Elidel (Pimecrolimus) Cream in Pregnancy

Elidel cream should be avoided during pregnancy due to its FDA Pregnancy Category C classification and lack of safety data in pregnant women. 1

Pregnancy Safety Classification

Pimecrolimus is classified as FDA Pregnancy Category C, meaning animal studies have shown potential risks but human data are insufficient 1
The medication is found in human milk and is not recommended for nursing mothers 1
No clinical evidence exists demonstrating safety of topical pimecrolimus use during pregnancy in humans 1

The Category C designation indicates that:

Animal reproduction studies have shown adverse effects on the fetus
There are no adequate and well-controlled studies in pregnant women
The drug should only be used if potential benefits justify potential risks to the fetus 1

For inflammatory skin conditions during pregnancy, alternative approaches should be prioritized:

Low-potency topical corticosteroids can be used cautiously on limited body surface areas during pregnancy when medically necessary 1
Emollients and moisturizers are generally considered safe throughout pregnancy and should be the foundation of therapy 1
For conditions requiring systemic immunosuppression (such as severe inflammatory diseases), pregnancy-compatible medications include hydroxychloroquine, azathioprine, cyclosporine, and tacrolimus when systemic therapy is absolutely necessary 1

The black box warning on pimecrolimus relates to potential malignancy risk with long-term use, though clinical evidence has not established a causal link 1
If inadvertent exposure occurs during early pregnancy, immediate referral to a maternal-fetal medicine specialist or pregnancy medication specialist is recommended for risk assessment 1
The primary concern is the lack of human safety data rather than proven teratogenicity 1

For facial or intertriginous inflammatory skin conditions during pregnancy:

Use emollients as first-line therapy 1
Consider low-potency topical corticosteroids for short-term use if absolutely necessary 1
Avoid pimecrolimus entirely until after delivery and cessation of breastfeeding 1