Cochrane for Clinicians

Putting Evidence into Practice

Topical Tacrolimus for Eczema


Am Fam Physician. 2016 Oct 1;94(7):549-550.

Clinical Question

Is topical tacrolimus (Protopic) safe and effective for the treatment of eczema?

Evidence-Based Answer

For children and adults with moderate to severe eczema, topical tacrolimus is an effective, albeit costly, alternative to topical corticosteroids. Both tacrolimus strengths (0.03% and 0.1%) are superior to low-potency topical corticosteroids, whereas tacrolimus 0.1% has similar effectiveness to moderate- to high-potency topical corticosteroids. A mild, self-limited, local burning sensation is common with use.1 (Strength of Recommendation: A, based on consistent, good-quality patient-oriented evidence.)

Practice Pointers

Although topical corticosteroids are the mainstay of treatment for eczema, they can cause skin atrophy on sensitive areas such as the face, eyelids, genitalia, and intertriginous zones. Topical calcineurin inhibitors such as tacrolimus, pimecrolimus (Elidel), and cyclosporine (Sandimmune) are immunosuppressants that do not cause skin atrophy.

The authors of this Cochrane review evaluated 20 randomized controlled trials with 5,885 participants from North America, Europe, Asia, and Africa.1 The trials compared topical corticosteroids with topical calcineurin inhibitors (primarily tacrolimus) in the treatment of moderate to severe eczema and included adults and children six months or older. Treatment duration ranged from two weeks to one year. Most of the studies were considered high quality with a low risk of bias. Both low- and high-potency tacrolimus (0.03% and 0.1%) were included. Primary outcomes were physician and participant assessments of global improvement (more than 90% subjective improvement being “clear or excellent”) and adverse effects.

The various trial regimens and durations limited the ability of the reviewers to carry out meta-analyses. In studies of children, low-potency tacrolimus (0.03%) was consistently better at achieving physician-assessed improvement than low-potency twice-daily topical corticosteroids. One study reported

Author disclosure: No relevant financial affiliations.


1. Cury Martins J, Martins C, Aoki V, Gois AF, Ishii HA, da Silva EM. Topical tacrolimus for atopic dermatitis. Cochrane Database Syst Rev. 2015;(7):CD009864.

2. U.S. Food and Drug Administration. FDA approves updated labeling with boxed warning and medication guide for two eczema drugs, Elidel and Protopic. Accessed September 9, 2016.

3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. J Am Acad Dermatol. 2014;71(1):116–132.

These are summaries of reviews from the Cochrane Library.

This series is coordinated by Corey D. Fogleman, MD, Assistant Medical Editor.

A collection of Cochrane for Clinicians published in AFP is available at



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