NEW
Aldara疣定寧

Aldara Adverse Reactions

imiquimod

Manufacturer:

iNova

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Adverse Reactions
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, this medicine can cause side effects, although not everybody gets them.
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 the skin reacts badly when using Aldara cream, advise patient to stop applying the cream, wash the area with mild soap and water.
In some individuals, a lowering of blood counts was noted. A lowering of blood counts might make the patient more susceptible to infections, bruise more easily or cause fatigue.
Serious skin reactions have been reported rarely. If the patient experiences skin lesions or spots on the 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, advise patient to stop using Aldara cream.
A small number of patients have experienced hair loss at the treatment site or surrounding area.
Patients treated for genital warts: Many of the undesirable effects of Aldara cream are due to its local action on the 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. The patient might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where Aldara cream is applied (8% patients). Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Common: 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 rare: 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.
Patients treated for basal cell carcinoma: Many of the undesirable effects of Aldara cream are due to its local action on the skin. Local skin reactions can be a sign that the drug is working as intended.
Very common: 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 for the patient during treatment, advise 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 with the patient. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommon: 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.
Patients treated for actinic keratosis: Many of the undesirable effects of Aldara cream are due to its local action on the skin. Local skin reactions can be a sign that the drug is working as intended.
Very common: The treated skin may be slightly itchy.
Common: Effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable for the patient during treatment, advise 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 with the patient. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Uncommon: 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.
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