Imiquimod Topical
Imiquimod is a prescription topical cream used to treat actinic keratoses, superficial basal cell carcinoma, and external genital and perianal warts.
🧬 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 11 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 ▾
Imiquimod cream is for use on the skin only. Do not apply it in or near your mouth, eyes, nose, or vagina. Applying it to these areas can cause serious harm.
📖 Imiquimod Topical: Patient Information Guide
A plain-language walkthrough of Imiquimod 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▾
Imiquimod is a topical cream approved for several distinct skin conditions — the brand, treatment area, and patient eligibility differ by use.
- Actinic keratoses (AK): Treats rough, sun-damaged skin patches on the face or scalp in adults with a healthy immune system
- Superficial basal cell carcinoma (sBCC): Treats this specific type of skin cancer on the trunk, neck, or limbs (excluding hands, feet, head, and anogenital area) in adults when surgery is not ideal; the diagnosis must be confirmed by biopsy first
- External genital and perianal warts (condyloma acuminata): Treats warts on the outside of the genitals and around the anus in patients 12 years and older
- Not approved for: Warts inside the urethra, vagina, cervix, rectum, or anal canal; molluscum contagiosum in children ages 2–12 (studies failed to show benefit); nodular or morpheaform basal cell carcinoma types
⚙️How it works▾
The exact mechanism of imiquimod is not fully known. Studies suggest it activates local immune responses in the skin — drawing in immune cells such as lymphocytes, dendritic cells, and macrophages, and triggering the release of cytokines (immune signaling proteins), including interferon-alpha. In people with genital warts, treatment was associated with a significant reduction in HPV viral material in the skin, though the clinical meaning of these findings is still being studied. Imiquimod has no direct antiviral effect when tested in cell cultures.
💊How it's taken▾
Imiquimod cream is applied to the skin at bedtime and washed off with mild soap and water after the required hours — it is never taken by mouth, used in the eyes, or placed inside the vagina. The schedule depends on what you are treating:
- Actinic keratoses: Twice a week for 16 weeks; leave on for about 8 hours
- Superficial basal cell carcinoma: Five times a week for 6 weeks; leave on for about 8 hours
- External genital warts: Three times a week until warts clear, up to 16 weeks; leave on for 6–10 hours
Always wash hands before and after applying. If skin reactions become severe, a few days' rest is allowed — but do not extend beyond the maximum treatment period. Use single-use packets and discard any leftovers.
🤒Side effects — in detail▾
Skin reactions at the treated area are the most common side effects, experienced by the majority of users — this is an expected part of how the medication works.
- Itching and burning
- Redness (erythema)
- Flaking, scaling, or dryness
- Scabbing or crusting
- Swelling (edema)
- Skin erosion or open sores
- Fatigue, headache, or fever
Call your doctor right away if you develop severe swelling of the outer genitalia, difficulty urinating, or strong flu-like symptoms such as chills, muscle aches, or nausea — these can signal that treatment needs to be paused or stopped.
⚠️Warnings & precautions▾
- Intense skin reactions: Redness, weeping, erosion, and sores can develop at the application site and may require a break in treatment. Do not restart until skin has calmed.
- Severe vulvar swelling: In women, swelling of the outer genitalia can become serious enough to cause urinary retention (inability to urinate) — stop treatment and contact your doctor immediately if this happens.
- Flu-like symptoms: Fever, chills, nausea, fatigue, and muscle aches may occur alongside or before skin reactions — dosing interruption should be considered.
- Sun sensitivity: Imiquimod increases the skin's vulnerability to sunburn and may speed up sun-related skin damage. Avoid sunlight and sunlamps, wear protective clothing, and use sunscreen every day during treatment.
- Autoimmune and inflammatory conditions: Imiquimod may worsen conditions like chronic graft-versus-host disease. Use with caution if you have a pre-existing autoimmune condition.
- Do not use on unhealed skin: Wait until the skin has fully healed from any prior drug or surgical treatment before applying.
🔀What it interacts with▾
The FDA label for imiquimod cream does not identify specific drug, food, or supplement interactions.
- Sunlight and UV exposure: Using imiquimod alongside significant sun exposure increases the risk of sunburn and may promote skin damage — minimize sun exposure and use sunscreen daily
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▾
- Weakened immune system: Safety and effectiveness have not been established in immunosuppressed patients — tell your doctor if you take immunosuppressant medications or have a condition that affects your immune system
- Autoimmune conditions: Imiquimod should be used with caution if you have pre-existing autoimmune disease, as it can worsen inflammatory skin conditions
- Pregnancy: Classified as Pregnancy Category C — animal studies showed fetal harm at high doses; use only if the potential benefit outweighs the risk to the baby
- Breastfeeding: It is unknown whether imiquimod passes into breast milk; caution is advised
- Children: Not approved for actinic keratoses or superficial basal cell carcinoma under age 18; approved for external genital warts only in patients 12 and older; not effective for molluscum contagiosum in children ages 2–12
- Older adults: No significant differences in safety or effectiveness were found in clinical trials including patients 65 and older, though individual sensitivity cannot be ruled out
- Basal Cell Nevus Syndrome or Xeroderma Pigmentosum: Safety and effectiveness have not been studied in these conditions
🚑If you take too much▾
Applying too much imiquimod cream to the skin can increase the severity of local skin reactions and may raise the risk of systemic (whole-body) effects. If the cream were accidentally swallowed in large amounts, low blood pressure (hypotension) has been reported — this resolved with fluids in clinical reports. If you suspect overuse or accidental ingestion, contact Poison Control at 1-800-222-1222.
