Aldara Side Effects

Please note - some side effects for Aldara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Aldara - for the Consumer

Aldara

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Aldara:

Back pain; changes in skin color; diarrhea; headache; itching, burning, mild pain, or tenderness at the application site; redness, dryness, flaking, swelling, or scabbing at the application site; small sores or mild drainage at the application site; thick or hardened skin at the application site; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue, unusual hoarseness); chest pain; fever, chills, or sore throat; irregular heartbeat; muscle pain or weakness; nausea; oozing, blistering, or bleeding at the application site; severe irritation or pain at application site, sores or ulcers at the application site; swollen lymph glands; trouble urinating; vaginal pain or swelling.

Aldara Side Effects - for the Professional

Aldara

Most common adverse reactions (incidence >28%) are application site reactions or local skin reactions: itching, burning, erythema, flaking/scaling/dryness, scabbing/crusting, edema, induration, excoriation, erosion, ulceration. Other reported reactions (> 1%) include fatigue, fever, and headache (6.1, 6.2, 6.3)

Side Effects by Body System

General

In general, the side effects associated with imiquimod topical may vary depending on the condition being treated.

Dermatologic

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).

Dermatologic side effects reported during treatment for superficial basal cell carcinoma have included hyperkeratosis (1.6%), rash (1.6%), skin disorder (0.5%), site infections that required treatment with antibiotics (1.3%), and erythema at remote site (1.6%). Dermatologic side effects reported during treatment for actinic keratosis have included alopecia (1.4%), dermatitis (1.4%), eczema (1.9%), hyperkeratosis (8.8%), photosensitivity reaction (0.9%), pruritus (0.9%), rash (2.3%), skin disorder (2.8), verruca (0.5%), burning at remote site (1.9%), induration at remote site (1.4%), irritation at remote site (1.4%), and itching at remote site (3.3%). Dermatologic side effects at remote sites reported during the treatment of external genital warts have included bleeding, burning, itching, pain, tenderness, and tinea cruris in more than 1% of patients. Imiquimod-induced psoriasis and at least 1 case each of vitiligo-like hyperpigmentation, contact pemphigus, pityriasis rubra pilaris exacerbation, and eruptive keratoacanthoma have been reported. There have been uncontrolled, non-detailed reports of exfoliative dermatitis.

Local

Local side effects reported during treatment for actinic keratosis have included erythema (97%, 18% severe), edema (49%), weeping/exudates (22%), vesicles (9%), erosion/ulceration (48%, 2% severe), flaking/scaling/dryness (93%, 7% severe), scabbing/crusting (79%, 8% severe), bleeding at the target site (3.3%), burning at target site (5.6%), induration at target site (2.3%), itching at target site (20.5%), pain at target site (2.8%), and tenderness at target site (1.9%). Local side effects reported during treatment for superficial basal cell carcinoma have included edema (71%, 7% severe), erosion (54%, 13% severe), erythema (69%, 31% severe), flaking/scaling (87%, 4% severe), induration (78%, 6% severe), scabbing/crusting (64%, 19% severe), ulceration (34%, 6% severe), vesicles (29%, 2% severe), itching at target site (16.2%), burning at target site (5.9%), pain at target site (3.2%), tenderness at target site (1.1%), papule(s) at target site (1.6%), bleeding at target site (2.2%), tingling at target site (0.5%), and infection at target site (1.1%). Local side effects reported during treatment for external genital warts (at wart site) have included erythema (65%, 4% severe), erosion (31%, 1% severe), excoriation/flaking (18%, 1% severe), edema (18%), induration (5%), ulceration (8%), scabbing (4%), vesicles (3%), itching (22 to 32%), burning (9 to 26%), pain (2 to 8%), and soreness (3%). Side effects at the application site reported in less than 1% of patients have included burning, hypopigmentation, irritation, itching, pain, rash, sensitivity, soreness, stinging, and tenderness.

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).

Respiratory

Respiratory side effects reported during treatment for actinic keratosis have included bronchitis (0.9%), coughing (2.8%), pharyngitis (1.9%), pulmonary congestion (0.5%), rhinitis (3.3%), sinusitis (7.4%), and upper respiratory tract infection (15.3%). Respiratory side effects reported during treatment for superficial basal cell carcinoma have included coughing (1.6%), pharyngitis (1.1%), rhinitis (2.7%), sinusitis (2.2%), and upper respiratory tract infection (3.2%). Dyspnea has also been reported.

