Orilissa: adverse event reports filed with FDA

3,198

reports as suspect product

0% of all reports · about 413 a year

29

reports, 12 months to June 2026

45 in the 12 months before

32.4%

marked serious by the reporter

23.4% across the class

0.1%

record death among outcomes, as reported

2 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Orilissa reports recording the termmedian drug in gonadotropin releasing hormone receptor antagonist

1. Hot flusha hot flush14.5%463
2. Painpain, site not specified13%415
3. Nauseafeeling sick9.5%305
4. Endometriosisendometriosis8.9%286
5. Headachehead pain8%256
6. Drug ineffectivethe medicine did not work as expected7%224
7. Depressionlow mood6%193
8. Arthralgiajoint pain5.9%188
9. Anxietyanxiety4.6%146
10. Insomniadifficulty sleeping4.5%143
11. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine4.3%138
12. Suicidal ideationthoughts of suicide4.3%137
13. Surgeryan operation4%129
14. Fatiguetiredness4%127
15. Mood swingsmood swings3.5%111
16. Night sweatssweating at night3.2%103
17. Migrainemigraine3.1%100
18. Amenorrhoeaperiods stopped2.8%91
19. Dysmenorrhoea2.8%91
20. Dizzinesslight-headedness or unsteadiness2.8%90
21. Hysterectomy2.7%85
22. Feeling abnormalfeeling odd or not right2.6%83
23. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%82
24. Abdominal painstomach or belly pain2.5%81
25. Alopeciahair loss2.5%80
26. Vomitingbeing sick2.5%79
27. Muscle spasmsmuscle cramps2.3%73
28. Weight increasedweight gain2.2%71
29. Back painback pain2.1%66
30. Pelvic pain1.9%60

Top 30 of 397 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the gonadotropin releasing hormone receptor antagonist class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 28,126 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 3,198 reports.

Drugs most often listed in the same reports

Other products listed in reports where Orilissa is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the gonadotropin releasing hormone receptor antagonist class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Orilissa as a suspect or interacting product; reports listing it only as a concomitant medication (104) are excluded. 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.