enzalutamide
Brand names: Xtandi
Xtandi contains enzalutamide. It is used to treat prostate cancer that is resistant to certain treatments.
What it does
Xtandi is used to treat prostate cancer in men.
Common side effects
Muscle or joint pain, Feeling tired, Hot flashes
Key warnings
Xtandi can cause seizures.
How It Works
Xtandi blocks the effect of hormones called androgens, like testosterone. Androgens can help prostate cancer cells grow. By blocking androgens, Xtandi can slow or stop the growth of prostate cancer.
How to Take It
Take Xtandi 160 mg once a day by mouth. You can take it with or without food. Swallow the capsule or tablet whole with enough water. Do not chew, dissolve, cut, crush, or open the capsules or tablets.
Pregnancy & Breastfeeding
Xtandi is not for use in women. It can cause harm to an unborn baby if taken by a pregnant woman. Men who are taking Xtandi and have partners who can get pregnant should use effective birth control during treatment and for 3 months after the last dose.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store Xtandi capsules and tablets at room temperature (68°F to 77°F) in a dry place and keep the container tightly closed.
Side Effects (from patient reports)
Based on 49,223 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 57,614 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.
Total Reports
57,614
Death-Related Reports
11,299
Hospitalization Reports
10,853
Top Indication
Prostate Cancer
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 10,159 |
| 2 | DEATH | 7,667 |
| 3 | MALIGNANT NEOPLASM PROGRESSION | 5,409 |
| 4 | PROSTATIC SPECIFIC ANTIGEN INCREASED | 4,295 |
| 5 | ASTHENIA | 4,120 |
| 6 | DRUG INEFFECTIVE | 4,028 |
| 7 | HOT FLUSH | 3,819 |
| 8 | DECREASED APPETITE | 3,379 |
| 9 | NAUSEA | 3,240 |
| 10 | DIZZINESS | 3,107 |
| 11 | DIARRHOEA | 2,783 |
| 12 | BACK PAIN | 2,282 |
| 13 | ARTHRALGIA | 2,124 |
| 14 | UNDERDOSE | 2,067 |
| 15 | CONSTIPATION | 1,807 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Xtandi can cause seizures. If you have a seizure while taking Xtandi, stop taking it permanently. Xtandi can also cause a condition called posterior reversible encephalopathy syndrome (PRES). If you experience PRES, stop taking Xtandi. Xtandi can harm an unborn baby, so men with partners who can get pregnant should use effective birth control during treatment and for 3 months after the last dose.
Known Drug Interactions
Anticancer drugs apalutamide, enzalutamide ↓ nirmatrelvir/ritonavir Co-administration contraindicated due to potential loss of virologic response and possible resistance [see Contraindications (4) ].
Mechanism: Enzalutamide lowers the levels of nirmatrelvir/ritonavir in your body by speeding up how it is processed. This can prevent the medicine from fighting the virus effectively.
What to do: This combination should not be used because it can cause the treatment to fail. Talk to your doctor about changing your medications.
Strong CYP3A4 Inducers The coadministration of XTANDI with rifampin (a strong CYP3A4 inducer and a moderate CYP2C8 inducer) decreases plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may decrease the efficacy of XTANDI.
Mechanism: Rifampin makes your body clear out enzalutamide faster than normal. This can lower the amount of medicine in your system and make it less effective at treating your condition.
What to do: Your doctor may need to change your dose or check how well your treatment is working because this combination can lower the drug's effectiveness.
7.3 Laboratory Test Interference XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin [see Warnings and Precautions ( 5.8 )] .
Mechanism: Enzalutamide interferes with the way labs measure digoxin in your blood, leading to test results that look higher than they really are. This is a problem with the test itself, not the actual amount of drug in your body.
What to do: Make sure your doctor and the lab know you are taking enzalutamide so they can use a special testing method to get the correct digoxin level.
( 7.2 ) 7.1 Effect of Other Drugs on XTANDI Strong CYP2C8 Inhibitors The coadministration of XTANDI with gemfibrozil (a strong CYP2C8 inhibitor) increases plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may increase the incidence and severity of adverse reactions of XTANDI.
Mechanism: Gemfibrozil blocks the body from breaking down enzalutamide properly. This causes the drug to stay in your blood longer and can increase your risk of having bad side effects.
What to do: Your doctor may need to adjust your dose or monitor you more often for side effects while you are taking both medications.
Common Questions
Can women take Xtandi?
What should I do if I have trouble swallowing the capsules or tablets?
Can Xtandi affect my fertility?
Will Xtandi interact with other medications I am taking?
What if my PSA level becomes undetectable?
What should I do if I experience a seizure while taking Xtandi?
Can I drive or operate machinery while taking Xtandi?
How long will I need to take Xtandi?
What should I do if I have a severe side effect?
Can I take Xtandi with food?
What are the common side effects of enzalutamide?
Does enzalutamide interact with other medications?
What drug class is enzalutamide?
Is enzalutamide safe during pregnancy?
Related Medications in Androgen Receptor Inhibitor
Other drugs grouped near enzalutamide — same-class peers and common alternatives.
abiraterone
Zytiga
Abiraterone (Zytiga) is a medicine used with prednisone to treat prostate cancer that has spread.
Compare with enzalutamide →
anastrozole
Arimidex
Anastrozole is a medicine used to treat breast cancer in women after menopause.
Compare with enzalutamide →
bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
Compare with enzalutamide →
cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
Compare with enzalutamide →
clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
Compare with enzalutamide →
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
🩺 Find a Doctor
Search prescribers for Androgen Receptor Inhibitor
🏨 Hospital Quality
CMS hospital ratings, safety scores & patient outcomes
💊 Supplement Data
NIH DSLD — check supplement ingredients & label claims
🍽️ Food Safety Alerts
FDA recalls, inspections & outbreak investigations
⚠️ Product Recalls
FDA, CPSC & NHTSA recall search
💉 Procedure Costs
Medicare procedure pricing for 9,297 procedures
Save on enzalutamide
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for enzalutamide
The FDA label for enzalutamide (sold under brand names such as Xtandi) classifies it as a prescription-only medication in the Androgen Receptor Inhibitor class. Xtandi is used to treat prostate cancer in men. Official labeling lists 11 commonly reported side effects, including Muscle or joint pain, Feeling tired, Hot flashes.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 49,223 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 12, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages