Pimecrolimus Topical
Pimecrolimus is a prescription topical cream used to treat mild to moderate atopic dermatitis (eczema) in adults and children 2 years and older when other treatments haven't worked or aren't appropriate.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Important safety warning: The long-term safety of pimecrolimus cream has not been fully established. Although no direct cause has been proven, rare cases of skin cancer and lymphoma (a cancer of the immune system) have been reported in people using this type of medication. Because of this potential risk: do not use pimecrolimus cream continuously for long periods; apply it only to skin areas affected by eczema; and do not use it in children under 2 years of age. Use the lowest amount needed for the shortest time needed to control symptoms.
📖 Pimecrolimus Topical: Patient Information Guide
A plain-language walkthrough of Pimecrolimus Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Pimecrolimus topical cream is approved to treat one main condition across the supported products:
- Mild to moderate atopic dermatitis (eczema) — in non-immunocompromised adults and children 2 years of age and older, as a second-line therapy when other topical prescription treatments have failed or are not advisable
Pimecrolimus cream 1% is not approved for children under 2 years of age and is not approved for use in people with weakened immune systems.
⚙️How it works▾
Pimecrolimus is a calcineurin inhibitor — it works by blocking a key enzyme called calcineurin, which normally switches on immune cells (T-cells) that drive skin inflammation. By blocking this pathway, pimecrolimus prevents the release of inflammatory proteins (cytokines) that cause the itch, redness, and rash of eczema. It also stops inflammatory chemicals from being released by mast cells, which play a role in allergic skin reactions.
Importantly, very little of this cream is absorbed into the bloodstream when applied to the skin at recommended doses, which helps limit systemic (whole-body) immune effects.
💊How it's taken▾
Pimecrolimus cream 1% is applied topically — directly onto affected skin — twice a day. Apply only a thin layer, and only to areas of skin affected by eczema. Stop using it once your symptoms clear up.
- Do not cover treated skin with occlusive (airtight) dressings
- If symptoms don't improve within 6 weeks, see your prescriber again
- Avoid continuous long-term use — use it for flares and stop when symptoms resolve
Always follow your prescriber's specific guidance. No specific milligram dose information should be self-adjusted.
🤒Side effects — in detail▾
The most common side effects with pimecrolimus cream 1% include:
- Burning, stinging, or soreness at the application site — most common in the first few days and usually improves as eczema heals
- Headache
- Nasopharyngitis (runny or stuffy nose and sore throat)
- Cough
- Flu (influenza)
- Fever
- Viral infections
- Skin infections
Call your doctor if you develop swollen lymph nodes, signs of a serious skin infection (such as herpes blisters or spreading redness), worsening warts, or any new or unusual skin changes — these need prompt medical attention.
⚠️Warnings & precautions▾
- Possible cancer risk with long-term use: Rare cases of skin cancer and lymphoma have been reported with this class of medication. A direct cause has not been proven, but long-term continuous use should be avoided. Apply only to affected areas and stop when symptoms resolve.
- Not for use in children under 2: Safety in this age group has not been established.
- Not for immunocompromised patients: Do not use if your immune system is weakened, or if you take systemic immunosuppressant drugs.
- Increased infection risk: May increase the risk of chickenpox, shingles, herpes, eczema herpeticum, and warts. Resolve any active skin infection before starting treatment.
- Swollen lymph nodes: If lymphadenopathy (swollen lymph nodes) develops and doesn't resolve, stop using the cream and see your doctor.
- Sun exposure: Minimize sun and UV light exposure during treatment — the effects on UV-damaged skin are not fully known.
- Do not use on cancerous or pre-cancerous skin: Some serious skin conditions like cutaneous T-cell lymphoma can look like eczema — make sure your diagnosis is confirmed.
🔀What it interacts with▾
Systemic drug interactions are not expected with normal topical use, since very little pimecrolimus enters the bloodstream. However, interactions cannot be fully ruled out, especially if large areas of skin are treated:
- CYP3A inhibitors (drugs that slow down a key liver enzyme) — including erythromycin (an antibiotic), itraconazole, ketoconazole, and fluconazole (antifungals) — may increase pimecrolimus levels; use with caution in patients with widespread disease
- Calcium channel blockers (used for blood pressure or heart rhythm) — potential interaction; tell your doctor if you take these
- Cimetidine (a stomach acid reducer) — potential interaction
- Vaccines and immunizations — interactions have not been fully studied; discuss with your doctor before getting vaccinated
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use if you have a known allergy to pimecrolimus or any ingredient in the cream
- Not approved for children under 2 years of age
- Do not use if you have a weakened immune system or are taking systemic immunosuppressant medications
- Tell your doctor if you are pregnant — there are no adequate studies in pregnant women, and this medication should only be used in pregnancy if clearly necessary
- Do not breastfeed without talking to your doctor — it is unknown whether pimecrolimus passes into human breast milk
- Tell your doctor if you have Netherton's Syndrome or a skin disease that increases absorption through the skin
- Tell your doctor if you have any active skin infections — these should be treated before starting pimecrolimus
- Minimize sun and UV light exposure during treatment
📡Pharmacodynamics — effects in the body▾
Pimecrolimus inhibits the activation of T-cells (immune cells that drive inflammation) by blocking calcineurin, preventing the production of inflammatory cytokines including Interleukin-2, interferon gamma, Interleukin-4, and Interleukin-10. It also prevents mast cells from releasing inflammatory mediators in response to allergen exposure. These combined effects reduce the immune-driven inflammation responsible for eczema symptoms.
