Xtandienzalutamide
According to the FDA label: XTANDI ® is indicated for the treatment of patients with: • castration-resistant prostate cancer (CRPC) • metastatic castration-sensitive prostate cancer (mCSPC) • non‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen receptor inhibitor indicated for the treatment of patients with: • castration-resistant prostate cancer. ( 1 ) • metastatic castration-sensitive prostate cancer.
58,003 adverse event reports submitted to the FDA (2012–2026)
Top Reported Adverse Events
The most frequently reported events in association with Xtandi in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Fatigue 10,208 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Death 7,681 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Malignant Neoplasm Progression 5,440 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →- Prostatic Specific Antigen Increased 4,325 reports
Asthenia 4,137 reports
Physical weakness or lack of strength.
Full definition in the glossary →Drug Ineffective 4,043 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Hot Flush 3,850 reports
A sudden feeling of heat, often in the face and upper body, sometimes with sweating. Often called a hot flash in American English.
Full definition in the glossary → See all drugs reporting this event →Decreased Appetite 3,394 reports
Nausea 3,247 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Dizziness 3,124 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 2,790 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Back Pain 2,290 reports
Arthralgia 2,137 reports
Underdose 2,073 reports
A report that less of a medication was taken than prescribed. This is a usage category.
Full definition in the glossary →Constipation 1,817 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 55,293 |
| Female | 363 |
| Unknown | 83 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 699 |
| 18-34 | 18 |
| 35-49 | 181 |
| 50-64 | 4,362 |
| 65-74 | 10,254 |
| 75+ | 18,554 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Xtandi. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 23,137 |
| Non-Serious | 22,301 |
| Death | 11,324 |
| Hospitalization | 10,957 |
| Life-Threatening | 701 |
| Disability | 337 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Xtandi. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2012 | 244 |
| 2013 | 2,555 |
| 2014 | 4,441 |
| 2015 | 5,923 |
| 2016 | 7,914 |
| 2017 | 10,285 |
| 2018 | 7,756 |
| 2019 | 3,394 |
| 2020 | 2,641 |
| 2021 | 2,409 |
| 2022 | 2,608 |
| 2023 | 2,329 |
| 2024 | 2,508 |
| 2025 | 2,631 |
| 2026 (partial) | 365 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Xtandi
In FDA adverse event reports that mention Xtandi, these medications appeared most often in the same report.
- Leuprolide (3,522 reports)
- Aspirin (3,236 reports)
- Prednisone (3,220 reports)
- Denosumab (2,821 reports)
- Abiraterone (2,739 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026