Skip to main content

Elidel Side Effects

Generic name: pimecrolimus topical

Medically reviewed by Drugs.com. Last updated on Mar 8, 2023.

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

Applies to pimecrolimus topical: topical cream.

Warning

Topical route (Cream)

Long-term safety of topical calcineurin inhibitors has not been established, and rare cases of malignancy (eg, skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors including pimecrolimus. Avoid continuous long-term use in any age group and apply to limited areas affected by atopic dermatitis. Not indicated for use in children less than 2 years of age.

Serious side effects of Elidel

Along with its needed effects, pimecrolimus topical (the active ingredient contained in Elidel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pimecrolimus topical:

More common

Less common

Incidence not known

Other side effects of Elidel

Some side effects of pimecrolimus topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to pimecrolimus topical: topical cream.

Dermatologic

Common (1% to 10%): Folliculitis, acne

Uncommon (0.1% to 1%): Furuncle, impetigo, herpes simplex, herpes zoster, skin papilloma, molluscum contagiosum, urticaria

Rare (less than 0.1%): Rash, angioedema, skin discoloration (e.g., hypopigmentation, hyperpigmentation)[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, sore throat, diarrhea, nausea

Uncommon (0.1% to 1%): Tonsillitis, upper abdominal pain, vomiting, toothache[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylaxis[Ref]

Immunologic

Common (1% to 10%): Influenza

Uncommon (0.1% to 1%): Molluscum contagiosum, staphylococcal infection, chickenpox[Ref]

Local

Very common (10% or more): Application site burning (26%), application site reactions (i.e., irritation, pruritus erythema) (14.6%)

Common (1% to 10%): Application site irritation

Uncommon (0.1% to 1%): Application site disorders (i.e., rash, pain, paresthesia, desquamation, dryness, edema)[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Metabolic

Rare (less than 0.1%): Alcohol intolerance (in most cases, flushing, rash, burning, itching, or swelling occurred shortly after the intake of alcohol)[Ref]

Oncologic

Postmarketing reports: Cutaneous and other types of lymphoma, skin cancers[Ref]

Other

Common (1% to 10%): Pyrexia

Uncommon (0.1% to 1%): Ear infection, otitis media[Ref]

Ocular

Common (1% to 10%): Conjunctivitis

Uncommon (0.1% to 1%): Eye infection[Ref]

Respiratory

Common (1% to 10%): Influenza, nasopharyngitis, upper respiratory infection, cough, asthma, rhinitis, bronchitis

Uncommon (0.1% to 1%): Sinus congestion, pharyngitis, nasal congestion, tonsillitis, sinusitis, dyspnea, epistaxis, pneumonia, viral upper respiratory tract infection, pharyngolaryngeal pain[Ref]

References

1. Product Information. Elidel (pimecrolimus topical). Novartis Pharmaceuticals. 2002.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.