Drug Notebook

FDA Alerts

  • Long-term safety of topical tacrolimus not established.
  • Malignancies (e.g., skin cancers, lymphoma) reported rarely in patients treated with topical calcineurin inhibitors, including tacrolimus; causal relationship not established.
  • Avoid continuous long-term use of topical tacrolimus; limit application to areas affected by atopic dermatitis. (See Carcinogenicity under Cautions.)
  • Topical tacrolimus is not indicated for use in children <2 years of age; only the 0.03% ointment is indicated for use in children 2–15 years of age.

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What is the most important information I should know about tacrolimus topical?

Do not use tacrolimus topical on a child 2 years of age or younger.

A small number of people have developed skin cancer after using tacrolimus or pimecrolimus (Elidel) skin medications. However, it is not known if either of these medicines causes skin cancer. Talk to your doctor about your individual risk.

Use this medication only on the skin, exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Tacrolimus is not for long-term use.

If you are using this medicine on a child younger than 16 years old, use only the 0.03% ointment. The 0.1% ointment is for adults and children who are at least 16 years old, but is too strong to use on younger children.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

Avoid sunlight, sun lamps, tanning beds, and phototherapy treatments with UVA or UVB light. If you must be outdoors, wear loose clothing over the skin areas treated with tacrolimus topical. Do not use sunscreen on treated skin unless your doctor has told you to.

Talk to your doctor if your skin condition does not improve after using tacrolimus topical for 6 weeks.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

There may be other drugs or skin products that can affect tacrolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Stop using this medication and get emergency medical help if you think you have used too much medicine or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

What is tacrolimus topical?

Tacrolimus is an immunosuppressant. It works by decreasing your body's immune system to help slow down the growth of atopic dermatitis (eczema) on your skin.

Tacrolimus topical is used to treat severe atopic dermatitis when other medications have not worked well.

Tacrolimus may also be used for purposes other than those listed here.

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