Imiquimod, Imiquimod Pump

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Brittany A. Duke, PharmD, RPh
Updated on October 10, 2023

Imiquimod (i mi KWI mod) is a generic medication prescribed for genital warts and certain skin conditions. Imiquimod belongs to a group of drugs called immune response modifiers.

The Food and Drug Administration (FDA) has approved imiquimod for:

• genital warts in adults and some children
• actinic keratosis (rough, scaly areas of skin) on the face or scalp in certain adults
• a specific type of skin cancer called basal cell carcinoma in adults

These approved uses differ based on the strength of imiquimod cream your doctor prescribes. This cream is available in two different strengths: 3.75% and 5%.

Side effects of imiquimod

Imiquimod may cause mild or serious side effects. More common mild side effects of imiquimod and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about imiquimod’s side effects, see this article or ask your doctor or pharmacist. You can also refer to the prescribing information for imiquimod listed in the “Resources” section.

Mild side effects

More common mild side effects reported with imiquimod cream are listed below. 

Imiquimod’s side effects can vary depending on the condition it’s prescribed to treat.

This article doesn’t include all possible mild side effects of the drug. To learn more about imiquimod’s side effects, refer to the prescribing information for imiquimod listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Imiquimod topical cream’s mild side effects include:

• skin reactions where the cream is applied, such as swelling, itching, pain, irritation, dryness, or crusting 
• fatigue (low energy)
• headache
• nausea
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for imiquimod” section.

Serious side effects

Serious side effects of imiquimod are listed below. These side effects can vary depending on the condition it’s prescribed to treat.

This article doesn’t include all possible serious side effects of the drug. To learn more about imiquimod’s side effects, refer to the prescribing information for imiquimod listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number. 

In general, imiquimod’s serious side effects include:

• serious skin irritations, such as skin erosion (breakdown of the skin’s outer layers)
• severe swelling of the vulva (part of female* genitals), which may lead to urination problems
• skin lightening or darkening in some areas, which may be permanent
• increased risk of sunburn
• severe allergic reaction†

* Sex and gender exist on spectrums. In this article, we use the term “female” to refer to a person’s sex assigned at birth.

† For details about this side effect, see the “Interactions and warnings for imiquimod” section.

Common questions about imiquimod

Below you’ll find answers to a few commonly asked questions about imiquimod.

Is imiquimod available over the counter?

No, this medication isn’t sold over the counter. Imiquimod cream is only available from pharmacies with a prescription from your doctor. 

If you have a condition that imiquimod cream is used to treat, you should see a doctor or other healthcare professional. These conditions aren’t treatable with over-the-counter (OTC) products. 

If you’d like to know more about treatments for your condition, talk with your doctor or pharmacist. 

What is imiquimod’s brand name?

Imiquimod cream is a generic drug. You may hear this drug referred to by the brand names of Zyclara or Aldara. Zyclara is currently available, but Aldara has been discontinued by the drugmaker.   

A generic medication is an identical copy of the active drug in a brand-name medication. (An active drug is the ingredient that makes a medication work.) Generic drugs are believed to be as effective and safe as brand-name drugs. And generic drugs typically cost less compared to brand-name drugs.

If you’d like to know more about this, talk with your doctor or pharmacist. 

How does imiquimod work? And how long does it take to start working?

Imiquimod’s mechanism of action (how it works) isn’t fully understood. The drug is thought to work by activating a certain receptor (type of protein) in your body. This may alter some of the usual processes within your immune system. When imiquimod cream is applied to the skin, certain immune cells may become more active than usual. 

Imiquimod cream begins working within 8 hours. How long imiquimod takes to reduce or clear your symptoms depends on the condition being treated and how your skin responds to the drug. Both strengths of imiquimod cream work the same way. Your doctor will tell you how long you’ll need to use the drug. 

If you’d like to know more about what to expect with imiquimod cream, talk with your doctor or pharmacist. 

Uses of imiquimod

The Food and Drug Administration (FDA) approves prescription drugs such as imiquimod for certain conditions. Approved uses for imiquimod are described below. These uses differ based on the strength of imiquimod prescribed.

