Pharmacologic class (EPC) · 5 drug pages

Androgen receptor inhibitor: adverse event reports filed with FDA

61,805 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

61,805
reports across the class: 0.3% of all reports; 1,987
reports, 12 months to June 2026: 2,329 in the 12 months before; 63.3%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Androgen receptor inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 61,805 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

1,987 reports arrived in the 12 months to June 2026, down 15% from 2,329 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 63.3% of the class's reports are marked serious, 18.8% record death among the outcomes and 20.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (16%), death (12.3%) and malignant neoplasm progression (9.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
XtandiEnzalutamide	brand	43,710	1,114	54.2%	Fatigue
Enzalutamide	generic	10,811	420	92.7%	Death
Bicalutamide	generic	2,978	184	93.5%	Drug ineffective
CasodexBicalutamide	brand	2,967	24	86%	Malignant neoplasm progression
WinleviClascoterone	brand	1,339	245	2.7%	Product storage error

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Fatiguetiredness16%9,895
Deaththe patient died; cause not stated by this term12.3%7,609
Malignant neoplasm progression9.3%5,764
Prostatic specific antigen increased7.3%4,505
Drug ineffectivethe medicine did not work as expected7.2%4,425
Astheniaweakness or lack of energy6.7%4,136
Hot flusha hot flush5.8%3,556
Decreased appetitereduced appetite5.5%3,401
Nauseafeeling sick5.4%3,314
Dizzinesslight-headedness or unsteadiness5%3,116
Diarrhoealoose or frequent stools4.5%2,762
Back painback pain3.6%2,254
Arthralgiajoint pain3.4%2,089
Underdoseless than the intended dose3.4%2,080
Falla fall2.9%1,811
Constipationconstipation2.9%1,810
Weight decreasedweight loss2.9%1,786
Painpain, site not specified2.7%1,685
Headachehead pain2.7%1,657
Dyspnoeashortness of breath2.6%1,601
Malaisegeneral feeling of being unwell2.6%1,582
Insomniadifficulty sleeping2.2%1,381
Peripheral swellingswelling of the arms or legs2.1%1,316
Dysphagiadifficulty swallowing2.1%1,299
Vomitingbeing sick2%1,257

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death18.8%11,603

Life-threatening1.7%1,051

Hospitalisation (initial or prolonged)20.1%12,412

Disability0.9%573

Congenital anomaly0%11

Other serious40.5%25,042

Not serious36.7%22,713

Patient age

Under 20%7

2 to 110%4

12 to 170.1%41

18 to 440.3%182

45 to 648.1%4,989

65 to 7418.1%11,212

75 and over32.7%20,183

Age not given40.8%25,187

Who reported

Physician17%10,531

Pharmacist4.9%3,001

Other health professional13.6%8,387

Lawyer0%25

Consumer or non-health professional63.1%38,989

Not given1.4%872

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Androgen receptor inhibitor reports

Which drugs are in the Androgen receptor inhibitor class on this site?

Xtandi, Enzalutamide, Bicalutamide, Casodex and Winlevi. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

61,805 reports through June 2026, 1,987 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fatigue (16%), death (12.3%), malignant neoplasm progression (9.3%), prostatic specific antigen increased (7.3%) and drug ineffective (7.2%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.