Imiquimod
Antivirals
Sold as Aldara · Zartra · VYLOMA · ZYCLARA · ALDARA P
- Drug class
- Antivirals
- Availability
- Prescription only
- Routes
- Topical
- Markets covered
- 4
- Products on record
- 35
- FDA reports (12 mo)
- 136
Overview
Plain-language summary, compiled from the cited regulatory records
Imiquimod is a topical medication classified as an antiviral [1]. It is approved for the treatment of certain skin conditions in immunocompetent adults. Specifically, it is indicated for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp [1]. Additionally, imiquimod cream is approved for biopsy-confirmed, primary superficial basal cell carcinoma on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), provided surgical methods are less appropriate [1].
In the past 12 months, there have been 136 adverse event reports associated with imiquimod [2]. Common adverse events reported include skin ulcer, skin irritation, treatment noncompliance, incorrect product usage, and fatigue [2]. Imiquimod is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 25 | April 17, 2026 |
| CA Canada | Health Canada | 7 | February 26, 2026 |
| EU European Union | EMA | 2 | July 22, 2025 |
| US United States | FDA | 1 | January 31, 2025 |
GBUnited Kingdom· MHRA
25 products
Uses
Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
How to take
CACanada· Health Canada
7 products
Uses
5 g of cream For a complete listing see Dosage Forms, Composition and Packaging section. INDICATIONS AND CLINICAL USE VYLOMA Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata, whether present at the start of therapy or emerging during therapy, in immunocompetent adults.
Geriatrics (> 65 years of age) Data from EGW clinical trials was too sparse to evaluate treatment effects in this population (see WARNINGS AND PRECAUTIONS, Geriatrics). Pediatrics Safety and efficacy in patients below the age of 18 years have not been established (See WARNINGS AND PRECAUTIONS, Pediatrics).
Immunosuppressed The safety and efficacy of VYLOMA Cream in immunosuppressed patients have not been established (See WARNINGS AND PRECAUTIONS, Immune). VYLOMA Cream should be used with caution in patients with pre-existing autoimmune conditions.
PrVYLOMA® Product Monograph Page 4 of
EUEuropean Union· EMA
2 products
Uses
Zyclara is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis (AK) of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
How to take
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE Imiquimod Cream is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. 0 cm on trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
2 ) • External genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older. 1 Actinic Keratosis Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults.
0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured. Establish the histological diagnosis of superficial basal cell carcinoma prior to treatment.
Drug interactions
Known interactions involving Imiquimod. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB463020209 · revised April 17, 2026
- [2]Health Canada (DPD) · 02365561 · revised March 22, 2025
- [3]European Medicines Agency · EMEA/H/C/002387 · revised July 22, 2025
- [4]FDA DailyMed · 1505cf54-37da-4b… · revised January 31, 2025 [PDF]
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.