Enzalutamide – Uses, Dosage, Side Effects, Interaction

Last updated: February 8, 2026Reviewed date: February 8, 2026Reading time: 106 min read
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Enzalutamide - Uses, Dosage, Side Effects, Interaction
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Enzalutamide is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in...

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Article Summary

Enzalutamide is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate-specific antigen (PSA) level. AR over-expression...

Key Takeaways

  • This article explains Mechanism of Action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
Educational health guideWritten for patient understanding and clinical awareness.
Reviewed content workflowUse writer and reviewer profiles for stronger trust.
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Seek urgent medical care if you notice

These warning signs are general safety guidance. Local emergency numbers and clinical judgment should always come first.

  • Severe symptoms, breathing difficulty, fainting, confusion, or rapidly worsening illness.
  • New weakness, severe pain, high fever, or symptoms after a serious injury.
  • Any symptom that feels urgent, unusual, or unsafe for the patient.
1

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2

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Enzalutamide is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Through a mechanism that is reported to be different from other approved AR antagonists, enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate-specific antigen (PSA) level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

Enzalutamide is a nonsteroidal antiandrogen used to treat metastatic castration-resistant prostate cancer. Enzalutamide is associated with a low rate of serum enzyme elevation during therapy but has not been linked to cases of clinically apparent liver injury with jaundice.

Enzalutamide is a benzamide obtained by formal condensation of the carboxy group of 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl}-2-fluorobenzoic acid with methylamine. Used for the treatment of metastatic castration-resistant prostate cancer. It has a role as an antineoplastic agent and an androgen antagonist. It is a member of benzamides, an imidazolidinone, a thiocarbonyl compound, a nitrile, a member of (trifluoromethyl)benzenes, and a member of monofluorobenzenes.

Deutenzalutamide is a deuterated form of enzalutamide, an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor (AR) with potential antineoplastic activity. Upon administration, deutenzalutamide competitively binds to and inhibits the activity of ARs expressed on prostate cancer cells, which impairs nuclear translocation and DNA binding, resulting in apoptosis of prostate cancer cells. This results in a reduction in prostate cancer cell growth. AR overexpression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance. Deuterium incorporation, by replacing the hydrogen atoms of the N-CH3 moiety with deuterium atoms, decreases enzalutamide‘s metabolism and allows for an increased pharmacokinetic profile, thereby enhancing its anti-tumor efficacy compared to non-deuterated enzalutamide. As the deuterated form can’t cross the blood-brain barrier (BBB), the deutenzalutamide form also reduces the unwanted brain-related side effects of enzalutamide and improves its safety profile.

Mechanism of Action

Enzalutamide is a competitive androgen receptor inhibitor that affects multiple stages of the signaling pathway. It is able to inhibit androgen binding to its receptor, androgen receptor nuclear translocation, and subsequent interaction with DNA. As a result, the proliferation of prostate cancer cells decreases which ultimately leads to apoptosis and decreased tumor volume.

Enzalutamide is an androgen receptor (AR) inhibitor for the treatment of castration-resistant prostate cancer (CRPC), both metastatic and non-metastatic.[rx] It is a second-generation antiandrogen agent that the FDA approved on August 31, 2012.[rx,rx] Although androgen deprivation therapy (ADT) is the first-line treatment of prostate cancer and remission can be achieved, arising resistance is inevitable, becoming castration-resistant prostate cancer.[rx] Until recently, docetaxel is the only treatment available for metastatic CRPC; however, AR inhibitors have been developed for more targeted therapy, although first-generation AR inhibitors like bicalutamide did not substantially increase the survival rate.[rx] Second-generation such as enzalutamide is more efficacious due to a higher affinity to AR and no partial agonist activity compared to bicalutamide.[rx,rx]

Enzalutamide is a second-generation antiandrogen that blocks the activity of androgen and androgen receptor (AR) in prostate cancer. AR activity and prostate cancer progression are closely related due to the normal physiology of prostate cells, providing the rationale for androgen deprivation therapy (ADT).[rx] However, resistance will eventually arise after the commencement of ADT in 2-3 years due to the accumulation of mutations, including constitutively active mutation, AR overexpression, and changes in AR splicing variants.[rx,rx] Enzalutamide was therefore designed to exploit these mutations.[rx] In vitro experiments in human prostate cancer cell line VCaP showed that enzalutamide can suppress cell growth and induce apoptosis while other antiandrogens like bicalutamide did not.[rx]

Clinical trials on prostate cancer patients indicated that enzalutamide can lead to a decrease in serum PSA for at least 12 weeks, although this response can be short-lived and thus result in enzalutamide resistance.[rx,rx] Patients receiving enzalutamide also had a 37% decrease in the risk of death compared to placebo.[rx]

