Prescription medication · Androgen Receptor Inhibitor
enzalutamide
Also sold as Xtandi. Xtandi is used to treat prostate cancer in men.
Data updated 2026-05-15
- 57,614
- FDA reportsOften reported
- 4
- InteractionsFew interactions
- Rx
- Availability
What the data shows
enzalutamide (Xtandi) is a prescription Androgen Receptor Inhibitor, more reported than most tracked drugs (57,614 FDA reports), with 4 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
enzalutamide (Xtandi) is a prescription Androgen Receptor Inhibitor. Xtandi is used to treat prostate cancer in men.
Xtandi contains enzalutamide. It is used to treat prostate cancer that is resistant to certain treatments.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from enzalutamide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of enzalutamide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of enzalutamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of enzalutamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 57,614 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for enzalutamide, by number of reports
- Feeling tired
Feeling tired
10,159 reports
- Death
Death
7,667 reports
- Cancer getting worse
Cancer getting worse
5,409 reports
- PSA level increased
PSA level increased
4,295 reports
- Weakness
Weakness
4,120 reports
- Hot flash 3,819
Hot flash
3,819 reports
- Less hungry 3,379
Less hungry
3,379 reports
- Feeling sick to your stomach 3,240
Feeling sick to your stomach
3,240 reports
- Feeling lightheaded 3,107
Feeling lightheaded
3,107 reports
- Diarrhea 2,783
Diarrhea
2,783 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for enzalutamide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where enzalutamide sits
enzalutamide has more FDA adverse-event reports than 76% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is enzalutamide; the line is the median (50th percentile).
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
Reports Mentioning Death
11,299
19.6% of reports — not proof of cause
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 |
| 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 |
| 16 | FALL | 1,790 |
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining 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.
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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
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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 57,614 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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