Benicar (olmesartan medoxomil) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Olmesartan medoxomil
Class: Angiotensin 2 receptor blocker

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 8,370 adverse event reports that name Benicar. In these reports the drug is a suspect or interacting product.

In the same period, 15,804 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 79 reports in the 12 months to June 2026 and 55 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, 79 (under 0.1%) name Benicar. Reports for female patients were 24% of the reports that name Benicar and 52.7% 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 Benicar 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 35 reports that name Benicar.
In January to March 2026, FDA received 22.
In April to June 2025, FDA received 13.

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 478 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 all 8,370 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 478 terms.

Reaction terms in the reports that name Benicar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 8,370 reports
Sprue-like enteropathy	3,112	37.2%
Gastrooesophageal reflux diseaseacid reflux	1,736	20.7%
Haemorrhoids	1,306	15.6%
Acute kidney injurysudden loss of kidney function	1,284	15.3%
Hiatus hernia	926	11.1%
Weight decreasedweight loss	871	10.4%
Large intestine polyp	827	9.9%
Dizzinesslight-headedness or unsteadiness	809	9.7%
Constipation	778	9.3%
Diarrhoealoose or frequent stools	774	9.2%
Diverticulum	755	9%
Diverticulitis	729	8.7%
Diverticulum intestinal	634	7.6%
Irritable bowel syndrome	619	7.4%
Hypotensionlow blood pressure	608	7.3%
Malabsorption	562	6.7%
Coeliac disease	436	5.2%
Nauseafeeling sick	391	4.7%
Chronic kidney diseaselong-term kidney disease	385	4.6%
Drug ineffectivethe medicine did not work as expected	377	4.5%
Syncopefainting	357	4.3%
Product administration errora mistake in giving the product	306	3.7%
Blood pressure increaseda raised blood pressure reading	282	3.4%
Vomitingbeing sick	279	3.3%
Dehydration	273	3.3%
Cholelithiasisgallstones	263	3.1%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	255	3%
Gastric ulcera stomach ulcer	250	3%
Renal failurekidney failure	239	2.9%
Headachehead pain	237	2.8%
Abdominal painstomach or belly pain	233	2.8%
Anxiety	228	2.7%
Drug administration errora mistake in giving the medicine	218	2.6%
Polyp	217	2.6%
Rectal haemorrhage	211	2.5%
Depressionlow mood	209	2.5%
Hypertensionhigh blood pressure	193	2.3%
Peptic ulcer	169	2%
Gastritisinflamed stomach lining	167	2%
Gastritis erosive	166	2%
Off label useused for a purpose or in a way not on the label	151	1.8%
Dyspnoeashortness of breath	149	1.8%
Fatiguetiredness	149	1.8%
Colitis ulcerative	147	1.8%
Gastrointestinal disorder	146	1.7%
Impaired gastric emptying	142	1.7%
Anaemialow red blood cells	140	1.7%
Haematocheziablood in the stool	137	1.6%
Cholecystitis chronic	136	1.6%
Astheniaweakness or lack of energy	135	1.6%

Download all 478 terms of Benicar (CSV)

The counts add to more than 8,370 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 Olmesartan medoxomil with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Olmesartan medoxomil	Generic name	4,777
Benicar (this page)	Brand name	8,370

Sum of the separately reported names: 13,147. 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 Benicar, 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	332	24	1	1	20	0	1	4	308
2005	155	34	2	5	22	4	1	5	121
2006	47	40	1	3	26	2	0	16	7
2007	90	74	3	5	40	2	1	37	16
2008	107	85	1	8	29	2	0	62	22
2009	118	95	2	4	31	4	0	67	23
2010	198	182	8	17	96	7	0	110	16
2011	203	187	11	7	104	8	0	110	16
2012	153	128	6	3	75	4	0	73	25
2013	174	153	9	8	98	6	0	76	21
2014	143	124	6	10	70	10	1	63	19
2015	747	185	10	8	85	13	0	115	562
2016	864	337	10	1	199	4	0	185	527
2017	178	154	9	2	92	1	0	84	24
2018	2,561	2,286	26	3	1,800	6	0	1,421	275
2019	1,865	1,481	34	4	1,237	4	0	1,090	384
2020	91	39	1	2	17	2	0	29	52
2021	58	25	0	1	7	1	0	19	33
2022	62	39	4	3	22	3	0	29	23
2023	59	40	1	0	24	1	0	35	19
2024	58	41	0	7	21	1	0	35	17
2025	47	32	1	3	19	1	1	28	15
2026	60	27	0	5	17	0	0	22	33

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 Benicar, 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 Benicar, by the year in which FDA received them
Year	Reports
2004	280
2005	204
2006	45
2007	78
2008	106
2009	118
2010	195
2011	220
2012	176
2013	169
2014	169
2015	1,158
2016	1,480
2017	1,249
2018	1,745
2019	559
2020	87
2021	59
2022	60
2023	58
2024	54
2025	44
2026	57

Reports that name Benicar, 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 Benicar
Age	Reports	Share
Under 2	2	under 0.1%
2 to 11	3	under 0.1%
12 to 17	1	under 0.1%
18 to 44	130	1.6%
45 to 64	733	8.8%
65 to 74	503	6%
75 and over	444	5.3%
Age not given	6,554	78.3%

Sex of the patient in the reports that name Benicar
Sex	Reports	Share
Female	2,005	24%
Male	1,196	14.3%
Unknown or not given	5,169	61.8%

Type of reporter in the reports that name Benicar
Reporter	Reports	Share
Physician	3,500	41.8%
Pharmacist	186	2.2%
Other health professional	344	4.1%
Lawyer	849	10.1%
Consumer or non-health professional	2,727	32.6%
Not given	764	9.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 88.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Benicar record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	3,692	44.1%
Essential hypertension	69	0.8%
Blood pressure management	48	0.6%
Blood pressure measurement	42	0.5%
Blood pressure	41	0.5%
Blood pressure abnormal	33	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 8,370 reports.

Pages near this one

Olmesartan medoxomil same ingredient
Azor same class
Candesartan same class
Avapro same class
Candesartan cilexetil same class
Avalide same class
Cozaar same class
Benepali next in the A to Z list
Benicar HCT next in the A to Z list
BeneFIX next in the A to Z list
Benlysta next in the A to Z list
Benefiber W/Wheat Dextrin 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 BenicarThe 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. Benicar: adverse event reports that FDA received. https://reportedreactions.com/drug/benicar/ 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 Benicar as a suspect or interacting product. The 15,804 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 Benicar 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 Benicar?

No. It is a count of what people reported to FDA: 8,370 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 (41.8%), consumer or non-health professional (32.6%) and lawyer (10.1%). 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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