Tacrolimus topical Pregnancy and Breastfeeding Warnings

Brand names: Protopic, Tacrus

Medically reviewed by Drugs.com. Last updated on Apr 2, 2025.

Tacrolimus topical Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned

Comment:
-Adequate methods of contraception should be encouraged prior to initiation of treatment with
this drug for both women and men of reproductive potential.

Animal studies have revealed evidence of embryolethality, malformations, developmental variations, late resorptions, and decreased pup weight and viability. There are no controlled data in human pregnancy. However, there is data from the voluntary Transplantation Pregnancy Registry International (TPRI).

This drug undergoes minimal systemic absorption after topical administration. Systemic administration has been associated with neonatal hyperkalemia and renal dysfunction. The systemic use of tacrolimus may be associated with maternal toxicity, hyperglycemia, gestational diabetes with no pre-existing diabetes or gestational diabetes, exacerbation of hypertension in pregnant women and increase pre-eclampsia.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Tacrolimus topical Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Tacrolimus is shown to be excreted in breast milk when taken systemically, however, levels have been shown to be low when this drug is used topically.
-Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity.

Some experts advise that topical administration of this drug presents a low risk to the nursing infant because it is poorly absorbed after topical application and peak blood concentrations are less than 2 mcg/L in most patients. The skin of the infant should not come into direct contact with the areas of skin that have been treated. If this drug is applied to the nipple, do so just after nursing and cleanse the nipples just before nursing.

See references

Further information

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

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