Latanoprost adverse event reports that FDA received

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

Name type: Generic name
Class: Prostaglandin analog
Also reported as: Latanoprost Solution, Latanoprost Ophthalmic

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.

Reports on file

From October 2004 to June 2026, FDA received 12,387 adverse event reports that name Latanoprost. In these reports the drug is a suspect or interacting product.

In the same period, 20,416 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 545 reports in the 12 months to June 2026 and 442 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Latanoprost 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 148 reports that name Latanoprost.
In January to March 2026, FDA received 131.
In April to June 2025, FDA received 116.

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 450 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 12,375 of the 12,387 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 450 terms.

Reaction terms in the reports that name Latanoprost, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 12,387 reports
Treatment failurethe treatment did not work	5,767	46.6%
Drug ineffectivethe medicine did not work as expected	1,173	9.5%
Eye irritation	907	7.3%
Hypersensitivityan allergic-type reaction	616	5%
Intraocular pressure increasedraised pressure in the eye	497	4%
Eye pain	476	3.8%
Ocular hyperaemiaa red eye	476	3.8%
Vision blurredblurred vision	429	3.5%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	281	2.3%
Eye pruritus	279	2.3%
Product quality issuea problem with the product itself	266	2.1%
Visual impairmentreduced vision	231	1.9%
Headachehead pain	215	1.7%
Dry eye	201	1.6%
Dizzinesslight-headedness or unsteadiness	167	1.3%
Glaucomaraised pressure in the eye	166	1.3%
Wrong technique in product usage processthe product was used in the wrong way	166	1.3%
Product closure removal difficult	160	1.3%
Product container issuea problem with the container	156	1.3%
Dyspnoeashortness of breath	148	1.2%
Lacrimation increasedwatery eyes	144	1.2%
Drug intolerancethe medicine was not tolerated	137	1.1%
Off label useused for a purpose or in a way not on the label	137	1.1%
Eye disorder	131	1.1%
Product substitution issuea problem after switching products	131	1.1%
Condition aggravatedthe condition being treated got worse	128	1%
Incorrect dose administeredthe wrong dose was given	124	1%
Foreign body sensation in eyes	122	1%
Eye swellinga swollen eye	110	0.9%
Erythemaskin redness	107	0.9%
Pruritusitching	107	0.9%
Product packaging quantity issue	103	0.8%
Cough	100	0.8%
Product storage errorthe product was stored wrongly	100	0.8%
Rashskin rash	100	0.8%
Burning sensationa burning feeling	99	0.8%
Malaisegeneral feeling of being unwell	96	0.8%
Painpain, site not specified	89	0.7%
Product dose omission issuea dose was missed	89	0.7%
Fatiguetiredness	88	0.7%
Visual acuity reducedreduced sharpness of vision	86	0.7%
Product use issuea problem in how the product was used	84	0.7%
Arthritis	82	0.7%
Cataractclouding of the eye lens	82	0.7%
Product use complaint	78	0.6%
Ocular discomfort	75	0.6%
Product use in unapproved indicationused for a purpose not on the label	74	0.6%
Insomniadifficulty sleeping	73	0.6%
Arthralgiajoint pain	71	0.6%
Photophobiasensitivity to light	71	0.6%

Download all 450 terms of Latanoprost (CSV)

The counts add to more than 12,387 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 Latanoprost with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Latanoprost (this page)	Generic name	12,387
Xalatan	Brand name	9,038
Xelpros	Brand name	610

Sum of the separately reported names: 22,035. 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 Latanoprost, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	10	10	0	0	2	1	0	8	0
2005	16	16	1	0	4	1	0	12	0
2006	20	19	4	1	2	1	0	12	1
2007	30	25	2	0	5	4	0	21	5
2008	31	30	0	0	3	0	0	28	1
2009	17	17	0	0	7	0	1	10	0
2010	29	13	1	0	1	2	0	11	16
2011	196	109	3	1	6	2	0	101	87
2012	330	172	4	0	19	2	0	157	158
2013	209	95	1	0	18	7	0	83	114
2014	167	74	1	0	8	1	0	66	93
2015	240	90	4	0	19	12	0	74	150
2016	401	126	1	3	27	4	0	105	275
2017	332	96	1	1	22	4	0	83	236
2018	484	129	3	2	27	5	0	108	355
2019	779	187	1	4	40	11	0	159	592
2020	6,368	199	3	3	48	8	1	171	6,169
2021	469	169	5	4	31	13	0	147	300
2022	479	185	5	1	49	7	0	153	294
2023	471	192	1	8	49	5	4	156	279
2024	489	207	6	2	69	6	0	181	282
2025	509	186	10	6	32	8	1	163	323
2026	311	103	4	4	27	7	0	91	208

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 Latanoprost, 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 Latanoprost, by the year in which FDA received them
Year	Reports
2004	8
2005	17
2006	18
2007	26
2008	34
2009	15
2010	29
2011	198
2012	361
2013	202
2014	177
2015	251
2016	418
2017	343
2018	507
2019	803
2020	6,456
2021	348
2022	455
2023	481
2024	469
2025	492
2026	279

Reports that name Latanoprost, 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 Latanoprost
Age	Reports	Share
Under 2	11	0.1%
2 to 11	25	0.2%
12 to 17	15	0.1%
18 to 44	171	1.4%
45 to 64	589	4.8%
65 to 74	865	7%
75 and over	1,512	12.2%
Age not given	9,199	74.3%

Sex of the patient in the reports that name Latanoprost
Sex	Reports	Share
Female	7,453	60.2%
Male	4,334	35%
Unknown or not given	600	4.8%

Type of reporter in the reports that name Latanoprost
Reporter	Reports	Share
Physician	1,316	10.6%
Pharmacist	353	2.8%
Other health professional	1,956	15.8%
Lawyer	0	0%
Consumer or non-health professional	8,530	68.9%
Not given	232	1.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 89.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Latanoprost record
Indication as recorded (MedDRA)	Reports	Share
Glaucoma	1,975	15.9%
Intraocular pressure increased	347	2.8%
Open angle glaucoma	238	1.9%
Ocular hypertension	115	0.9%
Intraocular pressure test	55	0.4%
Intraocular pressure test abnormal	55	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 12,387 reports.

Drugs in the same reports

Other drugs that the reports of Latanoprost name, in any role, in order of name
Drug	Reports that name the two
Azopt	793
Brimonidine	1,799
Dorzolamide	699
Lumigan	1,902
Timolol	1,759
Timolol maleate	687
Travatan	470
Travatan Z	525
Travoprost	675
Xalatan	292

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

Xalatan same ingredient
Xelpros same ingredient
Hemabate same class
Latanoprost ophthalmic solution 0.005% same class
Edex same class
Latisse same class
Durysta same class
Lumigan same class
Lastacaft next in the A to Z list
Lasix next in the A to Z list
Lasilix Special next in the A to Z list
Latisse 0 03% 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 LatanoprostThe 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. Latanoprost: adverse event reports that FDA received. https://reportedreactions.com/drug/latanoprost/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Latanoprost as a suspect or interacting product. The 20,416 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 Latanoprost 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 Latanoprost?

No. It is a count of what people reported to FDA: 12,387 reports from October 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 (68.9%), other health professional (15.8%) and physician (10.6%). 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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