Like all medicines, this medicine can cause side effects, although not everybody gets them. They are usually mild to moderate.
These side effects may occur with certain frequencies, which are defined as follows:
- Very common: may affect more than 1 in 10 people.
- Common: may affect up to 1 in 10 people.
- Uncommon: may affect up to 1 in 100 people.
- Rare: may affect up to 1 in 1,000 people.
- Very rare: may affect up to 1 in 10,000 people.
- Not known: frequency cannot be estimated from the available data.
Some side effects may be serious. Tell your doctor straight away if you get any of the following:
Very common or common side effects:
- Rapid weight gain. Imatinib may cause your body to retain water (severe fluid retention).
- Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Imatinib can reduce the number of white blood cells, so you might get infections more easily.
- Unexpected bleeding or bruising (when you have not hurt yourself).
Uncommon or rare side effects:
- Chest pain, irregular heart rhythm (signs of heart problems).
- Cough, having difficulty breathing or painful breathing (signs of lung problems).
- Feeling light-headed, dizzy or fainting (signs of low blood pressure).
- Feeling sick (nausea), with loss of appetite, light-coloured urine, yellow skin or eyes (signs of liver problems).
- Rash, red skin with blisters on the lips, eyes, skin or mouth, peeling skin, fever, raised red or purple skin patches, itching, burning sensation, pustular eruption (signs of skin problems).
- Severe abdominal pain, blood in your vomit, stools or urine, black stools (signs of gastrointestinal disorders).
- Severely decreased urine output, feeling thirsty (signs of kidney problems).
- Feeling sick (nausea) with diarrhoea and vomiting, abdominal pain or fever (signs of bowel problems).
Severe headache, weakness or paralysis of limbs or face, difficulty speaking, sudden loss of consciousness (signs of nervous system problems such as bleeding or swelling in skull/brain).
- Pale skin, feeling tired and breathlessness and having dark urine (signs of low levels of red blood cells).
- Eye pain or deterioration in vision.
- Pain in your hips or difficulty walking.
- Numb or cold toes and fingers (signs of Raynaud’s syndrome).
- Sudden swelling and redness of the skin (signs of a skin infection called cellulites).
- Difficulty hearing.
- Muscle weakness and spasms with an abnormal heart rhythm (signs of changes in the amount of potassium in your blood).
- Bruising.
- Stomach pain with feeling sick (nausea).
- Muscle spasms with a fever, red-brown urine, pain or weakness in your muscles (signs of muscle problems).
- Pelvic pain sometimes with nausea and vomiting, with unexpected vaginal bleeding, feeling dizzy or fainting due to low blood pressure (signs of problems with your ovaries or womb).
- Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal laboratory test results (e.g. high potassium, uric acid and phosphorous
levels and low calcium levels in the blood).
If you get any of the above, tell your doctor straight away.
Other side effects may include:
Very common side effects:
- Headache or feeling tired.
- Feeling sick (nausea), being sick (vomiting), diarrhoea or indigestion.
- Rash.
- Muscle cramps or joint, muscle or bone pain.
- Swelling such as round your ankles or puffy eyes.
- Weight gain.
If any of these affects you severely, tell your doctor.
Common side effects:
- Anorexia, weight loss or a disturbed sense of taste.
- Feeling dizzy or weak.
- Difficulty in sleeping (insomnia).
- Discharge from the eye with itching, redness and swelling (conjunctivitis), watery eyes or having blurred vision.
- Nose bleeds.
- Pain or swelling in your abdomen, flatulence, heartburn or constipation.
- Itching.
- Unusual hair loss or thinning.
- Numbness of the hands or feet.
- Mouth ulcers.
- Joint pain with swelling.
- Dry mouth, dry skin or dry eye.
- Decreased or increased skin sensitivity.
- Hot flushes, chills or night sweats.
If any of these affects you severely, tell your doctor.
Not known:
- Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
- Slowing of growth in children and adolescents.
If any of these affects you severely, tell your doctor.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system By reporting side effects you can help provide more information on the safety of this medicine.
<the national reporting system per country will be addressed at national phase>
