pharmacopeia
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/api/v1/drug/imiquimod

Mechanism of action

Sourced from openFDA

The mechanism of action of Imiquimod Cream in treating AK, sBCC, and EGW lesions is unknown.

Indications

Sourced from openFDA
  • Imiquimod Cream is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. ( 1.1 ) • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 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.

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

• For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use. ( 2.1 ) • AK: Apply once daily before bedtime 2 times per week for a full 16 weeks to a contiguous area of approximately 25 cm 2 on the face or scalp. Apply no more than 1 packet at each application. ( 2.2 ) • sBCC: Apply once daily before bedtime 5 times per week for a full 6 weeks to a target tumor with 2 cm maximum diameter on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). Amount of Imiquimod Cream used based on target tumor diameter. ( 2.3 ) • EGW: Apply thin layer once daily before bedtime 3 times per week until total clearance or for a maximum of 16 weeks. ( 2.4 ) 2.1 Important Dosage and Administration Instructions Imiquimod Cream is for topical use only. Imiquimod Cream is not for oral, ophthalmic, or intravaginal use. Instruct patients on proper application technique. Wash hands before and after applying Imiquimod Cream. Wash the treatment area with mild soap and water and allow the area to dry thoroughly (at least 10 minutes) before applying Imiquimod Cream. If an Imiquimod Cream dose is missed, apply the next dose at the regularly scheduled time. Avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. For patients with AK and sBCC, prescribe no more than 3 boxes (36 packets) of Imiquimod Cream for the entire treatment period. For EGW, one packet of Imiquimod Cream contains sufficient cream to cover a wart area of up to 20 cm 2 . Discard partially used packets and do not reuse.

Warnings & precautions

Sourced from openFDA

• 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. ( 5.1 ) • Local Hypopigmentation Reactions: Localized complete depigmentation has occurred and persisted. Discontinue if hypopigmentation develops. ( 5.2 ) • Systemic Reactions: Flu-like systemic signs and symptoms have occurred. Consider dosage interruption for systemic reactions. ( 5.3 ) • Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear sunscreen and protective clothing. ( 5.4 ) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with Imiquimod Cream and can occur after a few applications [see Adverse Reactions ( 6.1 )] . Concomitant use of Imiquimod Cream and any other imiquimod products, in the same treatment area, may increase the risk for and severity of local skin reactions. Imiquimod Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling and urinary retention. Avoid sexual (genital, anal, oral) contact while Imiquimod Cream is on the skin.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions ( 5.1 )] • Local Hypopigmentation Reactions [see Warnings and Precautions ( 5.2 )] • Systemic Reactions [see Warnings and Precautions ( 5.3 )] Most common application site or local skin adverse reactions (incidence >28%) are erythema, flaking/scaling/dryness, scabbing/crusting, edema, erosion/ulceration, induration, itching, burning, excoriation, vesicles. Other reported systemic adverse reactions (≥1%): fatigue, fever, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Actinic Keratosis The data described below reflect exposure to Imiquimod Cream or vehicle in 436 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [see Clinical Studies (14.1)] . Subjects applied Imiquimod Cream, 5% or vehicle topically, to a 25 cm 2 contiguous treatment area on the face or scalp once daily 2 times per week for 16 weeks. The incidence of selected adverse reactions reported by ≥1% of subjects during the trials is presented in Table 2.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Available data from case reports and case series of use with imiquimod during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are no controlled or large-scale epidemiologic studies and no exposure registries with imiquimod use in pregnant women. In animal reproduction studies, there were no adverse developmental effects observed after oral administration of imiquimod in pregnant rats and intravenous administration of imiquimod in pregnant rabbits during organogenesis at doses up to 98 times and 407 times, respectively, the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data The MRHD was set at 2 packets per treatment of Imiquimod Cream (25 mg imiquimod) for the animal multiples of human exposure presented in this label. Systemic embryofetal development studies were conducted in rats and rabbits.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Systemic absorption of imiquimod across the affected skin of 58 subjects with AK was observed with a dosing frequency of 3 applications per week for 16 weeks. Mean peak serum drug concentrations at the end of Week 16 were approximately 0.1, 0.2, and 3.5 ng/mL for the applications to face (12.5 mg imiquimod, 1 unit-dose packet), scalp (25 mg, 2 packets), and hands/arms (75 mg, 6 packets), respectively.

Overdosage

Sourced from openFDA

Topical overdosing of Imiquimod Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. The most clinically serious adverse reaction reported following multiple oral imiquimod doses of >200 mg (equivalent to imiquimod content of >16 packets of Imiquimod Cream) was hypotension, which resolved following oral or intravenous fluid administration. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Approval history

Sourced from openFDA
  • Mar 25, 2010NDANDA022483Bausch
  • Sep 7, 2010ANDAANDA078837Padagis Israel
  • Apr 15, 2011ANDAANDA200173Taro
  • Mar 6, 2012ANDAANDA201994Glenmark Pharms
  • Jan 26, 2021ANDAANDA205971Taro

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,224 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use25912%
  2. 2Erythema1798.0%
  3. 3Fatigue1767.9%
  4. 4Product Use In Unapproved Indication1667.5%
  5. 5Drug Ineffective1627.3%
  6. 6Pain1325.9%
  7. 7Nausea1125.0%
  8. 8Influenza Like Illness1014.5%
  9. 9Application Site Erythema944.2%
  10. 10Headache944.2%
  11. 11Pruritus833.7%
  12. 12Pyrexia833.7%
  13. 13Scab743.3%
  14. 14Malaise733.3%
  15. 15Diarrhoea723.2%

Literature

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Recent PubMed references pinned to Imiquimod as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 194 ClinicalTrials.gov registrations naming Imiquimod as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Imiquimod work?
The mechanism of action of Imiquimod Cream in treating AK, sBCC, and EGW lesions is unknown.
What is Imiquimod used for?
According to FDA labeling, Imiquimod carries indications including: Imiquimod Cream is indicated for the topical treatment of: • Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults. ( 1.1 ) • Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults with a maximum tumor diameter of 2.0 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Imiquimod?
Imiquimod is classified as Antivirals, Interferon Inducers, Increased Cytokine Activity, Increased Cytokine Production.
What are the brand names for Imiquimod?
Imiquimod is marketed under brand names including Zyclara.
What are the contraindications for Imiquimod?
Imiquimod labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for imiquimod is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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