Is topical tacrolimus (immunosuppressive medication) safe to use during pregnancy?

Safety of Topical Tacrolimus During Pregnancy

Topical tacrolimus should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus, as it is classified as pregnancy category C and may pose risks to fetal development. 1, 2

Risk Assessment for Topical Tacrolimus in Pregnancy

• Topical tacrolimus is classified as pregnancy category C, indicating that animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women 1
• Systemic tacrolimus (oral form) has been associated with increased risks of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress according to FDA labeling and postmarketing surveillance 2
• The safety profile of topical tacrolimus specifically during pregnancy has limited data, with most information extrapolated from systemic use 1, 2

Considerations for Use in Pregnancy

• Topical tacrolimus has significantly lower systemic absorption compared to oral tacrolimus, which may reduce potential risks to the fetus 1, 3
• Tacrolimus is found in human milk, and therefore is not recommended for nursing mothers 1
• When considering topical tacrolimus for facial and intertriginous psoriasis during pregnancy, the benefit of controlling maternal disease should be weighed against potential fetal risks 1, 3

Recommendations Based on Clinical Context

• For pregnant women with facial or intertriginous psoriasis:
  • Consider alternative topical treatments first, such as emollients which are generally considered safe during pregnancy 1
  • Low-potency topical corticosteroids may be safer alternatives for localized psoriasis in pregnancy 3
  • If tacrolimus is deemed necessary, use the lowest effective dose and limit application to small body surface areas to minimize systemic absorption 1, 3

Recent Evidence and Guidelines

• The 2025 EULAR recommendations for antirheumatic drugs in pregnancy include systemic tacrolimus as compatible with pregnancy when used at the lowest effective dose, which may be monitored by trough levels 1
• This suggests that the minimal systemic absorption from topical application would likely pose even lower risk, though specific guidance for topical formulations is not provided 1
• Research on systemic tacrolimus in transplant recipients suggests that while there are risks, these may be acceptable when the medication is necessary for maternal health 4, 5

Important Monitoring Considerations

• If topical tacrolimus is used during pregnancy, consider:
  • Limiting application to the smallest affected area possible 1, 3
  • Using the lower concentration product (0.03% rather than 0.1%) 1
  • Avoiding application under occlusion, which can increase systemic absorption 1
  • Consulting with the patient's obstetrician before initiating therapy 1

Conclusion for Clinical Practice

• For pregnant women requiring treatment for facial or intertriginous psoriasis, a stepwise approach is recommended:
  1. First-line: Emollients and other generally recognized safe topical treatments 1, 3
  2. Second-line: If necessary for disease control, topical tacrolimus may be considered for limited use on small areas, with careful risk-benefit assessment 1, 3
  3. The decision to use topical tacrolimus should involve shared decision-making with the patient after discussing potential risks and benefits 1