Bicalutamide – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 42 min read
Bicalutamide - Uses, Dosage, Side Effects, Interaction
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Article Summary

Bicalutamide is a nonsteroidal antiandrogen similar in structure to flutamide that is used widely in the therapy of prostate cancer and has been linked to rare instances of liver injury. Bicalutamide is a synthetic, nonsteroidal antiandrogen. Bicalutamide competitively binds to cytosolic androgen receptors in target tissues, thereby inhibiting the receptor binding of androgens. This agent does not bind to most mutated forms of androgen receptors. (NCI04)...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Use in Cancer in simple medical language.
  • This article explains Contraindications in simple medical language.
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Definition

Bicalutamide is a nonsteroidal antiandrogen similar in structure to flutamide that is used widely in the therapy of cancer and has been linked to rare instances of injury. Bicalutamide is a synthetic, nonsteroidal antiandrogen. Bicalutamide competitively binds to cytosolic androgen receptors in target tissues, thereby inhibiting the receptor binding of androgens. This agent does not bind to most mutated forms of androgen receptors. (NCI04)

Bicalutamide is an oral non-steroidal anti-androgen for prostate cancer. It is comprised of a racemic mixture that is a 50:50 composition of the (R)-bicalutamide and (S)-bicalutamide enantiomers. Bicalutamide binds to the androgen receptor.

Mechanism of Action

Bicalutamide competes with androgen for the binding of androgen receptors, consequently blocking the action of androgens of adrenal and testicular origin which stimulate the growth of normal and prostatic tissue.

Bicalutamide is a nonsteroidal antiandrogen that is structurally and pharmacologically related to flutamide and nilutamide. Bicalutamide inhibits the action of androgens by competitively blocking nuclear androgen receptors in target tissues such as the prostate, seminal vesicles, and adrenal cortex; blockade of androgen receptors in the hormone-sensitive cells may result in growth arrest or transient tumor regression through inhibition of androgen-dependent DNA and protein synthesis. Bicalutamide is a selective antiandrogen with no androgenic or progestational activity in various animal models. The relative binding affinity of bicalutamide at the androgen receptor is more than that of nilutamide and approximately 4 times that of hydroxyflutamide, the active metabolite of flutamide.

Common pharmacologic therapies for prostate cancer (ie, gonadotropin-releasing hormone [GnRH] analogs, nonsteroidal antiandrogens) when used as monotherapy initially result in increased serum testosterone concentrations, which may limit the effects of the drugs. Androgen receptors in the hypothalamus are blocked by bicalutamide, which disrupts the inhibitory feedback of testosterone on luteinizing hormone (LH) release, resulting in a temporary increase in the secretion of LH; the increase in LH stimulates an increase in the production of testosterone. As GnRH analogs have potent GnRH agonist properties, testicular steroidogenesis continues during the first few weeks after initiating therapy. However, the combination of orchiectomy or GnRH analog therapy to suppress testicular androgen production and an antiandrogen to block the response of remaining adrenal androgens provides maximal androgen blockade. Concomitant administration of antiandrogens such as bicalutamide in patients initiating therapy with a GnRH analog can inhibit initial androgenic stimulation and potential of symptoms (e.g., , urinary obstruction, liver , impending ) that may occur during the first month of GnRH analog therapy.

Indications

  • For treatment (together with surgery or LHRH analog) of advanced prostatic cancer.
  • Bicalutamide is a nonsteroidal antiandrogen similar in structure to flutamide that is used widely in the therapy of prostate cancer and has been linked to rare instances of liver injury.
  • Bicalutamide/ 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic of the prostate.

Use in Cancer

Bicalutamide is approved to treat:

Bicalutamide is also being studied in the treatment of other types of cancer.

Contraindications

  • are allergic to bicalutamide or any ingredients of the medication
  • have early-stage () prostate cancer and would otherwise undergo watchful waiting
  • a type of of the lung called interstitial pneumonitis
  • damage to the liver and inflammation
  • liver problems
  • abnormal liver function tests
  • pregnancy

Strengths: 50 mg

Prostate Cancer

  • In combination with an LHRH analog: 50 mg orally once a day (morning or evening)

Side Effects

The Most Common

  • hot flashes or flushing
  • bone, back, or
  • muscle or joint pain
  • increased blood pressure
  • of the hands, feet, ankles, or lower legs
  • gas
  • change in weight (loss or gain)
  • pain, burning, or in the hands or feet
  • difficulty sleeping
  • feeling of uneasiness or dread
  • rash
  • sweating
  • inability to get or keep an erection
  • need to urinate frequently during the night
  • bloody urine
  • painful or difficult urination
  • frequent and urgent need to urinate
  • difficulty emptying bladder
  • painful or swollen breasts

More Common

  • yellowing of the skin or eyes
  • pain in the upper right part of the stomach
  • extreme tiredness
  • unusual bleeding or bruising
  • lack of energy
  • upset stomach
  • loss of appetite
  • flu-like symptoms
  • dull or sharp side pain
  • chest pain
  • flatulence (passing gas)
  • hair loss or decreased hair regrowth
  • hot flashes
  • impotence or reduction in sexual desire
  • increased sensitivity of the skin to sun; increased risk of sunburn
  • indigestion

Rare

  • abdominal pain
  • blood in the urine
  • chest pain
  • severe itching
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of heart failure (e.g., tiredness, shortness of breath especially when lying down, swelling of the feet or ankles)
  • pain or tenderness in stomach
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • symptoms of lung problems (e.g., shortness of breath, painful breathing, sudden shortness of breath, cough, fever)
  • symptoms of a serious allergic reaction (e.g., hives, shortness of breath, difficulty swallowing, swelling of the face, lips, tongue or throat)

Drug Interaction

Pregnancy and Lactation

US FDA pregnancy category: Not assigned.

