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Imiquimod

A cream applied at home for external genital and perianal warts, which acts on the immune response rather than on the virus itself.

Class
Immune response modifier
Sold as
Sold as: Aldara, Zyclara
Prescription only

From the approved label

Imiquimod cream

Approved uses
  • Imiquimod cream, 3.75% is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age or older. Actinic Keratosis Imiquimod cream, 3.75% is indicated for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults.
Forms and strengths
  • Imiquimod cream is a white to faintly yellow cream available as: Cream: 3.75%, in unit-dose packets and pump bottles.
  • Each packet contains 0.25 grams of cream and each pump bottle, when actuated after priming, delivers 0.235 grams of cream.
  • Cream: 3.75% in pump bottles or unit-dose packets.
How it is taken
  • For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use.
  • 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.
  • 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.
Must not be used when
  • None. The label states that there are no contraindications.
Warnings and precautions
  • 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.
  • Systemic Reactions: Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions.
  • Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing.
Common side effects
  • 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.
Pregnancy
Available data from case reports and case series have not established a drugassociated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes when imiquimod is used during pregnancy. There are no controlled or large-scale epidemiologic studies and no exposure registries with imiquimod use in pregnant women.
How it acts
The mechanism of action of imiquimod cream in treating AK and EGW lesions is unknown.
Label holder:
Sun Pharmaceutical Industries, Inc.
Label version:

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.

Written by us

How it works

Imiquimod does not attack the virus directly. It acts on receptors of the innate immune system in the skin, and the response that follows is what clears the visible wart. The label is explicit that the mechanism in external genital warts is not fully established, and it describes local skin reactions at the site of application as expected rather than unusual.

Original and generic

Aldara was the original brand at 5 percent; Zyclara is the 3.75 percent strength. Both concentrations exist as generics, and the label of the generic is the same document as the brand.

What it costs

Sold by the sachet, so the cost of a course depends on how many applications the treated area needs and for how many weeks. A course runs for weeks rather than days, which is what separates it in price from a single antibiotic course.

How to get it legally

Prescription only in Europe and the United States. An online consultation fits the repeat case, where the diagnosis was already made in person. A first appearance of anogenital lumps is different: several unrelated conditions look alike there, and what is treated at home should be what a clinician has actually seen.

Questions

Does it get rid of the virus?
No. The label describes treatment of the visible warts, not elimination of the human papillomavirus, and it states that new warts may develop during or after treatment.
Can it be used inside the vagina or the urethra?
No. The approved use is external genital and perianal warts. The label does not cover internal warts, and applying the cream there is outside what was studied.
Are the skin reactions a sign that something went wrong?
The label lists redness, erosion, flaking and swelling at the application site among the most common reactions, and gives instructions for rest periods when the reaction is severe. That is a question for the prescriber rather than something to judge at home.

Sources

  1. Imiquimod: prescribing informationDailyMed, US National Library of Medicine. Label version 21 January 2026
  2. Drugs@FDA: ANDA205971US Food and Drug Administration
  3. Aldara: EPAR and product informationEuropean Medicines Agency

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