Pimecrolimus: uses, dosing, side effects & brands
Pimecrolimus is a calcineurin inhibitor immunosuppressant sold in the U.S. under one brand, for atopic dermatitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Calcineurin Inhibitor Immunosuppressant
- Treats
- Atopic Dermatitis
- Available as
- Topical
- Sold as
- Elidel
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $3 per gm — not your price
- Boxed warning
- Boxed warning
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How pimecrolimus is dosed
From the FDA label for Elidel (application NDA021302). Other pimecrolimus products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 )
Pimecrolimus side effects
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…
Who shouldn’t take pimecrolimus
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. ( 4 , 6.2 )
Pimecrolimus drug interactions
Potential interactions between Pimecrolimus Cream, 1% and other drugs, including immunizations, have not been systematically evaluated. Due to low blood levels of pimecrolimus detected in some patients after topical application, systemic drug interactions are not expected, but cannot be ruled out. The concomitant administration of known CYP3A family of inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Every pimecrolimus product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Elidel.
How long pimecrolimus keeps
No pimecrolimus label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does pimecrolimus expire? The in-use limits and storage rules from its labelsPimecrolimus and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for pimecrolimus: levels in milk, effects in breastfed infants, and the drugs it would consider insteadTopical pimecrolimus has not been studied during breastfeeding; however, it is used topically in children as young as 3 months of age. Because it is poorly absorbed after topical application and plasma concentrations after topical use in adults are less than 2 mcg/L, it is a low risk to the nursing infant. Ensure that the infant’s skin does not come into direct contact with the areas of skin that have been treated. Current guidelines allow topical pimecrolimus to be applied to the nipples just after nursing for eczema, with the nipples cleaned gently before nursing.
National Institute of Child Health and Human Development, record revised June 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about pimecrolimus
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,702 reports naming pimecrolimus, and the FDA flagged 34% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dermatitis atopic192 reports
- rash181 reports
- pruritus179 reports
- dry skin88 reports
- eczema86 reports
- erythema71 reports
- injection site pain69 reports
- skin exfoliation67 reports
Read these as a signal, not a rate. A report does not mean pimecrolimus caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 27, 2026.
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Frequently asked questions
What is pimecrolimus?
Elidel (Pimecrolimus) is a calcineurin inhibitor immunosuppressant used to treat Atopic Dermatitis.
What kind of drug is pimecrolimus?
The FDA classifies pimecrolimus as a calcineurin inhibitor immunosuppressant. Calcineurin inhibitors block an enzyme called calcineurin inside immune T-cells, which stops the cells from making interleukin-2 and other signaling chemicals. This keeps T-cells from activating and multiplying, dialing down the immune attack that drives organ rejection or autoimmune disease. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take pimecrolimus with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pimecrolimus against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pimecrolimus come in?
Across the brands we track, pimecrolimus is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pimecrolimus?
We do not currently list a generic-labelled pimecrolimus product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pimecrolimus: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pimecrolimus
- MLA
- “Pimecrolimus: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pimecrolimus.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pimecrolimus on DailyMed (NIH) ↗ — including its boxed warning in full.