What do medical sources say about Botox (Cosmetic) (Botox, Botox Cosmetic, Oculinum) during pregnancy?

1st Trimester: The FDA says cosmetic botulinum toxin injections are not recommended during pregnancy. MotherToBaby reports that limited studies and a manufacturer report did not report more birth defects, but says other studies have not examined miscarriage. Brin et al. reviewed 913 reported pregnancies, but only 397 had known outcomes; one major birth defect was reported among 152 live births. Brin et al. also report that 94.6% of exposures with known timing were before conception or during the first trimester, so the reports cannot establish that the treatment did not change risk; MotherToBaby says other botulinum toxin products have not been studied. Ask your provider about your situation. 2nd Trimester: The FDA says cosmetic botulinum toxin injections are not recommended during pregnancy, and Pregnancy, Birth and Baby says the beauty treatment is not medically necessary. MotherToBaby reports limited human pregnancy data and does not separate findings by trimester. Brin et al. report that 94.6% of exposures with known timing were before conception or in the first trimester, with limited data for later pregnancy. Loza et al. did not detect toxin in fetal samples from five term placentas in an ex vivo test, which does not establish clinical pregnancy outcomes; MotherToBaby says other botulinum toxin products have not been studied. Ask your provider about your situation. 3rd Trimester: The FDA says cosmetic botulinum toxin injections are not recommended during pregnancy, and Pregnancy, Birth and Baby says cosmetic Botox is not medically necessary. MotherToBaby reports that its human pregnancy evidence is limited and does not separate outcomes by trimester. Brin et al. report that later-trimester data are limited, since 94.6% of pregnancies with known timing involved exposure before conception or in the first trimester. Loza et al.'s five-placenta laboratory model did not measure pregnancy or newborn outcomes; MotherToBaby says other botulinum toxin products have not been studied. Ask your provider about your situation.

What do medical sources say about Botox (Cosmetic) (Botox, Botox Cosmetic, Oculinum) while breastfeeding?

The FDA says cosmetic botulinum toxin injections are not recommended while lactating, while LactMed and the European Headache Federation cite acceptance for chronic migraine; Pregnancy, Birth and Baby reports no special breastfeeding recommendation. LactMed reports facial-dose studies found no detectable toxin in milk from two women and minute amounts in five women after 40 to 92 units; Gu et al. detected 0 to 167 pg/mL by ELISA in three treated women, but did not measure infant outcomes. Wong et al. followed 94 breastfeeding cases during chronic-migraine treatment and reported no infant adverse outcomes through age one, but these data are not from cosmetic use. LactMed describes one toddler's mouth and upper-lip swelling after breastfeeding following an 85-unit injection, but says no specific evidence linked it to toxin in milk. Ask your provider about your situation.

Where do sources disagree on Botox (Cosmetic) (Botox, Botox Cosmetic, Oculinum) in pregnancy or breastfeeding?

Elective cosmetic treatment during pregnancy versus evidence after exposure MotherToBaby reports that limited studies and a manufacturer report did not report more birth defects, and the 2026 European Headache Federation consensus includes onabotulinumtoxinA among migraine treatments discussed for pregnancy. These sources concern evidence after exposure or treatment of a medical condition, not a recommendation for elective cosmetic use. FDA says cosmetic botulinum toxin injections are not recommended during pregnancy. Pregnancy, Birth and Baby says cosmetic Botox is not medically necessary and is not recommended during pregnancy. The product label reports no adequate human pregnancy data. The reassuring reports include mixed indications and mostly early exposures, while FDA and Pregnancy, Birth and Baby address elective cosmetic procedures that can be postponed. Chronic migraine treatment has a medical purpose and may involve a different risk-benefit decision. The evidence does not establish that cosmetic exposure caused harm, but it also does not establish outcomes for later pregnancy. The proposed pregnancy rating is avoid for elective cosmetic use, based on the stated purpose and explicit cosmetic-use cautions, not a claim that inadvertent exposure caused injury. Individual medical treatment is a separate decision with a clinician. This proposal requires Charlie's decision.

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Botox (Cosmetic)

Everyday exposureBeauty & personal care

Botox, Botox Cosmetic, Oculinum

Also called · 10 names▾

Botox, Botox Cosmetic, onabotulinumtoxinA, botulinum toxin type A, wrinkle injections, Oculinum, botulinum toxin cosmetic, facial injections, frown line injections, cosmetic muscle injections

Treatments

General information · effects depend on amount, timing, and how it is used. About these sources

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Pregnancy

Brin et al. (2023) reviewed the manufacturer's global postmarketing database for exposures during pregnancy or within three months before conception. Of 913 reported pregnancies, 397 had known outcomes. Among 195 prospective pregnancies with 197 fetuses, there were 152 live births and 45 fetal losses, including 32 spontaneous and 13 elective losses. One major birth defect was reported among the 152 live births (0.7%, 95% CI 0.1% to 3.6%). The review had no comparison group, reporting bias, and many unknown outcomes; AbbVie funded publication and several authors were its employees. Timing was known for 318 pregnancies, and 94.6% involved exposure before conception or in the first trimester, leaving later-trimester evidence sparse. Hamam et al. (2026) reviewed 18 studies with 486 pregnancies and 488 fetuses; reported outcomes included 98 pregnancy losses, including elective and therapeutic losses, and 11 birth defects. The authors concluded that evidence remains insufficient because studies were heterogeneous and data limited. Wong et al. (2025) prospectively followed 126 pregnancies among people treated for chronic migraine: 97 chose to continue and 29 to stop; miscarriages were reported in 2/97 and 1/29, with no fetal malformations reported. This was a small, self-selected therapeutic cohort, not a cosmetic-use study. Loza et al. (2026) tested five term placentas using an ex vivo perfusion model. OnabotulinumtoxinA was not detected in fetal samples under those test conditions, but the detection limit was about 40 to 50 pg/mL and this laboratory model does not measure clinical pregnancy outcomes. Eladawi et al. (2026) reviewed a different, overlapping evidence set and reported 555 exposed pregnancies, 97 losses, 1.6% fetal anomalies, and 94 reported breastfeeding cases. These totals are not combined with Hamam et al. because they use different evidence sets and denominators.

