Bicalutamide is generally well tolerated. Only in rare cases, the use of bicalutamide is canceled because of side effects caused by the drug. According to WHO recommendations, side effects that can cause bicalutamideare classified according to the frequency of their development as follows: very often ≥ 10%, often ≥ 1% and <10%, infrequently ≥ 0.1% and <1%, rarely ≥ 0.01% and <0 , 1%, very rarely - <0.01%, is unknown (can not be estimated based on available data).
Below are the side effects that occurred with the use of bicalutamide 150 mg once a day and with simultaneous application of bicalutamide 50 mg once a day with analogues of GnRH:
Violations of the blood and lymphatic system
often: anemia.
Immune system disorders
infrequently: hypersensitivity reactions (including angioedema and urticaria *).
Disorders of the psyche
often: decreased sexual desire (libido), depression.
Disturbances from the nervous system
Often: dizziness**;
often: drowsiness, headache *, paresthesia *, insomnia *, anxiety *.
Vascular disorders
Often: "hot flashes" **; often: arterial hypertension*.
Heart Disease
often: myocardial infarction (reported as fatal) *;
infrequently: heart failure.
Disorders from the gastrointestinal tract
Often: abdominal pain **, constipation **, nausea **, diarrhea *;
often: dyspepsia, flatulence, vomiting *.
Disturbances from the respiratory system, chest and mediastinal organs
Often: dyspnea;
often: increased cough *, pharyngitis *, bronchitis *, pneumonia *, rhinitis *;
infrequently: interstitial lung diseases (reported fatal cases) (postmarketing experience).
Disturbances from the liver and bile ducts
often: transient changes on the part of the liver (hepatotoxicity), incl. an increase in the activity of "liver" transaminases, jaundice, an increase in the activity of alkaline phosphatase * (described changes in liver function were rarely evaluated as serious, often transient, completely disappeared or decreased after drug withdrawal)
rarely: hepatic insufficiency (the cause-and-effect relationship with bicalutamide is not reliably established) (postmarketing experience).
Disturbances from the skin and subcutaneous tissues
Often: rash***;
often: alopecia, hirsutism / hair regrowth, dry skin, itchy skin, increased sweating *.
Disturbances from musculoskeletal and connective tissue
often: pain in the bones *, myasthenia *, arthralgia *, arthritis *, back pain *, pathological fractures *.
Disorders from the kidneys and urinary tract
Often: hematuria **, night urination to urinate *;
often: urinary tract infection *, frequent urination *, urinary retention *, urination disorder *, urinary incontinence *.
Violations of the genitals and mammary gland
Often: gynecomastia (can persist even after cessation of therapy, especially if the drug is taken for a long time) and tenderness of the mammary glands;
often: impotence / erectile dysfunction.
Disorders from the endocrine system
often: hyperglycemia *.
frequency is unknown: decrease in glucose tolerance (postmarketing experience) *.
Disorders from the metabolism and nutrition
Often: asthenia;
often: anorexia, weight gain, weight loss *.
General disorders and disorders at the site of administration
Often: chest pain **, peripheral edema **, pain *, pain in the area of small pelvis *, infection *;
often: influenza-like syndrome *.
* These side effects were observed only with the simultaneous administration of bicalutamide (50 mg once daily) with analogues of GnRH.
** These side effects were observed with bicalutamide 150 mg once daily often, and not very often.
*** These side effects were observed with the simultaneous administration of bicalutamide (50 mg once daily) with GnRH analogues often, and not very often.