Restasis (cyclosporine) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Restasis
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Cyclosporine
Class: Calcineurin inhibitor immunosuppressant

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 18,243 adverse event reports that name Restasis. In these reports the drug is a suspect or interacting product.

In the same period, 15,728 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 610 reports in the 12 months to June 2026 and 494 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 610 (under 0.1%) name Restasis. Reports from consumers or other non-health professionals were 82.7% of the reports that name Restasis and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Restasis is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 157 reports that name Restasis.
In January to March 2026, FDA received 166.
In April to June 2025, FDA received 120.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 405 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 18,216 of the 18,243 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 405 terms.

Reaction terms in the reports that name Restasis, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 18,243 reports
Eye irritation	5,611	30.8%
Drug ineffectivethe medicine did not work as expected	2,482	13.6%
Eye pain	2,160	11.8%
Vision blurredblurred vision	1,888	10.3%
Ocular hyperaemiaa red eye	1,676	9.2%
Dry eye	1,241	6.8%
Lacrimation increasedwatery eyes	1,036	5.7%
Eye pruritus	952	5.2%
Foreign body sensation in eyes	922	5.1%
Product container issuea problem with the container	915	5%
Incorrect dose administeredthe wrong dose was given	827	4.5%
Multiple use of single-use product	672	3.7%
Off label useused for a purpose or in a way not on the label	654	3.6%
Accidental exposure to product	642	3.5%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	603	3.3%
Eye discharge	582	3.2%
Product storage errorthe product was stored wrongly	566	3.1%
Product dose omissiona dose was missed	549	3%
Wrong technique in product usage processthe product was used in the wrong way	509	2.8%
Headachehead pain	499	2.7%
Drug dose omissiona dose was missed	453	2.5%
Visual impairmentreduced vision	405	2.2%
Eye swellinga swollen eye	384	2.1%
Cataractclouding of the eye lens	358	2%
Ocular discomfort	325	1.8%
Expired product administeredthe product was used past its expiry date	320	1.8%
Photophobiasensitivity to light	300	1.6%
Eye disorder	265	1.5%
Pruritusitching	248	1.4%
Hypersensitivityan allergic-type reaction	247	1.4%
Burning sensationa burning feeling	237	1.3%
Erythemaskin redness	236	1.3%
Dizzinesslight-headedness or unsteadiness	234	1.3%
Instillation site pain	229	1.3%
Incorrect product storagethe product was stored wrongly	226	1.2%
Eyelid oedemaa swollen eyelid	222	1.2%
Inappropriate schedule of product administrationthe product was taken at the wrong times	217	1.2%
Painpain, site not specified	217	1.2%
Erythema of eyelid	214	1.2%
Abnormal sensation in eye	203	1.1%
Product packaging quantity issue	195	1.1%
Product dropper issue	193	1.1%
Visual acuity reducedreduced sharpness of vision	186	1%
Rashskin rash	184	1%
Scleral hyperaemia	162	0.9%
Product use complaint	157	0.9%
Therapeutic response decreasedthe medicine worked less well	156	0.9%
Asthenopia	155	0.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	148	0.8%
Nauseafeeling sick	145	0.8%

Download all 405 terms of Restasis (CSV)

The counts add to more than 18,243 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Cyclosporine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Cyclosporine	Generic name	38,688
Cequa	Brand name	3,041
Cyclosporine Modified	Brand name	444
Gengraf	Brand name	543
Neoral	Brand name	11,363
Restasis (this page)	Brand name	18,243
Sandimmune	Brand name	1,871
Vevye	Brand name	4,794

Sum of the separately reported names: 78,987. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Restasis, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2004	12	10	0	0	1	1	8	2
2005	10	8	0	0	3	0	5	2
2006	10	7	0	0	4	0	3	3
2007	7	6	0	0	0	1	5	1
2008	50	39	0	1	1	6	33	11
2009	795	35	1	2	1	2	32	760
2010	832	46	1	7	6	1	36	786
2011	681	40	1	3	7	4	32	641
2012	63	37	3	1	4	4	31	26
2013	793	60	4	3	8	5	48	733
2014	1,200	59	0	3	13	7	47	1,141
2015	1,366	135	3	3	29	10	107	1,231
2016	1,842	181	12	10	33	13	147	1,661
2017	2,057	139	6	4	25	18	104	1,918
2018	1,311	73	7	0	10	4	57	1,238
2019	1,776	34	2	0	8	5	26	1,742
2020	1,021	81	1	0	16	3	70	940
2021	1,105	62	5	0	6	2	59	1,043
2022	862	56	7	0	8	4	47	806
2023	1,115	120	24	0	13	3	89	995
2024	445	151	35	0	28	5	103	294
2025	555	152	18	1	34	2	113	403
2026	335	91	3	0	22	5	79	244

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Restasis, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Restasis, by the year in which FDA received them
Year	Reports
2004	12
2005	10
2006	9
2007	7
2008	48
2009	39
2010	824
2011	823
2012	710
2013	794
2014	1,238
2015	1,389
2016	1,855
2017	1,990
2018	1,369
2019	1,761
2020	1,005
2021	1,108
2022	829
2023	1,113
2024	439
2025	548
2026	323

Reports that name Restasis, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Restasis
Age	Reports	Share
Under 2	5	under 0.1%
2 to 11	53	0.3%
12 to 17	50	0.3%
18 to 44	342	1.9%
45 to 64	2,189	12%
65 to 74	2,010	11%
75 and over	2,162	11.9%
Age not given	11,432	62.7%

Sex of the patient in the reports that name Restasis
Sex	Reports	Share
Female	14,366	78.7%
Male	2,720	14.9%
Unknown or not given	1,157	6.3%

Type of reporter in the reports that name Restasis
Reporter	Reports	Share
Physician	1,833	10%
Pharmacist	348	1.9%
Other health professional	750	4.1%
Lawyer	5	under 0.1%
Consumer or non-health professional	15,094	82.7%
Not given	213	1.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Restasis record
Indication as recorded (MedDRA)	Reports	Share
Dry eye	11,185	61.3%
Sjogren's syndrome	69	0.4%
Lacrimation increased	37	0.2%
Lacrimation decreased	30	0.2%
Blepharitis	28	0.2%
Eye disorder	23	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 18,243 reports.

Drugs in the same reports

Other drugs that the reports of Restasis name, in any role, in order of name
Drug	Reports that name the two
Aspirin	210
Calcium	184
Levothyroxine	295
Lisinopril	252
Losartan	178
Metoprolol	189
Refresh Tears	322
Synthroid	377
Vitamin d	185
Xiidra	179

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Cyclosporine same ingredient
Cequa same ingredient
Cyclosporine Modified same ingredient
Gengraf same ingredient
Neoral same ingredient
Sandimmune same ingredient
Prograf same class
Pimecrolimus same class
Tacrolimus same class
Vevye same class
Requip Xl next in the A to Z list
Restoril next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for RestasisThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

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Reported Reactions. Restasis: adverse event reports that FDA received. https://reportedreactions.com/drug/restasis/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Restasis as a suspect or interacting product. The 15,728 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Restasis was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Restasis?

No. It is a count of what people reported to FDA: 18,243 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (82.7%), physician (10%) and other health professional (4.1%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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