Pregnancy

This drug is contraindicated in females. This drug is contraindicated in pregnant women because it can cause fetal harm. Drugs that have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

Breastfeeding

This drug is contraindicated in females; therefore, it is contraindicated in lactation. Excreted into human milk: Unknown

Excreted into animal milk: Yes
The effects in the nursing infant are unknown.

How should this medicine be used?

Bicalutamide comes as a tablet to take by mouth. It is usually taken with or without food once a day, either in the morning or evening. Take bicalutamide at around the same time every day. You should begin taking bicalutamide on the same day you begin injecting the luteinizing hormone-releasing hormone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take bicalutamide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Bicalutamide along with the luteinizing hormone-releasing hormone may help stop the growth and spread of cancer cells but does not cure prostate cancer. Continue to take both bicalutamide and the luteinizing hormone-releasing hormone even if you feel better. Do not stop taking these medications without talking to your doctor.

What special precautions should I follow?

Before taking bicalutamide,

  • tell your doctor and pharmacist if you are allergic to bicalutamide, any other medications, or any of the ingredients in bicalutamide tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax); anticoagulants (‘blood thinners’) such as warfarin (Coumadin); aripiprazole (Abilify); buspirone (Buspar); calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac), felodipine (Plendil), nifedipine (Adalat, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Isoptin, Verelan); chlorpheniramine; cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor); clarithromycin (Biaxin); cyclosporine (Neoral, Sandimmune); diazepam (Valium); erythromycin (E.E.S., E-Mycin, Erythrocin); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir), and saquinavir (Invirase, Fortovase); methadone (Dolophine); midazolam (Versed); pimozide (Orap); quinidine (Quinidex, Quinaglute); quinine; sildenafil (Viagra); tacrolimus (Prograf); tamoxifen (Nolvadex); telithromycin (Ketek); trazodone (Desyrel); triazolam (Halcion); and vincristine (Vincasar). Many other medications may also interact with bicalutamide, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have or have ever had liver disease.
  • you should know that bicalutamide is only for use in men. If taken by pregnant women, bicalutamide can cause abnormalities in the fetus. Women who are or may become pregnant should not take bicalutamide. If you take bicalutamide while you are pregnant, call your doctor immediately.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Abnormal heart rhythm: Bicalutamide can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, amiodarone, sotalol, flecainide), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Anemia: Bicalutamide may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Diabetes: Bicalutamide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: This medication may cause drowsiness. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.

Heart disease: The risk of heart attack or heart failure is increased for people taking bicalutamide. If you have risk factors for heart disease (obesity, high blood cholesterol, smoking), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Bicalutamide is broken down by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

This medication may also cause liver problems. Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Lung disease: Rarely, and particularly when higher doses are used, cases of interstitial lung disease have been reported with this medication. If you experience any symptoms of lung problems such as breathing difficulties, wheezing, cough, fever, or shortness of breath, contact your doctor immediately.

Osteoporosis: Long-term use of bicalutamide has been shown to cause reduced bone strength and may increase the risk of bone fractures. If you have osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 50 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Children: The safety and effectiveness of this medication have not been determined for children.

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  6. Carbimazole

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RX Clinical Pathway Engine

Continue through a complete learning pathway

Move from understanding the topic to symptoms, tests, treatment, medicines, monitoring, and prevention.

Search the complete library
  1. Understand the condition Begin with the essential facts and a clear explanation of the topic.
  2. Recognize symptoms Learn common symptoms, signs, and patterns of presentation.
  3. Know when to seek help Review urgent warning signs and when professional assessment may be needed.
  4. Understand causes and risks Explore causes, risk factors, mechanisms, and contributing conditions.
  5. Explore tests and diagnosis Learn how clinicians assess the condition and which investigations may be discussed.
  6. Learn treatment approaches Review general treatment categories and management principles.
  7. Understand medicines safely Continue to medicine education, uses, precautions, and monitoring.
  8. Plan monitoring and follow-up Understand monitoring, complications, rehabilitation, and follow-up learning.
  9. Review prevention and self-care Explore prevention, healthy routines, and questions to discuss with a clinician.

Conditions & Diseases

Background, symptoms, causes, diagnosis, and care.

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Tests & Investigations

Laboratory, imaging, screening, and diagnostic education.

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Medicines

Uses, safety, monitoring, and related medicine knowledge.

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Cancer Knowledge

Cancer types, screening, oncology, and treatment education.

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Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Bicalutamide – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

Internal learning pathway

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