Pimecrolimus Side Effects

Please note - some side effects for Pimecrolimus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Pimecrolimus - for the Consumer

Pimecrolimus

Applies to: cream; topical

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pimecrolimus:

Burning sensation, stinging, soreness, or feeling of warmth at the application site; cough; headache; nose or throat irritation; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); flu syndrome (eg, fever, muscle aches); severe or persistent burning sensation at the application site; skin infection (eg, redness, swelling, pus discharge); swollen lymph nodes (glands); warts, sores, or other new growths on the skin, including herpes skin infections (eg, cold sores, chickenpox, shingles); worsening of your condition.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: 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

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.

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

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

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.

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.

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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