Imiquimod cream side effects

Contents

Aldara

Generic Name: imiquimod
Product Name: Aldara

Indication: What Aldara is used for

Aldara is used to treat solar keratosis (SK) on the face and scalp, superficial basal cell carcinoma (sBCC), and genital/perianal warts.

  • Solar keratoses are thickened, scaly patches of skin caused by too much sun exposure. Solar keratosis is also known as actinic keratosis;
  • Basal cell carcinoma is a type of skin cancer;
  • External genital/perianal warts (condyloma acuminata) are warts that appear on the surface of the penis or vulva (external female sexual organ) and around the anus.

Aldara is not recommended for use in patients under the age of 18 years as there have been no studies of its effects in this age group.

Your doctor may prescribe Aldara for another purpose. If you are not sure why you are using this medicine ask your doctor.

Action: How Aldara works

Imiquimod is an immune response modifier. Imiquimod has been shown to stimulate the innate and adaptive immune response through the induction of interferon-α (IFN-α) and other cytokine
production by multiple cell types (e.g. macrophages; monocytes; B cells; plasmacytoid dendritic cells (pDC)). pDCs, a major subset of (pre-)DCs, have the highest expression of Toll-like receptor7
(TLR7) amongst DC subsets.

Imiquimod has no direct in vitro antiviral activity. The antiviral activity is indirect through cytokine induction of IFN-α and immune activation. Imiquimod also appears to exert some pro-apoptotic activity against tumour cells. Imiquimod stimulates the infiltration of tumour-destructive cells (T-cell lymphocytes, dendritic cells and macrophages) at the superficial basal cell carcinoma lesions and reduces the defense mechanism of the tumour.

Each 250mg of Aldara cream 5% contains 12.5mg of the active ingredient, imiquimod. Aldara cream also contains isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan monostearate, glycerol, methyl hydroxybenzoate, propyl hydroxybenzoate, xanthan gum, purified water.

Dose advice: How to use Aldara

Before using Aldara

When you must not use it

Do not use Aldara:

  • If you are allergic to imiquimod or to any of the ingredients listed here;
  • On skin where there are open sores or wounds. Do not start using Aldara until after the area has healed:
  • On warts inside the vagina or inside the anus or inside the urethra (where you pass urine). The use of Aldara cream in these areas has not been studied;
  • On areas that are sunburnt;
  • If the packaging is torn or shows signs of tampering;
  • After the “use by” date shown on the box or sachet or after 4 weeks from first opening the Aldara pump.

Before you start to use it

Tell your doctor if:

  • You are pregnant or intend to become pregnant;
  • You are breastfeeding or intend to breastfeed;
  • You are or you think you are HIV positive;
  • You are taking any other medicines;
  • You have previously used Aldara cream or other similar preparations to treat your condition;
  • You have problems with your immune system;
  • You have an abnormal blood count;
  • You currently have, or in the past have had any other medical conditions.

Using Aldara

Dosage

Aldara is used to treat several skin conditions. Your doctor will tell you where to apply Aldara cream, how often and for how long to apply it for your condition. Aldara should be applied just before bedtime and left on the skin for 6-10 hours. Sufficient cream should be applied to cover the treatment area. Talk to your doctor if your condition re-appears after treatment.

Solar keratosis

If your doctor has prescribed Aldara for the treatment of SK, the usual dosage is once a day, at bedtime, three times a week. For three times a week application, Aldara can be applied, for example, on Monday, Wednesday, and Friday, or Tuesday, Thursday and Saturday.

Your doctor may tell you to continue applying Aldara cream for 4 weeks, followed by a period of 4 weeks without any treatment. Your doctor will then check your skin condition. If any SK lesions remain, the treatment should be repeated for another four weeks.

Alternatively, your doctor may want you to continue applying Aldara cream for up to 16 weeks, Each treatment should continue for no more than 16 weeks at a time.

Superficial basal cell carcinoma

If your doctor has prescribed Aldara for the treatment of sBCC, it should be applied to the affected area once a day at bedtime for five consecutive days per week (Monday to Friday), or as recommended by your doctor.

Treatment should continue for 6 weeks unless your doctor tells you otherwise.

External genital or perianal warts

If your doctor has prescribed Aldara for the treatment of external genital or perianal warts, it is to be applied once a day, at bedtime, three times a week or as recommended by your doctor. For three times a week application, Aldara can be applied on Monday, Wednesday, and Friday; or Tuesday, Thursday and Saturday.

Treatment should continue until the warts are completely gone. Aldara should not be used for more than 16 weeks at a time. It usually takes 8-10 weeks for your warts to disappear but warts may clear as early as 4 weeks. If your warts reappear, talk to your doctor.

If your skin reacts badly to Aldara, your doctor may recommend that you stop treatment for a few days. It is not necessary to make up the doses that you missed or to prolong the treatment period.

How to use it

  • Before applying Aldara, wash your hands and treatment area with mild soap and water and allow it to dry thoroughly. If you are using Aldara pump remove the protective cap and prime several times until cream appears at the nozzle. Alternatively, open a sachet of Aldara and squeeze some cream onto your fingertip;
  • Apply a thin layer of Aldara cream onto the treatment area and rub it gently into the skin until the cream vanishes. For sBCC lesions, enough cream should be applied to cover the lesion and about 1cm of surrounding skin. If using the pump, four actuation of the pump is equivalent to the content of one 250 mg sachet of Aldara cream. One sachet contains enough cream to cover a treatment area of 20 square centimetres (approximately 3 square inches);
  • If using the pump, replace the protective cap back on the pump after application of the cream. Carefully store where children cannot reach it. Wash your hands with mild soap and water. If using the sachet after application of the cream, carefully dispose of the unused Aldara cream in the sachet where children cannot reach it. Once opened, the contents of the pump are to be used within 4 weeks;
  • Leave Aldara cream on the affected area for 6 to 10 hours. Do not shower or bathe during this time;
  • After 6-10 hours, the area where Aldara cream was applied should be washed with mild soap and water.

While you are using it

Do not use more than the recommended amount of Aldara cream. A thin layer that completely covers the treatment area and surrounding skin is enough.

Do not cover the treatment area with bandages or other dressings after you have applied Aldara cream. Cotton gauze dressings are okay to use if needed.

