Cequa: adverse event reports filed with FDA

3,041

reports as suspect product

0% of all reports · about 462 a year

598

reports, 12 months to June 2026

1,237 in the 12 months before

4.6%

marked serious by the reporter

79.1% across the class

0.4%

record death among outcomes, as reported

13 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 Cequa reports recording the termmedian drug in calcineurin inhibitor immunosuppressant

1. Eye irritationeye irritation43%1,307
2. Therapy cessation11.8%359
3. Drug ineffectivethe medicine did not work as expected11.8%358
4. Eye paineye pain11.4%346
5. Product use issuea problem in how the product was used11%333
6. Ocular hyperaemiaa red eye6.9%210
7. Product dose omission issuea dose was missed6.9%209
8. Lacrimation increasedwatery eyes5.7%172
9. Product storage errorthe product was stored wrongly5.6%171
10. Eye pruritus4.6%140
11. Vision blurredblurred vision4.1%124
12. Headachehead pain3%90
13. Condition aggravatedthe condition being treated got worse2.2%67
14. Burning sensationa burning feeling2.1%65
15. Ocular discomfort2.1%63
16. Drug hypersensitivityan allergic-type reaction to a medicine1.9%58
17. Painpain, site not specified1.9%58
18. Eye swellinga swollen eye1.7%53
19. Dry eyedry eye1.6%48
20. Hypersensitivityan allergic-type reaction1.4%43
21. Multiple use of single-use product1.2%37
22. Therapy interrupted1.2%35
23. Urinary tract infectionbladder or urinary infection1.2%35
24. Expired product administeredthe product was used past its expiry date1.1%33
25. Photophobiasensitivity to light1%31
26. Swelling of eyelid1%29
27. Wrong technique in product usage processthe product was used in the wrong way1%29
28. Pruritusitching0.9%27
29. Deaththe patient died; cause not stated by this term0.8%24
30. Instillation site irritation0.8%24

Top 30 of 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 11 drugs in the calcineurin inhibitor immunosuppressant 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 206,378 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. 99.2% 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 3,041 reports.

Drugs most often listed in the same reports

Other products listed in reports where Cequa 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 calcineurin inhibitor immunosuppressant 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 Cequa as a suspect or interacting product; reports listing it only as a concomitant medication (684) 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.