Indications 

Aldara cream is a topical prescription medication used to treat: 

• Actinic keratosis (flat, scaly growths resulting from excessive sun exposure) on the face or scalp in adults with a normal immune system. 
• Superficial basal cell carcinoma (type of skin cancer) in adults when surgery is not recommended. 
• Genital or anal warts in individuals aged 12 years and above.  

As an immune response modifier, Aldara Cream treats genital and anal warts by boosting the body’s immune system activity. However, its mechanism of action for treating actinic keratoses and superficial basal cell carcinoma is unknown. 

Uses and Dosage 

Before using Aldara Cream and with each prescription refill, carefully read its medication guide and patient information leaflet. Seek guidance from your doctor or pharmacist if you have any questions or concerns. 

Aldara Cream dosage and length of treatment are determined based on the patient’s medical condition and response to treatment: 

• For the treatment of actinic keratoses: 
  • Aldara Cream is typically applied once a day for 2 days a week, with a 3–4-day interval (e.g., Monday and Thursday or Tuesday and Friday) for 16 weeks. 
  • The cream should not be applied larger than the forehead or cheek (about 2 inches by 2 inches) and should be left on the skin for around 8 hours. 
• For the treatment of superficial basal cell carcinoma: 
  • Aldara Cream is typically applied once a day for 5 days a week (e.g., Monday through Friday) for 6 weeks. 
  • The cream should be applied to the basal cell carcinoma and the immediate surrounding area and should be left on the skin for approximately 8 hours. 
• For the treatment of genital and anal warts: 
  • Aldara Cream is typically applied once a day for 3 days a week (e.g., Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday) until all warts are healed, up to a maximum of 16 weeks. 
  • The cream should be left on the skin for 6 to 10 hours.  

Aldara Cream should be applied just before bedtime; for proper application, follow these steps: 

1. Clean the area where the cream will be applied with mild soap and water.  
   1. Uncircumcised males with warts under the foreskin of the penis should retract the foreskin, clean the area, and continue to clean the area daily during treatment. 
2. Allow the area to dry for at least 10 minutes and wash your hands. 
3. Open a new packet of Aldara cream and apply a thin layer only to the affected area. 
4. Rub the cream into your skin until it is not visible and wash your hands. 
5. Leave the cream on the treated area for the duration your healthcare provider advised. Avoid getting the area wet during this time. 
   1. Avoid covering the treated area with tight bandages or dressings unless specifically instructed by your doctor. 
   2. Cotton gauze dressings may be used if necessary.  
6. For the genital or anal areas, cotton underwear may be worn after applying the cream. 
7. Once the appropriate duration has elapsed, cleanse the treated area with mild soap and water. 

Aldara cream is solely intended for topical application on the skin. Avoid applying it near or in your eyes, nostrils, lips, anus, or vagina. In case of accidental contact with the eyes or mouth, rinse thoroughly with water immediately. 

To achieve optimal results, use Aldara Cream as prescribed, and do not use it in larger or smaller amounts or for longer than directed. Overusing Aldara Cream can increase the risk of severe skin reactions or other side effects. 

Aldara Cream is packaged in single-use packets, and no more than 36 packets should be prescribed for a 16-week treatment. Unused or partially used packets should be disposed of and not reused. 

Side Effects 

Listed below are the side effects associated with the use of Aldara Cream. If any of them last or worsen, inform your doctor promptly. 

Common Side Effects 

• Mild skin pain, irritation, itching, redness, dryness, flaking, scabbing, crusting, scaling, or swelling at the application site 
• Skin discoloration in the treated area 
• Headache 
• Tiredness 
• Nausea 

Serious Side Effects 

• Flu-like symptoms: 
  • Fever 
  • Chills 
  • Nausea 
  • Tiredness 
  • Body aches 
  • Swollen glands 
• Bleeding or swelling of the application site 
• Severe swelling or urination problems while treating genital warts around the vagina 
• Skin sores 
• Blisters 
• Itching 
• Tingling 
• Burning pain 
• Rash on face or torso 

Get medical help right away if you have any of the serious symptoms listed above. 

Allergic Reactions 

Aldara Cream rarely causes severe allergic reactions. However, seek emergency medical help if you observe the following signs of an allergic reaction: 

• Rash 
• Itching or swelling, especially of the throat, tongue, and face 
• Severe dizziness 
• Trouble breathing 

This list does not contain all the potential side effects of Aldara Cream. Inform your doctor if any unlisted effects are experienced. 

Cautions 

Before using Aldara Cream, inform your doctor or pharmacist if you have any known allergies, especially to imiquimod, any medications, or any ingredients present in this cream. 

To ensure Aldara Cream is safe for you, disclose to your physician your medical background, specifically regarding any history of: 

• Recent/unhealed skin surgery 
• Immune system issues, including HIV 
• Chronic graft-versus-host disease (a complication of bone marrow or some organ transplants) 
• Autoimmune diseases like rheumatoid arthritis, lupus, or scleroderma 

Many products and medications may interact with Aldara Cream. To minimize the risk of drug interactions, disclose to your healthcare provider all the products and medications you currently use, including prescription and non-prescription drugs, dietary supplements, and herbal products. 

Aldara Cream can increase skin sensitivity to sunlight. Avoid sunlight exposure, wear protective clothing (e.g., hat, sunglasses, sunscreen) during daylight hours, and refrain from using tanning beds or sunlamps while using this cream. 

Aldara Cream can potentially weaken condoms and vaginal diaphragms, reducing their effectiveness in preventing pregnancy. Avoid any sexual contact, including genital, anal, or oral sex, when this cream is applied to the genital or anal skin.  

Consult with your healthcare provider if you are pregnant or planning to conceive, as the potential risk of harm to an unborn baby from using Aldara Cream is unknown. 

Discuss with your healthcare provider the best feeding option for your baby while using Aldara Cream, as it is unclear if imiquimod can pass into breast milk and cause harm.