Stop using Aldara cream if you become pregnant, and do not use it if you are breastfeeding.

If you are using Aldara to treat SK

Aldara cream should not be applied in or near the eyes, lips or nostrils.

Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible during treatment with Aldara cream. Wear protective clothing if you go outside during daylight.

New SK lesions may develop during treatment with Aldara cream. These lesions may resolve during the treatment period. Even though the initial SK lesions may clear with treatment, new lesions may develop in the future and require further treatment. Aldara cream is not a cure since SK is considered to be a chronic skin condition.

There is not enough data to support the use of Aldara to treat SK on the hands and arms.

Aldara cream should not be applied to an area greater than 25 square centimetres.

If you are using Aldara to treat sBCC

Aldara cream should not be applied in or near the hairline, eyes, ears, nose or lips.

Do not use sunlamps or tanning beds, and avoid going into the sun as much as possible during treatment with Aldara cream.

Wear protective clothing if you go outside during daylight.

Visit your doctor regularly if you are treating more than one sBCC lesion at the same time.

If you are using Aldara to treat genital warts

Avoid sexual (genital, anal or oral) contact. If you decide to have sexual relations, apply Aldara cream after, not before, sexual activity. If you have already applied the cream, it should be washed off before sexual activity.

Aldara cream may weaken condoms and diaphragms; therefore, the cream should be washed off before using a condom or diaphragm during sexual activity. Alternate forms of contraception should be considered.

The effect of Aldara cream on the transmission of genital warts is not known.

Uncircumcised men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If daily washing under the foreskin is not carried out, tightness of the foreskin may occur. Early signs of tightness include swelling and wearing away of the skin, or difficulty in pulling back the foreskin. If these symptoms occur, stop the treatment immediately and call your doctor.

Female patients should take special care if applying Aldara cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can result in pain or swelling, and may cause difficulty in passing urine.

Do not use Aldara for more than one course if you have problems with your immune system either due to illness or because of the medicines you are already taking. If you think this applies to you, talk to your doctor.

Aldara cream has been prescribed for your use only. Do not give it to anyone else even if you think their condition is the same as yours.

If you forget to use Aldara

If you forget a dose, apply the missed dose of cream as soon as you remember and then continue on the regular schedule. Do not double the dose at any time to make up the missed dose.

After using Aldara

Storage

Aldara cream should be kept in a cool dry place where the temperature stays below 25°C. Do not freeze.

Discard Aldara pump 4 weeks after opening.

Do not store Aldara cream or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

Keep Aldara pump and sachets of Aldara where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Aldara or it has past its expiry date, ask your pharmacist what to do with any that is left over.

Schedule of Aldara

Aldara is an S4 – prescription only medicine.

Side effects of Aldara

All medicines can have side effects and this may occur with the normal use of Aldara. Tell your doctor as soon as possible if you do not feel well while you are using Aldara.

The following effects have occurred during clinical trials with Aldara cream. If the following occur and are severe enough to worry you, tell your doctor:

  • Application site reactions including redness, wearing away of the skin, flakiness, swelling, hardening under the skin, small open sores, crust that forms during healing, small bubbles under the skin, itching, burning, pain, tenderness, irritation, rash, soreness, stinging, sensitivity, skin colour becomes lighter, bleeding, lumps on the skin, infection, and pimples. Most of these skin reactions are mild to moderate and are signs that the product is working. If your skin reacts badly or the skin reaction becomes too uncomfortable when using Aldara cream, wash the cream off with mild soap and water and contact your doctor. Your doctor may recommend that you stop treatment for a few days;
  • Flu symptoms, tiredness, fever, headache, diarrhoea, back pain, muscle pain, and swollen glands in the neck, armpit, and groin.

Some patients have experienced changes in skin colour (lighter or darker) in the area where Aldara cream was applied. These changes may be permanent in some cases.

Please tell your doctor if you experience other side effects or you do not feel well while you are using Aldara.

If you use too much Aldara

Using too much Aldara cream could cause severe skin reactions. If too much cream is applied, simply wash away the extra cream with mild soap and water. When any skin reaction has settled, you may then continue with your treatment.

If the cream is accidentally swallowed, nausea, vomiting, headache, muscle pain, and fever could occur. If you or someone else accidentally swallows Aldara cream, contact your doctor or Poisons Information Centre (in Australia call 131126; in New Zealand call toll-free 0800 POISON or 0800 764 766) or go to the Accident and Emergency department at the nearest hospital.

For further information talk to your doctor.

Imiquimod Topical

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Using too much of this medicine, or using it for too long can increase your risk of severe skin reactions.

Before applying imiquimod topical, wash your hands and wash the skin area to be treated. Allow the skin to dry for at least 10 minutes before applying the medicine. Always wash your hands after applying the medicine also.

Do not use imiquimod topical on areas of broken, wounded, or burned skin. Wait until these conditions have healed before using imiquimod topical.

Imiquimod topical is normally used 2 to 5 times per week for up to 16 weeks. How you use this medication will depend on the condition you are treating. Follow your doctor’s instructions.

Actinic keratosis:

Aldara is usually applied 2 times per week (such as Monday and Thursday, or Tuesday and Friday) for a full 16 weeks. Zyclara is applied once daily for 2 weeks followed by 2 weeks without treatment. Apply the cream to the treatment area in a thin layer, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Superficial basal cell carcinoma:

Usually applied 5 times per week (such as Monday through Friday) for a full 6 weeks. Apply the cream from one imiquimod topical packet to the treatment area and the border of skin around it, and rub in the cream until it disappears. Use the medicine before going to bed and leave it on for 8 hours. In the morning, wash off the medicine with water and a mild soap.

Genital warts:

Usually applied 3 times per week (such as Monday, Wednesday, and Friday) for no longer than 16 weeks. Apply the cream from one imiquimod topical packet to the treatment area, and rub in the cream until it disappears. Do not cover the treated skin areas with any type of plastic bandaging, and avoid nylon underwear. You may wear cotton gauze or underwear over the treated area. Use the medicine before going to bed and leave it on for 6 to 10 hours. Then wash off the medicine with water and a mild soap.

When treating genital warts under the foreskin of an uncircumcised penis, pull back the foreskin and wash it with mild soap and water before applying imiquimod topical. Clean this area daily during treatment.

