Last reviewed 2026-04-20 · How we verify

Elidel (PIMECROLIMUS)

Elidel works by inhibiting calcineurin, a protein that helps activate T-cells, which are involved in the allergic response.

Elidel (Pimecrolimus) is a calcineurin inhibitor immunosuppressant, a small molecule that targets the peptidyl-prolyl cis-trans isomerase FKBP1A. It was originally developed by Valeant Bermuda and is now owned by Bausch. Elidel was FDA-approved in 2001 for the treatment of atopic dermatitis and intractable eczema. The drug is off-patent, with two generic manufacturers available. Key safety considerations include potential skin cancer risk and local skin reactions.

At a glance

Mechanism of action

The mechanism of action of pimecrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As consequence, it inhibits cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T-cells. In addition, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/IgE.

Approved indications

• Atopic dermatitis
• Intractable Eczema

Boxed warnings

• WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. [see Warnings and Precautions (5.1) ] . Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis [see Dosage and Administration (2) , Warnings and Precautions (5.1) ] . • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED See full prescribing information for complete boxed warning. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. ( 5.1 ) Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis. ( 2 , 5.1 ) • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age. ( 1 , 5.1 , 8.4 )

Common side effects

• Application Site Burning
• Upper Respiratory Tract Infection NOS
• Application Site Reaction NOS
• Application Site Irritation
• Nasopharyngitis
• Application Site Erythema
• Pyrexia
• Application Site Pruritus
• Cough
• Headache
• Influenza
• Skin Infection NOS

Key clinical trials

• A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (PHASE3)
• A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment (PHASE3)
• Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy. (NA)
• 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
• LEO 29102 Cream in the Treatment of Atopic Dermatitis (PHASE2)
• A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD) (PHASE1)
• A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis (PHASE1)
• Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Elidel CI brief — competitive landscape report
• Elidel updates RSS · CI watch RSS
• Bausch Health portfolio CI