In this section, undesirable effects are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). (See table.)
Click on icon to see table/diagram/image
Rare cardiovascular effects such as angina, heart failure, conduction defects including PR and QT interval prolongations, arrhythmias and non-specific ECG changes have been observed.
Thrombocytopenia has been reported uncommonly.
In addition, the following adverse experiences were reported in clinical trials (as possible adverse drug reactions in the opinion of investigating clinicians, with a frequency of ≥1%) during treatment with bicalutamide plus an LHRH analogue.
No causal relationship of these experiences to drug treatment has been made and some of the experiences reported are those that commonly occur in elderly patients: Cardiovascular system:
anorexia, dry mouth, dyspepsia, constipation, flatulence.
Central nervous system:
dizziness, insomnia, somnolence, decreased libido.
Skin and appendages:
alopecia, rash, sweating, hirsutism.
Metabolic and nutritional:
diabetes mellitus, hyperglycaemia, oedema, weight gain, weight loss.
abdominal pain, chest pain, headache, pain, pelvic pain, chills.