Indications

  • Enzalutamide is indicated for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
  • Xtandi is indicated for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
  • Enzalutamide is a nonsteroidal antiandrogen used to treat metastatic castration-resistant prostate cancer.
  • It is indicated for use in conjunction with castration in the treatment of metastatic castration-resistant prostate cancer (mCRPC),[rx] nonmetastatic castration-resistant prostate cancer,[rx] and metastatic castration-sensitive prostate cancer (mCSPC).[rx] It is taken by mouth.[rx]
  • Castration-Resistant Prostate Cancer
  • Metastatic Castration Sensitive Prostate Cancer

Use in Cancer

Enzalutamide is approved to treat:

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

Contraindications

  • a low seizure threshold
  • brain injury
  • a low supply of oxygen-rich blood to the heart
  • a transient ischemic attack, a type of stroke that lasts only a few minutes
  • seizures
  • pregnancy
  • a patient who is producing milk and breastfeeding
  • a type of brain disorder called posterior reversible encephalopathy syndrome
  • history of stroke

Dosage

Strengths: 40 mg; 80 mg

Prostate Cancer

  • 160 mg (four 40 mg capsules) orally once a day
  • This drug can be taken with or without food.
  • Swallow the capsules whole. Do not chew, dissolve, or open the capsules.
  • Patients receiving this drug should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
  • Metastatic and non-metastatic castration-resistant prostate cancer

Dose Adjustments

Grade 3 or more toxicity or intolerable side effect:

  • Withhold dosing for one week or until symptoms improve to Grade 2 or less, then resume at the usual dose or reduce the dose to 120 mg or 80 mg once daily if necessary.

Strong CYP450 2C8 inhibitors:

  • Avoid concomitant use. If concomitant use is necessary, reduce the dose to 80 mg once daily and return to the prior dose if the strong CYP450 2C8 inhibitor is discontinued.

Strong CYP450 3A4 inducers:

  • The concomitant use of strong CYP450 3A4 inducers should be avoided if possible. If coadministration is necessary, increase the dose to 160 to 240 mg once daily. If the strong CYP450 3A4 is discontinued, the dose should be returned to the dose used prior to the initiation of the strong CYP450 3A4 inducer.

Administration advice:

  • Take it with or without food.
  • Swallow capsules whole with water. Do not chew, dissolve, or open the capsules.

Side Effects

The Most Common

  • asthenia/fatigue,
  • pain: Back pain means pain in the spine, muscles, discs, joints, or nerves of the back. সহজ বাংলা: পিঠ/কোমরের ব্যথা।" data-rx-term="back pain" data-rx-definition="Back pain means pain in the spine, muscles, discs, joints, or nerves of the back. সহজ বাংলা: পিঠ/কোমরের ব্যথা।">back pain,
  • diarrhea,
  • pain. সহজ বাংলা: জয়েন্টের ব্যথা।" data-rx-term="arthralgia" data-rx-definition="Arthralgia means joint pain. সহজ বাংলা: জয়েন্টের ব্যথা।">arthralgia,
  • hot flush,
  • peripheral edema,
  • musculoskeletal pain,
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache,
  • upper respiratory infection,
  • muscular weakness,
  • dizziness, insomnia,
  • lower respiratory infection,
  • spinal cord compression and cauda equina syndrome,
  • hematuria, numbness. সহজ বাংলা: ঝিনঝিন/অবশ/জ্বালাভাব।" data-rx-term="paresthesia" data-rx-definition="Paresthesia means abnormal feelings such as tingling, pins and needles, burning, or numbness. সহজ বাংলা: ঝিনঝিন/অবশ/জ্বালাভাব।">paresthesia, anxiety, and hypertension.

More Common

  • weakness
  • tiredness
  • joint pain
  • muscle weakness or stiffness
  • weight loss
  • loss of appetite
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache
  • dizziness
  • burning, numbness, or tingling in the arms, hands, or feet
  • decreased sense of touch or ability to feel sensation
  • hot flashes
  • difficulty falling asleep or staying asleep
  • anxiety
  • difficulty remembering, thinking, or paying attention
  • diarrhea
  • constipation
  • itching
  • dry skin
  • nosebleeds
  • frequent urination
  • taste changes
  • seizures
  • headache; confusion; or vision changes
  • swelling of the face, tongue, lips, throat, arms, legs, hands, or feet
  • fever, cough, sore throat, or other signs of infection
  • chest pain
  • shortness of breath
  • pain in the back, muscles, and/or legs
  • numbness or tingling in the buttocks or legs
  • difficulty controlling urination or bowel movements
  • difficulty breathing
  • falling
  • broken bones or fractures
  • hallucinating (seeing things or hearing voices that do not exist)
  • breast enlargement in men
  • pink or red urine

