Imiquimod

What it is and how it works

Mechanism of Action The mechanism of action of Imiquimod Cream in treating AK lesions is unknown.

Mechanism class: Interferon Inducers

Indications

Imiquimod Cream USP, 5% is indicated for the topical treatment of: Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults . Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured . External genital and perianal warts/condyloma acuminata in patients 12 years old or older . Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 2-12 ( 1.4 , 8.4 ) Actinic Keratosis Imiquimod Cream USP, 5% is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.

Dosage and administration (summary)

The application frequency for Imiquimod Cream is different for each indication. Imiquimod is not for oral, ophthalmic, or intravaginal use. Imiquimod Cream USP, 5% is not for oral, ophthalmic, or intravaginal use . Actinic keratosis: 2 times per week for a full 16 weeks Superficial basal cell carcinoma: 5 times per week for a full 6 weeks . External genital warts (EGW): 3 times per week until total clearance or a maximum of 16 weeks . Actinic Keratosis Imiquimod Cream should be applied 2 times per week for a full 16 weeks to a defined treatment area on the face or scalp (but not both concurrently).

Contraindications

None. None

Warnings and precautions

Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be required ( 2 , 5.1 , 6 ). Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention; dosing should be interrupted or discontinued. Flu-like systemic signs and symptoms including malaise, fever, nausea, myalgias and rigors may occur. Dosing interruption may be required ( 2 , 5.2 , 6 ). Avoid exposure to sunlight and sunlamps. Wear sunscreen daily .

Pregnancy

Pregnancy Pregnancy Category C: Note: The Maximum Recommended Human Dose (MRHD) was set at 2 packets per treatment of Imiquimod Cream (25 mg imiquimod) for the animal multiple of human exposure ratios presented in this label.

Storage and supply

Store at 4° to 25°C (39° to 77°F) Avoid freezing. Keep out of reach of children.

Source: Imiquimod (Imiquimod) — US FDA prescribing information, 2025-08-11, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.