Fertility: There are no fertility data available.
Pregnancy: There are no adequate data from the use of tacrolimus ointment in pregnant women. Studies in animals have shown reproductive toxicity following systemic administration.
The potential risk for humans is unknown.
Tacrolimus ointment should not be used during pregnancy unless clearly necessary.
Breast-feeding: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breast-feeding during treatment with Tacrolimus ointment is not recommended.