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Pimecrolimus (Topical)

Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established

  • Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including pimecrolimus cream.
  • Continuous long-term use of topical calcineurin inhibitors, including pimecrolimus cream, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
  • pimecrolimus cream is not indicated for use in children less than 2 years of age.

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Pimecrolimus

Additional Information

Updated January 2018