When treating genital warts around the vagina, avoid getting the cream on the more sensitive inner layers of vaginal tissue. This could result in vaginal swelling or irritation and painful urination.

Imiquimod topical is not a cure for genital warts and it may not keep you from spreading this condition to others through vaginal, anal, or oral sex. You may develop new lesions during treatment with imiquimod topical. For best results, keep using the medicine for the entire length of time prescribed by your doctor.

All conditions:

Your doctor will need to check your skin on a regular basis, especially if you have a more severe skin reaction to the medication. Do not miss any scheduled appointments.

Call your doctor if your skin condition does not improve or if it gets worse during treatment.

Do not use imiquimod topical to treat any skin condition that has not been checked by a doctor. Do not share this medication with anyone else, even if they have the same symptoms you have.

Each packet of imiquimod topical is for a single application only. Throw away the packet after one use, even if there is medicine left in it. If you treat more than one skin area at a time, ask your doctor how many packets to use.

Store at room temperature away from moisture and heat. Do not freeze. Keep each packet unopened until you are ready to use it.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

Skip the missed dose and wait until the next time you are getting ready for bed to use the medicine. Do not use extra medicine to make up the missed dose.

Copyright 1996-2020 Cerner Multum, Inc.

Latest Update: 11/9/2018, Version: 7.03

What should I discuss with my healthcare provider before using imiquimod topical (Aldara, Zyclara, Zyclara Pump)?

Do not use this medicine for genital warts on a child younger than 12 years old. All other uses of this medication are for adults over 18 only.

Tell your doctor if you have ever had:

  • a weak immune system or autoimmune disorder;
  • a sunburn or other skin problems; or
  • graft-versus-host disease.

If you are treating the genital or rectal area, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken rubber condoms or diaphragms, which could break during sex and result in an unplanned pregnancy.

Tell your doctor if you are pregnant or breastfeeding.

How should I use imiquimod topical (Aldara, Zyclara, Zyclara Pump)?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Topical medicine is for use only on the skin.

Using too much imiquimod topical or using it for too long can increase your risk of severe skin reactions. Do not use two different forms of imiquimod topical on the same treatment area.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after applying imiquimod. Also wash the skin to be treated and allow it to dry for at least 10 minutes before applying the medicine.

Apply the cream in a thin layer and rub in completely. Use at bedtime and leave the medicine on for 8 hours. In the morning, wash the skin with water and a mild soap. Do not cover treated skin with any type of plastic bandaging (you may use cotton gauze). Wear only cotton underwear when treating genital warts.

How often and how long you use imiquimod topical will depend on the condition you are treating.

Actinic keratosis:

  • Aldara is usually applied 2 times per week for 16 weeks.
  • Zyclara is usually applied once daily for 2 weeks, followed by 2 weeks without treatment.

Genital warts:

  • Aldara is usually applied 3 times per week for 16 weeks.
  • Zyclara is usually applied once daily for up to 8 weeks.

Superficial basal cell carcinoma:

  • Aldara is usually applied 5 times per week for 6 weeks. Apply the cream to the treatment area and surrounding skin, and rub in completely.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Imiquimod topical is not a cure for genital warts. You may still spread this condition to others through vaginal, anal, or oral sex. You also may develop new lesions during treatment with imiquimod topical.

Call your doctor if the condition you are treating with imiquimod does not improve, or if it gets worse.

Your doctor may tell you to stop using imiquimod topical for several days if you have a skin reaction to this medicine. Even if you have skipped some of your doses, do not add time to the total number of weeks you use imiquimod topical (2 weeks for actinic keratitis, 8 weeks for genital warts).

Your doctor will need to check your skin on a regular basis. If you have superficial basal cell carcinoma, you may need a skin biopsy after you have completed your 5-week treatment with imiquimod topical.

Store at room temperature. Do not freeze. Store the pump in an upright position. Keep each packet unopened until you are ready to use it.

How does this medication work? What will it do for me?

Imiquimod cream belongs to a group of medications called immune response modifiers. It works by stimulating the body’s defenses to fight certain types of skin conditions. Imiquimod cream is used to treat actinic keratosis (AK) on the face or balding scalp in adults. AK is a skin condition that could turn into skin cancer (symptoms include rough, red, scaly patches or lesions, or crusts) that is caused by chronic sun exposure.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

2.5%
Each gram of off-white to faintly yellow cream contains imiquimod 25 mg (2.5%). Nonmedicinal ingredients: isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

3.75%
Each gram of off-white to faintly yellow cream contains imiquimod 37.5 mg (3.75%). Nonmedicinal ingredients: isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.

How should I use this medication?

Before applying the cream, wash your hands with soap and water, gently wash the treatment area with mild soap and water, and allow the skin to dry thoroughly. Apply imiquimod cream to the affected skin area once daily just before going to bed. Do not apply to areas larger than either the face or the balding scalp. Apply a thin layer of this medication onto the clean, dry AK lesion and rub gently into the skin until the cream is absorbed. Avoid contact with eyes, lips, and nostrils. If the cream gets in your eyes, rinse them with large amounts of water. Wash your hands after using the medication. Do not apply an occlusive dressing (one made of airtight material) over this medication.

Leave the medication on the skin area for approximately 8 hours, and then remove it by washing the treated area with mild soap and water. Continue to use this medication for a total of 2 treatment cycles of 2 weeks, separated by a 2-week period with no treatment, or as directed by your doctor. A rest period from medication for several days may be taken depending on your discomfort and the severity of skin reactions, as directed by your doctor. Each treatment cycle should not last longer than 2 weeks even if a rest period is taken.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

This medication is for external use only. Do not take it by mouth.

