Lucentis: adverse event reports filed with FDA

20,417

reports as suspect product

0.1% of all reports · about 1,021 a year

203

reports, 12 months to June 2026

938 in the 12 months before

82.9%

marked serious by the reporter

87.6% across the class

21%

record death among outcomes, as reported

4,286 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 Lucentis reports recording the termmedian drug in vascular endothelial growth factor inhibitor

1. Deaththe patient died; cause not stated by this term16.6%3,385
2. Visual acuity reducedreduced sharpness of vision11.4%2,334
3. Visual impairmentreduced vision7%1,423
4. Off label useused for a purpose or in a way not on the label6.8%1,380
5. Cerebrovascular accidentstroke4.7%969
6. Drug ineffectivethe medicine did not work as expected4.7%956
7. No adverse eventno adverse event was reported4.5%926
8. Eye haemorrhage4.5%911
9. Vision blurredblurred vision4.4%902
10. Blindnessloss of sight4.4%890
11. Eye paineye pain4.1%835
12. Vitreous floatersfloaters in vision2.7%555
13. Malaisegeneral feeling of being unwell2.6%523
14. Endophthalmitisinfection inside the eye2.5%519
15. Retinal haemorrhage2.5%515
16. Cataractclouding of the eye lens2.5%504
17. Myocardial infarctionheart attack2.5%502
18. Macular oedema2.3%477
19. Falla fall2%418
20. Headachehead pain2%416
21. Blindness unilateral1.9%396
22. Ocular hyperaemiaa red eye1.9%391
23. Age-related macular degeneration1.8%373
24. Eye disorder1.8%367
25. Disease progressionthe disease advanced1.7%356
26. Eye irritationeye irritation1.4%291
27. Intraocular pressure increasedraised pressure in the eye1.4%281
28. Painpain, site not specified1.3%274
29. Macular degenerationa disease of the central retina1.3%266
30. Choroidal neovascularisation1.3%265

Top 30 of 1,148 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 10 drugs in the vascular endothelial growth factor inhibitor 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 176,429 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. 44.4% 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 20,417 reports.

Drugs most often listed in the same reports

Other products listed in reports where Lucentis 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 vascular endothelial growth factor inhibitor 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 Lucentis as a suspect or interacting product; reports listing it only as a concomitant medication (781) 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.