The frequency of side effects is classified as follows:
Very common side effects (likely to occur in more than 1 in 10 patients)
Common side effects (likely to occur in fewer than 1 in 10 patients)
Uncommon side effects (likely to occur in fewer than 1 in 100 patients)
Rare side effects (likely to occur in fewer than 1 in 1,000 patients)
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Like all medicines, Aldara cream can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Some patients have experienced changes in skin colour in the area where Aldara cream was applied. While these changes have tended to improve with time, in some patients they may be permanent. If your skin reacts badly when using Aldara cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
In some individuals a lowering of blood counts was noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of these symptoms, tell your doctor.
Serious skin reactions have been reported rarely. If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Aldara cream and tell your doctor immediately.
A small number of patients have experienced hair loss at the treatment site or surrounding area. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
- If you are being treated for genital warts:
Many of the undesirableeffects of Aldara cream are due to its local action on your skin.
Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients). Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Commonly some patients (4% or less) have experienced headache, uncommonly fevers and flu like symptoms joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears;
flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately.
- If you are being treated for basal cell carcinoma:
Many of the undesirableeffects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very Commonly the treated skin may be slightly itchy.
Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment). If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.
- If you are being treated for actinic keratosis
Many of the undesirable effects of Aldara cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very commonly the treated skin may be slightly itchy.
Common effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Aldara cream for a few days (i.e. to have a short rest from treatment). If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity, swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