You may apply up to 2 packets or medication or 2 full actuations of the pump to the treatment area. If you are using the packets, use a new packet for each application. Throw away the remainder of an opened packet each time.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and apply the cream at bedtime the next night. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, prevent it from freezing, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to imiquimod or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • blistering on skin
  • burning or stinging of skin (mild)
  • cracked lips
  • decreased appetite
  • diarrhea
  • dizziness
  • dry skin
  • fatigue
  • flaking or peeling of skin
  • headache
  • lightened or darkened skin colour where skin is treated
  • nausea
  • pain or irritation at the site of application
  • redness of skin (mild)
  • scabbing, crusted skin
  • skin itching
  • swelling of skin (mild)
  • trouble sleeping
  • vomiting

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • any sign or symptom in the treatment area that makes daily activity difficult or impossible
  • any sign or symptom that makes it difficult to continue applying the medication
  • chest pain
  • cold sores
  • flare up of herpes infection
  • flu-like symptoms (e.g., fever or chills, headache, muscle aches, nausea)
  • painful joints
  • rash
  • symptoms of an infection (e.g., coughing, sore throat, muscle or joint pain, swollen glands, fatigue)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • severe diarrhea

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Exposure to sunlight: You should avoid or minimize any exposure to sunlight (including sunlamps) and use protective clothing (such as long sleeves and a hat) during treatment with imiquimod cream due to an increased risk of sunburn. If you get a sunburn, stop using the medication until you are fully recovered.

Immunosuppressed individuals: The safety and effectiveness of imiquimod cream has not been determined for people with medical conditions affecting the immune system (e.g., HIV/AIDS, lupus, psoriasis) or people taking medications that reduce the effectiveness of the immune system. If you have any condition affecting the immune system, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

New actinic keratosis (AK) lesions: During treatment with imiquimod cream, new AK lesions may develop, but may clear with treatment. Even though initial AK lesions disappear with treatment, new lesions may develop in the future and will require further treatment. Keep in mind that AK is considered to be a chronic skin condition, and imiquimod cream is not a cure.

Skin colour changes: Some people using imiquimod cream notice that the area where the cream was applied has become lighter or darker. Sometimes, the change in skin colour is permanent.

Skin reactions: If you experience a severe skin reaction to this cream, wash the area with mild soap and water. Once the reaction has cleared, start using the cream again, unless your doctor has told you to stop using it.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if imiquimod passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between imiquimod and any of the following:

  • corticosteroids (e.g., prednisone)
  • echinacea
  • leflunomide
  • live vaccines (e.g., BCG, yellow fever)
  • medications that suppress the immune system (such as medications for cancer or organ transplants, e.g., tacrolimus, cyclosporine, methotrexate)
  • natalizumab
  • pimecrolimus
  • other medications applied to the skin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Zyclara

About imiquimod cream

Type of medicine An immunomodulator
Used for Anogenital warts; basal cell carcinoma; actinic keratosis
Also called Aldara®; Zyclara®
Available as Cream supplied in individual sachets

You will have been prescribed imiquimod to treat one of three different skin conditions. It is used to remove anogenital warts, or for a kind of sun damage called actinic keratosis, or for a type of skin cancer called basal cell carcinoma. It works with your body’s immune system to help it fight damage to the skin. There are two strengths of cream available – 3.75% (brand name Zyclara®) and 5% (brand name Aldara®).

Anogenital warts are caused by the human papillomavirus (HPV) which can be passed on by close sexual contact. They are small lumps that develop on the genitals and around the back passage (anus).

Actinic keratoses (also known as solar keratoses) are small, thickened, scaly growths which develop on the skin. They usually develop on areas of skin which have received a lot of sun exposure over a period of time.

Basal cell carcinoma is a common skin cancer which typically develops on sun-exposed areas of the skin such as the head and neck.

Before using imiquimod cream

To make sure this is the right treatment for you, before you start using imiquimod cream it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have ever had a problem with your immune system. For example, let your doctor know if you know you are immunosuppressed or if you have an autoimmune disease.
  • If you are a male using this cream for genital warts and you have not been circumcised.
  • If you have ever had an allergic reaction to a medicine.
  • If you are taking or using any other medicines. This includes any medicines you have bought without a prescription, as well as herbal and complementary medicines.

How to use imiquimod cream

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack and any additional information you are given by your doctor. These will give you more information about how to use imiquimod cream and will provide you with a full list of the side-effects which you may experience from using it.
  • Follow the instructions carefully when you are applying the cream and do not apply more than the recommended amount. You will be told how often to apply the cream and how long to use it for – this will depend upon the reason why you are using the cream. The directions will also be printed on the label of the pack to remind you what the doctor said to you. It is important that you read the label carefully. If you are prescribed Aldara®, you will be asked to apply the cream either on three nights a week, or on five nights a week. If you are prescribed Zyclara® you will be asked to apply the cream every night of the week. You should always apply the cream at bedtime.
  • Wash your hands and the area to be treated with mild soap and water before applying the cream. Make sure your skin is dry before you apply the cream.
  • Apply a thin layer of cream to the affected area, and gently rub it in until the cream is absorbed into the skin. Wash your hands again after applying the cream. Only use each sachet once – do not keep opened sachets to use later.
  • The following morning, it is important that you wash the treated area with mild soap and water to remove any traces of the cream.
  • If you forget to apply the cream on your usual day, use it on the next night and then continue with your regular schedule. Never apply the cream more than once a day.
  • Do not apply the cream to any broken or irritated areas of your skin, and try to avoid the cream coming into contact with your eyes or lips, or the insides of your nostrils. If this does happen by accident, wash it off with warm water as soon as possible. Do not cover any treated areas with bandages or dressings.
  • As the cream begins to work, the area of skin being treated may become red, sore and swollen. It is also likely to look different to the surrounding areas of healthy skin. This is to be expected. However, if you are concerned that your skin is reacting badly, or if you feel unwell in yourself, check again with your doctor.
  • A course of treatment typically lasts for 2-6 weeks. Your doctor may check your skin a few weeks after you’ve finished applying the cream to decide if a further course of treatment will be necessary for you.

Getting the most from your treatment

If you are using imiquimod for anal or genital warts

  • Be careful to apply the cream only to the wart. If the cream spreads on to normal skin it can cause skin reactions such as redness, swelling, flaking and irritation.
  • When you have anogenital warts you will usually be advised to have tests to check for other sexually transmitted infections. Your doctor or clinic will arrange these for you.
  • Sexual contact is not generally recommended while you are treating anogenital warts. You should ideally wait until your warts have gone and your skin has healed. If you do have sex, use a condom and do not apply imiquimod cream beforehand as the cream can damage latex condoms and diaphragms.
  • Treatment usually continues until the warts have cleared. If the area has still not cleared after 16 weeks of using the cream, you must stop using imiquimod and see your doctor for further advice.
  • Never use wart treatments that are sold over the counter in pharmacies to treat your anogenital warts.

