Pimecrolimus topical Side Effects

Some side effects of pimecrolimus topical 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 pimecrolimus topical: topical cream

Get emergency medical help if you have any of these signs of an allergic reaction while taking pimecrolimus topical: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• severe burning of treated skin;

• new symptoms of viral skin infection (warts, unusual rash or skin lesions, blistering or oozing, burning pain or tingling);

• worsened skin symptoms;

• swollen glands, sore throat; or

• fever, chills, body aches, flu symptoms.

Less serious side effects of pimecrolimus topical may include:

• mild burning or warm feeling of treated skin;

• headache;

• cold symptoms such as stuffy nose, sneezing;

• swollen hair follicles;

• acne or warts;

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

• upset stomach;

• muscle pain; 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 pimecrolimus topical: topical cream

Local

Most application site reactions were considered mild to moderate, started within 1 to 5 days of treatment initiation, and lasted for up to 5 days.

Local reactions have most commonly included application site reactions including burning (26%), irritation (6.4%), pruritus (5.5%), erythema (2.1%), and unspecified reactions (14.6%).

Other

Other side effects have included systemic and cutaneous infections. These have included bacterial infection (1.8%), staphylococcal infections (0.9%), ear infection (0.6%), and otitis media (0.6%). Influenza-like illness (1.8%) and pyrexia (1.2%) have also been reported.

Oncologic

Ten cases of cancer have been reported in postmarketing experience. Six cases were reported as cutaneous tumors, 1 as lymph node/cutaneous tumor, and the remaining 3 without specifying location. Four of these cases occurred in children (3 cases under the age of 6) with the remaining 6 cases were reported in adults. Four cases were reported as lymphomas, 1 as granulomatous lymphadenitis, and the remaining 5 as a variety of tumors (including basal cell carcinoma and squamous cell carcinoma). In addition, 2 of the cases reported lymphadenopathy. The median time to diagnosis was 90 days (range 7 to 300 days) following initiation of treatment with pimecrolimus topical. One adult was hospitalized. A causal relationship has not been established.

Oncologic side effects have included lymphoma and skin cancer. A definite causal relationship between these reports and pimecrolimus topical has not been clearly established. At least 10 cases of cancer have been reported during postmarketing experience.

Respiratory

In comparison to patients using pimecrolimus alone, patients using pimecrolimus topical and a topical corticosteroid sequentially experienced an increased incidence of rhinitis.

Respiratory side effects have included influenza (9.8%), nasopharyngitis (7.6%), upper respiratory infections (4.3%), cough (2.4%), asthma (2.4%), rhinitis (2.1%), sinus congestion (0.9%), pharyngitis (0.9%), nasal congestion (0.6%), tonsillitis (0.6%), sinusitis (0.6%), dyspnea (0.6%), epistaxis (0.3%), pneumonia (0.3%), viral upper respiratory tract infections (0.3%), and pharyngolaryngeal pain.

Gastrointestinal

Gastrointestinal side effects have included sore throat (3.7%), diarrhea (2.1%), nausea (1.8%), vomiting (0.6%), toothache (0.6%), upper abdominal pain (0.3%), abdominal pain (0.3%), and gastroenteritis (0.3%).

Genitourinary

Genitourinary side effects have included dysmenorrhea (1.2%).

Ocular

Ocular side effects have included conjunctivitis (3%) and eye infections (0.3%).

Dermatologic

A 43-year-old male with a history of seborrheic dermatitis experienced rosacea-like demodicidosis coincident with pimecrolimus therapy. The patient presented with a recurrence of seborrheic dermatitis. He was restarted on pimecrolimus 1% since he had previously responded to the therapy. After one week of therapy, the patient developed new, erythematous papules and confluent plaques around the nose and both cheeks. A diagnosis of demodicidosis was made based on clinical findings. Pimecrolimus therapy was discontinued, and the patient was started on 100 mg of minocycline once daily. After 4 weeks of therapy, the lesion had resolved completely.

Dermatologic side effects have included skin infections (6.4%), folliculitis (6.1%), herpes simplex (4%), impetigo (2.4%), acne (1.8%), urticaria (0.9%), herpes simplex dermatitis (0.6%), and chicken pox (0.3%). Skin discoloration has been reported during postmarketing experience. At least one case of rosacea-like demodicidosis has also been reported.

Hypersensitivity

Hypersensitivity reactions (not specified) have been reported in 3.4% of patients. Seasonal allergy has also been reported.

Musculoskeletal

Musculoskeletal side effects have included back pain (1.8%) and arthralgias (1.5%).

Nervous system

Nervous system side effects have included headache (7%).

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