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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tacrolimus topical
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What should I avoid while using tacrolimus topical?

Avoid using any other skin product that has not been recommended by your doctor.

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. Avoid drinking alcohol. Drinking alcohol while you are using tacrolimus topical may cause your skin or face to feel hot and become flushed or red.

What are the possible side effects of tacrolimus topical?

Stop using tacrolimus and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor if you have:

  • worsened skin symptoms;

  • signs of a skin infection (redness, swelling, itching, oozing);

  • swollen glands; or

  • fever, chills, body aches, flu symptoms.

Less serious side effects are more likely to occur. Continue using tacrolimus and talk with your doctor if you have any of these side effects:

  • burning, stinging, tingling, or soreness of treated skin (especially during the first few days of treatment);

  • swollen hair follicles;

  • acne;

  • upset stomach;

  • muscle pain;

  • headache; or

  • feeling more sensitive to hot or cold temperatures.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect tacrolimus topical?

Before using tacrolimus topical, tell your doctor if you are using any of the following drugs:

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.

Where can I get more information?

Your pharmacist has additional information about tacrolimus topical written for health professionals that you may read.

What does my medication look like?

Tacrolimus topical is available with a prescription under the brand name Protopic. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Protopic 0.03 % ointment

  • Protopic 0.1% ointment

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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