If you are using imiquimod for actinic keratosis or basal cell carcinoma

  • Some people find using a moisturiser (an emollient) on the skin around the damaged areas helps to keep the skin supple and moist. Moisturisers can be applied several times a day if required.
  • There is some general advice which will help prevent any further sun damage to your skin. Avoid being out in the sun between 11 am and 3 pm. Always use a broad-spectrum sunscreen with an SPF of 30 or higher, and which protects against both UVB and UVA light. Apply plenty of the sunscreen and re-apply it regularly, particularly after swimming and if you are sweating a lot. Do not use sunbeds.
  • Check your skin regularly and tell a doctor if you notice any changes, such as new moles, small dark patches developing, or a change in an existing mole. When you have had a lot of sun exposure, your risk of developing other skin problems is increased.

Can imiquimod cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with imiquimod cream. You will find a full list in the manufacturer’s information leaflet supplied with the cream. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common imiquimod side-effects What can I do if I experience this?
Skin irritation such as itching, pain, rash, swelling, ulceration or scabbing If this becomes severe, allow your skin to recover before you use the cream again. If it continues to be troublesome, ask your doctor for advice
Headache, flu-like symptoms, muscle aches and pains Ask your pharmacist to recommend a suitable painkiller
Feeling tired or feeling sick (nausea) If this continues or becomes troublesome, speak with your doctor

If you experience any other symptoms which you think may be due to the cream, speak with your doctor or pharmacist for further advice.

How to store imiquimod cream

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Make sure that the person supplying this medicine knows about any other medicines that you are using. This includes medicines you buy and herbal and homeopathic medicines.

If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are using.

This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.

This preparation is for use on the skin only. If you suspect that someone has swallowed some of it, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

General cancer information

Imiquimod cream is a cancer treatment and is also known by its brand name, Aldara.

It is a treatment for:

  • basal cell skin cancer (BCC)
  • a skin condition called actinic (solar) keratosis

Basal cell skin cancer (BCC)

Imiquimod cream is approved in the UK for the treatment of superficial basal cell skin cancers measuring up to 2cm across. It can be used on your chest, neck, arms or legs (including hands and feet). It is not approved for a type of BCC called nodular BCC.

Actinic (solar) keratosis

This skin condition might develop into squamous cell skin cancer, so it is usually treated.

Melanoma

Occasionally, imiquimod is used as a treatment for melanoma skin cancer.

How it works

Imiquimod cream uses your body’s natural defences to help kill the skin cancer cells. It works by releasing a number of chemicals called cytokines. One of these cytokines is called interferon.

Interferon is a protein that the body makes as part of the immune response. Interferon is also used as a cancer treatment. It is thought that imiquimod makes cells produce more interferon which destroys the skin cancer cells.

When you have it

To treat BCC, you usually put imiquimod cream on to the affected area once a day, 5 days a week for 6 weeks. You usually leave the cream on the skin for about 8 hours. You shouldn’t shower or bathe during this time.

Side effects

We haven’t listed all the side effects. It’s very unlikely that you will have all of these side effects, but you might have some of them at the same time.

How often and how severe the side effects are can vary from person to person. They also depend on what other treatments you’re having. For example, your side effects could be worse if you’re also having other drugs or radiotherapy.

When to contact your team

Your doctor, nurse or pharmacist will go through the possible side effects. They will monitor you closely during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse

Early treatment can help manage side effects better.

Contact your doctor or nurse immediately if you have signs of infection, including a temperature above 37.5C or below 36C.

Common side effect

This side effect can happen in more than 10 in 100 people (10%).

Itchy skin

You can get itchy skin in the treatment area soon after starting this treatment.

Let your doctor or nurse know if you have this.

Occasional side effects

These side effects happen in between 1 and 10 out of every 100 people (1 to 10%). You might have one or more of them. They include:

  • infections
  • pustules – small bumps on the skin that contain fluid or pus
  • enlarged lymph nodes
  • back pain
  • problems at the application site including pain, redness, rash, burning, bleeding, tingling, prickling, bumps

Rare side effects

These side effects happen in fewer than 1 in 100 people (1%). You might have one or more of them. They include:

  • feeling moody and irritable
  • feeling sick
  • dry mouth
  • inflammation of the skin
  • flu like symptoms
  • at the site of application swelling, leaking fluid, inflammation, scabs, small cyts, breakdown of the skin
  • tiredness and lacking energy

Coping with side effects

We have more information about side effects and tips on how to cope with them.

What else do I need to know?

Other medicines, food and drink

Cancer drugs can interact with some other medicines and herbal products. Tell your doctor or pharmacist about any medicines you are taking. This includes vitamins, herbal supplements and over the counter remedies.

Contraception and pregnancy

It is not known if this treatment can harm a developing baby in the womb. Talk to your doctor or nurse about effective contraception.

Breastfeeding

It is not known whether this drug comes through into the breast milk. Doctors usually advise that you don’t breastfeed during this treatment.

Treatment for other conditions

Always tell other doctors, nurses, pharmacists or dentists that you’re having this treatment if you need treatment for anything else, including teeth problems.

Immunisations

Don’t have immunisations with live vaccines while you’re having treatment and for up to 12 months afterwards. The length of time depends on the treatment you are having. Ask your doctor or pharmacist how long you should avoid live vaccinations.

In the UK, live vaccines include rubella, mumps, measles, BCG, yellow fever and the shingles vaccine (Zostavax).

You can:

  • have other vaccines, but they might not give you as much protection as usual
  • have the flu vaccine (as an injection)
  • be in contact with other people who have had live vaccines as injections

Avoid close contact with people who have recently had live vaccines taken by mouth (oral vaccines) such as oral polio or the typhoid vaccine.

This also includes the rotavirus vaccine given to babies. The virus is in the baby’s poo for up to 2 weeks and could make you ill. So avoid changing their nappies for 2 weeks after their vaccination if possible. Or wear disposable gloves and wash your hands well afterwards.

You should also avoid close contact with children who have had the flu vaccine nasal spray if your immune system is severely weakened.

