Drugs › Angiotensin converting enzyme inhibitor
Brand name · Amlodipine besylate and benazepril hydrochloride
Lotrel: adverse event reports filed with FDA
1,046 reports list it as a suspect or interacting product, 2004–2026. Class: Angiotensin converting enzyme inhibitor. Also reported as Lotrel /01289101/, Lotrel /01388302/.
- 1,046
- reports as suspect product
- 0% of all reports · about 47 a year
- 13
- reports, 12 months to June 2026
- 8 in the 12 months before
- 79.2%
- marked serious by the reporter
- 83.4% across the class
- 1.9%
- record death among outcomes, as reported
- 20 reports · not verified by FDA
Between January 2004 and June 2026, 1,046 adverse event reports received by FDA list the brand name Lotrel (amlodipine besylate and benazepril hydrochloride) as a suspect or interacting product. Reports that mention it only as a concomitant medication (7,782) are left out of every figure here.
In the 12 months to June 2026, 13 reports listed it, up 63% from 8 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 47 reports a year and 0% of the 20,646,523 reports in the database, and 1% of the reports for the angiotensin converting enzyme inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are dizziness (8.3%), angioedema (7.1%) and swollen tongue (6%). A report can list several reactions, so shares add to more than 100%; 264 different terms appear across these reports. Dizziness is recorded in 8.3% of these reports, a larger share than in the median angiotensin converting enzyme inhibitor drug (5%).
79.2% of the reports are marked serious by the reporter (83.4% across the class); 1.9% record death among the outcomes and 27.9% record hospitalisation, as reported. 35.2% of the reports came from physicians, and the largest patient age group is 45 to 64 (22.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Lotrel reports recording the termmedian drug in angiotensin converting enzyme inhibitor
- Dizzinesslight-headedness or unsteadiness8.3%87
- Angioedemadeep swelling of skin or mucous membranes7.1%74
- Swollen tongue6%63
- Coughcough5.9%62
- Blood pressure increaseda raised blood pressure reading5.4%56
- Headachehead pain5.1%53
- Angioneurotic oedema5%52
- Nauseafeeling sick5%52
- Drug hypersensitivityan allergic-type reaction to a medicine4.8%50
- Dyspnoeashortness of breath4.8%50
- Drug ineffectivethe medicine did not work as expected4.7%49
- Hypotensionlow blood pressure4.7%49
- Oedema peripheralswelling of the legs, ankles or hands4.7%49
- Swelling facea swollen face4.5%47
- Fatiguetiredness4.2%44
- Astheniaweakness or lack of energy4%42
- Vomitingbeing sick3%31
- Hypersensitivityan allergic-type reaction2.9%30
- Hypertensionhigh blood pressure2.6%27
- Rashskin rash2.6%27
- Chest painchest pain2.4%25
- Joint swellinga swollen joint2.3%24
- Lip swellingswollen lips2.3%24
- Blood creatinine increasedraised creatinine, a kidney test2.2%23
- Diarrhoealoose or frequent stools2.2%23
- Dysphagiadifficulty swallowing2.1%22
- Painpain, site not specified2.1%22
- Renal failurekidney failure2%21
- Malaisegeneral feeling of being unwell1.9%20
Top 30 of 264 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the angiotensin converting enzyme inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 102,327 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 86.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypertension | 518 | 49.5% |
| Blood pressure | 14 | 1.3% |
| Blood pressure measurement | 3 | 0.3% |
| Blood pressure increased | 2 | 0.2% |
| Ill-defined disorder | 2 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,046 reports.
In context
| Measure | Lotrel | Angiotensin converting enzyme inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,046 | 102,327 | 20,646,523 |
| Share of that pool | — | 1% | 0% |
| Reports, latest 12 months | 13 | — | 1,332,454 |
| Marked serious | 79.2% | 83.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 19 | 118 | 91 |
| Hospitalisation recorded, per 1,000 reports | 279 | 476 | 213 |
| Consumer-filed share | 34.1% | 22.6% | 45.8% |
| Top term, share of reports | Dizziness 8.3% | median 5% | 2.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the angiotensin converting enzyme inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Lisinopril | generic | 44,437 | 1,594 | 71.3% |
| Ramipril | generic | 37,202 | 2,250 | 95.6% |
| Enalapril | generic | 6,754 | 294 | 95.5% |
| Enalapril maleate | generic | 4,087 | 77 | 93.6% |
| Zestril | brand | 1,920 | 181 | 71.9% |
| Captopril | generic | 1,672 | 47 | 92.7% |
| Quinapril | generic | 1,231 | 12 | 59.7% |
| Perindopril erbumine | generic | 1,166 | 36 | 98.6% |
| Quinapril hydrochloride | generic | 941 | 19 | 89.3% |
| Benazepril hydrochloride | generic | 791 | 57 | 67.6% |
| Vasotec | brand | 558 | 2 | 70.6% |
| Lotensin | brand | 522 | 64 | 74.5% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Lotrel reports
How many adverse event reports has FDA received for Lotrel?
1,046 reports list Lotrel as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 13 of them arrived in the latest 12 months. Another 7,782 list it only as a concomitant medication.
What reactions are recorded in Lotrel reports?
dizziness (8.3%), angioedema (7.1%), swollen tongue (6%), cough (5.9%) and blood pressure inadequately controlled (5.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lotrel was responsible.
How serious are the reports?
79.2% are marked serious by the reporter. Among the outcomes recorded, 1.9% of reports include death and 27.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (35.2%), consumer or non-health professional (34.1%) and not given (12.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lotrel rising?
13 reports in the 12 months to June 2026, up 63% from 8 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lotrel was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lotrel?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Lotrel as a suspect or interacting product; reports listing it only as a concomitant medication (7,782) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.