Orgovyxrelugolix
According to the FDA label: ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
22,552 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Orgovyx 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.
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Hot Flush 7,229 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 →Fatigue 5,569 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →- Therapy Interrupted 3,298 reports
Incorrect Dose Administered 2,004 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Asthenia 1,858 reports
Physical weakness or lack of strength.
Full definition in the glossary →Arthralgia 1,504 reports
Diarrhoea 1,469 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 →Product Dose Omission Issue 1,283 reports
A report that a dose of the medication was missed or skipped.
Full definition in the glossary →Dizziness 1,249 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Constipation 988 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Death 925 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 →Weight Increased 851 reports
Insomnia 816 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Pain 807 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Myalgia 772 reports
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 | 11,924 |
| Female | 162 |
| Unknown | 5 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 10 |
| 18-34 | 22 |
| 35-49 | 131 |
| 50-64 | 1,273 |
| 65-74 | 3,076 |
| 75+ | 3,659 |
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 Orgovyx. 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 |
|---|---|
| Non-Serious | 16,964 |
| Other Serious | 3,969 |
| Hospitalization | 1,997 |
| Death | 1,088 |
| Life-Threatening | 59 |
| Disability | 39 |
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 Orgovyx. 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 |
|---|---|
| 2016 | 1 |
| 2019 | 5 |
| 2020 | 3 |
| 2021 | 472 |
| 2022 | 2,334 |
| 2023 | 2,978 |
| 2024 | 5,773 |
| 2025 | 10,312 |
| 2026 (partial) | 674 |
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 Orgovyx
In FDA adverse event reports that mention Orgovyx, these medications appeared most often in the same report.
- Aspirin (2,686 reports)
- Ergocalciferol (2,554 reports)
- Enzalutamide (1,887 reports)
- Lisinopril (1,528 reports)
- Darolutamide (1,430 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