Pimecrolimus

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.

• Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. 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) ] .ICD-10: L20.9

• Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.contraindicated

Apply a thin layer of Pimecrolimus Cream, 1% to the affected skin twice daily. The patient should stop using Pimecrolimus Cream, 1% when signs and symptoms (e.g., itch, rash and redness) resolve and should be instructed on what actions to take if symptoms recur. If signs and symptoms persist beyond 6 weeks, patients should be re-examined by their healthcare provider to confirm the diagnosis of atopic dermatitis. Continuous long-term use of Pimecrolimus Cream, 1% should be avoided, and application should be limited to areas of involvement with atopic dermatitis [see Warnings and Precautions (5.1) ] . The safety of Pimecrolimus Cream, 1% under occlusion, which may promote systemic exposure, has not been evaluated. Avoid use of Pimecrolimus Cream, 1% with occlusive dressings. • Apply a thin layer of Pimecrolimus Cream, 1% to the affected skin twice daily. ( 2 ) • If signs and symptoms persist beyond 6 weeks, patients should be re-examined. ( 2 ) • Continuous long-term use of Pimecrolimus Cream, 1% should be avoided. ( 2 ) • Avoid use with occlusive dressings. ( 2 )

• Should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. ( 5.1 ) • Avoid treatment on malignant or pre-malignant skin conditions, as these can present as dermatitis. ( 5.2 ) • Should not be used in patients with Netherton’s Syndrome or skin diseases with a potential for increased systemic absorption. ( 5.2 ) 5.1 Risk of Immunosuppression Prolonged systemic use of calcineurin inhibitors for sustained immunosuppression in animal studies and transplant patients following systemic administration has been associated with an increased risk of infections, lymphomas, and skin malignancies. These risks are associated with the intensity and duration of immunosuppression. Based on this information and the mechanism of action, there is a concern about a potential risk with the use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. While a causal relationship has not been established, rare cases of skin malignancy and lymphoma have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 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. • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age. • Pimecrolimus Cream, 1% should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications.

The most commonly reported adverse reactions (≥1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. No phototoxicity and no photoallergenicity were detected in clinical trials with 24 and 33 normal volunteers, respectively. In human dermal safety trials, Pimecrolimus Cream, 1% did not induce contact sensitization or cumulative irritation. In a 1-year safety trial in pediatric subjects age 2-17 years old involving sequential use of Pimecrolimus Cream, 1% and a topical corticosteroid, 43% of Pimecrolimus Cream, 1% treated subjects and 68% of vehicle-treated subjects used corticosteroids during the trial. Corticosteroids were used for more than 7 days by 34% of Pimecrolimus Cream, 1% treated subjects and 54% of vehicle-treated subjects. An increased incidence of impetigo, skin infection, superinfection (infected atopic dermatitis), rhinitis, and urticaria were found in the subjects that had used Pimecrolimus Cream, 1% and topical corticosteroid sequentially as compared to Pimecrolimus Cream, 1% alone.

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies with Pimecrolimus Cream, 1% in pregnant women. Therefore, Pimecrolimus Cream, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In dermal embryofetal developmental studies, no maternal or fetal toxicity was observed up to the highest practicable doses tested, 10 mg/kg/day (1% pimecrolimus cream) in rats (0.14X MRHD based on body surface area) and 10 mg/kg/day (1% pimecrolimus cream) in rabbits (0.65X MRHD based on AUC comparisons). The 1% pimecrolimus cream was administered topically for 6 hours/day during the period of organogenesis in rats and rabbits (gestational days 6-21 in rats and gestational days 6-20 in rabbits). A second dermal embryofetal development study was conducted in rats using pimecrolimus cream applied dermally to pregnant rats (1 g cream/kg body weight of 0.2%, 0.6% and 1.0% pimecrolimus cream) from gestation day 6 to 17 at doses of 2, 6, and 10 mg/kg/day with daily exposure of approximately 22 hours. No maternal, reproductive, or embryofetal toxicity attributable to pimecrolimus was noted at 10 mg/kg/day (0.66X MRHD based on AUC comparisons), the highest dose evaluated in this study. No teratogenicity was noted in this study at any dose.