Rare

  • cough with mucus
  • difficulty with breathing
  • dizziness
  • fever
  • loss of bladder or bowel control
  • nervousness
  • painful or difficult urination
  • pounding in the ears
  • slow or fast heartbeat
  • sore throat
  • tingling of the hands or feet
  • unable to move the legs
  • unusual weight gain or loss
  • Anxiety
  • confusion or excitement
  • depression
  • fainting
  • falling
  • lightheadedness
  • loss of memory
  • memory or attention span problems
  • nightmares or vivid dreams
  • rapid, shallow breathing
  • Headache
  • hives, itching, skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • redness of the skin
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • trouble breathing or swallowing
  • unusual drowsiness, tiredness, weakness, or feeling of sluggishness

Drug Interaction

Pregnancy and Lactation

AU TGA pregnancy category: X
US FDA pregnancy category: Not assigned.

Pregnancy

There are no data on pregnant women; however, in animal studies giving this drug during organogenesis caused adverse developmental effects at doses lower than the equivalent maximum recommended human dose (MRHD). This drug is not indicated for use in females. This drug should not be handled by women who are or may become pregnant. Male patients with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last dose. This drug may impair fertility in males of reproductive potential.

Lactation

  • This drug is not indicated for use in female patients.
  • Excreted into human milk: Unknown
  • Excreted into animal milk: Yes
  • This drug is not indicated for use in females.
  • The effects on the nursing infant are unknown.

What special precautions should I follow?

Before taking enzalutamide,

  • tell your doctor and pharmacist if you are allergic to enzalutamide, any other medications, or any of the ingredients in enzalutamide tablets or capsules. Ask your pharmacist or check the manufacturer’s information for the patient for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants (‘blood thinners) such as warfarin (Coumadin, Jantoven), carbamazepine (Carbatrol, Equetro, Tegretol, others), clopidogrel (Plavix), cyclosporine (Gengraf, Neoral, Sandimmune), dihydroergotamine (D.H.E. 45, Migranal), ergotamine (in Migergot, in Cafergot), fentanyl (Actiq, Duragesic, Fentora, Subsys, others), gemfibrozil (Lopid), itraconazole (Onmel, Sporanox), omeprazole (Prilosec), midazolam, phenobarbital, phenytoin (Dilantin, Phenytek), pimozide (Orap), quinidine (in Nuedexta), rifabutin (Mycobutin, in Talicia), rifampin (Rimactane, in Rifamate, in Rifater), rifapentine (Priftin), sirolimus (Rapamune), and tacrolimus (Prograf). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with enzalutamide, 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 what herbal products you are taking, especially St. John’s wort.
  • tell your doctor if you have or have ever had seizures, a brain injury, a brain tumor, a brain arteriovenous malformation (an abnormal connection between arteries and veins in the brain that forms before birth and may cause bleeding in the brain), broken bones, osteoporosis (a condition in which the bones become thin and weak and break easily), diabetes, high cholesterol levels, high blood pressure, heart disease, or have had a stroke or ministroke.
  • you should know that enzalutamide is only for use in men. Women should not take this medication, especially if they are or may become pregnant or are breastfeeding. Women, especially those who are or who may become pregnant should not touch enzalutamide capsules. If taken by pregnant women, enzalutamide may harm the fetus. If a pregnant woman takes enzalutamide, she should call her doctor immediately.
  • you should know that this medication may decrease fertility in men. However, you should not assume that your female partner cannot become pregnant. If your partner is pregnant, you must use a condom whenever you have sex during your treatment with enzalutamide and for 3 months after your final dose. If your partner is not pregnant but could become pregnant, you must use effective birth control whenever you have sex during your treatment and for 3 months after your final dose.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking enzalutamide.
  • you should know that enzalutamide may cause seizures. Do not drive a car or operate machinery until you know how this medication affects you.

References

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: Orthopedic / spine specialist, physical medicine doctor, or qualified clinician
Tests to discuss with doctor
  • Neurological examination for leg power, sensation, reflexes, and straight leg raise
  • X-ray only if injury, deformity, long-lasting pain, or doctor suspects bone problem
  • MRI discussion if severe nerve symptoms, weakness, bladder/bowel problem, or persistent symptoms
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?
  • Is physiotherapy, posture correction, or activity modification needed?

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: Enzalutamide – 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.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Is this article a replacement for a doctor?

No. It is educational content only. Patients should consult a qualified clinician for diagnosis and treatment.

When should I seek urgent care?

Seek urgent care for severe symptoms, rapidly worsening condition, breathing difficulty, severe pain, neurological changes, or any emergency warning sign.

References

Add references, clinical guidelines, textbooks, journal articles, or trusted medical sources here. You can edit this area from the RX Article Professional Blocks panel.

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