Timolol maleate adverse event reports that FDA received

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

Name type: Generic name
Class: beta-Adrenergic blocker
Also reported as: Timolol Maleate Ophthalmic Solution Usp, Timolol Maleate Ophthalmic Solution

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 January 2004 to June 2026, FDA received 2,743 adverse event reports that name Timolol maleate. In these reports the drug is a suspect or interacting product.

In the same period, 4,869 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 120 reports in the 12 months to June 2026 and 115 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, 120 (under 0.1%) name Timolol maleate. Reports from consumers or other non-health professionals were 63.1% of the reports that name Timolol maleate 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 Timolol maleate 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 23 reports that name Timolol maleate.
In January to March 2026, FDA received 30.
In April to June 2025, FDA received 20.

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 164 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 2,712 of the 2,743 reports (98.9%).

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 164 terms.

Reaction terms in the reports that name Timolol maleate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,743 reports
Treatment failurethe treatment did not work	956	34.9%
Drug ineffectivethe medicine did not work as expected	275	10%
Eye irritation	180	6.6%
Hypersensitivityan allergic-type reaction	137	5%
Intraocular pressure increasedraised pressure in the eye	126	4.6%
Ocular hyperaemiaa red eye	109	4%
Eye pruritus	108	3.9%
Vision blurredblurred vision	107	3.9%
Eye pain	98	3.6%
Dizzinesslight-headedness or unsteadiness	89	3.2%
Visual impairmentreduced vision	75	2.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	47	1.7%
Lacrimation increasedwatery eyes	47	1.7%
Dry eye	45	1.6%
Fatiguetiredness	45	1.6%
Dyspnoeashortness of breath	44	1.6%
Bradycardiaslow heart rate	41	1.5%
Off label useused for a purpose or in a way not on the label	41	1.5%
Product container issuea problem with the container	40	1.5%
Glaucomaraised pressure in the eye	38	1.4%
Hypotensionlow blood pressure	36	1.3%
Cataractclouding of the eye lens	34	1.2%
Headachehead pain	34	1.2%
Falla fall	33	1.2%
Condition aggravatedthe condition being treated got worse	32	1.2%
Alopeciahair loss	31	1.1%
Dry mouth	30	1.1%
Nauseafeeling sick	30	1.1%
Blindnessloss of sight	29	1.1%
Visual acuity reducedreduced sharpness of vision	29	1.1%
Corneal deposits	28	1%
Drug interactionan interaction between medicines	28	1%
Erythemaskin redness	27	1%
Product substitution issuea problem after switching products	27	1%
Heart rate decreased	26	0.9%
Product quality issuea problem with the product itself	24	0.9%
Product dose omission issuea dose was missed	23	0.8%
Product use in unapproved indicationused for a purpose not on the label	23	0.8%
Vertigoa spinning sensation	23	0.8%
Eye disorder	22	0.8%
Eye swellinga swollen eye	22	0.8%
Malaisegeneral feeling of being unwell	22	0.8%
Incorrect dose administeredthe wrong dose was given	21	0.8%
Recalled product administered	21	0.8%
Vomitingbeing sick	20	0.7%
Wrong technique in product usage processthe product was used in the wrong way	19	0.7%
Accidental exposure to product	18	0.7%
Product delivery mechanism issue	18	0.7%
Product storage errorthe product was stored wrongly	18	0.7%
Product use complaint	18	0.7%

Download all 164 terms of Timolol maleate (CSV)

The counts add to more than 2,743 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 Timolol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Timolol	Generic name	4,818
Timolol maleate (this page)	Generic name	2,743
Timoptic	Brand name	506

Sum of the separately reported names: 8,067. 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 Timolol maleate, 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	19	12	0	2	4	2	0	5	7
2005	22	19	0	2	5	1	0	14	3
2006	27	25	3	4	7	8	0	12	2
2007	26	24	2	4	5	5	0	13	2
2008	58	52	1	2	12	10	1	37	6
2009	35	32	0	3	13	3	0	19	3
2010	51	42	2	1	9	2	0	30	9
2011	77	61	4	3	18	3	0	42	16
2012	60	45	2	3	13	0	1	34	15
2013	57	40	4	2	8	0	1	33	17
2014	53	18	1	1	6	5	0	8	35
2015	44	22	0	1	8	2	0	15	22
2016	74	36	0	2	9	0	1	30	38
2017	88	34	0	4	11	2	0	27	54
2018	70	31	1	0	7	3	0	23	39
2019	178	35	1	1	7	1	0	31	143
2020	1,120	52	3	3	7	3	0	45	1,068
2021	142	34	2	2	5	0	0	30	108
2022	102	25	0	1	5	0	4	18	77
2023	137	62	0	5	28	1	0	46	75
2024	114	33	0	2	13	1	0	27	81
2025	120	61	5	1	13	1	0	47	59
2026	69	26	0	0	11	0	0	22	43

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 Timolol maleate, 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 Timolol maleate, by the year in which FDA received them
Year	Reports
2004	18
2005	21
2006	28
2007	25
2008	50
2009	33
2010	52
2011	80
2012	81
2013	51
2014	54
2015	47
2016	73
2017	92
2018	72
2019	193
2020	1,122
2021	122
2022	107
2023	133
2024	124
2025	112
2026	53

Reports that name Timolol maleate, 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 Timolol maleate
Age	Reports	Share
Under 2	29	1.1%
2 to 11	5	0.2%
12 to 17	11	0.4%
18 to 44	56	2%
45 to 64	176	6.4%
65 to 74	249	9.1%
75 and over	363	13.2%
Age not given	1,854	67.6%

Sex of the patient in the reports that name Timolol maleate
Sex	Reports	Share
Female	1,613	58.8%
Male	1,002	36.5%
Unknown or not given	128	4.7%

Type of reporter in the reports that name Timolol maleate
Reporter	Reports	Share
Physician	349	12.7%
Pharmacist	99	3.6%
Other health professional	421	15.3%
Lawyer	1	under 0.1%
Consumer or non-health professional	1,730	63.1%
Not given	143	5.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 80.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Timolol maleate record
Indication as recorded (MedDRA)	Reports	Share
Glaucoma	548	20%
Intraocular pressure increased	135	4.9%
Open angle glaucoma	54	2%
Ocular hypertension	27	1%
Intraocular pressure test abnormal	11	0.4%
Retinal detachment	11	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,743 reports.

Drugs in the same reports

Other drugs that the reports of Timolol maleate name, in any role, in order of name
Drug	Reports that name the two
Azopt	221
Brimonidine	440
Dorzolamide	251
Latanoprost	741
Lumigan	382
Timolol	340
Travatan	149
Travatan Z	275
Travoprost	114
Xalatan	95

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

Timolol same ingredient
Timoptic same ingredient
Tenormin same class
Toprol Xl same class
Propranolol hydrochloride same class
Tilidine next in the A to Z list
Tinactin next in the A to Z list
Tildrakizumab next in the A to Z list
Tinzaparin next in the A to Z list
Tikosyn next in the A to Z list
Tioconazole next in the A to Z list
Tiglutik 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 Timolol maleateThe 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. Timolol maleate: adverse event reports that FDA received. https://reportedreactions.com/drug/timolol-maleate/ 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 Timolol maleate as a suspect or interacting product. The 4,869 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 Timolol maleate 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 Timolol maleate?

No. It is a count of what people reported to FDA: 2,743 reports from January 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 (63.1%), other health professional (15.3%) and physician (12.7%). 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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