Nervous system

Two cases involving the development of chronic neuropathic pain following initiation of imiquimod topical 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 reported during treatment of actinic keratosis have included dizziness (1.4%). Nervous system side effects reported during treatment of superficial basal cell carcinoma have included dizziness (1.1%) and headache (7.6%). Nervous system side effects reported during treatment of external genital warts have included headache. Nervous system side effects have rarely included neuropathic pain. Agitation, convulsions, insomnia, aggravation of multiple sclerosis, and paresis have also been reported.

Gastrointestinal

A review of 3 case reports involving patients receiving imiquimod topical 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 reported during treatment for superficial basal cell carcinoma have included abdominal pain (0.5%), diarrhea (0.5%), dyspepsia (1.6%), gastrointestinal disorder (0.5%), and nausea (1.1%). Gastrointestinal side effects reported during treatment for external genital warts have included diarrhea. Gastrointestinal side effects have rarely included aphthous ulcers.

Musculoskeletal

Musculoskeletal side effects reported during treatment for actinic keratosis have included arthralgia (0.9%), arthritis (0.9%), myalgia (1.4%), and skeletal pain (0.5%). Musculoskeletal side effects reported during treatment for superficial basal cell carcinoma have included skeletal pain (1.6%). Musculoskeletal side effects reported during treatment for external genital warts have included myalgia.

Cardiovascular

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 flu-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.

Cardiovascular side effects reported during treatment for actinic keratosis have included chest pain (0.5%), hypertension (1.4%), and atrial fibrillation (1.4%). Cardiovascular side effects reported during treatment for superficial basal cell carcinoma have included hypertension (2.7%). A single case report of angioedema has been reported during topical treatment for squamous cell carcinoma. Capillary leak syndrome, cardiac failure, cardiomyopathy, cerebrovascular accident, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, and syncope have also been reported.

Genitourinary

Genitourinary side effects reported during treatment for actinic keratosis have included urinary tract infections (1.4%). Proteinuria has also been reported.

Immunologic

Immunologic side effects reported during treatment for actinic keratosis have included herpes simplex (1.9%) and viral infection (1.4%). Immunologic side effects reported during treatment for superficial basal cell carcinoma have included infection (0.5%), fungal infection (1.1%), and lymphadenopathy (2.7%). Immunologic side effects reported during treatment for external genital warts have included fungal infections (11% in females, 2% in males).

Ocular

Ocular side effects reported during treatment for actinic keratosis have included conjunctivitis (0.5%) and eye abnormality (1.9%).

Oncologic

Oncologic side effects reported during therapy for actinic keratosis have included basal cell carcinoma (2.3%) and squamous carcinoma (3.7%). 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.

Psychiatric

Psychiatric side effects reported during treatment for superficial basal cell carcinoma have included anxiety (1.1%). Depression and suicide have also been reported.

Metabolic

Metabolic side effects reported during treatment for actinic keratosis have included hypercholesterolemia (1.9%). Metabolic side effects reported during treatment for superficial basal cell carcinoma have included gout (1.1%).

Hypersensitivity

Hypersensitivity side effects have included uncontrolled, non-detailed reports of exfoliative dermatitis.

Other

Other side effects reported during treatment for actinic keratosis have included back pain (1.4%), fatigue (1.4%), fever (1.4%), headache (5.1%), hernia (1.9%), influenza-like symptoms (1.9%), pain (1.4%), rigors (1.4%), inflicted injury (8.8%), and postoperative pain (1.4%). Other side effects reported during treatment for superficial basal cell carcinoma have included aggravation of allergy (1.1%), back pain (3.8%), chest pain (1.1%), fatigue (2.2%), fever (1.6%), pain (1.6%), and inflicted injury (1.6%). Other side effects reported during treatment for external genital warts have included fatigue, fever, influenza-like symptoms (3% in females, 1% in males), headache (4% in females, 5% in males), and myalgia (1% in both females and males).

Endocrine

Endocrine side effects have included thyroiditis.

Hematologic

Hematologic side effects have included decreases in red cell, white cell, and platelet counts.

Hepatic

Hepatic side effects have included abnormal liver function.

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