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Label Changes for:

Protopic (tacrolimus) Ointment

November 2011

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2011



  • The use of tacrolimus ointment is not recommended in patients having skin conditions with a skin barrier defect where there is the potential for increased systemic absorption of tacrolimus, including but not limited to, Netherton's syndrome, lamellar ichthyosis, generalized erythroderma or cutaneous Graft Versus Host Disease. Oral application is also not recommended. Postmarketing cases of increased tacrolimus blood level have been reported in these conditions.


Postmarketing Experience
  • Application site edema.