Aldara Side Effects

Generic name: imiquimod topical

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.

Some side effects of Aldara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to imiquimod topical: topical cream

Get emergency medical help if you have any of these signs of an allergic reaction while taking imiquimod topical (the active ingredient contained in Aldara) hives; difficulty 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 is applied.

Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands.

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.

Less serious side effects of imiquimod topical may include:

• mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;

• changes in the color of treated skin;

• headache, dizziness, chest pain, back pain;

• cold sores, fever blisters;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• nausea, diarrhea, loss of appetite; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to imiquimod topical: topical cream

General

In general, the side effects associated with imiquimod topical (the active ingredient contained in Aldara) may vary depending on the condition being treated.

Local

Local side effects have included application site reaction (up to 33%), application site pain (up to 7%), application site irritation (up to 6%), application site pruritus (up to 4%), application site bleeding, application site swelling, treatment site infection, scarring, application site rash, application site cellulitis, and application site excoriation. Local skin reactions have included erythema (all grades: up to 100%; severe: up to 31%), scabbing/crusting (all grades: up to 93%; severe: up to 19%), flaking/scaling/dryness (all grades: up to 93%; severe: up to 8%), flaking/scaling (all grades: 91% ; severe: 4%), induration (all grades: up to 84% ; severe: up to 6%), edema (all grades: up to 78%; severe: up to 7%), erosion (all grades: up to 66% ; severe: up to 14%), erosion/ulceration (all grades: up to 62%; severe: up to 13%), exudate (all grades: up to 51%; severe: 6%), ulceration (all grades: up to 40% ; severe: up to 6%), weeping/exudate (all grades: up to 22%), vesicles (all grades: up to 31%; severe: up to 2%), excoriation/flaking (all grades: up to 26%; severe: up to 1%), and scabbing (all grades: up to 13%). Application site reactions have included itching (up to 20%), burning (6%), bleeding (up to 3%), stinging (3%), pain (3%), erythema (2%), papule(s) (2%), induration (2%), tenderness (up to 2%), irritation (2%), and infection (1%). Application site disorders reported in more than 1% of patients have included burning, hypopigmentation, rash, sensitivity, soreness, stinging, and tenderness. Itching (32% in females, 22% in males), burning (26% in females, 9% in males), pain (8% in females, 2% in males), and soreness (3% in females) were reported at the wart site. Tingling at the application site has been reported during postmarketing experience.

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from a study.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).

Flaking/scaling was reported in 40% of males and 26% of females and scabbing/crusting was reported in 34% of males and 18% of females; otherwise, frequency and severity of local skin reactions were similar in both genders.

Respiratory

Respiratory side effects have included upper respiratory tract infection (up to 15%), sinusitis (up to 7%), rhinitis (3%), coughing (2%), and pharyngitis (1%). Pulmonary congestion and bronchitis have been reported. Dyspnea and pulmonary edema have been reported during postmarketing experience.

Immunologic

Immunologic side effects have included fungal infection (11% in females, 2% in males), herpes simplex (up to 3%), oral herpes (up to 3%), viral infection (1%), herpes zoster, and infection. Herpes simplex has also been reported during postmarketing experience.

Nervous system

Two cases involving the development of chronic neuropathic pain following initiation of imiquimod topical (the active ingredient contained in Aldara) therapy for the treatment of warts have been reported. In the first case, a 53-year-old man with genital warts reported an erosion with substantial pain on the left lateral glans of the penis approximately 1 week following initiation of therapy with imiquimod applied topically 3 times a week. Imiquimod therapy was discontinued; however, the patient continued to report a burning-like pain and erythema in the area for approximately 2 years. The condition may have been exacerbated by aerobic exercise, sweating, and sexual activity. In the second case report, a 64-year-old woman with plantar warts developed numbness and pain in all toes and the balls of both feet following approximately 5 months of therapy with imiquimod topical applied each night with tape occlusion. Imiquimod topical was discontinued. This condition may have been exacerbated by a daily paring of the warts by the patient prior to imiquimod application. Approximately 2 years later, the patient reported a gradual improvement in the numbness and an absence of the burning-like pain. Neither patient had diabetes mellitus, or any other condition known to result in possible neuropathic pain.

Nervous system side effects have included headache (up to 8%), dizziness (up to 3%), insomnia, and lethargy. Nervous system side effects have rarely included neuropathic pain. Agitation, convulsions (including febrile convulsions), insomnia, multiple sclerosis aggravation, and paresis have been reported during postmarketing experience.

Other

Other side effects have included back pain (up to 4%), fatigue (up to 4%), influenza-like illness (up to 4%), pyrexia (up to 3%), pain (up to 3%), influenza-like symptoms (3% in females, 1% in males), rigors (1%), and chills. Hernia, inflicted injury, and postoperative pain have been reported.