More information about this treatment

For further information about this treatment go to the electronic Medicines Compendium (eMC) website.

You can report any side effect you have to the Medicines Health and Regulatory Authority (MHRA) as part of their Yellow Card Scheme.

Aldara Side Effects

Generic Name: imiquimod topical

Medically reviewed by Drugs.com. Last updated on Dec 10, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about imiquimod topical. Some of the dosage forms listed on this page may not apply to the brand name Aldara.

In Summary

Common side effects of Aldara include: dermal ulcer, abrasion, application site reaction, burning sensation, desquamation, edema, exfoliation of skin, pruritus, skin erosion, and erythema of skin. Other side effects include: back pain, headache, and pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to imiquimod topical: topical cream

Along with its needed effects, imiquimod topical (the active ingredient contained in Aldara) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking imiquimod topical:

More common

  • Blisters on the skin
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • itching in the genital or other skin areas
  • loss of voice
  • open sores or scabs on the skin
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin (severe)
  • scaling
  • shortness of breath or troubled breathing
  • skin rash
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness

Less common

  • Abdominal or stomach pain
  • ankle, knee, or great toe joint pain
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • cold flu-like symptoms
  • difficult, burning, or painful urination
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • frequent urge to urinate
  • hoarseness
  • joint stiffness or swelling
  • lower back or side pain
  • lump in the abdomen or stomach
  • nervousness
  • persistent non-healing sore
  • pink growth on the skin
  • pounding in the ears
  • reddish patch or irritated area
  • severe headache
  • shiny bump on the skin
  • slow or fast heartbeat
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • white, yellow or waxy scar-like area

Incidence not known

  • Blue lips and fingernails
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • dilated neck veins
  • extreme fatigue
  • fast, irregular, or pounding heartbeat
  • headache
  • irregular breathing
  • nausea or vomiting
  • pain in the shoulders, arms, jaw, or neck
  • slurred speech
  • sudden and severe inability to speak
  • suicide
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • temporary blindness
  • weakness in the arm or leg on one side of the body
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking imiquimod topical:

Symptoms of overdose

  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Some side effects of imiquimod topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Burning or stinging of the skin (mild)
  • flaking of the skin
  • mild headache
  • pain, soreness, or tenderness of the skin (mild)
  • rash
  • redness of the skin (mild)
  • swelling at place of application

Less common

  • Back pain
  • lightening of the treated skin

For Healthcare Professionals

Applies to imiquimod topical: topical cream

General

Local

Common (1% to 10%): Application site irritation, application site swelling, application site rash, application site bleeding, application site papules, application site paresthesia, application site stinging sensation, application site tenderness

Uncommon (0.1% to 1%): Application site dermatitis, application site hyperesthesia, application site inflammation, application site scar, application site skin breakdown, application site warmth

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15%)

Common (1% to 10%): Sinusitis

Uncommon (0.1% to 1%): Nasal congestion, pharyngolaryngeal pain, rhinitis, pharyngitis

Immunologic

Rare (less than 0.1%): Autoimmune condition exacerbated

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Lethargy, paresthesia, migraine, somnolence

Other

Very common (10% or more): Edema (up to 71%)

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, chelitis, vomiting

Uncommon (0.1% to 1%): Dry mouth, abdominal pain, rectal disorder, rectal tenesmus

Oncologic

Common (1% to 10%): Carcinoma squamous

Hematologic

Common (1% to 10%): Lymphadenopathy

Frequency not reported: Hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, platelet count decreased

Cardiovascular

Common (1% to 10%): Atrial fibrillation

Uncommon (0.1% to 1%): Flushing

Dermatologic

Common (1% to 10%): Dermatitis

Frequency not reported: Skin infection, alopecia, erythema multiforme, Stevens-Johnson syndrome, skin hyperpigmentation, cutaneous lupus erythematosus

Musculoskeletal

Common (1% to 10%): Myalgia, arthralgia, back pain

Uncommon (0.1% to 1%): Pain in extremity

Genitourinary

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Depression, irritability

Ocular

Uncommon (0.1% to 1%): Conjunctival irritation, eyelid edema

Metabolic

Common (1% to 10%): Anorexia, blood glucose increased

Hepatic

Frequency not reported: Hepatic enzyme increased

Endocrine

Postmarketing reports: Thyroiditis

1. “Product Information. Aldara (imiquimod topical).” 3M Pharmaceuticals, St. Paul, MN.

2. “Product Information. Zyclara (imiquimod topical).” Medicis Pharmaceutical Corporation, Scottsdale, AZ.

3. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

4. Cerner Multum, Inc. “Australian Product Information.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Related questions

  • What are the side effects of the HPV vaccine?

Medical Disclaimer

More about Aldara (imiquimod topical)

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  • Drug class: topical anti-infectives

Consumer resources

  • Aldara
  • Aldara Topical (Advanced Reading)

Other brands: Zyclara

Professional resources

  • Aldara (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Keratosis
  • Basal Cell Carcinoma
  • Human Papilloma Virus
  • Condylomata Acuminata
  • Molluscum Contagiosum

SIDE EFFECTS

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.

Clinical Trials Experience

Actinic Keratosis

The data described below reflect exposure to Aldara Cream or vehicle in 436 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle to a 25 cm2 contiguous treatment area on the face or scalp 2 times per week for 16 weeks.

Table 2: Selected Adverse Reactions Occurring in > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

Table 3: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Actinic Keratosis)

Local skin reactions were collected independently of the adverse reaction “application site reaction” in an effort to provide a better picture of the specific types of local reactions that might be seen. The most frequently reported local skin reactions were erythema, flaking/scaling/dryness, and scabbing/crusting. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 4: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Actinic Keratosis)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions. Overall, in the clinical studies, 2% (5/215) of subjects discontinued for local skin/application site reactions. Of the 215 subjects treated, 35 subjects (16%) on Aldara Cream and 3 of 220 subjects (1%) on vehicle cream had at least one rest period. Of these Aldara Cream subjects, 32 (91%) resumed therapy after a rest period.

In the AK studies, 22 of 678 (3.2%) of Aldara-treated subjects developed treatment site infections that required a rest period off Aldara Cream and were treated with antibiotics (19 with oral and 3 with topical).