🔬Pharmacokinetics — how your body processes it▾
When applied to the skin, pimecrolimus is minimally absorbed into the bloodstream. In adults treated for eczema covering up to 62% of the body, blood levels remained very low — in over 91% of measurements, levels were below 0.5 ng/mL. Once in the body, about 99.5% of pimecrolimus binds to proteins in the blood. It is broken down primarily by liver enzymes (the CYP3A family) and is eliminated mainly through the feces as metabolites, not as unchanged drug.
📦How to store it▾
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Do not freeze.
📄 Written from Pimecrolimus Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Pimecrolimus Topical
3 supplements and herbal products have documented interactions with Pimecrolimus Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Pimecrolimus Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What is pimecrolimus cream actually used for? ▾
How do I apply it and how often? ▾
I've heard there's a cancer warning with this cream — should I be worried? ▾
Can I use this on my child? ▾
What side effects should I expect, and which ones mean I should call my doctor? ▾
Is it safe to use if I'm pregnant or breastfeeding? ▾
Is Pimecrolimus Topical available over the counter? ▾
When was Pimecrolimus Topical first available? ▾
Who makes Pimecrolimus Topical? ▾
💬 Answers drafted from Pimecrolimus Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Pimecrolimus Topical comes
Pimecrolimus Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical cream, ointment or gel
How this form is used
- Pimecrolimus cream 1% is used as a second-line treatment for mild to moderate atopic dermatitis (eczema) in adults and children 2 years of age and older
- Pimecrolimus cream 1% is used when other topical prescription treatments have not worked well enough or are not appropriate
- Pimecrolimus cream 1%: apply a thin layer to the affected skin twice daily
- Pimecrolimus cream 1%: stop applying once signs and symptoms such as itch, rash, and redness resolve
- Pimecrolimus cream 1%: do not use with occlusive (airtight) dressings over the treated area
- Pimecrolimus cream 1%: if symptoms do not improve within 6 weeks, return to your healthcare provider for re-evaluation
📊 Pimecrolimus Topical across the U.S. market
How Pimecrolimus Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Pimecrolimus Topical is used
A general measure of how commonly Pimecrolimus Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Pimecrolimus Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Pimecrolimus Topical prescribed? Of the 1,596 medications we measure, Pimecrolimus Topical ranks #527 by Medicaid prescriptions — more than 67% of them.
Utilization by Pimecrolimus Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
pimecrolimus 10 MG/ML Topical Cream
Summed across the 9 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 562806
Other Pimecrolimus Topical products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 11 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pimecrolimus Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 10 of 25 listed Pimecrolimus Topical NDCs with Medicaid activity.
🔍 Compare Pimecrolimus Topical products
A representative set of FDA-listed product records for Pimecrolimus Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical cream, ointment or gel | ||||
| 10 mg/g | Topical | Actavis Pharma, Inc. | ANDA | View NDC → |
| 10 mg/g | Topical | Bausch Health US, LLC × 4 listings | NDA | View NDC → |
| 10 mg/g | Topical | Bryant Ranch Prepack | NDA AUTHORIZED GENERIC | View NDC → |
| 10 mg/g | Topical | Glenmark Pharmaceuticals Inc., USA × 3 listings | ANDA | View NDC → |
| 10 mg/g | Topical | Oceanside Pharmaceuticals × 6 listings | NDA AUTHORIZED GENERIC | View NDC → |
Showing 15 of 15 products — FDA National Drug Code Directory. See every product, package size and price: browse all 15 Pimecrolimus Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Pimecrolimus Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Pimecrolimus Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Pimecrolimus Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 321952 1 dose form · 1 strength
-
Dose form (SCDF) Topical Cream RxCUI 562805In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 562806
Look up RxCUI 321952 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Pimecrolimus Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Oceanside Pharmaceuticals is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.