Like all medicines this medicine can cause side effects, although not everybody gets them.
Advise the patient to seek medical advice immediately in case of any of the following side effects (urgent medical treatment may be needed): Allergic reaction (common), particularly if symptoms include swollen face, lips, tongue or throat, difficulty to swallow, hives, nettle rash and difficulty breathing.
Serious breathlessness, or sudden worsening breathlessness, possibly with a cough or fever. This may mean that the patient has an inflammation of the lungs called 'interstitial lung disease'. This may affect about 1 in 100 patients taking gefitinib and can be life-threatening.
Severe skin reactions (rare) affecting large areas of the body. The signs may include redness, pain, ulcers, blisters, and shedding of the skin. The lips, nose, eyes and genitals may also be affected. Dehydration (common) caused by long term or severe diarrhoea, vomiting (being sick), nausea (feeling sick) or loss of appetite.
Eye problems (uncommon), such as pain, redness, watery eyes, light sensitivity, changes in vision or ingrowing eyelashes. This may mean that the patient has an ulcer on the surface of the eye (cornea).
Advise the patient to seek medical advice immediately in case of any of the following side effects: Very common: side effects (may affect more than 1 in 10 people): Diarrhoea; Vomiting; Nausea; Skin reactions such as an acne-like rash, which is sometimes itchy with dry and/or cracked skin; Loss of appetite; Weakness; Red or sore mouth.
Increase of a liver enzyme known as alanine aminotransferase in a blood test; if too high, Gefitinib Genepharm may be discontinued.
Common: side effects (may affect up to 1 in 10 people): Dry mouth; Dry, red or itchy eyes; Red and sore eyelids; Nail problems; Hair loss; Fever; Bleeding (such as nose bleed or blood in the urine); Protein in the urine (shown in a urine test).
Increase of bilirubin and the other liver enzyme known as aspartate aminotransferase in a blood test; if too high, Gefitinib Genepharm may be discontinued.
Increase of creatinine levels in a blood test (related to kidney function).
Cystitis (burning sensations during urination and frequent, urgent need to urinate).
Uncommon: side effects (may affect up to 1 in 100 people): Inflammation of the pancreas. The signs include very severe pain in the upper part of the stomach area and severe nausea and vomiting.
Inflammation of the liver. Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes). This side effect is uncommon; however, some patients have died from this.
Gastrointestinal perforation.
Skin reaction on the palms of the hands and soles of the feet including tingling, numbness, pain, swelling or reddening (known as palmar-plantar erythrodysaesthesia syndrome or hand and foot syndrome).
Rare: side effects (may affect up to 1 in 1000 people): Inflammation of the blood vessels in the skin. This may give the appearance of bruising or patches of non-blanching rash on the skin.
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Reporting of side effects: Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph. Side effects can be reported directly via the national reporting system. Reporting side effects can help provide more information on the safety of this medicine.