Irbesartan and hydrochlorothiazide adverse event reports that FDA received

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

Name type: Generic name
Class: Angiotensin 2 receptor blocker
Also reported as: Irbesartan/Hydrochlorothiazide

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 November 2005 to December 2025, FDA received 541 adverse event reports that name Irbesartan and hydrochlorothiazide. In these reports the drug is a suspect or interacting product.

In the same period, 747 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 4 reports in the 12 months to June 2026 and 3 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, 4 (under 0.1%) name Irbesartan and hydrochlorothiazide. Reports for patients 75 and over were 25.7% of the reports that name Irbesartan and hydrochlorothiazide 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 Irbesartan and hydrochlorothiazide 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.

FDA received no report that names Irbesartan and hydrochlorothiazide in April to June 2026, in January to March 2026 or in April to June 2025.

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 56 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

This list is partial.

It covers 464 of the 541 reports (85.8%).

The site keeps reaction terms only for years in which the drug has 12 or more reports.

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 56 terms.

Reaction terms in the reports that name Irbesartan and hydrochlorothiazide, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 541 reports
Hyponatraemialow blood sodium	52	9.6%
Dizzinesslight-headedness or unsteadiness	30	5.5%
Falla fall	21	3.9%
Hypertensionhigh blood pressure	19	3.5%
Drug ineffectivethe medicine did not work as expected	18	3.3%
Hypokalaemialow blood potassium	18	3.3%
Recalled product administered	18	3.3%
Renal failure acute	18	3.3%
Drug interactionan interaction between medicines	17	3.1%
Hypotensionlow blood pressure	17	3.1%
Confusional stateconfusion	13	2.4%
Fatiguetiredness	13	2.4%
Nauseafeeling sick	13	2.4%
Blood pressure increaseda raised blood pressure reading	12	2.2%
Dehydration	12	2.2%
Pain in extremitypain in an arm or leg	12	2.2%
Renal failurekidney failure	12	2.2%
Basal cell carcinoma	11	2%
Headachehead pain	11	2%
Vomitingbeing sick	11	2%
Astheniaweakness or lack of energy	10	1.8%
Dyspnoeashortness of breath	10	1.8%
Hyperkalaemiahigh blood potassium	10	1.8%
Diarrhoealoose or frequent stools	9	1.7%
Lactic acidosisa build-up of lactic acid in the blood	9	1.7%
Malaisegeneral feeling of being unwell	9	1.7%
Urticariahives	9	1.7%
Arthralgiajoint pain	8	1.5%
Hyperglycaemiahigh blood sugar	8	1.5%
Hyperhidrosisexcessive sweating	8	1.5%
Insomniadifficulty sleeping	8	1.5%
Malignant melanomamelanoma, a skin cancer	8	1.5%
Pruritusitching	8	1.5%
Anaemialow red blood cells	7	1.3%
Blood pressure fluctuation	7	1.3%
Chest pain	7	1.3%
Completed suicidedeath by suicide	7	1.3%
Feeling abnormalfeeling odd or not right	7	1.3%
Product substitution issuea problem after switching products	7	1.3%
Acidosis	6	1.1%
Acute kidney injurysudden loss of kidney function	6	1.1%
Blood pressure decreaseda low blood pressure reading	6	1.1%
Dysgeusiaaltered taste	6	1.1%
Oedema peripheralswelling of the legs, ankles or hands	6	1.1%
Paraesthesiatingling or pins and needles	6	1.1%
Pemphigus	6	1.1%
Rashskin rash	6	1.1%
Rhabdomyolysismuscle breakdown	6	1.1%
Cerebrovascular accidentstroke	5	0.9%
Dry mouth	5	0.9%

Download all 56 terms of Irbesartan and hydrochlorothiazide (CSV)

The counts add to more than 541 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 Irbesartan and hydrochlorothiazide with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Irbesartan and hydrochlorothiazide (this page)	Generic name	541
Avalide	Brand name	1,236

Sum of the separately reported names: 1,777. 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 Irbesartan and hydrochlorothiazide, 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
2005	5	5	0	0	4	0	0	2	0
2006	13	11	0	0	3	0	0	8	2
2007	4	2	0	0	1	0	0	1	2
2008	8	8	1	2	6	0	0	4	0
2009	18	18	1	0	12	4	0	4	0
2010	13	13	1	0	7	0	0	6	0
2011	74	74	14	10	44	1	0	31	0
2012	82	80	3	13	53	2	0	43	2
2013	4	3	0	0	2	2	0	1	1
2014	6	4	1	1	0	1	0	2	2
2015	8	8	3	0	3	0	0	4	0
2016	23	19	6	3	9	0	0	4	4
2017	12	8	2	0	2	2	0	5	4
2018	45	42	2	4	16	1	0	36	3
2019	129	72	2	7	21	3	1	59	57
2020	33	27	0	0	19	0	0	20	6
2021	20	17	0	0	7	3	0	11	3
2022	12	9	0	0	5	0	0	8	3
2023	14	12	0	0	6	0	0	7	2
2024	10	8	0	0	3	0	0	6	2
2025	8	7	0	0	1	0	0	7	1
2026	0	0	0	0	0	0	0	0	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 Irbesartan and hydrochlorothiazide, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Irbesartan and hydrochlorothiazide, by the year in which FDA received them
Year	Reports
2005	2
2006	13
2007	4
2008	9
2009	18
2010	13
2011	74
2012	84
2013	4
2014	6
2015	9
2016	22
2017	16
2018	53
2019	129
2020	34
2021	14
2022	10
2023	14
2024	8
2025	5

Reports that name Irbesartan and hydrochlorothiazide, 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 Irbesartan and hydrochlorothiazide
Age	Reports	Share
Under 2	1	0.2%
2 to 11	0	0%
12 to 17	7	1.3%
18 to 44	4	0.7%
45 to 64	112	20.7%
65 to 74	98	18.1%
75 and over	139	25.7%
Age not given	180	33.3%

Sex of the patient in the reports that name Irbesartan and hydrochlorothiazide
Sex	Reports	Share
Female	304	56.2%
Male	159	29.4%
Unknown or not given	78	14.4%

Type of reporter in the reports that name Irbesartan and hydrochlorothiazide
Reporter	Reports	Share
Physician	112	20.7%
Pharmacist	43	7.9%
Other health professional	123	22.7%
Lawyer	0	0%
Consumer or non-health professional	254	47%
Not given	9	1.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Irbesartan and hydrochlorothiazide record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	228	42.1%
Essential hypertension	17	3.1%
Blood pressure abnormal	8	1.5%
Blood pressure measurement	3	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 541 reports.

Pages near this one

Avalide same ingredient
Irbesartan same class
Losartan same class
Filspari same class
Losartan potassium same class
Exforge HCT same class
Micardis HCT same class
Iressa next in the A to Z list
Iqirvo next in the A to Z list
Irinotecan next in the A to Z list
Ipren next in the A to Z list
Irinotecan hcl 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 Irbesartan and hydrochlorothiazideThe 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. Irbesartan and hydrochlorothiazide: adverse event reports that FDA received. https://reportedreactions.com/drug/irbesartan-and-hydrochlorothiazide/ 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 Irbesartan and hydrochlorothiazide as a suspect or interacting product. The 747 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 Irbesartan and hydrochlorothiazide 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 Irbesartan and hydrochlorothiazide?

No. It is a count of what people reported to FDA: 541 reports from November 2005 to December 2025. 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 (47%), other health professional (22.7%) and physician (20.7%). 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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