Frequencies are defined as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to ≤1/100); rare (≥1/10,000 to ≤1/1000); very rare (≤1/10,000); not known (cannot be estimated from the available data).
Bicalutamide 150-mg (Monotherapy): Blood and Lymphatic System Disorders: Common: Anemia.
Immune System Disorders: Uncommon: Hypersensitivity reactions (including angioneurotic edema and urticaria).
Metabolism and Nutrition Disorders: Common: Anorexia.
Psychiatric Disorders: Common: Decreased libido, depression.
Nervous System Disorders: Common: Dizziness, somnolence.
Vascular Disorders: Common: Hot flush.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Interstitial lung disease.
Gastrointestinal Disorders: Common: Abdominal pain, constipation, dyspepsia, flatulence, nausea.
Hepatobiliary Disorders: Common: Hepatic changes (including elevated levels of transaminases, jaundice)/hepatobiliary disorders
a. Rare: Hepatic failure
b.
Skin and Subcutaneous Tissue Disorders: Very Common: Rash. Common: Alopecia, hirsutism/hair regrowth, dry skin, pruritus.
Renal and Urinary Disorders: Common: Hematuria.
Reproductive System and Breast Disorders: Very Common: Gynecomastia and breast tenderness
c. Common: Impotence.
General Disorders and Administration Site Conditions: Very Common: Asthenia. Common: Chest pain, edema.
Investigations: Common: Weight gain.
Bicalutamide 150-mg (+ LHRH Analogue): Blood and Lymphatic System Disorders: Common: Anemia.
Immune System Disorders: Uncommon: Hypersensitivity reactions (including angioneurotic edema and urticaria).
Metabolism and Nutrition Disorders: Common: Anorexia.
Psychiatric Disorders: Common: Decreased libido, depression.
Nervous System Disorders: Very Common: Dizziness. Common: Somnolence.
Vascular Disorders: Very Common: Hot flush.
Respiratory, Thoracic and Mediastinal Disorders: Uncommon: Interstitial lung disease.
Gastrointestinal Disorders: Very Common: Abdominal pain, constipation, nausea. Common: Dyspepsia, flatulence.
Hepatobiliary Disorders: Common: Hepatic changes (including elevated levels of transaminases, jaundice)/hepatobiliary disorders
a. Rare: Heart failure
b.
Skin and Subcutaneous Tissue Disorders: Common: Alopecia, hirsutism/hair regrowth, dry skin, pruritus.
Renal and Urinary Disorders: Very Common: Hematuria.
Reproductive System and Breast Disorders: Very Common: Gynecomastia and breast tenderness
c. Common: Impotence.
General Disorders and Administration Site Conditions: Very Common: Asthenia, chest pain, edema.
Investigations: Common: Weight gain.
aHepatic changes are rarely severe and were frequently transient, resolving or improving with continued therapy or following cessation of therapy.
bHepatic failure has occurred rarely in patients treated with bicalutamide but a causal relationship has not been established with certainty. Periodic liver function testing should be considered (see Precautions).
cThe majority of patients receiving bicalutamide 150 mg as monotherapy experience gynecomastia and/or breast pain. In studies, these symptoms were considered to be severe in up to 5% of the patients. Gynecomastia may not resolve spontaneously following cessation of therapy, particularly after prolonged treatment (≤1/10,000), not known (cannot be estimated from the available data).
In addition, cardiac failure was reported in clinical trials (as a possible adverse drug reaction in the opinion of investigating clinicians with a frequency of >1%) during treatment with bicalutamide plus an LHRH analogue. There is no evidence of a causal relationship with drug treatment.