Restasis: adverse event reports filed with FDA

18,243

reports as suspect product

0.1% of all reports · about 814 a year

610

reports, 12 months to June 2026

494 in the 12 months before

8.9%

marked serious by the reporter

79.1% across the class

0.7%

record death among outcomes, as reported

133 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 Restasis reports recording the termmedian drug in calcineurin inhibitor immunosuppressant

1. Eye irritationeye irritation30.8%5,611
2. Drug ineffectivethe medicine did not work as expected13.6%2,482
3. Eye paineye pain11.8%2,160
4. Vision blurredblurred vision10.3%1,888
5. Ocular hyperaemiaa red eye9.2%1,676
6. Dry eyedry eye6.8%1,241
7. Lacrimation increasedwatery eyes5.7%1,036
8. Eye pruritus5.2%952
9. Foreign body sensation in eyes5.1%922
10. Product container issuea problem with the container5%915
11. Incorrect dose administeredthe wrong dose was given4.5%827
12. Multiple use of single-use product3.7%672
13. Off label useused for a purpose or in a way not on the label3.6%654
14. Accidental exposure to product3.5%642
15. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.3%603
16. Eye discharge3.2%582
17. Product storage errorthe product was stored wrongly3.1%566
18. Product dose omissiona dose was missed3%549
19. Wrong technique in product usage processthe product was used in the wrong way2.8%509
20. Headachehead pain2.7%499
21. Drug dose omissiona dose was missed2.5%453
22. Visual impairmentreduced vision2.2%405
23. Eye swellinga swollen eye2.1%384
24. Cataractclouding of the eye lens2%358
25. Ocular discomfort1.8%325
26. Expired product administeredthe product was used past its expiry date1.8%320
27. Photophobiasensitivity to light1.6%300
28. Eye disorder1.5%265
29. Pruritusitching1.4%248
30. Hypersensitivityan allergic-type reaction1.4%247

Top 30 of 722 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. 99.1% 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 18,243 reports.

Drugs most often listed in the same reports

Other products listed in reports where Restasis 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 Restasis as a suspect or interacting product; reports listing it only as a concomitant medication (15,728) 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.