Diphtheria toxoid / pertussis, acellular / tetanus toxoid Pregnancy and Breastfeeding Warnings

Brand names: Adacel (Tdap), Boostrix (Tdap)

Medically reviewed by Drugs.com. Last updated on Nov 21, 2023.

Diphtheria toxoid / pertussis, acellular / tetanus toxoid Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned.

Risk Summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Available data from patients who received this vaccine during or within 30 days prior to pregnancy show major birth defect and miscarriage rates consistent with estimated background rates.
-Some experts state that this drug may be used during the second and third trimester.

Animal studies have failed to reveal evidence of adverse effects on pregnancy, embryofetal development, parturition, and/or postnatal development. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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.

See references

Diphtheria toxoid / pertussis, acellular / tetanus toxoid Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects of this drug on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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

Medical Disclaimer