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OnabotulinumtoxinA Pregnancy and Breastfeeding Warnings

OnabotulinumtoxinA is also known as: Botox, Botox Cosmetic

Medically reviewed by Last updated on Feb 11, 2021.

OnabotulinumtoxinA Pregnancy Warnings

Intramuscular administration to pregnant mice or rats twice during the period of organogenesis (gestation day 5 and 13) resulted in reductions in fetal body weight and decreased fetal skeletal ossification at the two highest doses. The no-effect dose for developmental toxicity in these studies (4 Units/kg) was approximately equal to a human dose of 400 Units (based on weight [Units/kg]). Daily administration during the period of organogenesis (a total of 12 doses in rats and 13 doses in rabbits), resulted in reduced fetal body weights and decreased fetal skeletal ossification at the 2 highest doses in rats and at the highest dose in rabbits. Additionally, these doses were associated with significant maternal toxicity, including abortions, early deliveries, and maternal death. The developmental no-effect doses in these studies was 1 Unit/kg in rats and 0.25 Units/kg in rabbits; both doses being less than the human dose of 400 Units, based on Units/kg. When pregnant rats received IM injections (1, 4, or 16 Units/kg) at 3 different periods of development (prior to implantation, implantation, or organogenesis), no adverse effects on fetal development were observed. The developmental no-effect level for a single maternal dose in rats (16 Units/kg) has been estimated to be approximately 2 times the human dose of 400 Units, based on Units/kg. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use in pregnant women; in animal studies, adverse effects on fetal growth was observed at clinically relevant doses, which were also associated with maternal toxicity.

See references

OnabotulinumtoxinA Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Botox (onabotulinumtoxin A)." Allergan Inc, Irvine, CA.
  2. "Product Information. Botox Cosmetic (onabotulinumtoxinA)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. "Product Information. Botox Cosmetic (onabotulinumtoxinA)." Allergan Inc, Irvine, CA.
  2. "Product Information. Botox (onabotulinumtoxin A)." Allergan Inc, Irvine, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.