Breastfeeding

LactMed (revision September 15, 2026) reports that facial onabotulinumtoxinA doses of 40 to 92 units were followed by undetectable milk levels in two women and minute amounts in five others across two small studies. Hudson et al. (2024) studied four lactating women and 16 samples; eight samples had detectable amounts. Study milk was not fed to infants, so infant outcomes were not assessed. Gu et al. (2025) analyzed samples from five women, including three who received 64 units and two controls. ELISA detected 0 to 167 pg/mL in exposed participants, while mass spectrometry did not clearly detect toxin; the study did not assess infant effects. Wong et al. (2025) included 94 breastfeeding cases among people receiving treatment for chronic migraine and reported no infant adverse outcomes through one year. This was uncontrolled therapeutic follow-up, not a cosmetic treatment trial. Qin et al. (2025) reported a toddler's mouth and upper-lip swelling after breastfeeding following a maternal injection of 85 units of a product not sold in the United States; LactMed notes that no specific evidence linked the event to toxin in milk. The milk-measurement studies are small and do not establish infant outcomes after cosmetic treatment.

Elective cosmetic treatment during pregnancy versus evidence after exposure

Source A says: MotherToBaby reports that limited studies and a manufacturer report did not report more birth defects, and the 2026 European Headache Federation consensus includes onabotulinumtoxinA among migraine treatments discussed for pregnancy. These sources concern evidence after exposure or treatment of a medical condition, not a recommendation for elective cosmetic use. (MotherToBaby: OnabotulinumtoxinA (Botox), Brin et al. 2023: Pregnancy Outcomes in Patients Exposed to OnabotulinumtoxinA Treatment, Braca et al. 2026: Sex-specific management of migraine, European Headache Federation consensus)
Source B says: FDA says cosmetic botulinum toxin injections are not recommended during pregnancy. Pregnancy, Birth and Baby says cosmetic Botox is not medically necessary and is not recommended during pregnancy. The product label reports no adequate human pregnancy data. (FDA: Dermal Filler Do's and Don'ts for Wrinkles, Lips and More, Pregnancy, Birth and Baby: Cosmetic procedures and beauty treatments during pregnancy and breastfeeding, DailyMed: BOTOX Cosmetic prescribing information)
Why they differ: The reassuring reports include mixed indications and mostly early exposures, while FDA and Pregnancy, Birth and Baby address elective cosmetic procedures that can be postponed. Chronic migraine treatment has a medical purpose and may involve a different risk-benefit decision. The evidence does not establish that cosmetic exposure caused harm, but it also does not establish outcomes for later pregnancy.
What the evidence shows overall: The proposed pregnancy rating is avoid for elective cosmetic use, based on the stated purpose and explicit cosmetic-use cautions, not a claim that inadvertent exposure caused injury. Individual medical treatment is a separate decision with a clinician. This proposal requires Charlie's decision.

Cosmetic botulinum toxin during breastfeeding

Source A says: LactMed reports only minute or undetectable milk levels in small cosmetic-dose studies, cites 94 breastfeeding cases during chronic-migraine treatment without reported infant adverse events through one year, and cites migraine guidelines that consider onabotulinumtoxinA acceptable. Pregnancy, Birth and Baby says there are no special considerations or recommendations for Botox while breastfeeding. (LactMed: Botulinum Toxins, Therapeutic, Wong et al. 2025: OnabotulinumtoxinA treatment for chronic migraine in pregnancy, Braca et al. 2026: Sex-specific management of migraine, European Headache Federation consensus, Pregnancy, Birth and Baby: Cosmetic procedures and beauty treatments during pregnancy and breastfeeding)
Source B says: FDA says cosmetic botulinum toxin injections are not recommended while lactating. The milk studies are very small, do not measure infant outcomes, and LactMed describes a toddler swelling report for which it found no specific evidence of causality. (FDA: Dermal Filler Do's and Don'ts for Wrinkles, Lips and More, Hudson et al. 2024: Analysis of Breast Milk Samples in Lactating Women After Facial Botulinum Toxin Injections, Gu et al. 2025: Detection of nontoxic BoNT/A levels in post-facial Botox injection breastmilk, LactMed: Botulinum Toxins, Therapeutic, Qin et al. 2025: Swollen Lips in Young Toddler During Breastfeeding Following a Woman's Botulinum Toxin Injection)
Why they differ: The recommendations apply different caution thresholds and indications. Migraine guidance and observational follow-up involve treatment of a medical condition, while FDA's statement addresses cosmetic injections. Milk detection studies do not establish clinical infant effects, and the single swelling report does not establish a causal link.
What the evidence shows overall: Under R1, retain compatible because LactMed, the European Headache Federation, and Pregnancy, Birth and Baby describe acceptance or no special breastfeeding restriction, and FDA's cosmetic-specific precaution does not cite established infant harm. Four stars reflect small milk studies plus major clinical guidance under the locked rubric, not proof of an absence of risk. The proposed star increase requires Charlie's decision.

Last reviewed 2026-10-14

Independent check 2026-10-14

Not yet clinician-reviewed

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Botox (Cosmetic)

Botox (Cosmetic) — Breastfeeding

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What's in it / what was tested

Sources disagree

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Beyond pregnancy

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