Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Imiquimod
- Form
- Topical
- Strength
- Imiquimod 3.75%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Taro
- What the pharmacy pays
- ~$350.38 for 30 — not your price
- FDA application
- ANDA205971
What is Imiquimod?
From the FDA label:Imiquimod Cream, 3.75% is for topical administration. Each gram contains 37.5 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H -imidazol[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3. Its structural formula is: Chemical Structure
How to use
For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use. (2.1) AK: Apply a thin layer once daily at bedtime to affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Apply up to 0.5 grams at each application. (2.2) EGW: Apply a thin layer once daily at bedtime until total clearance or up to 8 weeks. Apply up to 0.25 grams at each application. (2.3) 2.1 Important Dosage and Administration Instructions Imiquimod cream is for topical use only. Imiquimod cream is not for oral, ophthalmic, intra-anal or intravaginal use. Instruct patients on proper application technique. Wash hands before and after applying imiquimod cream. Prime the imiquimod cream pump bottle before first use by repeatedly depressing the actuator until the cream is dispensed. It is not necessary to repeat this priming process during treatment. If a imiquimod cream dose is missed, apply the next dose at the regularly scheduled time. Avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. Prescribe no more than 2 boxes (56 packets) or two 7.5 g bottle pumps of imiquimod cream for the entire treatment course for AK or EGW. Discard partially used packets and do not reuse. Discard pump bottles after completion of a full treatment course. 2.2 Dosage and Administration for Actinic Keratosis Use imiquimod…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1)] • Systemic Reactions [see Warnings and Precautions (5.2)] Most common adverse reactions (≥4%) are local skin reactions (erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, exudate,), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling. 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. Actinic Keratosis The data described below reflect exposure to imiquimod cream or vehicle in 479 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [see Clinical Studies (14.1)]. Subjects applied up to two packets of imiquimod cream, 3.75%, or vehicle once daily, to the skin of the affected area (either entire face or…
Warnings
Important safety information
Local Skin Reactions: Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosage interruption may be required. Severe vulvar swelling may occur and lead to urinary retention; interrupt dosing or discontinue for severe vulvar swelling. (2.2, 2.3,5.1) Systemic Reactions: Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions. (5.2) Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing. (5.3) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with use of imiquimod cream and can occur after a few applications [see Adverse Reactions (6)] . Concomitant use of imiquimod cream and any other imiquimod products, in the same treatment area, may increase the risk for and severity of local skin reactions. Imiquimod cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling and to urinary retention. Avoid sexual (genital, anal, oral) contact while imiquimod cream is on the skin. To reduce the risk of local skin reactions and manage local skin reactions that occur with imiquimod cream treatment: Avoid concomitant use of imiquimod cream with any other imiquimod product in the same treatment area. Avoid application of imiquimod cream to skin that is not intact (i.e., any area with an abrasion, cut, burn, rash, infection, or other condition that has altered skin integrity). An interruption of dosing may be required for local skin reactions [see Dosage and Administration (2.2, 2.3)] . Interrupt dosing or discontinue imiquimod cream for severe vulvar swelling [see Dosage and Administration (2.3)]. If severe local skin reactions occur, instruct patients to remove imiquimod cream by washing the treatment area with mild soap and water. 5.2 Systemic Reactions Flu-like signs and symptoms have been reported with use of imiquimod cream andmay accompany, or even precede, local skin reactions [see Adverse Reactions (6)]. Signs and symptoms may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills. Concomitant use of imiquimod cream and any other imiquimod products may increase the risk for and severity of systemic reactions. Lymphadenopathy occurred in 2% of subjects with AK treated with imiquimod cream, 3.75% and in no patients in the vehicle arm [see Adverse Reactions (6.1)] . This reaction resolved in all subjects by 4 weeks after completion of treatment. Consider an interruption of dosing if systemic reactions occur. 5.3 Ultraviolet Light Exposure Risks Imiquimod cream may cause heightened sunburn susceptibility. Avoid or minimize exposure to sunlight (including sunlamps) during use of imiquimod cream. Instruct patients to use sunscreen and wear protective clothing (e.g., a hat). Advise patients not to use imiquimod cream until fully recovered from a sunburn. 5.4 Immune Cell Activation in Autoimmune Disease Imiquimod activates immune cells [see Clinical Pharmacology (12.2)]. Carefully monitor patients with pre-existing autoimmune conditions who are using imiquimod cream.
Who should not take Imiquimod
None. None. ( 4 )
Overdose — what happens if you take too much
Topical overdosing of imiquimod cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. Hypotension was reported in a clinical trial following multiple oral imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod content of more than 21 packets or pump actuations of imiquimod cream, 3.75% or more than 32 pump actuations of imiquimod cream, 2.5%). The hypotension resolved following oral or intravenous fluid administration. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Storing Imiquimod, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store imiquimod cream pump bottles upright.”
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Imiquimod treat?
- Imiquimod (Imiquimod) may be used to treat basal cell carcinoma, condylomata acuminata, actinic keratosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Imiquimod rated?
- pharmaranks gives Imiquimod a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Imiquimod cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $350.38 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Imiquimod?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Imiquimod. To pay less, Imiquimod is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Imiquimod?
- Imiquimod is marketed by Taro. You can see Taro's full profile, rating, and other products on pharmaranks.
- Is Imiquimod a brand-name or generic drug?
- Imiquimod is a generic medication; its active ingredient is Imiquimod. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Imiquimod available over the counter?
- No. Imiquimod is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Imiquimod come in?
- Imiquimod is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Imiquimod FDA-registered?
- Imiquimod is on record with the U.S. FDA under application number ANDA205971. You can verify this on its official FDA label.
- Has Imiquimod been recalled by the FDA?
- Imiquimod has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Imiquimod safe?
- There's no single safe-or-not verdict. pharmaranks gives Imiquimod a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Imiquimod?
- Imiquimod's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1)] • Systemic Reactions [see Warnings and Precautions (5.2)] Most common adverse reactions (≥4%) are local skin reactions (erythema,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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imiquimod
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