Lotrelamlodipine + benazepril
9,154 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Lotrel 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.
Show these terms with plain-language definitions
Tap any term below for a plain-language definition.
Nausea 620 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Fatigue 532 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 524 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 →Dizziness 480 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 454 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 →Dyspnoea 426 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Headache 416 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pain 400 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Asthenia 385 reports
Physical weakness or lack of strength.
Full definition in the glossary →Myocardial Infarction 352 reports
The medical term for a heart attack.
Full definition in the glossary →Renal Failure 322 reports
A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Full definition in the glossary →Hypertension 319 reports
Vomiting 308 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Cerebrovascular Accident 307 reports
The medical term for a stroke, which happens when blood flow to part of the brain is interrupted.
Full definition in the glossary →Cardiac Failure Congestive 305 reports
A form of heart failure, often called congestive heart failure, where the heart cannot pump blood as well as it should, leading to fluid buildup.
Full definition in the glossary →
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 | 5,000 |
| Male | 3,911 |
| Unknown | 13 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 13 |
| 18-34 | 89 |
| 35-49 | 706 |
| 50-64 | 2,093 |
| 65-74 | 1,598 |
| 75+ | 1,213 |
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 Lotrel. 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 |
|---|---|
| Non-Serious | 3,663 |
| Other Serious | 3,395 |
| Hospitalization | 2,785 |
| Death | 611 |
| Disability | 292 |
| Life-Threatening | 259 |
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 Lotrel. 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 | 470 |
| 2005 | 635 |
| 2006 | 699 |
| 2007 | 695 |
| 2008 | 554 |
| 2009 | 589 |
| 2010 | 779 |
| 2011 | 609 |
| 2012 | 483 |
| 2013 | 347 |
| 2014 | 548 |
| 2015 | 480 |
| 2016 | 483 |
| 2017 | 321 |
| 2018 | 379 |
| 2019 | 318 |
| 2020 | 182 |
| 2021 | 140 |
| 2022 | 116 |
| 2023 | 100 |
| 2024 | 111 |
| 2025 | 102 |
| 2026 (partial) | 14 |
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 Lotrel
In FDA adverse event reports that mention Lotrel, these medications appeared most often in the same report.
- Aspirin (1,831 reports)
- Atorvastatin (1,207 reports)
- Furosemide (1,059 reports)
- Levothyroxine (931 reports)
- Omeprazole (915 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