Aldara Side Effects

Generic name: imiquimod topical

Medically reviewed by Drugs.com. Last updated on Oct 14, 2024.

Note: This document provides detailed information about Aldara.

Applies to imiquimod topical: topical cream Side Effects associated with imiquimod topical. Some dosage forms listed on this page may not apply specifically to the brand name Aldara.

Applies to imiquimod topical: topical cream.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits for any unwanted effects that may be caused by this medicine.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, pain, redness, swelling, bleeding, oozing, scabbing, or peeling on the skin where the medicine was applied.

Stop using this medicine and check with your doctor right away if you have severe swelling near the opening of the vagina. This may cause painful urination, trouble in passing urine, or not able to urinate.

Stop using this medicine and check with your doctor right away if you or your child have severe skin irritation or flu-like symptoms, such as diarrhea, fever, chills, headache, nausea, muscle or joint pain, or unusual tiredness or weakness.

Avoid exposing your skin to sunlight, sunlamps, or tanning beds while you are using this medicine. Always use sunscreen or sun-blocking lotions and wear protective clothing and hats.

If you are being treated for external warts, avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the cream off your skin before you engage in any sexual activity. The medicine contains oils that can weaken latex (rubber) condoms and diaphragms, which will prevent them from working properly.

Imiquimod is not a cure for genital warts. New warts may develop while you are using the cream. Imiquimod will also not keep you from spreading genital warts to other people.

Do not use cosmetics or any other skin care products on the treated areas, unless directed to do so by your doctor.

Serious side effects of Aldara

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:

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

Other side effects of Aldara

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:

For healthcare professionals

Applies to imiquimod topical: topical cream.

General adverse events

The most frequently reported side effects are local skin reactions (e.g., erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, and erosion/ulceration), headache, application site reactions, influenza-like illness, fatigue, nausea, and fever.^[Ref]

Local

• Very common (10% or more): Induration (78%), application site reaction (up to 33%), application site application site vesicles (up to 29%), pruritus/itching (up to 26.4%), application site burning (up to 16.1%), application site erythema, application site scabbing, application site exfoliation, application site dryness, application site edema, application site ulcer, application site discharge, application site pain
• 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^[Ref]

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^[Ref]

Immunologic

• Rare (less than 0.1%): Autoimmune condition exacerbated^[Ref]

Nervous system

• Common (1% to 10%): Headache, dizziness
• Uncommon (0.1% to 1%): Lethargy, paresthesia, migraine, somnolence^[Ref]

Other

• Very common (10% or more): Edema (up to 71%)
• Common (1% to 10%): Fatigue, pyrexia, herpes simplex, pain, chest pain, influenza-like illness, infection, pustule, viral infection
• Uncommon (0.1% to 1%): Face edema, asthenia, chills, discomfort, inflammation, bacterial infection, fungal infection, tinnitus, rigors, malaise^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea, chelitis, vomiting
• Uncommon (0.1% to 1%): Dry mouth, abdominal pain, rectal disorder, rectal tenesmus^[Ref]

Oncologic

• Common (1% to 10%): Carcinoma squamous^[Ref]

Hematologic

• Common (1% to 10%): Lymphadenopathy
• Frequency not reported: Hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, platelet count decreased^[Ref]

Cardiovascular

• Common (1% to 10%): Atrial fibrillation
• Uncommon (0.1% to 1%): Flushing^[Ref]

Dermatologic

• Very common (10% or more): Excoriation/flaking/scaling/dryness (up to 87%), erythema (up to 69%), scab/crusting (up to 64%), erosion/ulceration (up to 54%), skin exfoliation, skin edema, skin ulcer, skin hypopigmentation
• Common (1% to 10%): Dermatitis
• Uncommon (0.1% to 1%): Pruritus, folliculitis, rash erythematous, eczema, rash, sweating increased, urticaria, actinic keratosis
• Frequency not reported: Skin infection, alopecia, erythema multiforme, Stevens-Johnson syndrome, skin hyperpigmentation, cutaneous lupus erythematosus^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia, arthralgia, back pain
• Uncommon (0.1% to 1%): Pain in extremity^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Genital candidiasis, vaginitis, vulvitis, dysuria, male genital pain, penile disorder, dyspareunia, erectile dysfunction, uterovaginal prolapse, vaginal pain, vaginitis atrophic, vulval disorder^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia
• Uncommon (0.1% to 1%): Depression, irritability^[Ref]

Ocular

• Uncommon (0.1% to 1%): Conjunctival irritation, eyelid edema^[Ref]

Metabolic

• Common (1% to 10%): Anorexia, blood glucose increased^[Ref]

Hepatic

• Frequency not reported: Hepatic enzyme increased^[Ref]

Endocrine

• Postmarketing reports: Thyroiditis^[Ref]

See also:

Frequently asked questions

• What are the most common skin conditions? (with photos)
• Does duct tape really remove warts?
• Is imiquimod the same as Aldara?
• How long does it take Aldara burns/scabs to heal?
• How effective is Aldara for genital warts?
• How do I know if Aldara is working for skin cancer?
• What are the side effects of the HPV vaccine?

Further information

Aldara side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer