Tacrolimus topical Pregnancy and Breastfeeding Warnings

Brand names: Protopic, Tacrus

Medically reviewed by Drugs.com. Last updated on Apr 12, 2023.

Tacrolimus topical Pregnancy Warnings

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

US FDA pregnancy category: C

This drug undergoes minimal systemic absorption after topical administration, resulting in peak blood levels ranging from undetectable to 20 ng/mL. Systemic administration has been associated with neonatal hyperkalemia and renal dysfunction.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Tacrolimus topical Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity.
-If this drug is applied to the nipple, an alternate drug is preferred.

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. This skin of the infant should not come into direct contact with the areas of skin that have been treated.

See references

Further information

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