Pataday adverse event reports that FDA received

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

Name type: Product name as reported

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 June 2008 to June 2026, FDA received 4,944 adverse event reports that name Pataday. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 2,122 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 28 reports in the 12 months to June 2026 and 9 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, 28 (under 0.1%) name Pataday. Reports from consumers or other non-health professionals were 83.4% of the reports that name Pataday 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 Pataday 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 18 reports that name Pataday.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 6.

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 60 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 4,906 of the 4,944 reports (99.2%).

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 60 terms.

Reaction terms in the reports that name Pataday, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,944 reports
Treatment failurethe treatment did not work	3,381	68.4%
Drug ineffectivethe medicine did not work as expected	837	16.9%
Eye irritation	214	4.3%
Eye pruritus	131	2.6%
Ocular hyperaemiaa red eye	95	1.9%
Vision blurredblurred vision	93	1.9%
Hypersensitivityan allergic-type reaction	92	1.9%
Eye pain	77	1.6%
Eye discharge	58	1.2%
Dry eye	48	1%
Lacrimation increasedwatery eyes	45	0.9%
Condition aggravatedthe condition being treated got worse	38	0.8%
Eye swellinga swollen eye	33	0.7%
Ocular discomfort	32	0.6%
Foreign body sensation in eyes	26	0.5%
Off label useused for a purpose or in a way not on the label	23	0.5%
Headachehead pain	22	0.4%
Product quality issuea problem with the product itself	21	0.4%
Product container issuea problem with the container	19	0.4%
Dizzinesslight-headedness or unsteadiness	18	0.4%
Visual impairmentreduced vision	18	0.4%
Eyelid margin crusting	17	0.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	16	0.3%
Erythemaskin redness	16	0.3%
Swelling of eyelid	16	0.3%
Abnormal sensation in eye	15	0.3%
Eye disorder	14	0.3%
Dysgeusiaaltered taste	13	0.3%
Pruritusitching	12	0.2%
Nauseafeeling sick	11	0.2%
Product physical consistency issue	11	0.2%
Contraindicated product administered	10	0.2%
Inappropriate schedule of product administrationthe product was taken at the wrong times	10	0.2%
Therapy non-responderthe treatment did not work	10	0.2%
Liquid product physical issue	9	0.2%
Product use in unapproved indicationused for a purpose not on the label	9	0.2%
Cough	8	0.2%
Drug effect less than expected	8	0.2%
Malaisegeneral feeling of being unwell	8	0.2%
Oropharyngeal painsore throat	8	0.2%
Therapeutic product ineffective	8	0.2%
Erythema of eyelid	7	0.1%
Expired product administeredthe product was used past its expiry date	7	0.1%
Eye allergy	7	0.1%
Product size issue	7	0.1%
Asthma	6	0.1%
Blood pressure increaseda raised blood pressure reading	6	0.1%
Burning sensationa burning feeling	6	0.1%
Conjunctivitis allergic	6	0.1%
Diarrhoealoose or frequent stools	6	0.1%

Download all 60 terms of Pataday (CSV)

The counts add to more than 4,944 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.

Outcomes by year

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

Outcomes in the reports that name Pataday, 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
2008	2	0	0	0	0	0	0	2
2009	2	1	0	0	1	0	0	1
2010	2	2	0	0	0	0	2	0
2011	2	2	0	0	0	0	2	0
2012	5	4	0	0	1	0	4	1
2013	6	3	0	0	0	0	3	3
2014	8	3	0	0	2	0	1	5
2015	38	2	1	0	0	0	1	36
2016	269	8	1	0	2	1	6	261
2017	71	14	1	1	2	1	9	57
2018	31	1	0	0	0	0	1	30
2019	106	7	2	0	1	0	4	99
2020	3,238	9	1	0	0	1	7	3,229
2021	874	9	0	0	1	0	8	865
2022	208	4	0	0	1	0	3	204
2023	31	9	0	1	0	0	7	22
2024	16	6	0	0	0	0	6	10
2025	11	0	0	0	0	0	0	11
2026	24	2	0	0	1	0	1	22

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 Pataday, 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 Pataday, by the year in which FDA received them
Year	Reports
2008	2
2009	2
2010	2
2011	2
2012	5
2013	6
2014	8
2015	42
2016	267
2017	74
2018	31
2019	109
2020	3,250
2021	864
2022	202
2023	29
2024	14
2025	11
2026	24

Reports that name Pataday, 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 Pataday
Age	Reports	Share
Under 2	1	under 0.1%
2 to 11	4	0.1%
12 to 17	5	0.1%
18 to 44	16	0.3%
45 to 64	53	1.1%
65 to 74	37	0.7%
75 and over	43	0.9%
Age not given	4,785	96.8%

Sex of the patient in the reports that name Pataday
Sex	Reports	Share
Female	3,213	65%
Male	1,160	23.5%
Unknown or not given	571	11.5%

Type of reporter in the reports that name Pataday
Reporter	Reports	Share
Physician	123	2.5%
Pharmacist	11	0.2%
Other health professional	665	13.5%
Lawyer	0	0%
Consumer or non-health professional	4,125	83.4%
Not given	20	0.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Pataday record
Indication as recorded (MedDRA)	Reports	Share
Conjunctivitis allergic	198	4%
Eye allergy	130	2.6%
Eye pruritus	108	2.2%
Hypersensitivity	41	0.8%
Dry eye	31	0.6%
Ocular hyperaemia	22	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,944 reports.

Drugs in the same reports

Other drugs that the reports of Pataday name, in any role, in order of name
Drug	Reports that name the two
Azelastine	495
Azelastine hydrochloride	386
Ketorolac	179
Ketorolac tromethamine	59
Ketotifen	489
Ketotifen fumarate	90
Olopatadine hydrochloride	1,345
Patanol	1,289
Zaditor	1,485

The table has the 9 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

Pasireotide next in the A to Z list
Pataday Once Daily Relief next in the A to Z list
Parsabiv next in the A to Z list
Patanol next in the A to Z list
Paroxetine hydrochloride next in the A to Z list
Paxil next in the A to Z list
Paroxetine next in the A to Z list
Paxlovid next in the A to Z list
Parnate next in the A to Z list
Pazeo next in the A to Z list
Parlodel next in the A to Z list
Pazopanib next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for PatadayThe 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.

Cite this page

Reported Reactions. Pataday: adverse event reports that FDA received. https://reportedreactions.com/drug/pataday/ 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 Pataday as a suspect or interacting product. The 2,122 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 Pataday 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 Pataday?

No. It is a count of what people reported to FDA: 4,944 reports from June 2008 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 (83.4%), other health professional (13.5%) and physician (2.5%). 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.

To the top of the page