,5. Depending on the product, use during breastfeeding is advised against1, is not recommended4,5 or should not take place2. The label of the short-acting toxin adds that a risk to the newborn or infant cannot be excluded5.

No label states how long to wait after you stop breastfeeding, or whether breastfeeding should be interrupted after an injection. If you are breastfeeding and the question arises, raise it with the doctor before any session rather than afterwards.

And fertility?

In humans, there are no data on the effect of botulinum toxins on fertility1,2,5. In animals, the results vary: one label reports reduced fertility in rats1, another reports no effect in rabbits2, and the label of the short-acting toxin states that a type A toxin impaired fertility in animals only at doses that caused exaggerated effects5. These animal data do not allow any conclusion to be drawn for a person who has had an aesthetic injection.

Talking to your doctor

Before any injection, the doctor needs to know if you are pregnant, if you think you might be, if you are planning a pregnancy or if you are breastfeeding. Doctors normally ask, but do not hesitate to raise it yourself. The other situations to mention (medicines, neuromuscular disorders, a recent injection) are covered in our answers to frequently asked questions about botulinum toxin and on the precautions page.

Key points

  • The labels advise against, or rule out, botulinum toxin during pregnancy1,2,3,5.
  • They also advise against it during breastfeeding: it is not known whether it passes into milk1,2,5.
  • After an injection given before you knew you were pregnant, tell the doctor following the pregnancy5.
  • Published data show no excess of major birth defects, but they remain limited6.

Frequently asked questions

  • Can you have Botox while pregnant?

    It is not recommended. The labels of the aesthetic botulinum toxins we reviewed advise against injection during pregnancy1,4,5, and one expressly rules it out3. The reason is not a proven danger in pregnant women but the lack of adequate studies, while effects on reproduction have been seen in animals1. Treating wrinkles can wait until after pregnancy and breastfeeding.

  • I had an injection before I knew I was pregnant: what should I do?

    Tell the doctor or midwife who is following your pregnancy, as well as the doctor who gave the injection, with the date and the product used. The package leaflet of the short-acting toxin asks patients to tell their doctor if they become pregnant after treatment5. Published safety data show no excess of major birth defects, but they have important limitations6.

  • Can you have a botulinum toxin injection while breastfeeding?

    The labels advise against it or rule it out, because it is not known whether the toxin passes into breast milk1,2,5. The label of the short-acting toxin states that a risk to the newborn or infant cannot be excluded5. No label sets a waiting period after you stop breastfeeding. If the question applies to you, talk to your doctor before any injection.

Sources

  1. 1.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 68150775) (opens in a new tab) — French public medicines database (BDPM)
  2. 2.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 61592762) (opens in a new tab) — French public medicines database (BDPM)
  3. 3.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 66865211) (opens in a new tab) — French public medicines database (BDPM)
  4. 4.SmPC of a type A botulinum toxin approved for aesthetic use in France (BDPM, CIS 69878363) (opens in a new tab) — French public medicines database (BDPM)
  5. 5.Summary of product characteristics of the serotype E botulinum toxin approved in the European Union (EPAR annex I) (opens in a new tab) — European Commission (Union Register of medicinal products)
  6. 6.Brin M.F. et al., pregnancy outcomes after exposure to a type A botulinum toxin: 29-year analysis of the manufacturer’s safety database, Neurology, 2023 (most authors employed by the manufacturer) (opens in a new tab) — Neurology (American Academy of Neurology)
  7. 7.Canadian product monograph of the serotype E botulinum toxin (authorization date: 2026-06-22) (opens in a new tab) — Health Canada
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