Of the 206 Aldara subjects with both baseline and 8-week post-treatment scarring assessments, 6 (2.9%) had a greater degree of scarring scores at 8-weeks post-treatment than at baseline.

Superficial Basal Cell Carcinoma

The data described below reflect exposure to Aldara Cream or vehicle in 364 subjects enrolled in two double-blind, vehicle-controlled studies. Subjects applied Aldara Cream or vehicle 5 times per week for 6 weeks. The incidence of adverse reactions reported by > 1% of subjects during the studies is summarized below.

Table 5: Selected Adverse Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

The most frequently reported adverse reactions were local skin and application site reactions including erythema, edema, induration, erosion, flaking/scaling, scabbing/crusting, itching and burning at the application site. The incidence of application site reactions reported by > 1% of the subjects during the 6 week treatment period is summarized in Table 6.

Table 6: Application Site Reactions Reported by > 1% of Aldara-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (Superficial Basal Cell Carcinoma)

Local skin reactions were collected independently of the adverse reaction “application site reaction” in an effort to provide a better picture of the specific types of local reactions that might be seen. The prevalence and severity of local skin reactions that occurred during controlled studies are shown in the following table.

Table 7: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (Superficial Basal Cell Carcinoma)

The adverse reactions that most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study) were local skin and application site reactions; 10% (19/185) of subjects received rest periods. The average number of doses not received per subject due to rest periods was 7 doses with a range of 2 to 22 doses; 79% of subjects (15/19) resumed therapy after a rest period. Overall, in the clinical studies, 2% (4/185) of subjects discontinued for local skin/application site reactions.

In the sBCC studies, 17 of 1266 (1.3%) Aldara-treated subjects developed treatment site infections that required a rest period and treatment with antibiotics.

External Genital Warts

In controlled clinical trials for genital warts, the most frequently reported adverse reactions were local skin and application site reactions.

Some subjects also reported systemic reactions. Overall, 1.2% (4/327) of the subjects discontinued due to local skin/application site reactions. The incidence and severity of local skin reactions during controlled clinical trials are shown in Table 8.

Table 8: Local Skin Reactions in the Treatment Area as Assessed by the Investigator (External Genital Warts)

Selected adverse reactions judged to be probably or possibly related to Aldara Cream are listed below.

Table 9: Selected Treatment Related Reactions (External Genital Warts)

Adverse reactions judged to be possibly or probably related to Aldara Cream and reported by more than 1% of subjects included:

Application Site Disorders: burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, tenderness

Remote Site Reactions: bleeding, burning, itching, pain, tenderness, tinea cruris.

Body as a Whole: fatigue, fever, influenza-like symptoms

Central and Peripheral Nervous System Disorders: headache

Gastro-Intestinal System Disorders diarrhea

Musculo-Skeletal System Disorders: myalgia

Dermal Safety Studies

Provocative repeat insult patch test studies involving induction and challenge phases produced no evidence that Aldara Cream causes photoallergenicity or contact sensitization in healthy skin; however, cumulative irritancy testing revealed the potential for Aldara Cream to cause irritation, and application site reactions were reported in the clinical studies .

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Aldara Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Application Site Disorders: tingling at the application site

Body as a Whole: angioedema

Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope

Endocrine: thyroiditis

Gastro-Intestinal System Disorders: abdominal pain

Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma

Hepatic: abnormal liver function

Infections and Infestations: herpes simplex

Musculo-Skeletal System Disorders: arthralgia

Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide

Respiratory: dyspnea

Urinary System Disorders: proteinuria, dysuria, urinary retention

Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar

Vascular: Henoch-Schönlein purpura syndrome

Read the entire FDA prescribing information for Aldara (Imiquimod)

Imiquimod

What is imiquimod?

Imiquimod is an immune response modifier. It is manufactured as a 5% (50 mg/g) cream called Aldara™. Generic forms of imiquimod cream are also available. The Perrigo brand is funded by PHARMAC in New Zealand (2019).

A 3.75% cream called Zyclara™ has also been approved by the FDA in the USA but is not yet available in New Zealand (March 2017).

What is imiquimod used for?

Imiquimod is mainly used to treat:

  • Actinic keratoses (also called solar keratoses or AKs).
  • Basal cell carcinoma (BCC), especially superficial BCC and sometimes low-risk nodular BCC
  • Intraepidermal carcinoma (also known as Bowen disease, or in-situ squamous cell carcinoma (SCC)), an unregistered indication at this time (June 2016)

It was first approved for use in genital warts. It may also be helpful in the unapproved treatment of common warts (once they have been thinned down by other means), plane warts, and herpes simplex. Experimentally it has been successful in reducing some keloid scars, granuloma annulare, vitiligo, melanoma in situ (lentigo maligna type) and, in combination with diphencyprone, metastatic melanoma (see topical and intralesional immunotherapy for melanoma.

Although sometimes prescribed for molluscum contagiosum, clinical trials have not shown imiquimod to be of benefit.

Before starting, a biopsy may be performed to confirm the diagnosis. Imiquimod is particularly useful in areas where surgery or other treatments may be difficult, complicated or otherwise undesirable, especially the face and lower legs.

How does imiquimod work?

Imiquimod works by stimulating the immune system to release a number of chemicals called cytokines, which are important in fighting viruses and destroying cancer cells.

When used to treat skin cancers and pre-cancerous lesions it results in inflammation, which destroys the lesion. The degree of inflammation is quite variable from person to person, in part due to the type of skin lesion and in part due to genetic factors. The imiquimod is taken up by the so-called ‘toll-like receptor 7’ on certain immune cells that are found in the outside part of the skin (the epidermis); these receptors are expressed more in some individuals and in some skin lesions than in others.

Treatment regimes for imiquimod cream

Various imiquimod treatment regimes are used. For example:

  • Actinic keratoses: imiquimod is typically used two or three times weekly for four to six weeks, repeated if necessary after a break of four weeks. Very scaly lesions should be frozen with liquid nitrogen about three weeks before starting imiquimod.
  • Basal cell carcinomas and intraepidermal carcinoma: imiquimod is used five times weekly for six weeks.
  • Genital warts: imiquimod is used three times weekly; or, if available, 3.75% cream daily; until total clearance or for up to 8 weeks.
  • (Off label) lentigo maligna: imiquimod is used three to seven times per week for six to 16 weeks. Close follow-up is essential.