Doctors may not prescribe imiquimod cream in certain situations in which the drug may not be safe or effective, such as:

• for children with molluscum contagiosum (a type of skin infection) 
• for people with weakened immune systems
• for people with certain rare skin conditions, including:
  • basal cell nevus syndrome 
  • xeroderma pigmentosum
• for people with actinic keratosis (AK) who’ve already been treated with imiquimod in the same skin areas

Also, the drug isn’t used for treating or preventing the spread of human papillomavirus (HPV). 

The drug’s uses and limitations differ based on the strength of imiquimod cream your doctor prescribes. This cream is available in two different strengths: 3.75% and 5%. Your doctor or pharmacist can provide more details about this.

Use for genital warts

Doctors may prescribe imiquimod cream for treating genital warts. It’s used for this purpose in adults and children ages 12 years and older. It’s usually prescribed as a short-term treatment.

Genital warts are a type of sexually transmitted infection caused by certain strains of HPV. Genital warts usually look like soft growths or bumps on the genitals. Symptoms can include pain and itching.

For this use, imiquimod cream is applied to warts on the external (outside) genitals or around the anus. The cream is only meant for external use on your skin. You shouldn’t apply it inside the vagina, anus, mouth, or to your eyes. 

Keep in mind that imiquimod isn’t used for treating HPV. And it doesn’t prevent the spread of HPV to others.

Use for certain skin conditions

Doctors may prescribe imiquimod cream for treating AK on the face or scalp. It’s also prescribed for treating a specific type of basal cell carcinoma (BCC) on certain areas of the body. The drug is used for these purposes in adults. It’s usually prescribed as a short-term treatment.

With AK, you have rough, scaly areas of skin due to damage from sun exposure. These areas are also called “sunspots”. AK isn’t cancerous, but it can lead to skin cancer if it isn’t treated.

BCC is a type of skin cancer. Imiquimod is only approved to treat certain types of superficial BCC. Superficial means it affects the outer layer of your skin.

For these uses, imiquimod cream is applied to the affected external (outside) areas of your skin. You shouldn’t apply the cream inside the vagina, anus, mouth, or to your eyes.

Interactions and warnings for imiquimod

Below you’ll find information about imiquimod’s possible interactions and warnings. 

Interactions of imiquimod

Imiquimod isn’t known to interact with any medications or supplements. Interactions can affect how a drug works. But this doesn’t mean drug interactions with imiquimod won’t happen or be reported sometime. For instance, medications created at a later time could interact with imiquimod.

Because of this, you should ask your doctor and pharmacist about possible interactions with imiquimod. They can check for any interactions that may affect you, such as those with:

• vaccines
• foods or alcohol
• other drugs

Warnings for imiquimod

Some people should not use imiquimod, and others should use it cautiously.

Imiquimod could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether imiquimod is a safe option for you. 

Ask your doctor about specific warnings for imiquimod, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Imiquimod can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to imiquimod or any of its ingredients, your doctor will likely not prescribe imiquimod. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause breathing problems 

If you have an allergic reaction to imiquimod, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of imiquimod

If you apply imiquimod cream, you should not use more than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve used too much imiquimod, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and imiquimod

Information about imiquimod and pregnancy and breastfeeding is described below.

Imiquimod and pregnancy

It’s not known whether imiquimod should be used during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before using this medication. 

Imiquimod and breastfeeding

It’s not known whether imiquimod should be used while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before using this medication. 

What to ask your doctor

Let your doctor know if you have questions about imiquimod or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• How long will I need to use imiquimod cream?
• How does imiquimod cream compare to other treatment options for my condition?
• Can I continue using my other skin medications during treatment with imiquimod cream?
• Should I avoid any particular skin or hair products while using imiquimod cream?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
• Imiquimod cream (3.75%). (2021). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/1de49a4d-dc7e-48ff-b18c-e1414282fe71/spl-doc
• Imiquimod cream (5%). (2021). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/1505cf54-37da-4b2b-9812-6ffd6a01a7c7/spl-doc
• Nanda J, et al. (2023). Imiquimod. https://www.ncbi.nlm.nih.gov/books/NBK557413/ 

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.