Drugs › Angiotensin converting enzyme inhibitor
Generic name
Enalapril: adverse event reports filed with FDA
6,754 reports list it as a suspect or interacting product, 2004–2026. Class: Angiotensin converting enzyme inhibitor. Also reported as Enalapril 5mg, Enalapril 10mg, Enalapril /00574902/.
- 6,754
- reports as suspect product
- 0% of all reports · about 300 a year
- 294
- reports, 12 months to June 2026
- 320 in the 12 months before
- 95.5%
- marked serious by the reporter
- 83.4% across the class
- 9.7%
- record death among outcomes, as reported
- 652 reports · not verified by FDA
Between January 2004 and June 2026, 6,754 adverse event reports received by FDA list enalapril, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (30,362) are left out of every figure here.
In the 12 months to June 2026, 294 reports listed it, close to the 320 of 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 300 reports a year and 0% of the 20,646,523 reports in the database, and 6.6% 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.
Reporters most often recorded acute kidney injury (12.8%), drug interaction (11.6%) and hypotension (8%). A report can list several reactions, so shares add to more than 100%; 1,164 different terms appear across these reports. Acute kidney injury is recorded in 12.8% of these reports, a larger share than in the median angiotensin converting enzyme inhibitor drug (3.6%).
95.5% of the reports are marked serious by the reporter (83.4% across the class); 9.7% record death among the outcomes and 53.1% record hospitalisation, as reported. 37% of the reports came from other health professionals, and the largest patient age group is 75 and over (26.9%). 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 Enalapril reports recording the termmedian drug in angiotensin converting enzyme inhibitor
- Acute kidney injurysudden loss of kidney function12.8%865
- Drug interactionan interaction between medicines11.6%782
- Hypotensionlow blood pressure8%541
- Drug ineffectivethe medicine did not work as expected7.4%497
- Hyperkalaemiahigh blood potassium6.7%450
- Dyspnoeashortness of breath6.2%421
- Hypertensionhigh blood pressure5.8%390
- Angioedemadeep swelling of skin or mucous membranes5.6%378
- Hyponatraemialow blood sodium4.7%320
- Diarrhoealoose or frequent stools4.6%308
- Off label useused for a purpose or in a way not on the label4.2%286
- Nauseafeeling sick4.1%278
- Dizzinesslight-headedness or unsteadiness3.6%241
- Toxicity to various agentspoisoning or toxic effect of one or more substances3.6%240
- Cardiac failureheart failure3.5%239
- Malaisegeneral feeling of being unwell3.5%236
- Coughcough3.4%232
- Headachehead pain3.2%215
- Vomitingbeing sick3%204
- Fatiguetiredness2.8%190
- Drug hypersensitivityan allergic-type reaction to a medicine2.8%186
- Syncopefainting2.6%177
- Dehydrationdehydration2.4%164
- Renal failure acute2.4%164
- Condition aggravatedthe condition being treated got worse2.4%162
- Arthralgiajoint pain2.3%155
- Blood pressure increaseda raised blood pressure reading2.3%152
- Falla fall2.2%149
- Blood pressure decreaseda low blood pressure reading2.1%142
- Lactic acidosisa build-up of lactic acid in the blood2.1%140
Top 30 of 1,164 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. 15.1% 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 | 2,447 | 36.2% |
| Cardiac failure | 278 | 4.1% |
| Cardiac failure chronic | 74 | 1.1% |
| Cardiac failure congestive | 67 | 1% |
| Essential hypertension | 48 | 0.7% |
| Blood pressure measurement | 23 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,754 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Enalapril reports |
|---|---|---|
| Furosemide | 1,044 | 15.5% |
| Amlodipine | 772 | 11.4% |
| Metformin | 637 | 9.4% |
| Hydrochlorothiazide | 557 | 8.2% |
| Bisoprolol | 539 | 8% |
| Omeprazole | 495 | 7.3% |
| Spironolactone | 494 | 7.3% |
| Metoprolol | 472 | 7% |
| Simvastatin | 464 | 6.9% |
| Aspirin | 439 | 6.5% |
Other products listed in reports where Enalapril is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Enalapril | Angiotensin converting enzyme inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 6,754 | 102,327 | 20,646,523 |
| Share of that pool | — | 6.6% | 0% |
| Reports, latest 12 months | 294 | — | 1,332,454 |
| Marked serious | 95.5% | 83.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 97 | 118 | 91 |
| Hospitalisation recorded, per 1,000 reports | 531 | 476 | 213 |
| Consumer-filed share | 15.6% | 22.6% | 45.8% |
| Top term, share of reports | Acute kidney injury 12.8% | median 3.6% | 0.7% |
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 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% |
| Lotrel | brand | 1,046 | 13 | 79.2% |
| 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 Enalapril reports
How many adverse event reports has FDA received for Enalapril?
6,754 reports list Enalapril as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 294 of them arrived in the latest 12 months. Another 30,362 list it only as a concomitant medication.
What reactions are recorded in Enalapril reports?
acute kidney injury (12.8%), drug interaction (11.6%), hypotension (8%), drug ineffective (7.4%) and hyperkalaemia (6.7%). 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 Enalapril was responsible.
How serious are the reports?
95.5% are marked serious by the reporter. Among the outcomes recorded, 9.7% of reports include death and 53.1% 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?
other health professional (37%), physician (35.2%) and consumer or non-health professional (15.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Enalapril rising?
294 reports in the 12 months to June 2026, close to the 320 of 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 Enalapril 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 Enalapril?
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 Enalapril as a suspect or interacting product; reports listing it only as a concomitant medication (30,362) 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.