Tacrolimus for Post-Traumatic Hyperpigmentation
No, tacrolimus should not be used for post-traumatic hyperpigmentation—it is FDA-approved only for atopic dermatitis and may paradoxically worsen or cause hyperpigmentation rather than treat it. 1
Why Tacrolimus Is Not Indicated
Approved Indications Are Limited
- Topical tacrolimus (0.03% and 0.1%) is FDA-approved exclusively for short-term and intermittent long-term treatment of atopic dermatitis in patients 2 years or older who are unresponsive to or intolerant of conventional therapies. 1
- There is no guideline support or FDA approval for using tacrolimus to treat post-inflammatory hyperpigmentation (PIH) or post-traumatic hyperpigmentation. 1, 2
Paradoxical Hyperpigmentation Risk
- Tacrolimus itself can cause hyperpigmentation as an adverse effect, which is the opposite of the desired outcome for treating post-traumatic pigmentation. 3
- A 2025 case report documented a 9-year-old girl treated with topical tacrolimus for vitiligo who developed marked, localized hyperpigmentation at the treatment site that resolved only after discontinuing tacrolimus. 3
- This paradoxical hyperpigmentation is temporally associated with tacrolimus use and represents a documented adverse effect rather than a therapeutic benefit. 3
Mechanism Mismatch
Tacrolimus Promotes Pigmentation, Not Depigmentation
- Tacrolimus is used to induce repigmentation in vitiligo (a depigmenting disorder), achieving 50-100% repigmentation rates in responsive areas. 1, 4
- Studies consistently show tacrolimus stimulates melanocyte activity and pigment production, with 87-89% of vitiligo patients experiencing at least partial repigmentation. 5, 6
- Using an agent that promotes pigmentation to treat hyperpigmentation is mechanistically counterproductive. 7, 5
Evidence-Based Alternatives for Post-Traumatic Hyperpigmentation
Established Treatment Options
- Post-inflammatory hyperpigmentation should be treated with topical combinations (hydroquinone, retinoids, corticosteroids), chemical peels, or laser therapy—not calcineurin inhibitors. 2
- These modalities target melanin production and distribution through appropriate mechanisms for hyperpigmentation. 2
Critical Safety Considerations
Off-Label Use Concerns
- Using tacrolimus off-label for post-traumatic hyperpigmentation exposes patients to potential adverse effects (including worsening hyperpigmentation) without evidence of benefit. 1, 3
- The American College of Allergy, Asthma and Immunology emphasizes that topical calcineurin inhibitors should be used only as approved and at amounts needed to control appropriate conditions. 1