Benicarolmesartan medoxomil
According to the FDA label: 1 INDICATIONS & USAGE Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
35,331 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Benicar in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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- Sprue-like Enteropathy 3,457 reports
Diarrhoea 2,443 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Weight Decreased 2,205 reports
Dizziness 2,084 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Gastrooesophageal Reflux Disease 2,076 reports
A condition, often called acid reflux or GERD, where stomach acid flows back into the food pipe, causing heartburn. Also spelled gastroesophageal in American English.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,017 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Acute Kidney Injury 2,000 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Drug Ineffective 1,945 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Fatigue 1,665 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Headache 1,386 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →- Haemorrhoids 1,369 reports
Dyspnoea 1,319 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Hypotension 1,301 reports
Constipation 1,300 reports
Difficulty passing stool, or having fewer bowel movements than usual.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,199 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 16,690 |
| Male | 10,902 |
| Unknown | 83 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 172 |
| 18-34 | 236 |
| 35-49 | 1,547 |
| 50-64 | 6,047 |
| 65-74 | 5,482 |
| 75+ | 5,456 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Benicar. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 14,229 |
| Hospitalization | 13,350 |
| Non-Serious | 12,156 |
| Death | 1,603 |
| Life-Threatening | 1,122 |
| Disability | 767 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Benicar. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 486 |
| 2005 | 567 |
| 2006 | 573 |
| 2007 | 776 |
| 2008 | 1,068 |
| 2009 | 1,286 |
| 2010 | 1,813 |
| 2011 | 1,743 |
| 2012 | 1,930 |
| 2013 | 1,205 |
| 2014 | 1,455 |
| 2015 | 2,878 |
| 2016 | 2,913 |
| 2017 | 3,141 |
| 2018 | 3,210 |
| 2019 | 2,113 |
| 2020 | 1,373 |
| 2021 | 1,203 |
| 2022 | 1,536 |
| 2023 | 1,437 |
| 2024 | 1,164 |
| 2025 | 1,196 |
| 2026 (partial) | 265 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Benicar
In FDA adverse event reports that mention Benicar, these medications appeared most often in the same report.
- Aspirin (4,938 reports)
- Furosemide (3,336 reports)
- Levothyroxine (2,976 reports)
- Omeprazole (2,916 reports)
- Olmesartan Medoxomil-hydrochlorothiazide (2,803 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026