What Is Protopic (Tacrolimus)?

Reviewed by: HU Medical Review Board | Last reviewed: March 2023 | Last updated: March 2023

Tacrolimus is a topical medication that is sometimes used off-label to treat the symptoms of psoriasis. It is available in the United States under the brand name Protopic®. The medicine usually comes in the form of an ointment. The ointment comes in 2 different strengths.1

Get to know this topical treatment

Tacrolimus is often used to treat the symptoms of eczema (also called atopic dermatitis) in people over the age of 2. Eczema is another type of skin condition. Tacrolimus is not currently approved by the US Food and Drug Administration (FDA) for use in treating psoriasis symptoms.

However, it is sometimes prescribed by healthcare providers for treating psoriasis symptoms that develop in certain sensitive areas of the skin, such as5:

  • face
  • genitals
  • within skin folds and creases

Tacrolimus contains an active ingredient that is similar to another type of drug, called pimecrolimus, that is approved to treat eczema but is sometimes used to treat plaque psoriasis. The difference is that tacrolimus is an ointment, while pimecrolimus is a cream.

Treating those with psoriasis

Psoriasis is a condition in which the patient’s immune system is overactive and causes special cells called T-cells to trigger excess inflammation. This inflammation causes the body to produce too many new skin cells, which leads to the development of plaques on the surface of the skin.

Tacrolimus is a calcineurin inhibitor. This type of medicine works by affecting the immune system and helping to prevent the T-cells from triggering inflammation and causing plaques to form1.

In people with psoriasis, tacrolimus seems to be most effective in areas where the skin is very thin and sensitive. Other types of topical medications are generally more effective for overall use, so tacrolimus is usually prescribed if other types of topical medications (such as corticosteroids) are not effective in controlling psoriasis symptoms.

It may also be recommended if the patient has had a bad reaction to other types of topical medicines that they tried first. Tacrolimus is usually prescribed to be used only for a short, limited amount of time5.

Studies are now being carried out to test the effectiveness of different forms of tacrolimus in treating plaque psoriasis, so there are no official recommendations yet about how much of the ointment to use at one time, and how often6. If you are prescribed tacrolimus for plaque psoriasis, your healthcare provider will give you instructions about how to use the medicine.

What are the common side effects?

There are no specific precautions for the use of topical calcineurin inhibitors such as tacrolimus for treating psoriasis. This is not an exhaustive list of side effects.

However, it should be noted that all of the information available is gathered from their use, including most frequent side effects, in treating atopic dermatitis3. Among people with atopic dermatitis, the most common side effects of treatment with tacrolimus ointment are6:

  • burning sensation (experienced by between 43%-58% of patients who are treated with the medicine)
  • itching (experienced by between 41%-46% of patients)
  • flu-like symptoms (23%-31% of patients)
  • skin redness or rash (12%-28% of patients)
  • headache (5%-20% of patients)

Tacrolimus has a boxed warning, the strictest warning from the FDA. It has this warning because people who use it have a slightly increased risk of certain types of cancers (such as lymphoma and skin tumors). Scientists recommend avoiding long, continuous use of the drug.

These are not all the possible side effects of tacrolimus. Talk to your doctor about what to expect when using tacrolimus. You also should call your doctor if you have any changes that concern you when using tacrolimus.

What are other considerations or risk factors?

Patients may be advised by healthcare providers to avoid phototherapy and other types of exposure to ultraviolet light during treatment7.

If a nursing mother is treated with tacrolimus, it can be found in her breastmilk. It is not recommended for women who are breastfeeding.

There are no adequate and well-controlled studies of systemically administered tacrolimus in pregnant women. Tacrolimus is transferred across the placenta. The use of systemically administered tacrolimus during pregnancy has been associated with neonatal hyperkalemia and renal dysfunction. PROTOPIC Ointment should be used during pregnancy only if the potential benefit to the mother justifies a potential risk to the fetus.

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