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Topical immunomodulator (TLR7 agonist) Pregnancy: No clinical data on exposed pregnancies are available; animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/foetal development. Caution should be exercised when prescribing to pregnant women. Breast-feeding: as no quantifiable levels (>5 ng/mL) of imiquimod are detected in serum after single and multiple topical doses, no specific advice can be given on whether to use in lactating mothers

Imiquimod 5%

Brand names: Aldara, Zyclara (3.75%)

Imiquimod is a topical immune-response modifier used for external anogenital warts, superficial basal cell carcinoma and actinic (solar) keratoses.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: External genital warts (adults): apply a thin layer of 5% cream to the wart area and rub in until the cream vanishes; leave on the skin for 6 to 10 hours, then remove with mild soap and water
Route: Topical (cream); apply prior to normal sleeping hours
Frequency: 3 times per week (e.g. Monday, Wednesday and Friday)
Max: Actinic keratosis: the maximum recommended dose is one sachet. Cream should not be applied more than once a day for any indication
Source: UK SPC for Aldara 5% Cream, §4.2. Application frequency and duration differ by indication. EXTERNAL GENITAL WARTS (adults): continue until clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode; a single-use sachet is sufficient to cover a wart area of 20 cm2. SUPERFICIAL BASAL CELL CARCINOMA (adults): apply 5 times per week (e.g. Monday to Friday) for 6 weeks, leaving on the skin for approximately 8 hours; apply sufficient cream to cover the treatment area including 1 cm of skin surrounding the tumour; assess response 12 weeks after the end of treatment. ACTINIC KERATOSIS (adults): treatment should be initiated and monitored by a physician; apply 3 times per week for four weeks, leaving on the skin for approximately 8 hours; after a 4-week treatment-free period, assess clearance and, if lesions persist, repeat for another four weeks; each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods; if not completely cleared at follow-up about 8 weeks after the last 4-week course, an additional 4-week course may be considered; recurrent cleared lesions may be re-treated with one or two further courses after a pause of at least 12 weeks. ALL INDICATIONS: if a dose is missed, apply as soon as remembered then continue the regular schedule, but do not apply more than once a day; avoid showering or bathing during the treatment period; sachets should not be re-used once opened; wash hands before and after application. Interrupt dosing if intense local inflammatory reactions occur or if infection is observed at the treatment site. PAEDIATRIC: use in the paediatric population is not recommended — there are no data on the use of imiquimod in children and adolescents in the approved indications, and it should not be used in children with molluscum contagiosum due to lack of efficacy.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Application site reactions at the treatment site (very common — 33.7% in external genital warts trials, 28.1% in superficial basal cell carcinoma trials, 22% in actinic keratosis trials)
  • Headache (3.7% in external genital warts trials)
  • Influenza-like symptoms (1.1% external genital warts; 0.5% superficial basal cell carcinoma)
  • Myalgia (1.5% external genital warts; 2% actinic keratosis) and back pain (1.1% superficial basal cell carcinoma)
  • Infection and pustules at the application site (common); lymphadenopathy; anorexia
  • Rarely, intense local inflammatory reactions including skin weeping or erosion, which may be accompanied or preceded by flu-like systemic signs and symptoms (malaise, pyrexia, nausea, myalgias, rigors)

Clinical monograph

How it works

It is a toll-like receptor 7 agonist that stimulates local innate and cell-mediated immunity, increasing interferon-alpha and other cytokines to produce an antiviral and antitumour response.

Prescribing in practice

  • Local skin reactions such as erythema, erosion, crusting and flaking are expected and reflect the intended immune response, but severe reactions warrant a treatment break.
  • It weakens latex condoms and diaphragms, so alternative contraception should be advised when treating genital warts.
  • Wash hands before and after application, apply to the lesion at night and wash off after the recommended period; treatment course and frequency differ by indication, so follow the SPC.

Monitoring

Review the treated area periodically for response and for severity of local skin reactions, adjusting or pausing therapy as needed.

Counselling the patient

  • Some redness, soreness and scabbing of the treated area is expected and shows the cream is working.
  • Apply at bedtime and wash the area in the morning; wash your hands afterwards.
  • This cream can weaken condoms and diaphragms, so use another form of contraception.

Evidence & guidelines

Imiquimod is recommended in NICE and dermatology guidance as a treatment option for superficial basal cell carcinoma, actinic keratoses and external genital warts.

Reference: BAD Genital Warts Guidelines; NICE CG8 Referral for Suspected Cancer; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.