📡Pharmacodynamics — effects in the body▾
Imiquimod applied to skin with actinic keratoses was associated with increased levels of immune cell markers (CD3, CD4, CD8) at the treatment site within two weeks. In superficial basal cell carcinoma, treatment appeared to draw immune cells — including lymphocytes, dendritic cells, and macrophages — into the tumor. In genital wart studies, imiquimod triggered production of interferon-alpha and other immune signaling proteins at the site, and HPV viral material in the skin was significantly reduced after treatment. The clinical meaning of all these findings is not yet fully established.
🔬Pharmacokinetics — how your body processes it▾
Imiquimod is absorbed through the skin in small but measurable amounts, and absorption appears to increase with the size of the area treated rather than simply the amount of cream used. The drug stays in the skin for a relatively long time — its apparent half-life (the time for the body to clear half the drug) after topical use is roughly ten times longer than after injection, suggesting it is retained in skin tissue. Only a very small fraction of the applied dose is recovered in urine. In studies of patients with genital warts and actinic keratoses, blood levels remained very low throughout treatment.
📦How to store it▾
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Avoid freezing. Store Imiquimod Cream pump bottles upright.
📄 Written from Imiquimod 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 Imiquimod Topical
3 supplements and herbal products have documented interactions with Imiquimod 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 Imiquimod Topical — the kind of thing our pharmacy team would talk through with you at the counter.
How long does it take for imiquimod to work, and will the treated area look worse before it gets better? ▾
Can I use imiquimod every day to speed things up? ▾
Can I go in the sun while using this cream? ▾
Are there parts of the body I should never apply this cream to? ▾
I'm pregnant — is it safe to use imiquimod? ▾
What should I do if the skin reaction gets really bad? ▾
Is Imiquimod Topical available over the counter? ▾
When was Imiquimod Topical first available? ▾
Who makes Imiquimod Topical? ▾
💬 Answers drafted from Imiquimod 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 Imiquimod Topical comes
Imiquimod 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
- Treats actinic keratoses on the face or scalp in adults with a healthy immune system
- Treats biopsy-confirmed superficial basal cell carcinoma on the trunk, neck, or limbs (not hands, feet, or face) in adults when surgery is not the best option
- Treats external genital and perianal warts in patients 12 years and older
- Not proven effective for molluscum contagiosum in children ages 2–12
- Apply to skin at bedtime and wash off with mild soap and water after the required number of hours; wash hands before and after each application
- For actinic keratoses: apply twice a week for a full 16 weeks to a defined area on the face or scalp; leave on for approximately 8 hours
- For superficial basal cell carcinoma: apply five times a week for a full 6 weeks, including a 1 cm margin around the tumor; leave on for approximately 8 hours
- For external genital warts: apply three times a week until warts clear or for a maximum of 16 weeks; leave on for 6–10 hours; do not cover the area with tight dressings
📊 Imiquimod Topical across the U.S. market
How Imiquimod 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 Imiquimod Topical is used
A general measure of how commonly Imiquimod 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 Imiquimod 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 Imiquimod Topical prescribed? Of the 1,596 medications we measure, Imiquimod Topical ranks #523 by Medicaid prescriptions — more than 67% of them.
Utilization by Imiquimod 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.
imiquimod 50 MG/ML Topical Cream Most dispensed
Summed across the 4 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310982
imiquimod 37.5 MG/ML Topical Cream
Summed across the 3 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 967017
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 Imiquimod 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 7 of 29 listed Imiquimod Topical NDCs with Medicaid activity.
🔍 Compare Imiquimod Topical products
A representative set of FDA-listed product records for Imiquimod 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 | ||||
| 2.5 mg/g | Topical | Bausch Health US, LLC × 3 listings | NDA | View NDC → |
| 37.5 mg/g | Topical | Bausch Health US, LLC × 6 listings | NDA | View NDC → |
| 50 mg/g | Topical | Bausch Health US LLC × 2 listings | NDA | Find on DailyMed ↗ |
| 12.5 mg/0.25 g | Topical | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 37.5 mg/g | Topical | Bryant Ranch Prepack × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 12.5 mg/0.25 g | Topical | Direct Rx × 2 listings | ANDA | View NDC → |
| 50 mg/g | Topical | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | ANDA | View NDC → |
| 50 mg/g | Topical | Glenmark Pharmaceuticals Inc., USA × 3 listings | ANDA | View NDC → |
| 37.5 mg/g | Topical | Oceanside Pharmacueticals × 2 listings | NDA | View NDC → |
| 12.5 mg/0.25 g | Topical | Padagis Israel Pharmaceuticals Ltd × 3 listings | ANDA | View NDC → |
| 37.5 mg/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 50 mg/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 37.5 mg/g | Topical | Taro Pharmaceuticals U.S.A., Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/g | Topical | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
| 37.5 mg/g | Topical | Teva Pharmaceuticals USA, Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
Showing 34 of 34 products — FDA National Drug Code Directory. See every product, package size and price: browse all 34 Imiquimod 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 Imiquimod 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 Imiquimod 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 Imiquimod 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 59943 1 dose form · 3 strengths
-
Dose form (SCDF) Topical Cream RxCUI 378638In current FDA listings
Look up RxCUI 59943 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 Imiquimod 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
RxNorm drug class
Imiquimod Topical belongs to the Antivirals class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 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 11 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. Bausch Health US, LLC 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.