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imiquimod

Aldara, Zyclara · ATC code D06BB10

Brand names: Aldara, Zyclara, Imikeraderm, Aksunim, Aldosil, Alquira, Imidara

Key facts
Active substance
imiquimod
ATC code
D06BB10
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ALDARA 5% cream · Zyclara 3.75% cream
Marketing authorisation holder
Viatris Healthcare Limited
Information as of
2026-10-27

Key facts

Imiquimod is a topical immune response modifier (cream). It is used in adults for external genital warts, superficial basal cell carcinoma and actinic keratoses.

What it is used for

  • Aldara 5%: external genital and perianal warts (condylomata acuminata) in adults
  • Aldara 5%: small superficial basal cell carcinomas in adults
  • Aldara 5%: typical, nonhyperkeratotic actinic keratoses on the face or scalp in immunocompetent adults
  • Zyclara 3.75%: actinic keratosis of the full face or balding scalp in immunocompetent adults

Dosing

  • Aldara, genital warts: 3 times per week before sleeping hours, left on for 6 to 10 hours; until clearance, maximum 16 weeks
  • Aldara, superficial BCC: 5 times per week for 6 weeks, left on for approximately 8 hours
  • Aldara, actinic keratosis: 3 times per week for four weeks; assess after a 4-week treatment-free period and repeat if needed
  • Zyclara: once daily before bedtime, up to 2 sachets, two 2-week treatment cycles separated by a 2-week break
  • Do not apply more than once a day; not recommended in children

Contraindications

  • Hypersensitivity to the active substance or any of the excipients

Important warnings

  • Avoid contact with eyes, lips and nostrils; no occlusive dressings
  • Do not use on broken skin before healing from prior treatment (increased systemic absorption)
  • Caution in autoimmune conditions and organ transplant patients
  • Intense local inflammatory reactions may occur; minimise sun exposure

Side effects

  • Very common: application site reactions (erythema, scab, exfoliation, dryness)
  • Genital warts: application site reactions in 33.7%; headache (3.7%), influenza-like symptoms, myalgia
  • Zyclara: headache 6%, fatigue 4%; herpes simplex common

Interactions

  • Caution with concomitant immunosuppressive medication
  • Avoid using Zyclara with other imiquimod creams in the same area

Pregnancy and breastfeeding

  • No clinical data; caution in pregnant women, Zyclara only if benefit justifies the risk

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • AldaraViatris Healthcare Limited · EMEA/H/C/000179
  • ZyclaraViatris Healthcare Limited · EMEA/H/C/002387

Source: European Medicines Agency (EMA), product information

Austria

  • ImikeradermDermapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • AksunimBasics Gmbh · 1 register entry
  • ImikeradermDermapharm Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • AldaraVİATRİS İLAÇLARI LİMİTED ŞİRKETİ · 3 register entries
  • AldosilBEYMED SAĞLIK İNŞAAT SAN. VE TİC. A.Ş. · 1 register entry
  • AlquiraBEYMED İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ImidaraARGİS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 11 more European countries
Cyprus
Modiwart
Greece
Modiwart, Quimodia
Iceland
Aldara, Zyclara
Italy
Imunocare
Liechtenstein
Aldara, Zyclara
Netherlands
Bascellex
Norway
Aldara, Bascellex, Zyclara
Poland
Imikeraderm
Portugal
Imicare
Spain
Imikeraderm, Imunocare
Sweden
Bascellex

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Aldara – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/aldara-epar-product-information_en.pdf
  2. European Medicines Agency. Zyclara – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/zyclara-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.