The imiquimod should be applied less often if the reaction is excessive, and more often if no reaction occurs (perhaps accompanied by a topical retinoid to enhance absorption of imiquimod into the skin). The course can be repeated, and treatment is sometimes continued for up to 16 weeks.

Treatment should be carefully monitored, because the cream may need to be applied more or less frequently than originally planned or for a shorter or longer course, depending on response. Once the inflammation has settled there is generally a good or excellent cosmetic result with little scarring.

The 5% product is supplied either as a box of sachets, each containing 250 mg, or as a pump-pack (2 g). Wash hands before and after applying imiquimod cream.

Cut the top off the sachet or pierce the sachet with a needle and squeeze out a tiny amount of cream onto your fingertip. If using the pump pack, remove the protective cap and prime several times before pressing the pump once only to dispense the cream. Apply the cream to the affected areas.

Although the information on the packet states that the sachet is for single-use, some people seal it using a paper clip or tape and store it in a closed container to prevent the cream drying out.

Imiquimod is usually used during the winter months but, as it is not photosensitising, it may be used at any time of year. Sun protection with clothing and sunscreen can continue as usual.

Imiquimod in the genital area should be washed off before having sexual intercourse. It can weaken rubber condoms.

What to expect from imiquimod cream

Areas treated with imiquimod will become inflamed. The effects include itching, burning, redness, ulceration (sores), scabbing, flaking and pain. These reactions indicate that the cream is likely to be effective – if there is no inflammation, imiquimod is unlikely to clear the lesions. An exaggerated response may clear the skin lesion sooner than expected — sometimes after as few as three or four applications. In some patients, surrounding untreated areas also become inflamed but this will settle when treatment is discontinued.

If black scabs and ulceration occur or there are severe systemic symptoms, the cream should be discontinued.

Effect of imiquimod

More images of the effect of imiquimod.

Systemic side effects from imiquimod cream

When using imiquimod cream, ‘flu-like symptoms may develop, such as fever, fatigue, headache, nausea, diarrhoea and muscle pain. These are generally mild and may be treated with paracetamol. Side effects should resolve within a few days of stopping treatment. They may also resolve with continuing treatment.

New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

Imiquimod topical

Generic Name: imiquimod topical (i MI kwi mod TOP ik al)
Brand Name: Aldara, Zyclara, Zyclara Pump

Medically reviewed by Drugs.com on May 29, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is imiquimod topical?

Imiquimod topical (for the skin) is used to treat actinic keratosis (a condition caused by too much sun exposure) on the face and scalp.

Imiquimod topical also treats genital warts on the outside of the body, in adults and children at least 12 years old. imiquimod topical is not a cure for genital warts.

Imiquimod topical is also used to treat a minor form of skin cancer called superficial basal cell carcinoma, when surgery would not be an appropriate treatment.

Imiquimod topical may also be used for purposes not listed in this medication guide.

Important Information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Do not use imiquimod topical for genital warts on a child younger than 12 years old. All other uses of this medication are for adults over 18 only.

Tell your doctor if you have ever had:

  • a weak immune system or autoimmune disorder;

  • a sunburn or other skin problems; or

  • graft-versus-host disease.

If you are treating the genital or rectal area, avoid sexual activity while the medicine is on your skin. Imiquimod topical can weaken rubber condoms or diaphragms, which could break during sex and result in an unplanned pregnancy.

Tell your doctor if you are pregnant or breastfeeding.

What happens if I miss a dose?

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe skin irritation, feeling light-headed, or fainting.

What should I avoid while using imiquimod topical?

Avoid swimming or taking a bath or shower while the medicine is on your skin.

Avoid using imiquimod on open wounds or on skin that has not yet healed from surgery or other medical treatment.

Avoid getting imiquimod topical in your eyes, nose, mouth, vagina, or rectum. If contact does occur, rinse with water.

Avoid exposure to sunlight or tanning beds. Imiquimod topical can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Imiquimod will not protect against sexually transmitted diseases, including genital warts, chlamydia, gonorrhea, herpes, HIV, syphilis, and trichomoniasis. Talk with your doctor about safer sex practices.

Do not use imiquimod to treat any condition that has not been checked by your doctor. Do not share this medicine with another person, even if they have the same symptoms you have.

Imiquimod topical side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine was applied.

When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Call your doctor at once if you have:

  • flu-like symptoms such as fever, chills, nausea, tiredness, body aches, or swollen glands;

  • bleeding or swelling where you applied this medicine; or

  • symptoms of herpes zoster (shingles)–skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common side effects may include:

  • minor skin pain, irritation, itching, redness, dryness, flaking, scabbing, crusting, scaling, or swelling where the medicine was applied;

  • changes in the color of treated skin (may be permanent);

  • headache;

  • tiredness; or

  • nausea.

What other drugs will affect imiquimod topical?

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 8.01.

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Imiquimod Side Effects

Visit your health care professional for regular checks on your progress.

Do not use this medicine until the skin has healed from any other drug (example: podofilox or podophyllin resin) or surgical skin treatment.

Females should receive regular pelvic exams while being treated for genital warts. Most patients see improvement within 4 weeks. It may take up to 16 weeks to see a full clearing of the warts. This medicine is not a cure. New warts may develop during or after treatment. Avoid sexual (genital, anal, oral) contact while the cream is on the skin. If warts are visible in the genital area, sexual contact should be avoided until the warts are treated. The use of latex condoms during sexual contact may reduce, but not entirely prevent, infecting others. This medicine may weaken condoms, diaphragms, cervical caps or other barrier devices and make them less effective as birth control. Do not cover the treated area with an airtight bandage. Cotton gauze dressings can be used. Cotton underwear can be worn after using this medicine on the genital or anal area.

Actinic keratoses that were not seen before may appear during treatment and may later go away. The treatment area and surrounding area may lighten or darken after treatment with this medicine. These skin color changes may be permanent in some patients.

If you experience a skin reaction at the treatment site that interferes or prevents you from doing any daily activity, contact your health care provider. You may need a rest period from treatment. Treatment may be restarted once the reaction has gotten better as recommended by your doctor or health care professional.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

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