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Pimecrolimus topical Side Effects

In Summary

Commonly reported side effects of pimecrolimus topical include: application site reaction and localized burning. Other side effects include: local irritation and local pruritus. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pimecrolimus topical: topical cream

As well as its needed effects, pimecrolimus topical may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking pimecrolimus topical, check with your doctor immediately:

More common:
  • Abdominal or stomach pain
  • body aches or pain
  • burning, itching, redness, skin rash, swelling, or soreness at the application site
  • change in hearing
  • chills
  • cold or flu-like symptoms
  • congestion (ear or nasal)
  • cough producing mucus
  • diarrhea
  • difficulty with breathing or shortness of breath
  • dryness or soreness of the throat
  • earache or pain in the ear
  • ear drainage
  • fever
  • general feeling of discomfort or illness
  • headache
  • hoarseness
  • itching
  • joint pain
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • nausea
  • pain
  • redness
  • runny nose
  • shivering
  • sneezing
  • sweating
  • swelling
  • tenderness
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with swallowing
  • trouble with sleeping
  • unusual tiredness or weakness
  • voice changes
  • vomiting
  • warmth on the skin
  • wheezing
Less common:
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • blurred vision or other change in vision
  • eye pain
  • fast heartbeat
  • hives
  • itchy, raised, round, smooth, skin-colored bumps found on just one area of the body that are oozing, thick, white fluid
  • irritation
  • joint pain, stiffness or swelling
  • rash
  • redness of the eye
  • redness of the skin
  • sensitivity of the eyes to light
  • skin rash on the face, scalp, or stomach
  • swelling of the eyelids, face, lips, hands, or feet
  • tearing
  • troubled breathing or swallowing
Incidence not known:
  • Black, tarry stools
  • change in size, shape, or color of existing mole
  • cough
  • dizziness
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • large, hive-like swelling on the face
  • mole that leaks fluid or bleeds
  • new mole
  • small, red skin lesion, growth, or bump usually on the face, ears, neck, hands, or arms
  • sores that will not heal
  • weight loss
  • yellow eyes and skin

Minor Side Effects

Some pimecrolimus topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Burning, itching, and pain in hairy areas
  • pus at the root of the hair
Less common:
  • Blemishes on the skin
  • bloody nose
  • burning or stinging of the skin
  • difficulty having a bowel movement (stool)
  • flushing; redness of skin; unusually warm skin at site
  • heavy bleeding
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • pimples
  • redness or swelling in the ear
  • vaginal pain and cramps
Incidence not known:
  • Burning, stinging, itching, or mild discomfort of the eye (after applying the cream to the eyelids or near the eyes)
  • feeling of warmth (with alcohol use)
  • redness of the face, neck, arms, and occasionally, upper chest (with alcohol use)

For Healthcare Professionals

Applies to pimecrolimus topical: topical cream


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.[Ref]

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%).[Ref]


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.[Ref]


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.[Ref]

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.[Ref]


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

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.[Ref]


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%).[Ref]


Genitourinary side effects have included dysmenorrhea (1.2%).[Ref]


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


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.[Ref]

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.[Ref]


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


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

Nervous system

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


1. "Product Information. Elidel (pimecrolimus topical)." Novartis Pharmaceuticals, East Hanover, NJ.

2. FDA. U.S. Food and Drug Administration. Center for Drug Evaluation and Researach "Elidel cream (pimecrolimus) information. FDA Alert. Available from: URL:" ([2005 Feb 14]):

3. Gollnick H, Kaufmann R, Stough D, et al. "Pimecrolimus cream 1% in the long-term management of adult atopic dermatitis: prevention of flare progression. A randomized controlled trial." Br J Dermatol 158 (2008): 1083-93

4. Yoon TY, Kim HJ, Kim MK "Pimecrolimus-induced rosacea-like demodicidosis." Int J Dermatol 46 (2007): 1103-5

It is possible that some side effects of pimecrolimus topical may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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