Toviaz (fesoterodine fumarate) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Fesoterodine fumarate
Also reported as: Toviaz Er

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 2009 to June 2026, FDA received 6,670 adverse event reports that name Toviaz. In these reports the drug is a suspect or interacting product.

In the same period, 3,786 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 13 reports in the 12 months to June 2026 and 28 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, 13 (under 0.1%) name Toviaz. Reports for patients 75 and over were 23.6% of the reports that name Toviaz and 9.5% 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 Toviaz 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 2 reports that name Toviaz.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 8.

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 337 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 6,660 of the 6,670 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 337 terms.

Reaction terms in the reports that name Toviaz, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 6,670 reports
Drug ineffectivethe medicine did not work as expected	1,248	18.7%
Dry mouth	762	11.4%
Urinary retentionbeing unable to empty the bladder	476	7.1%
Constipation	415	6.2%
Dizzinesslight-headedness or unsteadiness	253	3.8%
Malaisegeneral feeling of being unwell	197	3%
Vision blurredblurred vision	197	3%
Falla fall	196	2.9%
Dysuriapain on passing urine	194	2.9%
Pollakiuriapassing urine more often	192	2.9%
Drug effect incomplete	166	2.5%
Off label useused for a purpose or in a way not on the label	160	2.4%
Urinary incontinenceleaking urine	158	2.4%
Painpain, site not specified	146	2.2%
Diarrhoealoose or frequent stools	141	2.1%
Headachehead pain	132	2%
Feeling abnormalfeeling odd or not right	127	1.9%
Somnolencedrowsiness	122	1.8%
Memory impairmentmemory problems	121	1.8%
Nauseafeeling sick	121	1.8%
Confusional stateconfusion	120	1.8%
Fatiguetiredness	118	1.8%
Gait disturbancedifficulty walking	112	1.7%
Insomniadifficulty sleeping	112	1.7%
Urinary tract infectionbladder or urinary infection	108	1.6%
Rashskin rash	105	1.6%
Condition aggravatedthe condition being treated got worse	102	1.5%
Drug interactionan interaction between medicines	96	1.4%
Abdominal pain upperupper stomach pain	94	1.4%
Dry eye	91	1.4%
Therapeutic product effect incomplete	87	1.3%
Dysphagiadifficulty swallowing	85	1.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	83	1.2%
Nocturia	82	1.2%
Hypoacusisreduced hearing	81	1.2%
Deaththe patient died; cause not stated by this term	79	1.2%
Dyspnoeashortness of breath	79	1.2%
Vomitingbeing sick	79	1.2%
Dementia	78	1.2%
Astheniaweakness or lack of energy	75	1.1%
Loss of consciousnesspassing out	74	1.1%
Cerebrovascular accidentstroke	73	1.1%
Micturition urgency	70	1%
Intentional product misusedeliberate use not as intended	67	1%
Pruritusitching	66	1%
Abdominal discomfortstomach discomfort	65	1%
Oedema peripheralswelling of the legs, ankles or hands	63	0.9%
Back pain	62	0.9%
Bladder disorder	62	0.9%
Dry throat	58	0.9%

Download all 337 terms of Toviaz (CSV)

The counts add to more than 6,670 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 Fesoterodine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Fesoterodine	Generic name	280
Toviaz (this page)	Brand name	6,670

Sum of the separately reported names: 6,950. 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 Toviaz, 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
2009	371	108	1	2	17	1	0	96	263
2010	715	379	5	1	28	2	0	364	336
2011	480	235	9	4	31	5	1	205	245
2012	724	314	8	8	39	3	0	287	410
2013	874	264	6	4	54	11	0	231	610
2014	558	168	14	4	43	6	0	137	390
2015	306	165	3	7	65	4	0	136	141
2016	291	156	7	0	46	5	0	121	135
2017	255	158	10	6	69	7	0	126	97
2018	274	183	8	7	101	3	0	107	91
2019	358	226	15	14	83	5	0	175	132
2020	461	241	3	18	71	10	1	194	220
2021	351	190	16	28	50	5	1	154	161
2022	390	184	16	14	59	7	0	156	206
2023	161	101	10	4	32	4	1	83	60
2024	58	41	6	6	19	1	0	36	17
2025	33	28	2	0	11	0	0	23	5
2026	10	10	0	0	7	0	0	4	0

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 Toviaz, 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 Toviaz, by the year in which FDA received them
Year	Reports
2009	75
2010	998
2011	491
2012	764
2013	873
2014	592
2015	298
2016	300
2017	271
2018	281
2019	426
2020	547
2021	309
2022	281
2023	99
2024	32
2025	30
2026	3

Reports that name Toviaz, 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 Toviaz
Age	Reports	Share
Under 2	3	under 0.1%
2 to 11	4	0.1%
12 to 17	1	under 0.1%
18 to 44	120	1.8%
45 to 64	633	9.5%
65 to 74	940	14.1%
75 and over	1,576	23.6%
Age not given	3,393	50.9%

Sex of the patient in the reports that name Toviaz
Sex	Reports	Share
Female	3,947	59.2%
Male	1,847	27.7%
Unknown or not given	876	13.1%

Type of reporter in the reports that name Toviaz
Reporter	Reports	Share
Physician	1,564	23.4%
Pharmacist	342	5.1%
Other health professional	563	8.4%
Lawyer	2	under 0.1%
Consumer or non-health professional	3,972	59.6%
Not given	227	3.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 80.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Toviaz record
Indication as recorded (MedDRA)	Reports	Share
Hypertonic bladder	1,580	23.7%
Urinary incontinence	532	8%
Pollakiuria	307	4.6%
Bladder disorder	263	3.9%
Incontinence	191	2.9%
Micturition urgency	85	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 6,670 reports.

Drugs in the same reports

Other drugs that the reports of Toviaz name, in any role, in order of name
Drug	Reports that name the two
Amlodipine	122
Aspirin	120
Levothyroxine	167
Lisinopril	145
Lyrica	102
Metformin	182
Omeprazole	124
Simvastatin	112
Synthroid	133
Vesicare	108

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

Fesoterodine same ingredient
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Toujeo next in the A to Z list
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Tracrium next in the A to Z list
Toripalimab next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for ToviazThe 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. Toviaz: adverse event reports that FDA received. https://reportedreactions.com/drug/toviaz/ 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 Toviaz as a suspect or interacting product. The 3,786 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 Toviaz 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 Toviaz?

No. It is a count of what people reported to FDA: 6,670 reports from January 2009 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 (59.6%), physician (23.4%) and other health professional (8.4%). 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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