Gastrointestinal

A review of 3 case reports involving patients receiving imiquimod topical (the active ingredient contained in Aldara) applied 2 or 3 times weekly for treatment of actinic cheilitis in the lip region reported the formation of aphthous ulcers approximately 2 to 3 weeks following initiation of treatment. In each case, the aphthous ulcers resolved upon discontinuation of imiquimod topical and treatment with a topical steroid. None of the patients consented to a rechallenge.

Gastrointestinal side effects have included nausea (up to 4%), anorexia (up to 3%), diarrhea (up to 3%), dyspepsia (2%), cheilitis (up to 2%), and vomiting (up to 1%). Gastrointestinal disorder and aphthous ulcers (rare) have been reported. Abdominal pain has been reported during postmarketing experience.

Oncologic

Oncologic side effects have included squamous cell carcinoma (up to 4%). Basal cell carcinoma has been reported. Oncologic side effects reported during non-FDA approved treatment of melanoma in situ have included a single case report of the development of invasive melanoma.

An 87-year-old Caucasian woman developed invasive amelanotic melanoma with satellite lesions within 14 weeks after initiation of treatment with imiquimod three times per week. It is unknown if this was a probable side effect of imiquimod or a progressive event of melanoma in situ.

Hematologic

Hematologic side effects have included lymphadenopathy (up to 3%) and pancytopenia. Decreases in red cell, white cell, and platelet counts (including idiopathic thrombocytopenic purpura), and lymphoma have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included chest pain (up to 2%), atrial fibrillation (1%), and hypertension. Capillary leak syndrome, cardiac failure, cardiomyopathy, cerebrovascular accident, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope, and Henoch-Schonlein purpura syndrome have been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included eczema (2%), alopecia (1%), dermatitis, and pruritus. Remote site skin reaction were reported and included erythema (3% in females, 1% in males), ulceration (2% in females), erosion (2% in males), edema (1% in females, 1% in males), induration (1% in males), and excoriation/flaking (1% in males). Remote site reactions reported in more than 1% of patients have included bleeding, burning, itching, pain, tenderness, and tinea cruris. Hyperkeratosis, rash, skin disorder, photosensitivity reaction, verruca, and remote site irritation have been reported. Imiquimod-induced psoriasis and at least 1 case each of vitiligo-like hyperpigmentation, contact pemphigus, pityriasis rubra pilaris exacerbation, erosive pustular dermatosis of the scalp, and eruptive keratoacanthoma have been reported. Exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypopigmentation, and hypertrophic scar have been reported during postmarketing experience.

In the studies involving treatment of genital/perianal warts, the skin reactions reported were more frequent and more intense with daily application of the cream than with the application of the cream three times per week.

In studies involving treatment of actinic keratosis or superficial basal cell carcinoma, the dermatologic side effects classified as local and application site most frequently resulted in clinical intervention (e.g., rest periods, withdrawal from study, treatment site infections requiring treatment with antibiotics).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (up to 3%) and myalgia (up to 1%). Arthritis and skeletal pain have been reported. Arthralgia has also been reported during postmarketing experience.

Genitourinary

Genitourinary side effects have included bacterial vaginitis (up to 3% of females), urinary tract infections (1%), scrotal pain, scrotal erythema, scrotal ulcer, and scrotal edema. Proteinuria, urinary retention, and dysuria have been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety (1%). Depression and suicide have been reported during postmarketing experience.

Ocular

Ocular side effects have included conjunctivitis and eye abnormality.

Hypersensitivity

A 61-year-old man developed angioedema 3 weeks into treatment for squamous cell carcinoma in situ located on the right forearm. One week prior he had developed ulceration over the application site. The angioedema started in the right hand at which time the imiquimod therapy was discontinued. Within 36 hours of discontinuation the angioedema had encompassed both hands and feet and the ulcerated application site. Fifty-four hours following discontinuation of therapy the patient was awakened by severe swelling of the tongue, diagnosed by the emergency room physician as angioedema of the tongue. The patient experienced difficulty talking and swallowing, but no respiratory distress. The patient denied presence of chills, fever, or influenza-like symptoms. The patient denied history of urticaria, angioedema, or anaphylaxis. The patient was stable on all medications prior to initiation of imiquimod therapy. The patient improved following treatment with intravenous diphenhydramine and methylprednisolone. It is thought that the large application site (16.7 m2) and the ulceration may have facilitated in the absorption of imiquimod resulting in the angioedema.

Hypersensitivity side effects have included angioedema during postmarketing experience. Aggravation of allergy has been reported.

Metabolic

Metabolic side effects have included hypercholesterolemia and gout.

Hepatic

Hepatic side effects have included abnormal liver function during postmarketing experience.

Endocrine

Endocrine side effects have included thyroiditis during postmarketing experience.

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