Prescription medicine
Pimecrolimus First approved as Elidel
Pimecrolimus (Elidel) is a prescription medicine with an FDA approval on record since 2001. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $3.31 per gram (Pimecrolimus 1% cream) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the pimecrolimus FDA label on DailyMed (effective April 30, 2026, Oceanside Pharmaceuticals); the NDA 21302 record on Drugs@FDA; every pimecrolimus label on DailyMed.
Highlights of the record
FDA label of April 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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. […]
Used for
From the label: indications and usagePimecrolimus 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.
Forms and strengths
- 10 mg/g
Cream.
On the market
- Earliest approval on file
- December 13, 2001 Elidel, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first December 27, 2018; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $3.31 per gram Pimecrolimus 1% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,704 through July 30, 2026
What is pimecrolimus used for?
From the label: indications and usagePimecrolimus 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) ]. […]
Conditions named in the indications of pimecrolimus's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Calcineurin Inhibitor Immunosuppressant.
Source: FDA drug label (Pimecrolimus), NDA021302 (Bausch), as published by Oceanside Pharmaceuticals, effective April 30, 2026 (SPL set 6601e43e-ce7d-446a-8568-8e7b24b86f06), via openFDA; the full label on DailyMed
What does the patient leaflet for pimecrolimus say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Pimecrolimus Cream, 1%?It is not known if Pimecrolimus Cream, 1% is safe to use for a long period of time. A very small number of people who have used Pimecrolimus Cream, 1% have developed cancer (for example, skin cancer or lymphoma). But a link that Pimecrolimus Cream, 1% use caused these cancers has not been shown. Because of this concern: • Do not use Pimecrolimus Cream, 1% continuously for a long time. • Use Pimecrolimus Cream, 1% only on areas of your skin that have eczema. • Do not use Pimecrolimus Cream, 1% on a child under 2 years of age.
From the patient leaflet: What should I avoid while using Pimecrolimus Cream, 1%?You should not use sun lamps, tanning beds, or get treatment with ultraviolet light therapy during treatment with Pimecrolimus Cream, 1%. • Limit your time in the sun during treatment with Pimecrolimus Cream, 1% even when the medicine is not on your skin. If you need to be outdoors after applying Pimecrolimus Cream, 1%, wear loose fitting clothing that protects the treated area from the sun. Ask your doctor what other types of protection from the sun you should use. It is not known how Pimecrolimus Cream, 1% may affect your skin with exposure to ultraviolet light. • Do not cover the skin being treated with bandages, dressings or wraps. You can wear normal clothing. • Pimecrolimus Cream, 1% is for use on the skin only. Do not get Pimecrolimus Cream, 1% in your eyes, nose, mouth, vagina, or rectum (mucous membranes). […]
From the patient leaflet: How should I store Pimecrolimus Cream, 1%?Store Pimecrolimus Cream, 1% at room temperature between 68° to 77°F (20° to 25°C). • Do not freeze Pimecrolimus Cream, 1%. Keep Pimecrolimus Cream, 1% and all medicines out of the reach of children.
Source: FDA drug label (Pimecrolimus), NDA021302 (Bausch), as published by Oceanside Pharmaceuticals, effective April 30, 2026 (SPL set 6601e43e-ce7d-446a-8568-8e7b24b86f06), via openFDA; the full label on DailyMed
Is there a generic for pimecrolimus (Elidel)?
The FDA approved the first generic pimecrolimus on December 27, 2018. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pimecrolimus from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2001 earliest approval on file
- 2018 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pimecrolimus (Elidel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.31 per gram (Pimecrolimus 1% cream), up 22% from $2.72 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Pimecrolimus 1% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pimecrolimus 1% cream | Generic | $3.31 per gram | n/a | +22% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the pimecrolimus label say about other medicines?
The pimecrolimus label names 5 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cimetidine | drug interactions | Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. |
| Erythromycin | drug interactions | Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. |
| Fluconazole | drug interactions | Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. |
| Itraconazole | drug interactions | Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. |
| Ketoconazole | drug interactions | Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine. |
Source: FDA drug label (Pimecrolimus), NDA021302 (Bausch), as published by Oceanside Pharmaceuticals, effective April 30, 2026 (SPL set 6601e43e-ce7d-446a-8568-8e7b24b86f06), via openFDA; the full label on DailyMed
What do FAERS reports show for pimecrolimus?
The FDA Adverse Event Reporting System holds 1,704 reports that list pimecrolimus among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22 are coded as a death and 192 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pimecrolimus?
7 other medicines are given the same way (topical) and in the same FDA class as pimecrolimus or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Tacrolimus | Eczema (atopic dermatitis) | 4 labelers | $0.970 per gram 0.1% ointment | No current entry |
| Oatmeal | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Desonide | Eczema (atopic dermatitis) | 12 labelers | $0.252 per gram 0.05% cream | No current entry |
| Crisaborole | Eczema (atopic dermatitis) | none listed | $11.68 per gram 2% ointment | No current entry |
| Delgocitinib | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Difamilast | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Ruxolitinib | Eczema (atopic dermatitis) | none listed | $34.01 per gram 1.5% cream | No current entry |
Every medicine labeled for the same conditions as pimecrolimus
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pimecrolimus
- 7 medicines for the same use
- Other calcineurin inhibitor immunosuppressants
- the pharmacologic class, with prices and generics
- Pimecrolimus side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other