Irbesartan adverse event reports that FDA received

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

Name type: Generic name
Class: Angiotensin 2 receptor blocker
Also reported as: Irbesartan Tabs, Irbesartan Tablets, Irbesartan 300mg Tablet

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 10,055 adverse event reports that name Irbesartan. In these reports the drug is a suspect or interacting product.

In the same period, 22,504 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 692 reports in the 12 months to June 2026 and 925 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, 692 (0.1%) name Irbesartan. Reports from consumers or other non-health professionals were 21.9% of the reports that name Irbesartan 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 Irbesartan 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 172 reports that name Irbesartan.
In January to March 2026, FDA received 160.
In April to June 2025, FDA received 232.

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 875 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 10,009 of the 10,055 reports (99.5%).

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 875 terms.

Reaction terms in the reports that name Irbesartan, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 10,055 reports
Acute kidney injurysudden loss of kidney function	1,268	12.6%
Falla fall	817	8.1%
Hypotensionlow blood pressure	760	7.6%
Nauseafeeling sick	542	5.4%
Hyponatraemialow blood sodium	530	5.3%
Malaisegeneral feeling of being unwell	501	5%
Fatiguetiredness	500	5%
Vomitingbeing sick	464	4.6%
Hyperkalaemiahigh blood potassium	457	4.5%
Drug interactionan interaction between medicines	437	4.3%
Drug ineffectivethe medicine did not work as expected	427	4.2%
Astheniaweakness or lack of energy	425	4.2%
Blood pressure increaseda raised blood pressure reading	425	4.2%
Confusional stateconfusion	420	4.2%
Headachehead pain	414	4.1%
Cough	413	4.1%
Dyspnoeashortness of breath	385	3.8%
Diarrhoealoose or frequent stools	365	3.6%
Dizzinesslight-headedness or unsteadiness	359	3.6%
Anxiety	347	3.5%
Muscular weaknessmuscle weakness	340	3.4%
Cerebrovascular accidentstroke	333	3.3%
Pyrexiafever	324	3.2%
Painpain, site not specified	317	3.2%
Chest discomfort	304	3%
Muscle spasticity	304	3%
Dysphagiadifficulty swallowing	299	3%
Aphasiadifficulty with language	294	2.9%
Dysarthria	291	2.9%
Hemiplegia	288	2.9%
Rhinorrhoeaa runny nose	283	2.8%
Coordination abnormal	281	2.8%
Palpitationsawareness of the heartbeat	281	2.8%
Sensory loss	281	2.8%
Hemiparesis	280	2.8%
Affect lability	279	2.8%
Personality disorder	277	2.8%
Carotid artery thrombosis	274	2.7%
Hypertensionhigh blood pressure	271	2.7%
Eating disorder	269	2.7%
Motor dysfunction	269	2.7%
Neurologic neglect syndrome	268	2.7%
Adjustment disorder	265	2.6%
Rashskin rash	262	2.6%
Influenzaflu	261	2.6%
Off label useused for a purpose or in a way not on the label	253	2.5%
Pneumonialung infection	249	2.5%
Atrial fibrillationan irregular heart rhythm	246	2.4%
Bradycardiaslow heart rate	245	2.4%
Abdominal painstomach or belly pain	241	2.4%

Download all 875 terms of Irbesartan (CSV)

The counts add to more than 10,055 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 with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Irbesartan (this page)	Generic name	10,055
Avapro	Brand name	2,516

Sum of the separately reported names: 12,571. 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, 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	67	62	9	5	39	3	0	21	5
2005	78	75	6	10	56	5	0	19	3
2006	39	37	2	4	19	1	0	19	2
2007	115	115	12	14	76	2	1	44	0
2008	123	122	13	14	83	5	0	44	1
2009	116	116	16	6	74	8	4	39	0
2010	83	79	17	8	45	3	0	25	4
2011	170	168	30	9	100	2	0	86	2
2012	200	191	20	28	105	6	1	105	9
2013	241	173	21	12	74	16	1	83	68
2014	194	162	1	12	77	6	0	98	32
2015	222	197	7	17	86	4	1	119	25
2016	256	214	2	22	145	10	3	116	42
2017	303	255	31	13	98	3	0	172	48
2018	711	663	10	54	423	23	0	340	48
2019	1,279	1,134	64	112	728	21	1	567	145
2020	1,054	1,020	45	126	633	62	17	523	34
2021	778	746	72	100	418	42	11	456	32
2022	852	813	82	92	516	33	13	522	39
2023	941	905	91	132	543	22	13	522	36
2024	852	830	53	126	518	40	6	518	22
2025	909	886	37	150	508	79	22	645	23
2026	472	463	33	77	293	47	3	343	9

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, 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 Irbesartan, by the year in which FDA received them
Year	Reports
2004	60
2005	73
2006	47
2007	117
2008	126
2009	117
2010	83
2011	178
2012	215
2013	241
2014	196
2015	221
2016	273
2017	345
2018	786
2019	1,346
2020	1,092
2021	867
2022	824
2023	871
2024	811
2025	833
2026	332

Reports that name Irbesartan, 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
Age	Reports	Share
Under 2	31	0.3%
2 to 11	17	0.2%
12 to 17	15	0.1%
18 to 44	447	4.4%
45 to 64	1,934	19.2%
65 to 74	2,264	22.5%
75 and over	3,114	31%
Age not given	2,233	22.2%

Sex of the patient in the reports that name Irbesartan
Sex	Reports	Share
Female	4,881	48.5%
Male	3,775	37.5%
Unknown or not given	1,399	13.9%

Type of reporter in the reports that name Irbesartan
Reporter	Reports	Share
Physician	3,290	32.7%
Pharmacist	1,591	15.8%
Other health professional	2,747	27.3%
Lawyer	24	0.2%
Consumer or non-health professional	2,202	21.9%
Not given	201	2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Irbesartan record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	4,960	49.3%
Essential hypertension	87	0.9%
Cardiac failure	84	0.8%
Abdominal discomfort	73	0.7%
Blood pressure measurement	51	0.5%
Blood pressure abnormal	43	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 10,055 reports.

Drugs in the same reports

Other drugs that the reports of Irbesartan name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	586
Amlodipine	1,197
Aspirin	840
Atorvastatin	959
Bisoprolol	905
Furosemide	1,397
Hydrochlorothiazide	1,399
Metformin	1,012
Omeprazole	684
Pantoprazole	690

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

Avapro same ingredient
Filspari same class
Irbesartan and hydrochlorothiazide same class
Exforge HCT same class
Losartan same class
Exforge same class
Losartan potassium same class
Iqirvo next in the A to Z list
Ipren next in the A to Z list
Iressa next in the A to Z list
Ipratropium bromide and albuterol sulfate next in the A to Z list
Irinotecan 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 IrbesartanThe 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.

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Reported Reactions. Irbesartan: adverse event reports that FDA received. https://reportedreactions.com/drug/irbesartan/ 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 as a suspect or interacting product. The 22,504 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 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?

No. It is a count of what people reported to FDA: 10,055 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?

Physician (32.7%), other health professional (27.3%) and consumer or non-health professional (21.9%). 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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