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MedsAcross

Molecule

Imiquimod

Interferon Inducers
Available on requestImmune stimulantsDermatology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Imiquimod is a prescription medicine indicated for the topical treatment of clinically typical, visible, or palpable actinic keratoses (AK) of the face or balding scalp in immunocompetent adults, among other approved uses. MedsAcross supplies Imiquimod for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Interferon Inducers, Increased Cytokine Activity, Increased Cytokine Production
ATC classification
D06BB10 Imiquimod · Antibiotics and antivirals for the skin, subgroup D06B, subgroup D06BBL03AX Cytovir-3 · Immunostimulant
US FDA first approval
27 February 1997
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Cream
Identifiers
UNII P1QW714R7MRxCUI 59943CAS 99011-02-6DrugBank DB00724Q423417

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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. 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.

Source: US FDA prescribing information

Dosing overview

For topical use only, Imiquimod Cream is not for oral, ophthalmic, intra-anal or intravaginal use. 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.

Source: US FDA prescribing information

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.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Local Skin Reactions Systemic Reactions 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.

Source: US FDA prescribing information

Storage

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F). Avoid freezing. Store Imiquimod Cream pump bottles upright.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Imiquimod, sorted by availability.

MedicineManufacturerRegisterAvailability
Imiquimod 5% creamTopicalGeneric name—US FDAAvailable on request
Imiquimod 3.75% creamTopicalGeneric name—US FDAAvailable on request
Zyclara 3.75% creamTopicalBausch HealthUS FDAAvailable on request
Zyclara 0.25% creamTopicalBausch HealthUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 February 1997Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Imiquimod in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Imiquimod available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Imiquimod and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Imiquimod have?

The catalogue lists 1 brand names for Imiquimod, including Zyclara.

Is Imiquimod approved by the US FDA?

Yes. The US FDA first approved Imiquimod on 27 February 1997, according to Drugs@FDA.

Is Imiquimod authorised in the European Union?

Yes. Imiquimod has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Imiquimod need cold chain shipping?

No listed presentation of Imiquimod is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Imiquimod in?

Imiquimod is classified under ATC code D06BB10 (Imiquimod).

References

  1. Imiquimod prescribing information (Teva Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 30 June 2025
  2. Aldara: European public assessment report (EPAR). European Medicines Agency. Retrieved 18 July 2025
  3. Zyclara: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 July 2025

Request Imiquimod for export supply

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