Iluvien: adverse event reports filed with FDA

730

reports as suspect product

0% of all reports · about 70 a year

106

reports, 12 months to June 2026

122 in the 12 months before

55.8%

marked serious by the reporter

77.7% across the class

1.2%

record death among outcomes, as reported

9 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 Iluvien reports recording the termmedian drug in corticosteroid

1. Intraocular pressure increasedraised pressure in the eye23.3%170
2. Device failurethe device failed14.9%109
3. Circumstance or information capable of leading to medication errora situation that could lead to a medication error11.8%86
4. Device dislocationthe device moved out of position11.1%81
5. Medical device removalthe device was removed10.5%77
6. Off label useused for a purpose or in a way not on the label8.8%64
7. Vitrectomy7%51
8. Product administration errora mistake in giving the product6.8%50
9. Glaucomaraised pressure in the eye5.5%40
10. Visual impairmentreduced vision5.5%40
11. Needle issuea problem with the needle5.3%39
12. Cataract operation4.8%35
13. Blindnessloss of sight4.7%34
14. Hypotony of eye4.1%30
15. Corneal oedema3.8%28
16. Drug dose omission by device3.6%26
17. Drug ineffectivethe medicine did not work as expected3.4%25
18. Vitreous haemorrhage3.3%24
19. Device difficult to usethe device was hard to use3.2%23
20. Eye paineye pain3%22
21. Cataractclouding of the eye lens2.9%21
22. Endophthalmitisinfection inside the eye2.7%20
23. Trabeculectomy2.7%20
24. Eye operation2.5%18
25. Visual acuity reducedreduced sharpness of vision2.2%16
26. Condition aggravatedthe condition being treated got worse2.1%15
27. Glaucoma drainage device placement2.1%15
28. Trabeculoplasty2.1%15
29. Macular oedema1.9%14
30. Device issuea problem with the device1.8%13

Top 30 of 99 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 74 drugs in the corticosteroid 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 808,789 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. 64% 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 730 reports.

Drugs most often listed in the same reports

Other products listed in reports where Iluvien 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 corticosteroid 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 Iluvien 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.