Drug Notebook

FDA Alerts

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

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pimecrolimus topical
(pih meh KRA lih muss TOP ik al)

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

  • cimetidine (Tagamet).

  • erythromycin (Ery-Tab, E-Mycin, E.E.S. and others);

  • an antifungal medicine such as ketoconazole (Nizoral), itraconazole (Sporanox), or fluconazole (Diflucan); or

  • a heart medicine such as verapamil (Calan, Verelan), diltiazem (Cardizem, Dilacor XR, Tiazac), nifedipine (Adalat, Procardia), or nicardipine (Cardene).

There may be other drugs or skin products that can affect pimecrolimus. 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 pimecrolimus 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 pimecrolimus 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 pimecrolimus 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 or warts;

  • upset stomach;

  • muscle pain;

  • runny or stuffy nose;

  • 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.

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