Fensolvi: adverse event reports filed with FDA

748

reports as suspect product

0% of all reports · about 127 a year

114

reports, 12 months to June 2026

141 in the 12 months before

4.4%

marked serious by the reporter

50.5% across the class

0%

record death among outcomes, as reported

0 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 Fensolvi reports recording the termmedian drug in gonadotropin releasing hormone receptor agonist

1. Off label useused for a purpose or in a way not on the label27.7%207
2. Intercepted product preparation error26.5%198
3. Syringe issue20.2%151
4. Device leakagethe device leaked16.7%125
5. Wrong technique in product usage processthe product was used in the wrong way12.3%92
6. Drug ineffectivethe medicine did not work as expected10%75
7. Injection site painpain where the injection was given6.7%50
8. Injection site mass4.5%34
9. Product administration errora mistake in giving the product4%30
10. Product physical consistency issue3.9%29
11. Incorrect dose administeredthe wrong dose was given2.8%21
12. Device occlusionthe device blocked2.7%20
13. Product quality issuea problem with the product itself2.5%19
14. Product dose omission issuea dose was missed2.4%18
15. Product packaging quantity issue2.3%17
16. Blood luteinising hormone increased1.6%12
17. Occupational exposure to product1.6%12
18. Intercepted product administration error1.3%10
19. Intermenstrual bleeding1.3%10
20. Needle issuea problem with the needle1.3%10
21. Breast enlargement1.2%9
22. Injection site extravasation1.2%9
23. Oestradiol increased1.2%9
24. Blood luteinising hormone abnormal1.1%8
25. Injection site discharge1.1%8
26. Blood follicle stimulating hormone increased0.9%7
27. Weight increasedweight gain0.9%7
28. Poor quality product administered0.8%6
29. Device breakagethe device broke0.7%5
30. Device issuea problem with the device0.7%5

Top 30 of 89 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 7 drugs in the gonadotropin releasing hormone receptor agonist 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 61,409 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. 99.3% 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 748 reports.

Drugs most often listed in the same reports

Other products listed in reports where Fensolvi 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 agonist 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 Fensolvi as a suspect or interacting product; reports listing it only as a concomitant medication (5) 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.