Doxazosin mesylate adverse event reports that FDA received

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

Name type: Generic name
Class: alpha-Adrenergic blocker
Also reported as: Doxazosin Mesylate Tablets

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 1,731 adverse event reports that name Doxazosin mesylate. In these reports the drug is a suspect or interacting product.

In the same period, 6,143 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 76 reports in the 12 months to June 2026 and 85 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, 76 (under 0.1%) name Doxazosin mesylate. Reports for male patients were 63.7% of the reports that name Doxazosin mesylate and 34.6% 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 Doxazosin mesylate 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 Doxazosin mesylate.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 17.

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 286 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 1,687 of the 1,731 reports (97.5%).

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 286 terms.

Reaction terms in the reports that name Doxazosin mesylate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,731 reports
Asthma	275	15.9%
Productive cougha cough with phlegm	226	13.1%
Wheezing	215	12.4%
Full blood count abnormal	199	11.5%
Condition aggravatedthe condition being treated got worse	194	11.2%
Thrombosis	183	10.6%
Hypoxialow oxygen	181	10.5%
Dyspnoeashortness of breath	173	10%
Pulmonary embolisma blood clot in the lung	173	10%
Normochromic normocytic anaemia	171	9.9%
Sleep disorder due to a general medical condition	170	9.8%
Therapeutic product effect incomplete	170	9.8%
Conjunctivitis allergic	167	9.6%
Nodule	167	9.6%
Dust allergy	166	9.6%
Mite allergy	166	9.6%
Mycotic allergy	166	9.6%
Spirometry abnormal	164	9.5%
Arteriosclerosis	157	9.1%
Arteriosclerosis coronary artery	132	7.6%
Hypotensionlow blood pressure	131	7.6%
Obstructive airways disorder	115	6.6%
Loss of personal independence in daily activities	105	6.1%
Dizzinesslight-headedness or unsteadiness	100	5.8%
Pain in extremitypain in an arm or leg	98	5.7%
Anxiety	85	4.9%
Lung disordera lung problem, type not specified	85	4.9%
Syncopefainting	85	4.9%
Drug ineffectivethe medicine did not work as expected	84	4.9%
Drug interactionan interaction between medicines	84	4.9%
Hypothyroidismunderactive thyroid	79	4.6%
Pulmonary alveolar haemorrhage	79	4.6%
Pulmonary fibrosis	79	4.6%
Cough	77	4.4%
Haemoptysiscoughing up blood	77	4.4%
Neuritis	77	4.4%
Pulmonary vasculitis	77	4.4%
Neurological symptom	76	4.4%
Eosinophilic granulomatosis with polyangiitis	74	4.3%
Respiratory symptom	73	4.2%
Vasculitisinflammation of blood vessels	71	4.1%
Hypertensionhigh blood pressure	68	3.9%
Falla fall	59	3.4%
Fatiguetiredness	57	3.3%
Antineutrophil cytoplasmic antibody positive	54	3.1%
Forced expiratory volume decreased	53	3.1%
Total lung capacity abnormal	52	3%
Skin exfoliationpeeling skin	51	2.9%
Eosinophilia	49	2.8%
Middle insomnia	49	2.8%

Download all 286 terms of Doxazosin mesylate (CSV)

The counts add to more than 1,731 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 Doxazosin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Doxazosin	Generic name	4,251
Doxazosin mesylate (this page)	Generic name	1,731
Cardura	Brand name	1,803

Sum of the separately reported names: 7,785. 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 Doxazosin mesylate, 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	60	57	9	1	27	2	0	24	3
2005	32	30	2	1	17	1	0	16	2
2006	48	45	6	11	24	3	0	17	3
2007	93	81	2	12	35	6	0	43	12
2008	93	83	2	17	38	1	0	43	10
2009	76	66	2	10	32	8	0	35	10
2010	117	105	18	11	39	4	0	54	12
2011	169	163	21	12	78	5	0	87	6
2012	121	116	5	8	50	12	0	66	5
2013	44	44	1	4	16	3	0	26	0
2014	22	21	2	0	10	2	0	8	1
2015	12	8	1	1	4	1	0	5	4
2016	14	11	1	0	6	1	0	6	3
2017	8	7	0	2	1	0	0	4	1
2018	19	18	1	1	9	1	0	14	1
2019	10	8	0	0	2	0	0	7	2
2020	25	20	0	2	8	1	0	17	5
2021	106	97	2	4	68	2	0	62	9
2022	266	250	15	3	165	0	0	189	16
2023	121	115	5	12	83	1	0	75	6
2024	103	92	8	19	71	4	0	66	11
2025	110	104	21	43	72	5	2	79	6
2026	62	59	14	27	49	4	0	51	3

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 Doxazosin mesylate, 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 Doxazosin mesylate, by the year in which FDA received them
Year	Reports
2004	57
2005	33
2006	40
2007	93
2008	97
2009	71
2010	120
2011	171
2012	139
2013	41
2014	23
2015	14
2016	8
2017	12
2018	23
2019	32
2020	50
2021	149
2022	245
2023	112
2024	92
2025	76
2026	33

Reports that name Doxazosin mesylate, 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 Doxazosin mesylate
Age	Reports	Share
Under 2	1	0.1%
2 to 11	10	0.6%
12 to 17	8	0.5%
18 to 44	122	7%
45 to 64	370	21.4%
65 to 74	460	26.6%
75 and over	364	21%
Age not given	396	22.9%

Sex of the patient in the reports that name Doxazosin mesylate
Sex	Reports	Share
Female	458	26.5%
Male	1,102	63.7%
Unknown or not given	171	9.9%

Type of reporter in the reports that name Doxazosin mesylate
Reporter	Reports	Share
Physician	391	22.6%
Pharmacist	217	12.5%
Other health professional	593	34.3%
Lawyer	0	0%
Consumer or non-health professional	397	22.9%
Not given	133	7.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 18.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Doxazosin mesylate record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	460	26.6%
Benign prostatic hyperplasia	111	6.4%
Ill-defined disorder	34	2%
Essential hypertension	20	1.2%
Prostatic disorder	16	0.9%
Blood pressure	10	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,731 reports.

Drugs in the same reports

Other drugs that the reports of Doxazosin mesylate name, in any role, in order of name
Drug	Reports that name the two
Albuterol	250
Amlodipine besylate	164
Budesonide	234
Diltiazem	182
Dutasteride	182
Ergocalciferol	168
Furosemide	191
Prednisone	261
Rosuvastatin calcium	208
Tiotropium bromide	227

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

Doxazosin same ingredient
Cardura same ingredient
Prazosin same class
Coreg CR same class
Prazosin hcl same class
Coreg same class
Prazosin hydrochloride same class
Doxazosin Mesilate next in the A to Z list
Doxepin next in the A to Z list
Doxepin hcl next in the A to Z list
Dovato next in the A to Z list
Doxepin hydrochloride 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 Doxazosin mesylateThe 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. Doxazosin mesylate: adverse event reports that FDA received. https://reportedreactions.com/drug/doxazosin-mesylate/ 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 Doxazosin mesylate as a suspect or interacting product. The 6,143 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 Doxazosin mesylate 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 Doxazosin mesylate?

No. It is a count of what people reported to FDA: 1,731 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?

Other health professional (34.3%), consumer or non-health professional (22.9%) and physician (22.6%). 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.

To the top of the page