Protopic Side Effects

Generic name: tacrolimus topical

Note: This document contains side effect information about tacrolimus topical. Some of the dosage forms listed on this page may not apply to the brand name Protopic.

Some side effects of Protopic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tacrolimus topical: topical ointment

Get emergency medical help if you have any of these signs of an allergic reaction while taking tacrolimus topical (the active ingredient contained in Protopic) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tacrolimus and call your doctor at once if you have a serious side effect such as:

• severe stinging, burning, itching, or soreness where the medicine is applied;

• swollen glands;

• redness or crusting around your hair follicles; or

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

Less serious side effects of tacrolimus topical may include:

• mild burning, stinging, or itching;

• skin redness;

• acne;

• cold or flu symptoms such as stuffy nose, sneezing, sore throat;

• headache; or

• feeling more sensitive to hot or cold temperatures.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to tacrolimus topical: topical ointment

Dermatologic

Dermatologic effects have included skin burning (46% to 58%), pruritus (25% to 46%), skin erythema (12% to 28%), skin infection (5% to 12%), herpes simplex (4% to 12%), folliculitis (4% to 11%), pustular rash (3% to 6%), dry skin (3%), hyperesthesia (3% to 7%), urticaria (3% to 6%), skin tingling (2% to 8%), acne (2% to 7%), rash (2% to 5%), maculopapular rash (2% to 4%), vesiculobullous rash (2% to 4%), eczema (2% to 3%), sunburn (1% to 4%), skin disorder (1% to 4%), contact dermatitis (1% to 3%), exfoliative dermatitis (1% to 3%), fungal dermatitis (1% to 2%), eczema herpeticum (1% to 2%), benign skin neoplasm (1% to 2%), and varicella zoster/herpes zoster (1%). Other dermatologic side effects have included facial flushing, ecchymosis, cellulitis, skin discoloration, alopecia, angioedema, and sweating.

Oncologic

Oncologic side effects have included lymphoma and skin cancer. A definite causal relationship between these effects and tacrolimus topical (the active ingredient contained in Protopic) has not been clearly established.

As of December 2004, nineteen postmarketing cases of cancer in patients receiving treatment with tacrolimus topical have been reported to the FDA MedWatch program. Ten cases were reported as cutaneous tumors (7 at site of application), 9 cases as lymphomas, and the remaining as a variety of tumors (including squamous cell carcinoma, cutaneous sarcoma, and malignant melanoma). Three of these cases were reported to have occurred in children, with the remaining 16 cases reported in adults. In addition, 6 of the cases reported lymphadenopathy. The median time to diagnosis was 150 days (range 21 to 790 days) following initiation of treatment with tacrolimus topical. Two deaths were reported in adults and 8 patients were hospitalized (6 adults, 2 children). Causality has not been established.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (3% to 4%), gastroenteritis (2% to 4%), nausea (1% to 4%), dyspepsia (1% to 4%), abdominal pain (1% to 3%), and vomiting (1%). Other gastrointestinal side effects have included taste perversion, anorexia, and constipation.

Musculoskeletal

Musculoskeletal side effects have included back pain (2% to 3%), asthenia (2% to 3%), and myalgia (1% to 3%). Other musculoskeletal side effects have included arthritis, arthralgia, and neck pain.

Respiratory

Respiratory side effects have included asthma (4% to 6%), pharyngitis (3% to 5%), rhinitis (3% to 5%), sinusitis (2% to 5%), bronchitis (2% to 3%), increased cough (1% to 3%), and pneumonia (1%). Other respiratory side effects have included dyspnea, hypoxia, and lung disorder.

Nervous system

Nervous system side effects have included headache (10% to 20%), and insomnia (1% to 4%). Other nervous system side effects have included dizziness, anxiety, migraine, neuritis, and paresthesia.

Metabolic

Metabolic side effects have included increased ALT, AST, increased creatinine, hyperglycemia, hypoglycemia, and bilirubinuria.

Ocular

Ocular side effects have included conjunctivitis (2% to 4%). Other ocular side effects have included eye pain and eye disorder.

Immunologic

Immunologic symptoms have included flu like symptoms (22% to 31%), infection (1% to 14%), fever (1% to 4%), lymphadenopathy (1% to 3%), and periodontal abscess (1% to 3%). Other immunologic side effects have included leukocytosis and leukopenia.

Cardiovascular

Cardiovascular side effects have included peripheral edema (2% to 4%). Other cardiovascular side effects have included angina pectoris, cerebrovascular accident, peripheral vascular disorder, arrhythmias, palpitations, hypertension, and vasodilation.

General

General side effects have included lack of drug effect (1% to 10%), accidental injury (3% to 6%), alcohol intolerance (2% to 7%), facial edema (1% to 3%), pain (1% to 4%), and cyst (1% to 3%). Other general side effects have included chills, and increased dehydration.

Other

Other side effects have included otitis media (1%) and ear pain.

Genitourinary

Genitourinary side effects have included dysmenorrhea (2% to 4%). Other genitourinary side effects have included unintended pregnancy and vaginal moniliasis.

Local

Local side effects have included exacerbation of the untreated area and postmarketing reports of application site edema.

Hepatic

Hepatic side effects have included liver function test abnormalities.

Psychiatric

Psychiatric side effects have included depression.

Hematologic

Hematologic side effects have included epistaxis.

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