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AIDSinfo Drug Database

AIDSinfo Drug Database

Drugs by class

FDA-approved

Investigational

Imiquimod  Audio icon

Other Names: Aldara, Zyclara
Drug Class: Opportunistic Infections and Coinfections
Chemical Image:
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imiquimod
imiquimod
Molecular Weight: 240.308

What is imiquimod?

Imiquimod is a prescription medicine approved by the U.S. Food and Drug Administration (FDA). It is a cream that is meant to be applied topically (on the skin only). There are several different strengths of imiquimod cream available: 2.5%, 3.75%, and 5%. All three strengths are approved to treat actinic keratosis (AK)—a skin condition that may develop into skin cancer—on the face or scalp in adults with normal immune systems. Imiquimod cream 5% is approved to treat some types of primary superficial basal cell carcinoma (sBCC)—a type of skin cancer—in adults with normal immune systems.

Additionally, imiquimod creams 3.75% and 5% are approved to treat external genital warts (warts on the outside of the genitals) and perianal warts (warts around the outside of the anus) in people 12 years of age and older. External genital and perianal warts are caused by the human papillomavirus (HPV). HPV is an opportunistic infection. An opportunistic infection is an infection that occurs more frequently or is more severe in people with weakened immune systems—such as those infected with HIV—than in people with healthy immune systems.

Imiquimod can also be used “off-label” to treat other opportunistic infections of HIV infection. “Off-label” use refers to use of an FDA-approved medicine in a manner different from that described on the medicine label. Good medical practice and the best interests of a patient sometimes require that a medicine be used “off-label.”

What HIV-related opportunistic infections is imiquimod used for?

The Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents, prepared by the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the HIV Medicine Association of the Infectious Diseases Society of America (IDSA-HIVMA), includes recommendations on the HIV-related use of imiquimod to treat:

  • External genital warts caused by HPV.
  • Herpes simplex virus (HSV) disease in people for whom the medicine acyclovir will not effectively treat HSV (also known as acyclovir-resistant HSV). (This is an “off-label” use.)
The above list may not include all of the HIV-related uses of imiquimod recommended in the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. Some recommended uses, such as uses in certain rare circumstances, may have been omitted.

What should I tell my health care provider before taking imiquimod?

Before taking imiquimod, tell your health care provider:

  • If you are allergic to imiquimod or any other medicines.
  • About any medical conditions you have or have had, for example, diabetes or liver problems.
  • About anything that could affect your ability to use imiquimod, such as difficulty with applying a cream to the affected area or trouble with remembering a scheduled dose.
  • If you are pregnant or plan to become pregnant. Whether imiquimod can harm an unborn baby is unknown. Imiquimod should be used during pregnancy only if the potential benefit justifies the potential risk to the unborn baby. Talk to your health care provider about possible risks with taking imiquimod when pregnant.  
  • If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Imiquimod may affect the way other medicines or products work, and other medicines or products may affect how imiquimod works. Ask your health care provider if there are interactions between imiquimod and the other medicines you take.

Ask your health care provider about possible side effects from imiquimod. Your health care provider will tell you what to do if you have side effects.

How should I take imiquimod?

Take imiquimod according to your health care provider’s instructions. Your health care provider will tell you how much imiquimod to take and when to take it. Before you start imiquimod and each time you get a refill, read any printed information that comes with your medicine.

How should imiquimod be stored?

  • Store imiquimod creams 2.5% and 3.75% at room temperature, 59°F to 86°F (15°C to 30°C). Do not freeze. Store imiquimod cream pumps upright.
  • Store imiquimod cream 5% at 39°F to 77°F (4°C to 25°C). Do not freeze.
  • Do not use imiquimod if the original seal on the medicine carton is broken or missing.
  • Throw away imiquimod that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of unused medicine.
  • Keep imiquimod and all medicines out of reach of children.

Where can I find more information about imiquimod?

More information about imiquimod is available:

The above Patient Version drug summary is based on the following FDA label(s): Cream (2.5% and 3.75%); Cream (5%).

Last Reviewed: April 23, 2015

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