Metabolism

Absorption In adult subjects (n=52) being treated for atopic dermatitis [13%-62% Body Surface Area (BSA) involvement] for periods up to a year, a maximum pimecrolimus concentration of 1.4 ng/mL was observed among those subjects with detectable blood levels. In the majority of samples in adult (91%; 1244/1362) subjects, blood concentrations of pimecrolimus were below 0.5 ng/mL.

• Dec 13, 2001NDANDA021302Bausch
• Dec 27, 2018ANDAANDA209345Actavis Labs Ut Inc
• Aug 29, 2019ANDAANDA211769Glenmark Pharms Ltd

1. 1Drug Ineffective23415%
2. 2Dermatitis Atopic19112%
3. 3Rash17511%
4. 4Pruritus17311%
5. 5Product Use In Unapproved Indication1207.5%
6. 6Off Label Use986.1%
7. 7Dry Skin875.4%
8. 8Eczema845.3%
9. 9Erythema694.3%
10. 10Injection Site Pain674.2%
11. 11Skin Exfoliation674.2%
12. 12Condition Aggravated664.1%
13. 13Pain613.8%
14. 14Product Dose Omission Issue603.8%
15. 15Sleep Disorder Due To A General Medical Condition593.7%

The 10 most recently updated of 73 ClinicalTrials.gov registrations naming Pimecrolimus as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 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
  Recruiting · Phase 3 · Interventional · 636 enrolled · Sanofi
  NCT06241118updated 2026-06-05
• A Phase 3 Study to Evaluate the Efficacy and Safety of Pimecrolimus 0.3% Ophthalmic Ointment
  Terminated · Phase 3 · Interventional · 477 enrolled · Famy Life Sciences, a Viatris Company
  NCT06400511updated 2026-01-07
• Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.
  Not yet recruiting · Interventional · 45 enrolled · Milosz Pietrus
  NCT07240389updated 2025-11-20
• 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
  Active not recruiting · Observational · 8,000 enrolled · Bausch Health Americas, Inc.
  NCT00568997updated 2025-09-16
• LEO 29102 Cream in the Treatment of Atopic Dermatitis
  Completed · Phase 2 · Interventional · 183 enrolled · LEO Pharma
  NCT01037881updated 2025-03-10
• A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)
  Completed · Phase 1 · Interventional · 30 enrolled · LEO Pharma
  NCT02376049updated 2025-02-24
• A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis
  Completed · Phase 1 · Interventional · 30 enrolled · LEO Pharma
  NCT02103725updated 2025-02-24
• Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
  Unknown · Observational · 130 enrolled · MEDA PHARMA SPA, a Viatris company
  NCT06052995updated 2023-09-25
• Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
  Completed · Observational · 130 enrolled · Mylan Inc.
  NCT04976868updated 2023-05-24
• A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients
  Unknown · Phase 1 · Interventional · 80 enrolled · HK inno.N Corporation
  NCT05729074updated 2023-02-15

Frequently asked questions

How does Pimecrolimus work?

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.

What is Pimecrolimus used for?

According to FDA labeling, Pimecrolimus carries indications including: Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. 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) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pimecrolimus?

Pimecrolimus is classified as Agents for dermatitis, excluding corticosteroids, Calcineurin Inhibitor Immunosuppressant, Calcineurin Inhibitors, Enzyme Inhibitors, Decreased Cytokine Activity, Decreased Cytokine Production, Increased Cytokine Degradation.

What are the brand names for Pimecrolimus?

Pimecrolimus is marketed under brand names including Elidel.

What are the contraindications for Pimecrolimus?

Pimecrolimus labeling lists contraindications including: Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream. Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.. Always consult the full prescribing information and a clinician.